€¦ · 2014-12-11 · 1 Minutes for 246th Meeting of Registration Board held on 10-11th...
Transcript of €¦ · 2014-12-11 · 1 Minutes for 246th Meeting of Registration Board held on 10-11th...
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Minutes for 246th
Meeting of Registration Board held on
10-11th
December, 2014.
Item No. Detail of Item
Item No.I Confirmation of minutes of 245th
meeting Registration Board
Item No.II Agenda points referred by Members, Registration Board
Item No.III Cases for conduction of Clinical Trials – Pharmacy Services Division
Item No.IV Matters referred for deliberation by Registration Board
Item No.V Registration of drugs - Pharmaceutical Evaluation Cell
Item No.VI Miscellaneous cases - Pharmaceutical Evaluation & Registration Division
Item No.VII Registration of Biological Drugs – Biological Evaluation & Research
Division
Item No.VIII Quality Control Cases – Quality Assurance & Lab Testing Division
Item No.IX Registration of Medical Devices – Medical Devices Division
Item No.X Local Manufacturing of Biological Drugs.
Item No.XI Applications for transfer of registrations
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246th
meeting of Registration Board was held on 10-11th
December, 2014 in the
Committee Room, M/o National Health Regulation Services and Coordination, Islamabad. The
meeting was chaired by Mr. Ghulam Rasool Dutani, Director, Pharmaceutical Evaluation &
Registration Division. The meeting started with the recitation of Holy Verses. The meeting was
attended by the following:-
1. Lt General (R) Karamat Ahmed Karamat.
Member
2. Prof.Dr.Rafi uz Zaman Saeedul Haq
Assocaite Dean, Faculty of Pharmacy, University of
Lahore, Islamabad
Member
3. Brig (R). Dr. Muzammil Hasan Najmi,
Associate Dean, Basic Sciences Division,
Foundation Medical University, Rawalpindi.
awalpindi.
Member
4. Brig.Dr.Aslam Khan,
Professor of Medicine, Military Hospital Rawalpindi.
Member
5. Dr. Muhammad Arshad,
President, Pakistan Veterinary Medical Council
Member
6. Abdul Razak
Director Drugs Testing Laboratory
Government of Sind, Karachi.
Member
7. Dr.Muhammad Khalid Khan
Director Drugs Testing Laboratory
Government of Khyber Pakhtunkhwa, Peshawar.
Member
8. Dr.Amanullah Khan
Director Drugs Testing Laboratory
Government of Baluchistan, Quetta.
Member
9. Shaikh Ansar Ahmad
Director Biological Drugs, DRAP
Member
10. Dr.Noor Muhammad Shah
Director MD&MC, DRAP
Member
11. A.Q.Javed Iqbal
Director QA <, DRAP
Member
12. Dr. Obaidullah, Deputy Director General (Reg.I). Secretary/Member
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Dr. Muhammad Arshad did not attend the meeting on 10.12.2014 and Dr. Muhammad
Khalid Khan did not attend the meeting on 11.12.2014. Both days, meeting started at 09:30 AM
and continued till 08:00 PM.
Dr.Masud ur Rehman DDG (Biological), Dr. Abdur Rasheed DDG (Pharmacovigilance),
Dr. Tariq Siddique (DDG R.II), Muhammad Arif (DDC R.I), Muhammad Amin (DDC R.V),
Babar Khan (Incharge, PEC), Muneeb Ahmad Cheema ADC (PEC), Ammad Zaka ADC (PEC),
Atiq ul Bari ADC (PEC), Tehreem Sara (DDC MD&MC), Asif Jalil (ADC MD&MC) and
Khalid Mehmood (DDC QC) assisted relevant Directors and Secretary of the Board with agenda.
Mr.Shamim Ahmad and Abuzar Faizy, Mr.Nadeem Alamgeer and Muhammad Farooq
Memon attended the meeting as observer on behalf of PPMA, Pharma Beauru and PCDA
respectively.
In addition to routine agenda, the Board discussed and decided various other matters, as
follows:
1. In future agenda will be circulated about 07 days before the meeting.
2. Registration Board deliberated on agenda point referred by Director DTL, Quetta
regarding attending the meeting by observers (PPMA, Pharma Bureau and PCDA). The
Board decided that respective observer will leave the meeting by ownself, when agenda
related to its company will be discussed. All observers also consented to the decision
3. Registration Board authorized its Chairman for grant of registration for export purpose on
contract manufacturing basis excluding controlled drugs and new drug as per contract
manufacting policy.
4. Dr.Aslam Khan Director Malaria Control Program and Dr.Qutub-ud-Din Kakar, WHO
National Professional Officer briefed the Board about irrational use of antimalarial drugs
in the country particularly injectable anti-malarial therapy and development of emerging
artemisinin resistance. Keeping in view briefing by experts, Registration Board decided
that Malaria Control Program will hold a consultative meeting of all the stakeholders
including DRAP, prescribers, provincial governments, pharmaceutical manufacturers etc
for framing recommendations on the matter.
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5. Registration Board discuused comments of its members, stakeholders and international
practices and agreed that for all topical preparations viz. eye / ear preparations, external
preparations (cream / ointment / gel / lotion / spary) and aerosols, steroid manufacturing
may be permitted on campaign manufacturing basis in general manufacturing areas for
these dosage forms provided that manufacturer has segregated dispensing booths,
validation and controls studies for processes and adequate system to minimize any
potential risk of cross contamination. Registration Board decided to forward above
recommendation to Licensing Division for ultimate decision by Central Licensing Board.
6. Registration Board deliberated on the storage requirement for Misoprostol and keeping in
view EMA’s assessment report decided that Misoprostol 1% HMPC dispersion
(processed material) will be permitted for use in tablet dosage form with storage
condition of 5+3 °C.
7. Registration Board discussed matter regarding non-availability of finished drugs in
country of origin and advised stake holders (PPMA, Pharma Bureau and PCDA) to
forward their comments till 15.01.2015 to already constituted committee for framing its
recommendations for considerartion by Registration Board.
8. Registration Board advised stake holders (PPMA, Pharma Bureau and PCDA) to forward
their comments on case of re-registration of drugs till 15.01.2015 for considerartion by
Registration Board.
9. While discussing case for grant of registration for export purpose, Mr.A Q Javed Iqbal,
Director QA < opined that for export purpose only those formulations should be
registered, which are already registered in Pakistan. For new fornulations (which are not
registered in Pakistan), manufacturers should first conduct stability studies and then
registration for export purpose be granted. Prof. Muzammil H Najmi also endorsed it.
Registration Board after deliberation decided that inorder to facilitate export of quality
drugs (non-me too drugs), export registration will be granted and manufacturer will
comply following conditions before export of drug:
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Manufacturer will export the product after complying all the conditions as required under
Drug Act, 1976 including No objection certificate from concerned DRAP office.
Moreover, Federal Inspector of drugs will take sample from each consignemnet for
analysis from CDL, Karachi.
Manufacturer will also furnish export documents endorsed from custom authorities in
order to ensure the export of the product.
These conditions will also be applicable to products approved for exports
(Sofosbuvir) by Chairman, registration Board.
10. Chairman again advised all members, PPMA and Pharma Bureau to forward their
scientific comments and relevant references on manufacturing requirements till
15.01.2015 for following classes of drugs:
a. Immunosuppresants.
b. Clomiphene and letrozole
c. Prostaglandins and its analogues.
d. Vancomycin
11. On the direction of the Honorable Ombudsman, the case for local manufacturing of
biological drugs was re-examined by Registration Board. Representatives of local
manufacturers (Hilton, Getz, Nextar and Macter) were also heard and the Board then
decided the matter in light of directions of Ombudsman.
12. Registration Board discussed the matter regarding issuance of registration letter of
products for which product specific inspections have been conducted and recommended
by the panel of inspectors or cases where product specific inspections are not required /
exempted as per Import Policy for Finished Drugs. The Board authorized its Chairman
for issuance of registration letter in both aforementioned cases. In cases where there is
any ambiguity in inspection reports or products not recommended by panel of inspectors
then such cases will be placed before Regisrtration Board for decision.
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Item No I: Confirmation of minutes of 245th
meeting Registration Board.
245th
meeting of Registration Board was held on 28-29th
September, 2014 and minutes
were circulated to all members through e-mail. Two members forwarded following comments, as
follows:
Dr. Amanullah Khan (Director, DTL, Quetta):
Agenda Item No II:
The following comments may be added as discussed in the 245th Registration Board Meeting regarding
Registration of Sofosbuvier which is very important drug and very badly required for the country man.
“The stability study shall be conducted by the manufacturer and accordingly stability data must be
submitted to the Registration Board before the launch of their product into the market, my point is this
that registration may be granted to the firms with the undertaking that they will provide stability study
before the launch of their product into the market as per previous practice.”
Case No. 50. Cases deferred by Registration Board.
M/s Ideal Pharma, Lahore- Product Specific Inspection-
There is typographic error and needs correction for record purpose, the inspection for product specific
inspection was carried out by two members only that is Director DTL, Quetta and area FID.
Mr.A.Q.Javed Iqbal, Director QA & LT, DRAP.
g. Import of raw materials for experimental purpose and stability studies etc.
Director QA stated that any such Import for trial batch is not discouraged subject to meet all
codal formalities required for the production of commercial batch as per defined policy
Item No.VII: Miscellenous cases. Case No.15. Change in company name from M/s.
Bayer Schering Pharma AG to M/s. Bayer Pharma AG.
Company also informed that German authorities have confirmed the GMP of manufacturer of this
product & product is available in Switzerland and UK which is part of EMA/ SRA.
Minutes were approved after incorporation of above points.
Registration Board in 245th meeting discussed and approved following case but erroneously
decision was not recorded in minutes. However, later on Chairman, Registration Board approved
correction in minutes as decided by the Board.
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Case No.30 Registration of Drugs for export purpose-Not me too Drugs.
Following firms have requested for registration of following drugs for export purpose
only which are not me-too. Details are as under:-
S.
No.
Name of
Company
Name of product(s) Date of application,
Diary No. & Form
1. M/s
PharmEvo
Karachi
Procoxam Forte 1500mg
Tablet
Each tablet contains:-
Glucosamine HCl ....1500mg
13-05-2014
688
Rs.20,000/-
2. -do- Procoxam 625mg Tablet
Each tablet contains:-
Glucosamine HCl …..625mg
13-05-2014
686
Rs.20,000/-
3. M/s
Medisure
Labs,
Karachi
Calvita Syrup
Each 5ml contains:-
Calcium lacatate
Gluconate…………..40mg
Vitamin A ………….1200IU
Vitamin D3 ………….100IU
Vitamin B1 HCl …….1mg
Vitamin B2 5-sodium
phosphate …….. …….1mg
Vitamin B5 HCl.. …0.5mg
Nicotinamide ………..5mg
Dexpanthenol ……….2mg
Vitamin C…….. …….50mg
Vitamin E acetate ……1mg
15-04-2014
668
Rs.20,000/-
4. M/s
Kaizen
Pharma,
Karachi
Vitacal Syrup
Calcium lacatate
Gluconate…………..40mg
Vitamin A ………….1200IU
Vitamin D3 ………….100IU
Vitamin B1 HCl …….1mg
Vitamin B2 5-sodium
phosphate …….. …….1mg
Vitamin B5 HCl.. …0.5mg
Nicotinamide ………..5mg
Dexpanthenol ……….2mg
Vitamin C…….. …….50mg
Vitamin E acetate ……1mg
26-06-2014
701
Rs.20,000/-
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5. M/s
Genix
Pharma,
Karachi
Apitonic Syrup
Each 5ml contains:-
Cyproheptadine HCl
(anhydrous) BP ……..2mg
Thiamine HCl (B-1) ...2mg
Riboflavin BP (as 5-
phosphate sodium)…2mg
Pyridoxine HCl ….0.75mg
D-Panthenol BP ….2.5mg
Nicotinamide BP ….22.5mg
27-08-2014
719
Rs.20,000/-
6. -do- Calceg Injection 100mg/ml
Each ml contains:-
Calcium gluconate
(10%)……. …….10mg
27-08-2014
720
Rs.20,000/-
7. -do- Tyca Tablet 90
Each tablet contains:-
Ticagrelor ………90mg
27-08-2014
726
Rs.20,000/-
Decision: Registration Board approved minutes of 245th
meeting with above correction
/ amendment in already approved minutes.
Item No II: Agenda points referred by Members, Registration Board.
Dr. Amanullah Khan, Director DTL, Quetta:
a. PPMA Representation from North zone.
Reference to the above , it is submitted that for the last few DRB Meetings it is observed
that PPMA from North Zone/Region nominates that member for to attend the DRB Meetings
whose case is part of the agenda and in my opinion its a matter of conflict of interest. Therefore
it is requested that in the forthcoming meeting of DRB , this matter may be placed as agenda
item before the DRB and take decision whether such conflict of interest nomination may be
allowed or otherwise. Furthermore it is expected that PPMA from both the regions may
nominate(s) a member for DRB for a specified period.
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Decision: Registration Board deliberated on the point and it was decided that
respective observer will leave the meeting by ownself, when agenda related to its company
will be discussed. All observers also consented to the decision.
b. Registration of drugs under Drugs Act, 1976.
Reference DRAP letter No. F.1-20/2000-Reg-I(Pt) dated 23rd April 2014 on the subject cited
above, in this regard it is submitted that DRAP has constituted a panel to carryout inspection
abroad at Argentina, the panel comprised of the following officials,
(I) Dr. Amanullah Khan, Director Drugs Testing Laboratory Government of
Balochistan, Quetta/ Member Drug Registration Board DRAP.
(II) Ms Sara Naeem, Assistant Drugs Controller, DRAP Lahore.
As per said letter there were four (04) importers / firms who have requested for the
import of their products from Argentina and accordingly on the request of the importers/firms the
panel was constituted to carry out inspections of their Principals abroad for the purpose of
registration of drugs under Drugs Act, 1976. The following is the list of firms/importers who had
requested for registration of drugs under the Drugs Act 1976.
i. M/s Pine International Lahore.
ii. M/s Atco Pharma International (Pvt) Ltd Karachi.
iii. M/s Oncogene Pharmaceuticals Karachi.
iv. M/s Nawab Sons, Karachi.
As per procedure of the DRAP the letter for inspection is issued only when all the
prerequisite documents/information for the Registration of the Drugs is completed and
accordingly the said letter is also issued on the same grounds by the competent authority,
however regret to mention that M/s Pine International Lahore has declined to carryout
inspection of their Principal abroad so there is need that the Firm has to clear their position and
explain their position for refusing inspection abroad and why action may not be taken against
them in wasting the time of the officials/inspectors and by enlarge of the DRAP.
Regret to mention that M/s Oncogene Pharmaceuticals Karachi as per DRAP, changed
their principal without approval from the DRAP which is not accepted ethically and officially.
They kept the inspection in grey and at any stage never accepted their mistake of change of
Principal and ultimately on 16th October 2014 the coordinator of the inspection team from Atco
Pharma has forwarded an e-mail from Mr Zubair Khalil owner of M/s Oncogene
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Pharmaceuticals Karachi, and explained that DRAP has refused our request for change of
Principal and further added that i will be obliged if Atco Pharma etc takes my case to DRAP for
not carryout inspection abroad. As a Member Drug Registration Board i am not comfortable with
such offensive statement issued from M/s Oncogene Pharmaceuticals Karachi and there is need
to ask them explain their position on such offended statement.
M/s Atco Pharma International (Pvt) Ltd Karachi and M/s Nawab Sons, Karachi also
declined to carry out their inspection abroad by giving no reason.
Keeping in view an exercise of more than six months wherein the Inspectors from time to
time has to reschedule their official activities for the purpose to carryout inspection abroad
smoothly , but regret to say that the inspectors have been kept in dark by the firms/importers and
there was nobody who could come up with truth that we are not in position to carryout
inspection , as from the beginning it was apparent that the importers/firms were not interested to
carryout inspection abroad and it was also apparent that among the firms/importers blame game
has started which was not a good sign for inspection.
I would like that the case may be kept as Agenda Point in the forthcoming meeting of
DRB and a decision may be taken against the firm/importers who are responsible for this Act.
The cases may be dealt as per Drug Act and as per Policy of DRAP to stop such practices in
future and the offenders may be treated as per policy/Drug Act and I also request for the
cancellation of their requested products.
Decision: Registration Board advised pharmaceutical Evaluation & Registration
Division to present update status of these cases in its forthcoming meeting.
Mr.A.Q.Javed Iqbal, Director QA & LT, DRAP.
c. This point should be brought into discussion of next meeting that Board should define
uniform guidelines to scrutinize variations if it is related to API / quality of Drug substance in
light of ICH guidelines (Q 8, Q9 & Q10) for all originators and for generic products as well.
Moreover the all respective change should be assessed under the scope of applied variations.
Decision: Registration Board discussed the matter and it was decided that QA & LT
Division will develop guidelines for this purpose in consultation with PPMA and Pharma
Bureau.
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Item No.III Cases for conduction of Clinical Trials – Pharmacy Services Division
Case No.01. Polio End-game strategies-Poliovirus Type 2 challenge study. A Five Arm
Community Based Randomized Trial, Karachi. Pakistan.
Aga Khan University has applied for the clinical trial to be conducted in collaboration
with WHO in assistance with EPI Programme.
The key feature of the trial is as under:
Title Polio End-game strategies-Poliovirus Type 2 challenge study. A Five Arm
Community Based Randomized Trial, Karachi. Pakistan.
Phase III
Background Polio disease is present in only three countries including Pakistan. Since the
injectable polio vaccine has better results, WHO “Polio Endgame Strategy ”
is to slowly withdraw the current vaccines replace all oral polio vaccine with
injectable polio vaccine.
Objective The over all purpose of this study is to compare the suggested five different
polio vaccine strategies to see which produces the best immunity for Pakistani
Children and prevents the spread of polio.
Participating
Country/Sites.
Pakistan
Outreach Primary clinics in Karachi at Rehri Goth, Ali Akber Shah Goth,
Ibrahim Hyderi and Bhains Colony.
Number of
participants
1000 children each study group (arm) will have 200 children.
Duration of
Trial.
One year (June 2014-15)
Study
Interventions. Oral Bivalent vaccine – Available from EPI
Oral Trivalent Vaccine – Available from EPI
Inactivated Polio Vaccine (IPV) – To be imported
Inactivated Polio Vaccine2 (IPV2) – To be imported
Oral Monovalent Vaccine2 (mOPV2) – To be imported at a later stage
in the study. An amendment and request will be sent to DRA at that
time.
Study
Outcomes To determine which vaccine best protects the children from polio
Quantity of
Drug to be
Imported.
IPV= 1510 Doses
IPV= 230 Doses
Other vaccines are already registered and standard of care. These will
be purchased from EPI.
Registration
Status of drugs
in Pakistan.
Oral Bivalent, trivalent polio vaccine is provided to EPI by WHO.
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Monitor of the
Trial. Dr. Maha Mohamed Saadeldine Salama
Head Clinical Research Sector/VACSERA, Cairo Egypt.
Sponsor World Health Organization (Geneva)
Bilthoven Biologicals BV (BBIO) has been a manufacturer of IPV and monovalent bulk
components since 1994. The company has now developed an investigational monovalent high
dose inactivated poliovirus vaccine (m-IPV2 HD) in alignment with the Global Polio Eradication
Initiative (GPEI) and World Health Organization (WHO)’s strategic advisory group of experts
(SAGE) recommendation for the eradication of polio. The m-IPV2 HD vaccine contains 32 D-
antigen (D-Ag) units of inactivated type 2 poliovirus, which is four times the current dose of type
2 polioviirus in the trivalent inactivated poliovirus vaccine (t-IPV). This high dose of antigen
should permit the one step immunization of children against type 2 polioviirus while avoiding
the safety issues associated with the attenuated type 2 poliovirus used in the oral poliovirus
vaccine (OPV).
Bulk virus was initially produced in monkey kidney cells and is now produced in Vero
cell line. Full nonclinical toxicology testing was performed on the trivalent polio vaccine.
Manufactured using bulk viruses produced in monkey kidney cells. Extensive clinical data were
also obtained for this formulation. When production of IPV was switched from sub cultured
monkey kidney cells to Vero cells, a limited number of preclinical and clinical studies were
conducted to compare the safety and the efficacy of IPV produced in Vero cells (IPV-Vero) to
the safety and the efficacy of IPV produced in subculture monkey kidney cells (IPV-MK). A
nonclinical toxicology study in rats showed no unexpected toxicological findings.
There are currently no clinical data with the m-IPV-HD. However, clinical studies
showed that t-IPV-Vero is a safe, well-tolerated vaccine that induces as effective immune
response similar to that of IPV-MK. The safety and effectiveness of IPV-Vero is further
supported by post-marketing surveillance bases on a 15-year follow-up of more than 90 million
IPV-Vero vaccine doses distributed worldwide in close to 60 countries.
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As per procedure in vogue the submitted trial was referred to three experts for expert
opinion to facilitate the decision making process by the Registration Board. The same is
summarized as under:
S.No. Expert Name Opinion
1. Syed Sohail Zahoor
Zaidi, Chief Scientist
(Virology) Head of
Department of Virology
It is hereby informed that the subject study is well planned to
determine the improved effect of vaccination with combined
formulations i.e bivalent OPV + IPV vaccines to fill-in the
gaps in immunity type 2 polioviruses among Pakistani
Children.
The study will be conducted with the financial and technical
support of WHO Head Quarters, Geneva and does not pose
any apparent burden on the GoP/National or international stake
holders providing assistance for the Polio Eradication program
in the country.
I hope that the findings and outcomes of this interventional
study will improve our understanding and help to devise
progressive recommendations for vaccination to achieve the
goal of Polio eradication.
2. Mr.Mazharullah
Memon, Principal
Scientific
Officer/Manager
Quality Control
Laboratory.
The five arms plan for End Game Polio Virus, the pattern of
dosing as described are suitable for the subject study and the
subject clinical trial is suggested in my opinion and there is no
financial burden on the Government of Pakistan.
3. Dr. Haider Sherazi,
Neonatology, PIMS,
Islamabad.
Comments are still awaited in spite of reminders
The institution has also requested for import of the following trial material to supplied by the WHO
through EPI:
Drug Name Quantity required
Inj IPV 1510 Doses
Inj IPV2 230 Doses
Decision: Registration Board discussed trial for its all prons and cons keeping in view
the prevalence of polio in the country. Dr.Abdur Rasheed, DDG (Pharmacovigilance)
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informed that Dr. Haider Sherazi has also given his expert views in favor of the trial.
However, after thorough deliberation the Board deferred the case for presentation by
Principal Investigator of the trial.
Case No.02. Phase III (b) Clinical Trial for use of Buprenorphine for treatment and
detoxification of injectable drug users in Pakistan.
Pakistan is signatory to the Millennium Development Goals (MDGs). Goal 6 state that
Pakistan will halt and begin to reverse the spread of HIV/AIDs Globally the most
recommendation intervention to halt the spread of HIV/AIDs infections among the group of
injectable drug users is Buprenorphine which is being used by the drug users for Detoxification,
treatment or at lease substitute the other injectable drugs with oral dosage form.
National AIDs Control Programme, Ministry of National Health Services, Regulation &
Coordination Islamabad has submitted a project proposal to the subject cited above. It is
hypothesized that Buprenorphine has challenges of misuse considering the non regulated
environment if produced and made available in higher doses.. Safety, as reflected by Adverse
Events (AEs) and severe Adverse Events (SAEs), withdrawal severity, stabilization dose and
treatment retention during the study will also be explored.
This is an open-label study, 1,000 (One Thousand) IDU’s seeking treatment for opiate
dependence will be enrolled in 5 centers across Pakistan. Participants are expected to be
predominantly males and non-pregnant and non-lactating females who are at least 18 years-of-
age at the time of enrollment. Following screening, there will be a 28 day stabilization period on
Buprenorphine. All participants will be inducted onto the drug over a period of 3 days with doses
not to exceed 8mg on the first day, 12 mg on the second day and 16mg of third day. Until the end
of the third week doses may be adjusted in 4 or 8mg increments to a total dose of 8, 16, 24mg
based on clinical need, as judged by the treating physician/investigator. The duration of study
participation for each participant will be a maximum of approximately 6 months, including
screening, stabilization, tapering, post-tapering and follow-up, results from this study will add to
the knowledge bases of the clinical use of Buprenorphine in Pakistani population and provide
clinicians/regulatory bodies with data to guide the process of Buprenorphine treatment.
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Principal investigator has submitted ethical approval issued by the National Bioethics
Committee (NBC Pakistan) on 5.11.2014. The trial material is proposed to be arranged from two
following sources if approved by the Registration Board:-
S.No Name of Firms 2mg tablets 8mg tablets
1. M/s. Valor Pharmaceutical, Islamabad 1,80,000 tabs 1,80,000 tabs
2. M/s. Wilshire Labs, Lahore 1,80,000 tabs 1,80,000 tabs
Decision: Dr.Basir Achakzai, Director National AIDS Control Programme and his
team presented in detail background of the case with special refrenece to Pakistan scenario.
The Board also discussed that internationally such therapies are available in combination
with Naloxone for patients admitted in hospital. After detailed deliberation, registration
Board deferred the case dor following:
National AIDs Control Programme will revise its protocol in line With International
Best Practices recommended / adopted for this purpose.
Pharmacy Services Division, DRAP will forward revised protocols to Narcotic
Control Division anf following expert for their views:
o Prof.Dr.Rizwan Taj, PIMS, Islamabad.
o Maj.Gen.Saleem Jehangeer, AFIMH, Pawalpindi.
o Prof.Dr.Ghulam Rasool, Quetta.
Item No.IV Matters referred for deliberation by Registration Board
a. Comments of Director Malaria Control, Islamabad regarding injectable anti-
malarial therapy.
Registration Board in 245th
meeting discussed following comments of Director Malaria
Control, Islamabad.
“The matter has been discussed with the National Professional Officer, MCE, WHO Pakisan
and technical team of this Directorate. Due to emerging Artemisinin resistance in the South East
Asia, which also threatened Pakistan, because of uncontrolled / irrational use of parental
Artemisinin Monotherapy derivatives including Artemether in uncomplicated P. Falciparium
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case and also in clinical Malaria cases by the unregulated Private Sector. During the recent 6th
Inter Country Meeting of National Malaria Control Managers held at Cairo, Egypt on 13th
– 14th
August, 2014 WHO EMRO Region showed their serious concern on production of Artemisinin
monotherapy and injectable chloroquine in Pakistan. According to the approved National Anti-
Malaria Drug Policy only Injection Artesunate is recommended for confirmed severe
Falciparium Malaria cases in hospital settings and as pre-referral treatment in RHCs /BHUs.
Directorate of Malaria Control intends to convene a meeting with Drug Regulatory Authority of
Pakistan along-with other stake holders to share the views on emerging artemisinin resistance
and irrational use of antimalarial drugs in the country. It is also requested to halt further
registration Antimalarial Drugs”.
Registration Board in 245th
meeting deferred all injectable anti-malarial drugs and invited
Director Malaria Control, Islamabad in forthcoming meeting for detailed discussion.
Discussion: Dr.Aslam Khan Director Malaria Control Program and Dr.Qutub-ud-Din Kakar,
WHO National Professional Officer briefed the Board about irrational use of antimalarial drugs
in the country particularly injectable anti-malarial therapy and development of emerging
artemisinin resistance. Crux of the briefing is as follows:
a. Resistance to antimalarial drugs is the biggest challenge to malaria control in the country
resulting from “increased drug pressure” due to irrational use of antimalarial drugs
particularly the “monotherapies”.
b. Malaria is re-emerging due to “failure” of control interventions particularly the low coverage
of “effective treatment” and vector control.
c. Effective treatment is the “Foundation stone” of malaria control today which is dependent on
correct lab diagnosis and effective medicines. Effective treatment is the most effective tool to
reduce transmission potential due to reduction in parasite reservoir in human hosts.
d. Malaria Control programmes have been left with limited choices of treatment for confirmed
cases and there has been no development made in the development of new effective and safe
drugs in near future. This calls for rational and restricted use of available regimens where the
mainstay of treatment is Artemesinin Combination Therapies.
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e. In Pakistan the positivity rate in suspected cases has been lower than 5% in highly endemic
areas and <1% in low endemic province of Punjab, treatment of malaria cases on clinical
grounds is mostly wrong in 98% of suspected cases, which is the major reason of misuse of
these drugs. No antimalarial drug should be dispensed in Pakistan without confirmatory test,
is the national policy and promotion of produced “anti-malarial” molecules by the industry
has led to the indiscriminate prescriptions by the untrained physicians, paramedics and
kwakes.
f. As per policy injectable quinine and Artesunate only can be sued in the treatment of
complicated and severe malaria cases, which are only seen in a fraction malaria cases due to
falciparum species only. The total estimated number of confirmed cased due to falciparum
malaria in the country are not >200,000 cases and the number of true severe malaria cases
will not be more than 20,000 warranting treatment with injectable quinine and Artesunate.
g. Treatment of severe cases of malaria is a medical emergency requiring intravenous
medication with above mentioned drugs and can only be dealt in at Secondary or tertiary care
hospitals only.
h. Huge quantities of Artesunate injections have been provided by the Global Fund from WHO
Pre-Qualified manufacturer (Guillin Pharma) sufficient to cover all the country needs of
dealing with severe cases.
i. Resistance is rapidly developing against artemisinin group and within short time the care
delivery system will be unable to treat the complicated cases at hospitals.
Decision: Registration Board appreciated the concern raised during the briefing. It
was then decided that Malaria Control Program will hold a consultative meeting of all the
stakeholders including DRAP, prescribers, provincial governments, pharmaceutical
manufacturers etc for framing recommendations on the matter.
18
b. Transfer of registered drugs.
Under Rule 27 of Drugs (Licensing, Registering & Advertisement) Rules 1976, a
certificate for registration is issued for a period of five years unless earlier suspended or
cancelled. As per practice in vogue, if a firm applies for transfer of registration, such cases are
transferred according to the following provisions incorporated in schedule F vide SRO
877(I)/2000 dated 09th
December, 2000:-
An application for:-
(i) transfer of registration from one importer or manufacturer to another,
(ii) transfer from import to local manufacture,
(iii) import in bulk and repacking locally, and
(iv) change of name of registered drug, shall be considered as for grant of a new
registration and shall be made as per rule 26(1).
Registration Board in its 240th
meeting also approved the following SOPs to stream line
the transfer of registrations and delegated its powers to the Chairman Registration Board to
approve such cases:-
Transfer of registration:
i) With change in manufacturing site:
a. Application with Form-5 and required fee as per relevant SRO.
b. Copy of registration letter and renewal status.
c. NOC for CRF clearance.
d. Copy of approved section by Central Licensing Board.
e. Copy of last inspection report.
f. NOC from existing manufacturer / registration holder permitting for transfer of
product.
g. Statement / undertaking that applicant do not have registration of same products.
If so, it has to apply for cancellation of product.
h. Accelerated stability studies of 6 months with to conduct real time stability
studies up to assigned shelf life & report if any result falls outside shelf life
specifications with proposed action).
i. Validated method of analysis, master formula and product development data
ii) Change in name / title of manufacturer (site of manufacturing remains the same)
a. Application on Form-5 with required fee as per relevant SRO.
b. Copy of registration letter and renewal status.
c. NOC for CRF clearance.
d. Approval of new name / title from CLB.
19
e. Undertaking that the formulation, API source & Specifications, manufacturing
process, analytical test methods, release & shelf life specifications have not
changed.
However, schedule F was amended as per SRO 1117(I)/2012 dated 10th
September, 2012
and above provisions defined for transfer of registration vide SRO 877(I)/2000 dated 09th
December, 2000 have been omitted now.
In view of above, directions /guidance of Registration Board is solicited to process cases
of transfer of registration of drugs.
Decision: Registration Board deliberated on the matter and it was decided that
following procedure will be adopted for these cases.
Registration will be cancelled from name of existing registration holder. The
applicant will comply all requiremenrs for grant of registration and then
registration Board will decide the case for grant of registration keeping in view
safety, efficacy and quality parameters.
For imported drugs, Import Policy for Finished Drugs will be followed.
A reference will be sent to Cost & Pricing Division whether such cases for grant of
registration shall be considered at existing MRP or otherwise.
Cases will be divided into any of following category and requisite documents will be
as follows:
o Registration of drug for local manufacturing.
a. Application with Form-5 and required fee as per relevant SRO.
b. Copy of registration letter and renewal status.
c. NOC for CRF clearance.
d. Copy of approved section by Central Licensing Board.
e. Copy of last inspection report.
f. NOC from existing manufacturer / registration holder permitting for cancellation
of product from its name and grant to new registration holder / manufacturer.
g. Statement / undertaking that applicant do not have registration of same products.
If so, it has to apply for cancellation of product.
20
o Registration of drug for import (Change of authorized agent in Pakistan only).
a. Application on Form 5A with required fee as per relevant SRO.
b. Copy of registration letter and last renewal status.
c. Notorized termination letter (original) from manufacturer for previous importer.
d. Notorized authority letter/sole agent letter (original) from manufacturer.
e. NOC from existing importer / registration holder permitting for cancellation of
product from its name and grant to new importer / registration holder.
o Registration of drug when title of firm has been changed by firm and approved
by Central Licensing Board (manufacturing site remains the same).
Registration Board discussed that in this case registration will not be cancelled from
previous name as there is no change in manufacturing site and only title of registration
holder has been changed. Thus case will be processed for change of title of the firm and
firm will submit following documents.
a. Application on Form-5 with required fee as per relevant SRO.
b. Copy of registration letter and renewal status.
c. NOC for CRF clearance.
d. Approval of new name / title from CLB.
e. Undertaking that the formulation, API source & Specifications, manufacturing
process, analytical test methods, release & shelf life specifications have not been
changed.
c. Re-registration of drugs.
Under Rule 27 of Drug (Licensing Registration and Advertising) rule, 1976, a certificate
of registration, shall unless earlier suspended or cancelled, be in force for a period of five
years from the date of registration of the drug and may thereafter be renewed for periods not
exceeding five years. Provided that an application for the renewal of registration shall not be
entertained unless it has been made within sixty days after the expiry of the registration and
when and application has been made as aforesaid the registration shall subject to the orders
passed on the application for renewal continue in force for the next period of five years.
Previously, in case a firm applies for re-registration of drug i.e after expiry of renewal
of registration of a drug, such cases were processed for re-registration on payment of full
registration fee and submission of form-5. Chairman Registration Board was authorized to
approve such cases on file.
21
Decision: Registration Board advised stake holders (PPMA, Pharma Bureau and
PCDA) to forward their comments till 15.01.2015 for considerartion by Registration Board.
d. Registration of 10 Products per section for New Drug Manufacturing Licence/
Additional Section.
Registration Board in 245th
meeting constituted following committee to review policy of
registration of 10 products per section to new manufacturers/ additional sections.
- Prof. Muzamil Hassan Najmi, Member Registration Board
- Mr. A Q Javed, Director QA, DRAP.
- Mr. Arif Chowdhry, DDC Reg-I
The Committee forwarded following recommendations:
To achieve the standards as laid down in GMP, the present practice of granting
registrations of ten products in a section to the new licensees may be continued.
The operational status of the manufacturer may be assessed by a panel inspection after 60
days of commencement of manufacturing activity.
Subject to compliance of GMP, as determined by the inspection panel, another ten
products per section may be granted to the new licensees on priority.
Decision: Registration Board was informed that DRAP’s Policy Board has also
discussed and deferred instant matter for further deliberation. The Board decided that
above points will be forwarded to DRAP’s Policy Board as recommendation from
Registration Board.
e. Non-Availability of finished drugs in country of origin.
Registration Board in 245th
meeting discussed that in some cases, finished drug of a
manufacturing site is neither available / authorized for sale in country of origin / manufacture
nor approved by any of regulatory authority of USFDA, Australian TGA, Japan or EMA, but
applicant intend to import finished product from that site. The Board constituted following
committee to look into the matter keeping in view international practices in such cases and
frame its recommendations.
- Prof. Muzamil Hassan Najmi, Member Registration Board.
- Mr. A Q Javed, Director QA & LT
22
- Mrs. Sara Mahreen ADC, PEC
Mrs. Sara Mahreen could not join the committee due to her posting in DRAP, Lahore and
Mr.Ammad Zaka, ADC was assigned the task.
The Committee forwarded following recommendations:
If any such drug which is not available in country of origin and not approved by reference
regulatory authorities i.e., USFDA, Australian TGA, Japan or EMA, it may be considered
for registration or approval of post registration variation, provided:
o Its registration has not been cancelled / withdrawn by any ICH member countries,
which are considered SRA, for safetyreasons.
o There is no new toxicity data reported about the drug requiring re-evaluation of its
status.
o It is available in atleast threeSRAcountries as notified by International Conference
onHarmonization of Technical Requirements for Registration of Pharmaceuticals
for Human use (ICH) on www.ich.org.
Decision: Registration Board advised stake holders (PPMA, Pharma Bureau and
PCDA) to forward their comments till 15.01.2015 to already constituted committee for
framing its recommendations for considerartion by Registration Board.
f. Export of drugs with same brand name of different manufacturers
M/s Ambrosia Pharmaceuticals, Islamabad has informed that they have exported
following drug:-
Name of product Regn No. for M/s
Ambrosia in
Pakistan
Regn No. for M/s
Ambrosia in Kingdom
of Combodia
Util Capsule 40mg
(Esomeprazole)
046889 CAM 0279-10
Firm has submitted that they were surprise and shock that M/s Medisure Labs, Karachi
exporting their same molecule “Esomeprazole” with same brand name “Util” to Kingdom of
Combodia with printed same registration number granted to them in Cambodia. This kind of act
is not only hurting their marketing and market share and image in Kingdom of Combodia as their
23
product are more effective and superior quality but more importantly damaging the image of
DRAP. At this time their distributor in Combodia has refused to place any further orders or
accept shipments of above products till such time they receive letter from DRAP stating that
DRAP will cancel these EX registrations of M/s Medisure and also confirmed that this brand
name will not be issued to any other manufacturers / companies in Pakistan by DRAP for export
purposes in the future.
Decision: Registration Board was informed that M/s Ambrosia Pharmaceuticals,
Islamabad has also submitted similar type of complaint against M/s English Pharma,
Lahore. Thus the Board decided to call these three manufacturers in forthcoming
Registration Board meeting with relevant record for presentation of their case.
g. Registration of generic Nilotinib
Advocate Mr. Kazim Hasan, Barrister-at-Law of M/s Novartis Pharma Limited has informed
that they have been instructed by Novartis to advise the Drug Registration Board of the DRAP
that the intellectual property rights to Nilotinib vests in Novartis globally. Nilotinib is a
breakthrough treatment of Lukemia and it has been developed by Novartis. M/s Novartis has
come to know that M/s Genix Pharma has applied for generic registration of Nilotinib under the
trade name Lukopenil. Being intellectual property rights to Nilotinib vests in Novartis globally a
generic Nilotinib would be a violation intellectual property rights.
Advocate Mr. Kazim Hasan has further submitted that such registration would also constitute
a sovereign breach, as Pakistan is a signatory to international treaties which guarantee protection
of intellectual property rights. He requested that application filed by Genix Pharma for generic
registration of a Novartis product may be rejected and Drug Registration Board should not even
entertain any application for generic registration Nilotinib under any trade name.
Decision: Registration Board decided to forward instant letter to IPO, Pakistan for its
comments for consideration by the Board.
e. Recommendation of Review committee.
Registration Board in 245th
meeting considered following recommendations of review
committee and advised PPMA and Pharma Bureau to forward their comments for consideration
24
of Registration Board. Now both stake holders forwarded their comments on these
recommendations, as follows:
PPMA:
A. Trimethyl Phologlucinol 80mg+Phloroglucinol 80mg.
i. Products Containing Phloroglucinol are available in many countries of the world, including Italy,
France, Switzerland, Luxemburg, Belgium, China and South Korea where more than 42
Companies including Multinationals have market since many years.
ii. In Italian health system, inclusion of Phloroglucinol as a fully reimbursed product is a further
guarantee of its efficacy and safety. In June , 2011 the transparency Committee of the Prestigious
HAS, France as recommended continued inclusion on the list of medicines refundable by national
health insurance and on the list of medicines approved for hospital uses in the indication of
“Symptomatic Treatment of Pain Related to Functional Disorder of the Gastrointestinal tract
including IBS and dosages given in the marketing authorization”.
iii. The product containing this molecule in France has been in the market since very long and is one
of the highest used specialties in gynaecology. Today about 15 French and multinational
companies have marketed their brands in France only.
iv. Also in Pakistan where this is the most used specialty for renal colic, biliary colic, abdominal
colics, IBS andfor the facilitation of labor, since almost 20 years with excellent safety and
efficacy.
v. All the leading medical specialists of Pakistan in related fields confirm its usefulness and are
completely satisfied.
vi. The clinical trials conducted within Pakistan have been included in International Literatures.
Volumes of data speak about its safety and efficacy.
vii. Phloroglucinol is well documented in well reputed medical reference books including Extra
pharmacopeia Martindale and Merck Index.
viii. The molecule Phloroglucinol is not under any review by EMA (European Medicine Agency) and
FDA (Food and Drug Authority of America).
ix. Only authentic documents about the safety of a product in Europe are PSUR (Periodic Safety
Update Report), which confirms the safety of the product.
B. Omeprazole + Sodium Bicarbonate 20mg, 40mg.
i. The product is safe for use to cure GERD. Authentic clinical trials/study attached to your
reference to use product for short term only (4 to 8 weeks) depending upon the patient health
severity. Minor side effects like hypokalemia, alkalosis and problem with acids base balance only
related with long term use. Companies already not recommended product for long term use.
25
ii. Product is approved in USFDA and on under prescription.
C. Citicoline.
i. Availability in Multiple Countries:
Citicoline is available in multiple European, North America and Asia Pacific Countries. It
highlights the wide spread usage of Citicoline as Nootropic and Neurotonic agent with
established efficacy and safety.
ii. Evidence of Citicoline’s Mode of Action as Neuroprotective:
A study of International Society for Neurochemistry in Journal of Neurochemistry has established
Citicoline as an intermediate in the biosynthesis of phosphahatidylcholine which has beneficial
effects in number of CNS injury models and patholological conditions of brain.
iii. Reference of Citicoline in Authentic & Reputable Journals:
a. British Medical Journal has highlighted Citicoline as more effective if given within 24 hours of
stroke than placebo while referring the study of clinical trial “Stroke Management” by Elizabeth
Warburton; Josef A Alawneh; Philip L Clatworthy; Rhiannon S Morris”.
b. Journal of the American Heart Association has highlighted beneficial therapeutic effect of the
long term treatment of Citicoline in acute cerebral infarction.
c. According to Clinical Interventions in Aging, a world renowned journal, Citicoline is effective
and well tolerated in patients with mild vascular cognitive impairment.
iv. Citicoline Granted Novel Food Ingredient Status in EU
Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition
and Allergies (NDA) delivered a scientific opinion on Citicoline as a novel food ingredient (NFI),
which concluded on October 2013 that Citicoline is safe under the proposed use and use levels.
The Commission Implementing Decision 2014/423/EU on July 1, 2014 authorized Kyowa Hakko,
New York, NY, to market and manufacture Citicoline as a NFI under Regulation (EC) No 258/97 of
the European Parliament and of the Council.
v. Huge prescription base in Pakistan
According to the latest “Sales” data, around 700,000 injections of 250mg whereas 1,000,000 tablets
have been selling in a year in Pakistan. It reflects strong confidence of leading neurologists and
neuro-surgeons in efficacy and safety of the product which leads to such a massive prescription base.
D. Diacerein.
i. The molecule is registered with the European Medicines Agency.
ii. The product is very effective for the treatment of Osteoarthritis Specially in advanced age
26
iii. The product is available and authorized to be used in the European Union Including France.
E. Calcium Dobesilate.
i. The molecule is included in the European Pharmacopoeia.
ii. Molecule is registered and available in Switzerland (COPP available)
iii. Molecule is registered in more than sixty countries of the world and marketed in more than fifty
countries.
iv. The molecule has been registered and marketed since 1972 and available in European Union
since 1975.
F. Smectite.
i. The molecule is available in France, Greek and USA.
ii. The molecule is extremely useful in the treatment of Acute Diarrhea.
iii. It is a time tested and important product for treatment of Dierrhea specially in children.
iv. The molecule is available in the European Union including Switzerland, Germany, Austria, Italy,
Spain and countries of Eastern Europe as well as South America and South Anastasia.
v. It is an important molecule to prevent Hepatotoxicity.
G. Saccharomyces Boulardi.
i. Clinical efficacy has been established for chronic disease like Crohn disease, Ulcerative Colitis,
Irritable Bowel Syndrome, Parasitic infection & Human Immunodeficiency virus related
Diarrhea. An overdose of saccharomyces boulardii and long term use ae not likely to cause life-
threatening symptoms.
ii. USFDA are withdrawing a notice of eligibility and recommendation of safety data for
consideration as OTC product and recommended product monograph for antidiarrheal drug..
iii. Product is already approved and recommended by TGA.
iv. In many of countries like in Vietnam, Product registered as drug and in Pakistan this product is
under price control and if product transfers to OTC division then market price might be change
and ultimately effect on patient.
H. Piracetam.
i. Availability in Multiple Countries:
Piracetam is available as “Central Stimulant” and “Nootropic Agent” in large number of countries
including multiple European, South America and Asia Pacific Countries. Among them the most
significant are Germany, France, Belgium, India, Malaysia, Turkey, Singapore etc.
ii. Authentic References:
- Assay method given in “British Pharmacopoeia” highlighting the authenticity of the product.
27
- Piracetam has been mentioned in “Martindale - The extra Pharmacopoeia” 36th Edit on with
mode of action and its therapeutic uses.
iii. Mode of Action:
Mode of Action of Piracetam is well-explained which highlights its beneficial influence on
neuronal and vascular functions. Further Piracetam also improves the function of neurotransmitter
acetylcholine.
iv. Wide-spread Usage of Piracetam by leading Neurologists & Neuro-Surgeons in Pakistan:
There are significant number of Piracetam users all around the Pakistan who are very much
satisfy with therapeutic results as Nootropic and Neurotonic Agent.
v. Huge Prescription Base in Pakistan:
According to the latest “Sales” data, around 400,000 syrups have been selling in a year in
Pakistan. It reflects strong confidence of leading neurologists and Neuro-surgeons in efficacy and
safety of the product which leads to such a massive prescription base.
I. Thiocolchicoside.
i. Committee for Medicinal Products for Human use (CHMP) of the European medicines agency in
its assessment report no. EMA/40340/2014 dated 17th January, 2014 as made the following
conclusion.
a. Having considered all available data from pre-clinical studies, Pharmacoepidemiological studies,
published literature, post-marketing experience on the safety of thiocolchicoside containing
medicinal products for systemic use with regards to its genotoxicity, the Committee considered
that thiocolchicoside containing medicinal products for systemic use remain an effective adjuvant
treatment of painful muscle contractures in acute spinal pathology.
b. However, having considered the risks, thiocolchicoside containing medicinal products for
systemic use should only be administered to patients over 16 years of age in acute conditions.
With treatment duration limited to 7 (oral) and 5 (IM) consecutive days. In that respect, the
CHMP was of the view that the indication in “Parkinson’s disease and drug-induced
Parkinsonism with special consideration to neurodyslectic syndrome” should be removed as this
is a chronic condition which requires longer treatment duration. The package size should be
adapted to new recommended treatment-days.
c. The committee considered also that thiocolchicoside containing medicinal products for systemic
use should be contraindicated during the entire pregnancy period. These products should also be
contraindicated in women of childbearing potential not using contraception and during lactation.
The CHMP also recommended further changes to the product information including information
on fertility.
28
d. The Committee as consequence concluded that the benefit-risk balance of thiocolchicoside
containing medicinal products for systemic use as adjuvant treatment of painful muscle
contractures acute spinal pathology in adults and adolescents from 16 years onwards remains
favorable, subject to the restrictions, warnings, other changes to the products information,
additional pharmacovigilance activities and risk minimization measures agreed.
ii. The molecule is available in France, Greece, Italy, Portugal, Malta, Spain, Hungary, Czech
Republic, India and many countries of the Fareast.
iii. The molecule has been in use in Europe since last more than 30 years.
J. Dry Powder Suspension of Famotidine.
Famotidine has many advantages in the Dry Powder form (reconstitute before use) as compared
to liquid suspension due to the following reasons.
i. International Availability of Dry Powder Suspension by the Innovator: Please see the
attached Annexure, I, which clearly shows that in USA, the research company Merck & Co is
manufacturing Famotidine in Dry Powder Suspension. We have attached Product information
available freely on internet for your perusal and record.
ii. Proof of availability of this formulation i.e. Dry Powder Suspension is attached as Annexure II –
IV, which shows that renowned companies such as Zydus Pharmaceutical USA, Paddock
Laboratories Inc., Minneapolis and Lupin Pharmaceuticals Inc., USA are manufacturing and
marketing their products in USA which is approved by USA FDA. We have attached the product
details downloaded from Internet.
iii. Pharmacopeial Monograph: For your kind record, please note that Dry Powder Suspension is
mentioned in the Monograph of Famotidine in USP (Please see Annexure - V ). It is mentioned in
the monograph that total impurities in the Oral suspension should not be more than 2.0%. it is
very unlikely that Famotidine that is not stable in water could meet criteria of impurities of 2% if
provided in the form of liquid suspension.
iv. Comments on Stability: Famotidine stability in aqueous solution is temperature dependent,
therefore storage condition for Famotidine injection is recommended at 2-8oC(See Annexure VI).
Various studies are available in the literature which supports termal degradation of Famotidine in
Aqeouse Solution at room temperature (See Annesure VII), hence liquid suspension degrade at
room temperature.
v. Based on the above authentic references, it may be noted that Dry Powder Suspension is more
stable and is used within 30 days after reconstitution (USA product brief). Therefore this
formulation is the benchmark as marked by its researcher. Therefore liquid suspension at room
temperature is not stable and should be look into for patient safety.
K. Silymarin
29
Silymarin is mentioned in more than one standards books like:
1) Martindale: The complete drug Reference, which is a comprehensive & reliable reference
source on drug & medicines used throughout the world.
2) U.S.P 34: Silymarin is prescribed in more than 50 countries of the world, we are enclosing
herewith reference of substantial internationally available brands.
S.No Brand name Manufacturing/Availability
1 Lagalon
Austria,Bahrain,Balgaria,China,Colombia,Georgia
Germany, Italy,Hungary,Mexico,Philippine, Poland,
Portugal,Romania, South Africa, Spain,
Switzeland,Slovakia,Thailand, Venezuela.
2 Simepar Switzerland
3 Cefasilymarin Germany
4 Samarin 140 Thailand
5 Doindi Vietnam
6 Silymarin Forte Romania
7 Silymarin Duo Macedonia
8 Hepasil Bangladesh
9 Esimerin Plus India
10 Good Liver India
11 Heptosil 200ml India
12 Livoriv-B India
13 Livosil-B India
14 Silyvit India
15 Tezaliv India
It is an important molecule used in various liver disorders. Various studies regarding
usage of Silymarin are available in different medical Journals.
30
Various manufacturers have also forwarded their comments on various formulations.
Recommendations of review committee considered by Registration Board in 245th
meeting
are as follows:
S.
No
Drug Name
Generic (Brands)
Approv
al by
Internat
ional
Regulat
ory
Bodies
Status in
Authentic
Textbooks
(Pharmacol
ogical basis
of
therapeutic
s-Goodman
& Gilman,
Basic &
Clinical
pharmacolo
gy-B G
Katzung,
Current
Medical
Diagnosis &
Treatment
– 2013)
Research
published in
Reputed/
Authentic
Journals
Concluding
Remarks &
Recommendation
1. Keto Injection
Each vial contains:-
Ketamine HCl
Ketamine 500 mg
(General Anesthetics)
Yes
FDA
EMA &
others
Recommend
ed for use in
general
anesthesia.
Numerous Ketamine is
chemically related to
phencyclidine and
therefore has a
potential for abuse.
The drug is included in
the controlled list and
is placed in Schedule
III in USA.
In view of its useful
role in anesthesia,
Ketamine is
recommended to be
retained as a
registered drug.
However, it should be
dealt with narcotics
and appropriate
restrictions may be
applied to prevent its
abuse.
31
Recommended for
registration.
2. Fluoxetine + Olenzapine
Citrate
Each capsule contains:-
Fluoxetine HCl 25 mg
Olenzapine Citrate
Olenzapine 12 mg
(Antidepressant)
FDA
only
The
individual
drugs are
recommende
d but the
combination
has not been
mentioned.
Available Fluoxetine is an
SSRI and can
interact with MOAIs
to cause serotonin–
syndrome. Since it is
converted into a very
long acting
metabolite, the
interaction can occur
during 4 weeks after
cessation of
Fluoxetine. The risk
of QT prolongation
and causing Torsade
de pointes also
exists.
The Fixed-Dose
combination may
be allowed with
relevant warning
and to be dispensed
on prescription by
qualified
psychiatrist only.
Recommended for
registration.
3. Each capsule contains:-
Omeprazole 20 mg
Sodium Bicarbonate 1100
mg
(Proton Pump Inhibiter)
Tentativ
e
approval
by FDA
only.
Not
approve
d by
EMA,
PMDA,
TGA
The
individual
drugs are
recommende
d but the
combination
has not been
mentioned.
No independent
scientifically
designed studies
available to
support the
combination of
these two drugs.
Omeprazole, a PPI,
is a prodrug which
requires acidic
environment for
conversion into
active form. It blocks
the H/K ATPase
irreversibly and
reduces the gastric
acid secretion to very
low levels (most
potent among all
anti- secretory
drugs).
Sodium bicarbonate
is a rapidly acting
32
systemic antacid. It
absorbs into blood
and long-term use
may cause systemic
alkalosis, besides
other toxicity.
It is irrational to
combine the two
drugs as the antacid
may impair
activation of
Omeprazole. Further,
in the face of strong
acid-inhibiting effect
of Omeprazole, it is
superfluous to
administer an antacid
on regular basis.
The combination
adds to the cost and
increases adverse
effects.
Not Recommended
for registration.
4. Each capsule contains:-
Omeprazole 40 mg
Sodium Bicarbonate 1100
mg
(Proton Pump Inhibiter)
Tentativ
e
approval
by FDA
only.
Not
approve
d by
EMA,
PMDA,
TGA
The
individual
drugs are
recommende
d but the
combination
has not been
mentioned.
No independent
scientifically
designed studies
available to
support the
combination of
these two drugs.
Omeprazole, a PPI,
is a prodrug which
requires acidic
environment for
conversion into
active form. It blocks
the H/K ATPase
irreversibly and
reduces the gastric
acid secretion to very
low levels (most
potent among all
anti- secretory
drugs).
Sodium bicarbonate
is a rapidly acting
systemic antacid. It
absorbs into blood
and long-term use
may cause systemic
alkalosis, besides
33
other toxicity.
It is irrational to
combine the two
drugs as the antacid
may impair
activation of
Omeprazole. Further,
in the face of strong
acid-inhibiting effect
of Omeprazole, it is
superfluous to
administer an antacid
on regular basis.
The combination
adds to the cost and
increases adverse
effects.
Not Recommended
for registration.
5. U-Fit 10 mg Dry Suspension
Each 5ml contains:-
Famotidine 10 mg
(Antiulcer)
Famotidi
ne in dry
suspensi
on form
is not
approve
d by any
reputed
internati
onal
agency
NA NA Famotidine is widely
available in Tablet,
Capsule, Suspension,
Chewable &
Dispersible tablet
forms. Dry
suspension does not
seem to offer any
advantage over the
existing formulations
and is not supported
by international
market scenario.
Not Recommended
for registartion.
6. Sacopan Sachets
Each sachet contains:-
Saccharomyces
Boulardii 250mg
(anti Diarrhoeal)
Not
approve
d by
FDA,
EMA,
PMDA
Approve
d by
TGA
only
Some studies
about the role of
probiotics in
IBS and CD
infection have
been published
but their role
requires more
elucidation.
The probiotics are in
evaluation stage and
their benefits in IBS,
Crohn’s disease, C.
difficle infection etc.
have not been
established. In
immune-compromised
patients these may
cause life-threatening
infection. In most of
the countries these are
34
available as food-
supplements or OTCs.
Some of these are
already available as
additives in milk
formulas for infants.
May be de-registered
as drug and allowed
as food supplements.
7. Ritocin-B Dry Suspension
200 mg
Each 5ml contains:-
Erythromycin Ethyl
Succinate.
Erythromycin 200mg
Bromhexine HCl 4mg
(Macrolide)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
Erythromyci
n as single
drug is
recommende
d by books
for
infections by
susceptible
organisms.
Bromhexine
is not even
mentioned.
Studies have
been published
showing in vitro
effect of
bromhexine as
mucolytic.
There is no
evidence for
such action in
vivo after oral
administration.
Mucolytics are
useful in
management of
COPD after
administration by
inhalation. Evidence
is lacking for any
benefit after oral
administration.
All oral
formulations
containing
bromhexine as
single drug or in
combination with
other drugs, are
recommended to be
de-registered.
8. Spardix Tablets 100mg
Each tablet contains:-
Sparfloxacin 100 mg
(Anti-infective,
Fluoroquinolone)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
Mentioned
as member
of
fluoroquinol
one group.
Studies have
been published
showing activity
of sparfloxacin
against Gram
positive
bacteria.
Reports are
published
describing
potassium
channel
blocking
activity causing
QT prolongation
and life-
threatening
Several of the
Fluoroquinolones
have been reported
to cause QT
prolongation and
cardiac arrhythmias.
The potential is
highest for
Sparfloxacin.
In view of the
unfavorable
risk/benefit ratio,
the drug is not
recommended for
registration.
35
torsade de
pointes
arrhythmias.
9. ES ZIN 20mg Tablets Each
tablet contains:-
Esomeprazole 20mg
Magnesium 700mg
Sodium Bicarbonate 20mg
Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
The
individual
drugs are
recommende
d but the
combination
has not been
mentioned.
No independent
scientifically
designed studies
available to
support the
combination of
these drugs.
The comments given
above at No.3 also
hold good for this
preparation.
All dosage
strengths
recommended for
de-registration.
10. ES ZIN 40mg Tablets Each
tablet contains:-
Esomeprazole 40 mg
Magnesium 700 mg
Sodium Bicarbonate 40mg
Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
The
individual
drugs are
recommende
d but the
combination
has not been
mentioned.
No independent
scientifically
designed studies
available to
support the
combination of
these drugs.
The comments given
above at No.3 also
hold good for this
preparation.
All dosage
strengths
recommended for
de-registration.
11. Calzob-500 Capsules
Each capsule contains:-
Calcium dobesilate 500mg
(Vasotherapeutics,
Coagulants, Haemostatics)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
Not
mentioned
in any
standard
textbook.
The published
clinical trials
have shown that
calcium
dobesilate does
not reduce the
occurrence of
diabetic
retinopathy in
patients.
Calcium dobesilate
was developed for
prevention of
diabetic retinopathy.
Theoretically its
mechanism of action
(inhibition of aldose
reductase and
reduction of capillary
permeability)
supports its use for
this purpose.
However, in
evidence-based
medicine, benefits of
this drug could not
be established.
Recommended for
de-registration.
12. Ciprozan Tablets 1gm
Each film coated SR-tablet
contains:-
Ciprofloxacin ……… 1 gm
(Quinolone Antibiotic)
One Gm
SR
dosage
form not
approve
One Gm
extended-
release
tablet
mentioned
The strength is
within the
therapeutic
range of dose
described in
The slow release
tablet of 1 Gm is not
in vogue but has
been described by
the standard
36
d by
FDA,
EMA,
TGA &
PMDA.
by B G
Katzung
published
studies.
textbook and lies
within the
therapeutic range of
dose. The applicant
may be asked to
provide full
justification for the
formulation, quoting
examples of
countries where
similar forms are
available.
Final decision may
be pended till point
of view of the
applicant is
evaluated.
13. Diacin 50mg
Capsules Each capsule
contains:-
Diacerein 50mg
( Anti-Rheumatic )
Not
approved
by FDA,
TGA &
PMDA.
Approved
by EMA
for use in
epidermo
lysis
bullosa
only
Not
mentioned
in any
standard
textbook
Some in vitro
studies on
chondrocytes
have been
published.
Clinical trials
have reported
slight but
statistically
significant
superiority over
placebo.
Diacerein is an anti-
inflammatory drug
acting by inhibition
of Interleukin-1beta.
It has been used in
osteoarthritis where
it may produce slight
improvement. In
limited number of
countries where it is
available, it is being
reviewed and
withdrawn due to
hepatotoxicity.
In view of the
limited usefulness
and concerns of
toxicity, diacerein is
not recommended
for registration.
14. Swanliag 5 mg Tablet
Each tablet contains:-
Cyclobenzaprine 5mg
(Skeletal Muscle Relaxant)
Not
approved
by EMA,
TGA &
PMDA.
5 mg
dosage-
form
discontin
Mentioned
by BG
Katzung
Studies have
been published
in which
cyclobenzaprine
was found to be
superior to
placebo and
equivalent to
Although 5 mg dosage
form has been
discontinued by FDA,
but other dosage forms
contain higher doses
which may be
associated with more
side effects. By virtue
of its non-addictive
37
ued by
FDA. other
spasmolytics.
nature It may be
superior to
benzodiazepines.
In view of the
scientific evidence for
efficacy of the drug,
Cyclobenzaprine may
be retained as a
registered drug.
15. Mepridone 20mg Capsules
Each capsule contains:-
Esomeprazole Magnesium
Trihydrate Pellets eq. to
Esomeprazole 20 mg
Domperidone 30mg
(Proton Pump Inhibitor /
Anti-Dopaminergic)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
The
individual
drugs are
recommende
d but the
combination
has not been
mentioned.
Studies on
individual drugs
are available but
not on this
combination.
Besides the
combination,
Domperidone as an
individual drug is not
approved by FDA. It
has been associated
with cardiac
arrhythmias. The
combination is
irrational and carries
the risk of toxicity.
Recommended to
be de-registered.
16. Each Sachet contains:-
Omeprazole 20 mg
Sodium Bicarbonate 1100
mg
(Proton Pump Inhibiter)
Tentativ
e
approval
by FDA
only.
Not
approve
d by
EMA,
PMDA,
TGA
The
individual
drugs are
recommende
d but the
combination
has not been
mentioned.
No independent
scientifically
designed studies
available to
support the
combination of
these two drugs.
Omeprazole, a PPI,
is a prodrug which
requires acidic
environment for
conversion into
active form. It blocks
the H/K ATPase
irreversibly and
reduces the gastric
acid secretion to very
low levels (most
potent among all
anti- secretory
drugs).
Sodium bicarbonate
is a rapidly acting
systemic antacid. It
absorbs into blood
and long-term use
may cause systemic
alkalosis, besides
other toxicity.
It is irrational to
38
combine the two
drugs as the antacid
may impair
activation of
Omeprazole. Further,
in the face of strong
acid-inhibiting effect
of Omeprazole, it is
superfluous to
administer an antacid
on regular basis.
The combination
adds to the cost and
increases adverse
effects.
Not Recommended
for registration.
17. Floronol Tablets
Each tablet contains:-
Phloroglucinol hydrate 80
mg Trimethyl
Phloroglucinol 80 mg (Anti
Spasmodic)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
Not
mentioned
by any
standard
textbook
No scientifically
designed
clinical studies
are available. In
vitro and
toxicological
studies have
been published.
Phloroglucinol is a
synthetic phenol
having
antispasmodic
properties. However
its use in medicine
has remained
restricted due to
toxicity concerns. It
is mainly used in
explosive industry.
The adverse effects
reported by FDA
include neutropenia,
hepatotoxicity, renal
failure, metabolic
acidosis,
hyperkalemia and
allergic reactions.
In view of severely
unfavorable
benefit/risk ratio all
preparations
containing
phloroglucinol are
recommended to be
de-registered.
39
18. EsmoDome 20 Tablets
Each tablet contains:-
Esomeprazole Magnesium
Esomeprazole 20 mg
Domperidone Maleate
Domperidone 30 mg
(Antiemetics &
Antinauseants)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
The
individual
drugs are
recommende
d but the
combination
has not been
mentioned.
Studies on
individual drugs
are available but
not on this
combination.
Besides the
combination,
Domperidone as an
individual drug is not
approved by FDA. It
has been associated
with cardiac
arrhythmias. The
combination is
irrational and carries
the risk of toxicity.
Recommended to
be de-registered.
19. EsmoDome 40 Tablets Each
tablet contains:-
Esomeprazole as
Magnesium……..40mg
Domperidone Maleate
Domperidone 30 mg
(Antiemetics &
Antinauseants)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
The
individual
drugs are
recommende
d but the
combination
has not been
mentioned.
Studies on
individual drugs
are available but
not on this
combination.
Besides the
combination,
Domperidone as an
individual drug is not
approved by FDA. It
has been associated
with cardiac
arrhythmias. The
combination is
irrational and carries
the risk of toxicity.
Recommended to
be de-registered.
20. Piram 1 gm Syrup
Each 5 ml contains:-
Piracetam 1g
(Psychostimulants,
Nootropic, Neurotonic)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
Not
mentioned
by any
standard
textbook
Scientifically
conducted
clinical studies
have not shown
any benefit of
piracetam.
Piracetam is used in
treatment of
cognitive disorders
and myoclonus but
scientific evidence
for efficacy is
lacking. Side effects
including anxiety,
insomnia, irritability,
headache, agitation,
nervousness, tremor,
and hyperkinesia,
have been reported
with its use.
Not Recommended
for registration.
40
21. Wincoline 250 mg Injection
Each 2ml ampoule
contains:- Citicoline
Sodium
Citicholine 250 mg
(Nootropics & Neurotonic)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
Not
mentioned
by any
standard
textbook.
Efficacy has not
been established
in scientifically
conducted
clinical trials.
Citicoline is cytidine
diphosphate choline
which is said to
increase
dopaminergic
receptor density in
brain. It has been
used in cognitive and
some other disorders
on this basis but
evidence for efficacy
is lacking.
Not recommended
for registration.
22. Each film coated tablet
contains:- Citicoline
Sodium
Citicholine 500 mg
(Nootropics and
Vasotherapeutic)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
Not
mentioned
by any
standard
textbook.
Efficacy has not
been established
in scientifically
conducted
clinical trials.
Citicoline is cytidine
diphosphate choline
which is said to
increase
dopaminergic
receptor density in
brain. It has been
used in cognitive and
some other disorders
on this basis but
evidence for efficacy
is lacking.
Not recommended
for registration.
23. Esso Forte Tablets Each
tablet contains:-
Naproxen USP 500 mg
Esomeprazole Magnesium
Trihydrate
Esomeprazole 20mg
( NSAID + PPI )
Delayed
release
tablets
are
approve
d by
FDA
and
TGA.
Not
approve
d by
EMA &
PMDA.
This
particular
combination
is not
mentioned
but
combining
NSAIDs
with PPIs
and H2
blockers is
recommende
d in general
for
prevention
of
gastropathy.
Studies on this
particular
combination are
not found.
It is rational to
combine NSAIDs
with PPIs for
prevention of
gastropathy. Both the
drugs individually
are well established
in their respective
categories.
Recommended for
registration.
41
24. Valex Talets
Each film coated tablet
contains:- Phloroglucinol
hydrate 80 mg Trimethyl
Phloroglucinol 80 mg
(Gastrointestinal/Antispasm
odics)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
Not
mentioned
by any
standard
textbook
No scientifically
designed
clinical studies
are available. In
vitro and
toxicological
studies have
been published.
Phloroglucinol is a
synthetic phenol
having
antispasmodic
properties. However
its use in medicine
has remained
restricted due to
toxicity concerns. It
is mainly used in
explosive industry.
The adverse effects
reported by FDA
include neutropenia,
hepatotoxicity, renal
failure, metabolic
acidosis,
hyperkalemia and
allergic reactions.
In view of severely
unfavorable
benefit/risk ratio all
preparations
containing
phloroglucinol are
Recommended to
be de-registered.
25. S.OM-D 30mg Capsules
Each capsule contains:-
Esomeprazole Enteric
Coated Pellets eq.
Esomeprazole 40 mg
Domperidone 30mg
(Proton Pump Inhibitor /
antiemetic)
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
The
individual
drugs are
recommende
d but the
combination
has not been
mentioned.
Studies on
individual drugs
are available but
not on this
combination.
Besides the
combination,
Domperidone as an
individual drug is not
approved by FDA. It
has been associated
with cardiac
arrhythmias. The
combination is
irrational and carries
the risk of toxicity.
Recommended to
be de-registered.
42
26. Thicol 4mg Capsules
Each capsule contains:-
Thiocolchicoside……..4 mg
(Muscle Relaxant)
Not
approve
d by
FDA,
EMA &
TGA
Not
mentioned
by any
standard
textbook.
No reference
found in
authentic
journals
Thiocolchicosideis a
muscle relaxant with
anti-inflammatory and
analgesic effects. It
acts as a competitive
GABAA receptor
antagonist and also
glycine receptor
antagonist. A variety
of adverse effects have
been reported with this
drug. Particularly of
concern are its ability
to cause seizures and
potential to cause
tratogenecity and male
infertility.
Not recommended for
registration.
27. Darcin ER 15mg Tablets
Each extended release tablet
contains:-
Darifenacin 15 mg
(Anti-Cholinergic)
Approve
d by
EMA &
TGA.
Tentativ
e
approval
granted
by FDA.
Recommend
ed for use in
genito-
urinary
disorders.
Available. Darifenacin is a M 3
selective
antimuscarinic drug
used for control of
urinary incontinence
in adults. A
congener, solifenacin
is already registered.
Recommended for
registration.
28. Darcin ER 7.5mg Tablets
Each extended release tablet
contains:-
Darifenacin ………. 7.5mg
(Anti-Cholinergic)
Approve
d by
EMA &
TGA.
Tentativ
e
approval
granted
by FDA.
Recommend
ed for use in
genito-
urinary
disorders.
Available. Darifenacin is a M 3
selective
antimuscarinic drug
used for control of
urinary incontinence
in adults. A
congener, solifenacin
is already registered.
Recommended for
registration.
29. CarionJect 500mg Injection
Each 10 ml injection
contains:- Iron Ferric
Carboxymaltose
Iron Element 500mg
(Haematinic)
Approved
by FDA
(750mg/1
5 ml) &
TGA
(500mg/1
0ml)
This
particular
preparation
not
mentioned.
Few but
available.
It is a new parenteral
form of iron.
Comparable to the
existing formulations
in efficacy and safety
profiles.
Recommended for
43
registration.
30. C-Zyme Tablet
Each tablet contains:-
Metoclopramide HCl 6mg
Sodium dehydrocholate 20
mg Bromelain 35000 PU
Pancreatin 210 FIPPU
Simethicone 50 mg
Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
Not
mentioned
by any
standard
textbook.
No reference
found in
authentic
journals.
A completely
irrational
combination
containing drugs
whose efficacy is not
established.
Not recommended
for registration.
31. Carolate Injection
Each 1ml ampoule
contains:- Glycopyrrolate
0.5 mg Neostigmine
methylsulphate 2.5mg
Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
This
particular
combination
is not
mentioned
but use of
atropine-like
drugs to
counter the
muscarinic
effects of
anticholinest
erases is
recommende
d.
Available Neostigmine is
generally used to
reverse muscle
paralysis induced by
curare-like drugs
during anesthesia.
This action is exerted
on nicotinic
receptors but is
accompanied with
unwanted muscarinic
stimulation. This is
countered by
administration of
antimuscarinic drugs
like glycopyrrolate.
Recommended for
registration.
32. Isotretinoin Cap/
Isotretinoin Tablet
Recdommen
ded for
severe acne
and certain
malignant
disorders.
Available Isotretinoin is 13-cis
retinoic acid. It is used
in treatment of cystic
acne, squamous cell
carcinoma of skin and
certain other
malignancies. In view
of its established
efficacy, the drug is
recommended to be
retained.
Any issues related to
dosage
form/formulation
may be resolved after
obtaining view point
of manufacturers.
33. Amoxicillin + Sulbactum The general
principal for
It is rational to
combine penicillin
44
combining
penicillins
with beta
lacatmase
inhibitors is
described.
with beta lactamase
inhibitors but
Amoxicillin is
generally combined
with clavulanate.
The manufacturers
may be asked to
provide reasons for
using sulbactam
along with references
in the favor of this
combination.
May be deferred for
the time being.
34. Silymarin Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
Not
mentioned
by any
standard
textbook.
No scientifically
designed studies
available in
authentic
journals.
Silymarin is a dried
extract obtained from
Milk thistle plant.
Efficacy in hepatic
disorders has not
been proved in
authentic clinical
trials. Adverse
effects have been
reported in patients
using milk thistle
capsules.
Not recommended
for registration.
35. Aescin Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
Not
mentioned
by any
standard
textbook.
No scientifically
designed studies
available in
authentic
journals.
Aescin is a mixture
of saponins present
in horse chestnut
plant. It is claimed to
have anti
inflammatory and
vasoprotective
effects but this has
not been proved in
scientifically
designed clinical
studies
Not recommended
for registration.
36. Solcoseryl Not
approve
Not
mentioned
No scientifically
designed studies
Solcoseryl is
deproteinated blood
45
d by
FDA,
EMA,
TGA &
PMDA.
by any
standard
textbook.
available in
authentic
journals.
of calves. It has been
used in a variety of
formulations for
various purposes but
scientific evidence
for efficacy is
lacking. Not
recommended for
registration.
37. Serratiopeptidase Not
approve
d by
FDA,
EMA,
TGA &
PMDA.
Not
mentioned
by any
standard
textbook.
No scientifically
designed studies
available in
authentic
journals.
Serratiopeptidase is a
proteolytic enzyme
present in silkworm
gut which helps it to
dissolve the cocoon.
It has been used as
an anti-inflammatory
agent without any
scientific evidence of
efficacy.Takeda
Pharmaceuticals, the
brand leader
Japanese company,
had agreed for
voluntary withdrawal
from market in 2011.
Not recommended
for registration.
38. Smectite Not
mentioned
by any
standard
textbook.
No clinical
studies available
to support
efficacy.
Smectite is mineral
clay having
adsorbent properties.
It is similar to kaolin
in its medicinal
value.
Not recommended
for registration.
Decision: Keeping in view recommendations of Review Committee and comments of
stake holders, Registration Board decided as follows:
Following formulations will be considered for registration by Registration Board
and thus the Board advised P E & R Division to place all deferred cases in agenda of
the meeting.
46
i. Ampoule (1ml) containing Glycopyrrolate 0.5 mg Neostigmine + methylsulphate 2.5mg
ii. Injection (10 ml) containing Iron Ferric Carboxymaltose Iron Element 500mg.
iii. Extended release tablet containing Darifenacin 7.5mg, 15mg.
iv. Tablet containing Naproxen USP 500 mg + Esomeprazole Magnesium Trihydrate
Esomeprazole 20mg.
v. Tablet containing Cyclobenzaprine 5mg.
vi. Capsule containing Fluoxetine HCl 25 mg + Olenzapine Citrate Olenzapine 12 mg.
vii. Injection containing Ketamine HCl Ketamine 500 mg
Registration Board discussed comments of stakeholders for following formulations
and decided that Review Committee will review these comments for framing its final
recommendation. The Board also advised the committee to take assistance of any
expert (if required) and can also call any stakeholder for their views. These
formulations are as follows:
viii. Trimethyl Phologlucinol 80mg+Phloroglucinol 80mg.
ix. Omeprazole + Sodium Bicarbonate 20mg+1100mg, 40mg+1100mg.
x. Citicoline.
xi. Diacerein.
xii. Calcium Dobesilate.
xiii. Smectite.
xiv. Saccharomyces Boulardi.
xv. Piracetam.
xvi. Thiocolchicoside.
xvii. Dry Powder Suspension of Famotidine.
xviii. Silymarin
Keeping in view recommendations of Review Committee, Registration Board
decided to proceed further for cancellation of registration as per procedure laid
down in Drugs (L R & A) Rules, 1976 of following items.
xix. Suspension containing Erythromycin Ethyl Succinate Erythromycin 200mg +
Bromhexine HCl 4mg
xx. Sparfloxacin 100mg
xxi. Tablets containing Esomeprazole 20mg + Magnesium 700mg + Sodium Bicarbonate 20mg
xxii. Tablets containing Esomeprazole 40mg + Magnesium 700mg + Sodium Bicarbonate 20mg
xxiii. Capsule and tablet containing Esomeprazole 20mg, 40mg + Domperidone 30mg
xxiv. Serratiopeptidase.
xxv. Solcoseryl
xxvi. Aescin
xxvii. Tablet containing Metoclopramide HCl 6mg + Sodium dehydrocholate 20 mg + Bromelain
35000 PU + Pancreatin 210 FIPPU + Simethicone 50 mg.
47
Registration Board advised Review Committee to finalize recommendation for
following formulations. The Board also advised the committee to take assistance of
any expert (if required) and can also call any stakeholder for their views. These
formulations are as follows:
xxviii. Amoxicillin + Sulbactum
xxix. Isotretinoin Capsule/ Tablet
xxx. Film coated Sustained release containing 1 gm Ciprofloxacin
f. Manufacturing requirement for various classes of drugs.
Registration Board in 245th
meeting discussed manufacturing requirements for various
classes of drugs, and Chairman advised all members, PPMA and Pharma Bureau to forward their
scientific comments and relevant references on manufacturing requirements for following classes
of drugs:
- Steroids.
- Immunosuppresants.
- Clomiphene and letrozole
- Prostaglandins and its analogues.
- Storage requirement of Misoprostol
- Vancomycin
Two members and PPMA has forwarded their comments on manufacturing requirements for
steroids, as follows:
Dr. Amanullah Khan (Director, DTL, Quetta).
For all steroidal preparations except topical preparations must have separate
manufacturing area, so it may be added that topical preparations may be manufactured in the
same approved area and exempted from separate area.
Lt General (R) Karamat Ahmed Karamat.
Reference to the Board meeting proceedings, all non-inflammatory steroids like
prednisolone, Dexamethasone are manufactured in the same general area on campaign basis.
Topical steroids like eye preparations/drops, otic drops, creams and ointments are manufactured
through wet process and should be allowed to manufacture across the board as everywhere in the
world. However, sensitive steroids which fall under category A like penicillin, cytotoxic
substances, Beta lactam and sex hormones may be considered to be manufactured in the
dedicated area.
48
PPMA.
Requirement by international regulatory agencies / cGMP
Internationally the dedicated facility is recommended for certain hormones, as evident from the
following:
Medicinal Control Agency U.K Requirements:
The Orange book published by Medicine Control Agency (MCA) of U.K in chapter 3 dealing
with premises and equipment, of guide to Good Manufacturing Practices for Medicinal Products,
under section 3.6 states requirements which are very close to section 5.2 of Pakistan drug rules.
“In order to minimize the risk of serious medical hazard due to cross contamination, dedicated
and self contained facilities must be available for the production of particular medicinal products,
such as highly sensitizing materials {e.g Penicillin} or biological preparations {e.g from live
microorganism}. The production of certain additional products, such as certain antibiotics,
Certain hormones, certain cytotoxics, certain highly active drugs and non medicinal products
should not be conducted in the same facilities. For those products, in exceptional cases, the
principle of campaign working in the same facilities can be accepted provided that specific
precautions are taken and the necessary validation made. The manufacture of technical poisons,
such as pesticides and herbicides, should not be allowed in premises used for the manufacture of
medicinal products.
As can be observed that requirement is for certain hormones.
Canadian GMP:
11. Prevention of cross-contamination druring manufacturing is the responsibility of the
fabricator and packager. They must demonstrate that the premises are designed in such a manner
that the risk of cross-contamination between products is minimized.
11.1 In order to minimize the risk of a serious health hazard due to cross-contamination,
additional controls, including the need for self-contaiment, should be considered for particular
drugs such as:
-Certain hormones (e.q. estrogen)
-Certain cytotoxic drugs
-other highly active drugs
Factors to consider are the manufacturing process, use of closed systems, dedication of product
contact equipment parts, HVAC controls, engineering controls such as fail safe systems, coupled
with validation and ongoing monitoring using highly sensitive analytical methods.
49
11.2 Campaign production can be accepted where, on a product by product by basis,
proper justification is provided, validation conducted and rigorous, validated controls and
monitoring are in place and demonstrate the minimization of any risk of cross
contamination.
As can be observed tht requirment is for certain hormones, Specifically Canadian cGMP
refers to Estrogens, Further Canadian GMP allows campaign production provided validation
conducted.
Indian cGMP
Schedule M describing GMP & requirements of Premises Plant & equipment for pharmaceuitcal
product, under section 8.2 states as under:
The licensee shall ensure processing or sensitive drugs like Beta-Lactum antibiotics, Sex
hormones and cycotoxic substances in segregated areas or isoliated production areas within the
building with independent air-handling unit and proper pressure differentials. The effective
segregation of these areas shall be demonstrated with adequate records of maintenance and
services.
As can be observed tht requirment is for certain hormones which are sex hormones.
Technical perspective
In order to exercise better control on Steroids, the PPMA Technial Committee members
observed that there should be clarity between the definition of “Anabolic Steroids” and
“Corticosteroids”.
References reveal that in human body, adrenal glands produce an anti-inflammatory steroid
similar to cortisone {corticosteroids}. Simulating human body secretion, synthetic Cortisone are
developed and prescribed to treat asthma, rashes, and various kinds of swelling or inflammation.
Whereas, another kind of steroids are calles anabolic steroids. The term anabolic means building
up of a bodily substance. Anabolic steroids are related to the major sex hormones, which are
produced in both men and women and their synthetic substitutes are uese as supporitve therapy.
Ref. Hormone Abuse Overview, http://www.hormone.org/Abuse/overview.com
Above references cleary state that all Steroids doesn’t fall under the category of “Highly
sensitizing materials”. Furhter, that the Steroids are classified as Corticosteroids (Anti-
50
Inflammatory hormones) and Anabolic Steroids (Sex hormones) and later are requirmed to be
manufactured under special controlled conditions.
Based on above submissions, our recommendations are;
1. That all Steroids do not fall in the category of “Highly sensitizing materials”
2. Anabolic/Sex hormones e.q. Progesterone., Testosteron and Contraceptive hormone
needs special conditions for manufacturing.
3. Corticosteroids, Dexamethasone, Prednisolone and others are used as anti-inflammatory
drugs which are not included in the category of “highly sensitizing materials” as such
should be allowed tomanufacture in general purpose are exercising standard controls to
avoid cross contamination.
4. Since several companies have been granted license to manufracture sex hormones in their
existing facility, campaign manufacturing may be allowed if necessary precautions have
been taken and that future plans for seprate facility are in place.
M/s Sante Pharmaceuticals, Karachi.
1. Drugs (Licensing, Registration & Advertisement) Rules 1976. Schedule B- 5.2.
Dedicated Facility for production states that:
Dedicated and self -contained facilities for the production of particular drugs shell be provided in
addition to general facilities such as highly sensitizing materials ( e.g. penicillin) or biological
preparation (e.g. live microorganism) or cytotoxic substances or veterinary immunological preparations
or sterile products or for that matter such other highly active pharmaceutical products, antibiotics,
hormones as may be identified by the Central Licensing Board at any stage in order to minimize the risk
of serious medical hazard due to cross- contamination. In exceptional cases of emergency, the principal of
campaign working in the same facilities may be allowed by the Central Licensing Board provided that
specific precautions are taken and necessary validations are made.
2. In 195th
Meeting of Central Licensing & Registration Board held on 24th
Nov. 2005 a
presentation was made by PPMA and Pharma Bureau
Item No.3.
Dedicated /Segregated Facilities for Particular Drugs : Detailed history of dedicated facilities was
discussed.
A team of Pharma Bureau and PPMA members presented their view about the matter of segregated
facilities for “Quinolones / Antibiotics (except Beta lactam antibiotics) and psychotropic / Narcotic drugs.
They explained that the dedicated facilities are required for highly sensitizing drugs e.g. Penicillin,
Cephalosporin, and Biological which fall under category A drugs.
51
Decision of Registration Board:
It was decided that the permission to manufacture the Quinolone products will be allowed on the
basis of campaign manufacturing, subject to compliance to the GMP and cGMP regulation.
HVAC system and cleaning validation is mandatory.
3. EU guideline for GMP for Medicinal Products and Veterinary Use Part I Chapter
5:Production
Section 3.6: Production Area states that:
Dedicated facilities are required for manufacturing when a medicinal product present a risk;
a) Which cannot be adequately controlled by operational and/ technical measures.
b) Scientific data does not support threshold values ( e.g. allergic potential from highly sensitizing
materials such as beta lactam) or
c) Threshold values derived from toxicological evaluation are below the level of detection
4. GMP and requirements of Premises, Plant and Equipments of PHARMACEUTICAL
PRODUCTS
PART II-SECTION 3, SUB-SECTION (i)] - Ministry of Health -New Delhi- INDIA
SCHEDULE M. Production area.—
In order to avoid the risk of cross-contamination, separate dedicated and self contained facilities
shall be made available for the production of sensitive pharmaceutical products like penicillin or
biological preparations with live micro-organisms. Separate dedicated facilities shall be provided
for the manufacture of contamination causing and potent products such as Beta lactam, Sex
Hormones and Cytotoxic substances.
5. ICH guideline
“Self-contained facilities shall be made available for the production of highly
sensitive pharmaceutical products like penicillin or biological preparations with live micro-
organisms. Separate dedicated facilities shall be provided for the manufacture of
contamination causing and potent products such as Beta lactam, Sex Hormones and
Cytotoxic substances.”
6. Based on the current guidelines by EU Orange Guide, ICH, WHO, Indian GMP guidelines, Saudi
FDA and others;
“Dedicated facility is required for highly sensitive products like Beta lactam, Sex
Hormones, Cephalosporin and Cytotoxic products”
DEFINITION OF HORMONES
1. Different types of steroid hormones, a class of hormones chemically similar to each other, have
different functions. For example, the adrenal glands produce an anti-inflammatory steroid similar
52
to cortisone. Cortisone may be prescribed to treat asthma, rashes, and various kinds of swelling or
inflammation.
2. The term anabolic means building up of a bodily substance. Anabolic steroids are related to the
major male hormone testosterone, which is produced in the testes in men and in the adrenal
glands in both men and women. These chemicals are recognized for their effects on building up
muscle.
3. Anabolic steroids should not be confused with corticosteroids, which are used routinely as anti-
inflammatory medications to help treat illnesses in which inflammation is part of the disease
process.
4. Steroids include the dietary fat cholesterol, the sex hormones estradiol and testosterone, and the
anti-inflammatory drug Dexamethasone.
5. Steroid: One of a large group of chemical substances classified by a specific carbon structure.
Steroids include drugs used to relieve swelling and inflammation, such as Prednisone and
Cortisone.
IMPACT OF CROSS CONTAMINATION
There are certain categories of hormones
1. Sex Hormones
Sex hormones comes under category A. In category A, Sex hormones like progesterone (female
sex hormone), testosterone (male sex hormone) contraceptive hormones (estrogens). They fall
under “Highly sensitizing materials” where cross contamination in very less quantity (microgram)
can cause risk of serious health hazard. The cross contamination of male sex hormone with in a
manufacturing process can produce changes in the secondary behavior in female like extra hair
growth, voice change etc. and vice versa female sex hormone cross contamination during
manufacturing operation can cause serious health hazard like diminishing of sexual desire,
enlargement of mammary glands etc. therefore in order to minimize the risk of serious health
hazard due to cross contamination addition control during manufacturing operation, used of
closed system, dedicated product contact equipment parts, HVAC control are necessary.
2. Anabolic Steroids
They also fall in category A and are those used for muscle building weight gain and weak
anabolic activities. Same principal followed during the manufacturing operation for cross
contamination.
3. Corticosteroids (Dexamethasone, Prednisolone & Hydrocortisone)
Corticosteroids should not be confused with sex hormones as they do not fall in category A of
highly sensitive materials and used in topical preparations as anti inflammatory drugs in Eye
preparation, Otic preparation and Eye / Skin Ointments. The cross contamination of
corticosteroids during the manufacturing operation can not impact the same health hazards as sex
hormones even in micro grams quantities hence no dedicated self contained facility is suggested
53
by international guideline agencies like Eur. ICH, and orange guide where they recommend use
of same facility with following instructions on campaign bases and cleaning validation.
RISK ASSESSMENT / ANALYSIS OF CROSS CONTAMINATION DURING
MANUFACTURING OPERATION
What is the risk involved in case a cross contamination of corticosteroids occur during the manufacturing
operation in spite of observing instructions and guidelines provided by the international agencies due to
certain negligence and improper supervision? The quantities of API (Active Pharmaceutical Ingredients
i.e. Dexamethasone, Prednisolone, Mometasone, Betamethasone, and Triamcenolone) is very minute i.e.
in 0.1%, 0.2% up to 0.5%. The entire manufacturing process is wet process, after the dispensing of API it
is transferred to glass jar under Laminar Air Flow hood in a diluent system comprising of HPMC / water
dispersion, then these glass jars with glass beads are placed on Ball Mill to get the desired particle size
finally blend was transferred to main bulk container in liquid form there is no less chances of dust
generation during the process. During the product change over a cleaning validation procedure is
followed by QC who only allows next batch processing after their approval.
There are two strong arguments in favor of using the same facility for steroid and non-steroid
preparations.
1. If there is any risk of health hazard involved due to cross contamination of corticosteroids during
the manufacturing operation the international agencies like European Union (Orange Guide),
WHO and ICH will never recommend the same facility on campaign basis following the cleaning
validation method as in case of sex hormones because corticosteroids are not classified under the
highly sensitizing materials even the cross contamination of corticosteroids cannot impact any
bad health hazard.
2. Currently topical steroid containing preparations are produced in same facility (Non Steroids)
under toll manufacturing agreement for international brands like Allergan, Alcon, Bausch &
Lomb etc. and there audit for facility will also conducted by their corporate office under
international GMP guidelines, who allows them to manufacture steroids and non steroids in the
same facility. So far no adverse drug reaction was reported internationally and nationally which is
due to cross contamination.
CONCLUSION
1. All Steroids do not fall in the category of “Highly sensitizing materials”.
2. Sex hormones e.g. Progesterone, Testosterone and Contraceptive hormone may be classified in
category A.
3. Anabolic Steroids are those used for muscles building and used by weightlifters, wrestlers and
sportsmen may be classified in category A
4. Corticosteroids (Dexamethasone, Prednisolone, Mometasone, Betamethasone, and
Triamcenolone) are used as anti-inflammatory drug and are not potent and highly sensitizing
materials.
54
Corticosteroids do not fall in the category of highly sensitive materials and the companies
like Alcon, Allergan, Bausch & Lomb and many Local Companies are manufacturing eye
drops, ointments, creams etc. containing steroids like Dexamethasone, Prednisolone,
Mometasone, Betamethasone and Triamcenolone in the same facility with following the
instructions on campaign basis.
MANUFACTURING OF EYE DROPS, OINTMENT & CREAMS
In eye drops the entire manufacturing method is wet process except dispensing of materials.
The concentration of steroids in Topical and Tropical preparations
Ophthalmic Preparation is 0.1 to 0.2 %
Otic Preparations (Drops and Ointments) is 0.1 to 0.2%
The steroids are dispensed in dispensing booth with laminar flow having strong extraction
system.
These steroids are immediately transferred under laminar flow, into glass jars containing a
mixture of water and HPMC
Tightly close Jars are placed on ball mill to reduce the particle size of steroids.
Then ready slurry is transferred into bulk under laminar flow.
Eye Drops, Eye Ointments, Otic Drops and Creams are being manufactured by local manufacturers
having Dexamethasone, Prednisolone, Hydrocortisone in the same manufacturing facility for the last
many years.
Decision: Registration Board discuused comments of its members, stakeholders and
international practices and agreed that for all topical preparations viz. eye / ear preparations,
external preparations (cream / ointment / gel / lotion / spary) and aerosols, steroid
manufacturing may be permitted on campaign manufacturing basis in general manufacturing
areas for these dosage forms provided that manufacturer has segregated dispensing booths,
validation and controls studies for processes and adequate system to minimize any potential
risk of cross contamination. Registration Board decided to forward above recommendation to
Licensing Division for ultimate decision by Central Licensing Board.
Storage requirement of Misoprostol.
- M/s Pfizer Pakistan, Karachi.
There is an obligation to maintain a temperature of -200C and has to kept in an air tight
container.
55
- M/s Rasco Pharma, Lahore.
The firm has provided assessment report (EMA) of misoprostol API which is reproduced as
under:-
Misoprostol, as described in the Ph.Eur., is an only liquid which is very unstable and
difficult to be process into a drug product in liquid form. The stability of misoprostol is
significantly enhanced when it is dispersed in hypromellose. Hence, misoprostol
dispersed in hypromellose is used as an intermediate in the manufacture of misoprostol
tablet. The dispersion consists of a powder that can be stored at 5+3 °C, whereas the
actual active substance is an oily liquid that needs to be stored at -20 °C.
The certificate of analysis of the misoprostol API of the firm shows that the product is
Misoprostol 1% HMPC dispersion (White to off-white powder) and it is to be stored at 2-
8 °C.
Decision: Registration Board deliberated on the matter indetail and keeping in view
EMA’s assessment report decided that as per EMA,s report, Misoprostol 1% HMPC
(processed material) dispersion will be permitted for use in tablet dosage form with
storage condition of 5+3 °C.
Chairman again advised all members, PPMA and Pharma Bureau to forward their
scientific comments and relevant references till 15.01.2015 on manufacturing requirements
for following classes of drugs:
a. Immunosuppresants.
b. Clomiphene and letrozole
c. Prostaglandins and its analogues.
d. Vancomycin
56
Item No. V Registration of drugs – Pharmaceutical Evaluation Cell.
Case No.01. Correction in minutes M-245
S/N Name and
address of
manufacturer /
Applicant
1. Brand Name
2. Dosage Form
3. Composition
4. Pharmacological
group
1. Type of Form
2. Type of
application
3. Demanded
Price / Pack size
4. Initial date,
diary. 5. Date on
which fee
becomes
complete
according to type
of application /or
Form
1.Finished
Product
Specification
2. Facility where
drug has to be
manufactured
with status
whether approved
by CLB or not
3. Last GMP
inspection report
with date &
status.
Decision in
245th
meeting of
the
Registratio
n Board
Correction
required by the
applicant
Decision
1. M/s. Ali Gohar &
Company (Pvt)
Limited, Karachi.
Manufacturer
M/s. Boehringer
Ingelheim Pharma
GmbH & Co. KG,
Located in Binger
Strasse 173,
55216 Ingelheim
am Rhein,
Germany.
Jentadueto
2.5mg/850mg
Tablets
Each Film Coated
Tablets contains:-
Linagliptin…..2.5
mg
Metformin
Hydrochloride…….
850mg
(Drugs used in
Diabetes,
combination of oral
blood glucose
lowering drugs).
Form 5 A
01-07-2013
Rs.50000/-
Rs. 7130/
Per packs of 60
Tablets.
International:
Jantadueto 2.5/850
(FDA)
Local: Me too (M
243)
Approved. The firm
applied for
packs of 10’s &
30’s as under
just before
meeting of
Registration
Board that’s
why it was
missed in
agenda &
minutes.
Rs. 0.9 x 10
USD for 10’s
Rs. 0.9 x 30
USD for 30’s &
Rs. 7130/
Per packs of 60
Tablets.
(Word CIF as
appeared in
firm’s request
was
inadvertantly
missed for 10’s
& 30’s pack
sizes).
The Board
acceded to the
request of the
firm with
approval of
following
price & pack
sizes.
1. Rs. 7130/
Per packs of
60 Tablets.
2. CIF price
for 10’s pack
size:
0.9 x 10 USD
for 10’s
3. CIF price
for 30’s pack
size:
0.9 x 30 USD
for 30’s
57
2. M/s. Ali Gohar &
Company (Pvt)
Limited, Karachi.
Manufacturer
M/s. Boehringer
Ingelheim Pharma
GmbH & Co. KG,
Located in Binger
Strasse 173,
55216 Ingelheim
am Rhein,
Germany.
Jentadueto
2.5mg/1000mg
Tablets
Each Film Coated
Tablets contains:-
Linagliptin…..2.5
mg
Metformin
Hydrochloride…….
1000mg
(Drugs used in
Diabetes,
combination of oral
blood glucose
lowering drugs).
Form 5 A
01-07-2013
Rs.50000/-
Rs.7130/
Per packs of 60
Tablets
International: Jantadueto
2.5/1000 (FDA)
Local: Me too (M
243)
Approved. The firm
applied for
packs of 10’s &
30’s as under
just before
meeting of
Registration
Board that’s
why it was
missed in
agenda &
minutes.
Rs. 0.9 x 10
USD for 10’s
Rs. 0.9 x 30
USD for 30’s &
Rs. 7130/
Per packs of 60
Tablets.
(Word CIF as
appeared in
firm’s request
was
inadvertantly
missed for 10’s
& 30’s pack
sizes).
The Board
acceded to the
request of the
firm with
approval of
following
price & pack
sizes.
1. Rs. 7130/
Per packs of
60 Tablets.
2. CIF price
for 10’s pack
size:
0.9 x 10 USD
for 10’s
3. CIF price
for 30’s pack
size:
0.9 x 30 USD
for 30’s
58
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary
name + Dosage
Form +
Strength)
Composition
Pharmacological
Group
Finished
product
Specification
Type of Form
Initial date,
diary
Fee including
differential
fee
Demanded
Price / Pack
size
Decision of
Previous
Meeting
Remarks on the
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities.
Decision
3. M/s. Medisearch
Pharmacal (Pvt)
ltd, 5-Km,
Raiwind Manga
Road, Lahore.
Molus
Dry Suspension
When
reconstituted
Each 5ml
contains:-
Montelukast
Sodium…..5mg
(anti-asthmatic)
(Manufacturer’s
Spec.s)
Form-5
20-12-
2013(1308)
Rs.20,000/-
As per
SRO/60ml
Approved.
Letter will be
issued after
rectification
of
shortcomings.
(M-243)
The Formulation
was erroneously
approved by the
Drug Registration
Board. This
Formulation is
under review by the
Review Committee.
Deferred till
review of
formulation by
Review
Committee.
4. M/s Allmed Pvt.
Ltd.
(Formerly,
EverGreen
Pharmaceuticals,
Pvt. Ltd.
Plot.No.590,
Sundar Industrial
Estate Lahore.
Reevo Tablets
Each tablet
contains:
Levocarnitin……
………….250mg
(Aminoacid
derivative/suppli
ment)
Form5
06-08-2010
Rs.8000/-
11-10-2012
Rs.12,000/-
Rs.350/10’s
Deferred for
confirmation of
pharmacologic
al group as
applied by
firm.
(M-244)
Initially the Firm
had applied for Levocarnitine………
……250mg per
Tablet formulation on
Form 5. Before the
formation of
Pharmaceutical
Evaluation Cell some
Registration
applications were
sent to various DRAP
officers for
evaluation including
this one. Agenda of
these applications
was prepared for M-
Deferred for the
following:
1) Fee for
application on
Form 5D for 330
mg Tablet
strength.
2) Evaluation of
Form 5D.
3) Confirmation of
pharmacological
group as applied
by the firm.
59
242 but could not be
discussed. Later on
the Firm submitted
Form 5-D for this
formulation and
changed the
formulation to
Levocarnitine…330m
g mg per Tablet. The
left over agenda of
M-244 was discussed
in M-244 but the
change was not
incorporated. The
Registration Board
considered the
formulation as
Levocarnitine…250m
g per Tablet and
deffered it merely for
confirmation of
pharmacological
group as applied by
firm. Registration
Board may ask the
firm to submit the
firm to submit
differential fee
required for
application on Form
5-D and evaluate the
application
accordingly.
60
Evaluator – III
Case No.02. Registration of a Patent Drug – Iodine Complex
M/s MTI Medical (Pvt) Limited Lahore has informed that they have developed Iodine complex
molecule in their Research & Development Laboratories and the said molecule has been awarded patent in
Pakistan. The firm submitted that they have conducted preclinical studies in UVAS (University of Veterinary
& Animal sciences, Lahore) and human studies in different teaching hospitals in Pakistan. Results of these
studies have been published in international and national journals which show that addition of iodine complex
with standard therapy of Hepatitis gives significant results.
S/N
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological Group (as
submitted by the firm)
Finished product Specification
Type of Form
Initial date, diary
Fee including differential fee
Demanded Price / Pack size
1. IODIRIN Tablets
200mcg
Each tablet contains:
Iodine complex equivalent to
elemental Iodine…….200mcg
Iodine deficiency disorder/
Antithyroid
Manufacturer
Form-5E
23-10-14 Dy. No: 1271
50,000/-
Not provided
2. IDOMARINE Capsules
50mg
Each capsule contains:
Iodine complex equivalent to
elemental Iodine…….50mg
Iodine deficiency disorder/
Antithyroid/ Immunomodulator
Manufacturer
Form-5E
23-10-14 Dy. No: 1271
50,000/-
Not provided
3. RENESSANS Capsule
200mg
Each capsule contains:
Iodine complex equivalent to
elemental Iodine…….200mg
Antiviral/ Hepatic Preps/
Antithyroid/ Immunomodulator
Form-5E
23-10-14 Dy. No: 1271
50,000/-
Not provided
61
The firm has also claimed that the above mentioned molecule is a major breakthrough avoiding and
treating some deadly diseases and diseases due to iodine deficiency, therefore requested to register the drug on
fast track basis in public interest. In this regard, they have submitted registration applications on Form-5 E in
different dosage forms. Details of which are tabulated below.
2. The request of the firm has been evaluated / assessed by the cell. Prima facie the following
observations have been noticed:
a. The applicant has been granted patent for the said molecule named as “Iodine Complex” for cure
against Hepatitis C. Here, the question arises that whether patent is valid for purpose of getting
the registration for a patent drug or not.
b. The application has been filed on Form 5-E for the purpose of registration of a patent drug and
currently the Pharmaceutical Evaluation Cell has no approved check list for the said form. There
are many clauses of the said form wherein the applicant is unable to answer properly. Evaluation
reports clearly depicts the same.
c. The Safety & Efficacy aspects of the drug are important to be evaluated in the instant case (being
new molecule not else- where approved in the world). At present, the Cell for the said purpose
(especially in cases of new drug molecule), relies on the approvals by the Stringent or Reference
Drug Regulatory Agencies of the world like USFDA, EMA, TGA, Health Canada & PMDA
Japan etc. While the drug under discussion has no such approval from any of the drug regulatory
agency in the world.
5. In the light of the above observations, the case was handed over to Pharmacy Services Division, who has
taken up the case. The said Division has forwarded the submitted clinical trial data / research publication
of the applicant to the Executive Director of PMRC for the validity of the trials / research conducted.
Their reply is awaited. The case is therefore, placed for consideration before Registration Board.
Decision: Dr. Muhammad Ajmal and his team appeared and presented before the Board
about development of above formulations and results of clinical trials conducted on the above
formulations. Registration Board then directed the applicant to provide all the documents
Manufacturer
4. RENESSANS
Suspension 15mg/ 5ml
Each 5ml contains:
Iodine complex equivalent to
elemental Iodine…….15mg
Antiviral/ Hepatic Preps/
Antithyroid/ Immunomodulator
Manufacturer
Form-5E
23-10-14 Dy. No: 1271
50,000/-
Not provided
62
related to development of formulations and their clinical studies for confirmation of safety and
efficacy Prof. Dr. Muzammil H.Najmi, Member Registration Board for further evaluation.
Recommendations / views the expert will be considered by the Board for further processing of
case.
Case No.03. Grant of registrations of newly approved DMLs (Drug Manufacturing Licenses).
Evaluator – II
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date, diary
Fee including
differential fee
Demanded Price /
Pack size
Remarks on the
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
Decision
1. M/s Sigma
Pharma
International Pvt.
Limited E-50,
N.W.I.Z., Port
Qasim Karachi
(Tablet General:
No. F.6-6/2014-
Lic (M-237 dated
17-10-2014)
Klar 250mg Tablet
Each film coated Tablet
contains:-
Clarithromycin(USP)…
250mg
(Macrolide Antibiotic)
(USP Spec,s)
Form 5
17-11-2014 (232)
Rs. 20,000/-
As Per SRO/
Pack 10’s
BNF: Klaricid
(Abbott Healthcare)
Claritek 250mg Tablet
Getz Pharma Pvt. Ltd.
Karachi
New Licensee
Approved
2. -do- Klar 500mg Tablet
Each film coated Tablet
contains:-
Clarithromycin(USP)…
500mg
Form 5
17-11-2014(228)
Rs. 20,000/-
As Per SRO/
BNF: Klaricid
(Abbott Healthcare)
Claritek 250mg Tablet
Getz Pharma Pvt. Ltd.
Karachi
Approved
63
(Macrolide Antibiotic)
(USP Spec,s)
Pack 10’s
New Licensee
3. -do- Monti 10mg Tablet
Each film coated Tablet
contains:-
Montelukast Sodium as
Montelukast…10mg
(Bronchodilators &
Anti-asthma
(Leukotriene
antagonist))
(Manufacturer’s Spec.s)
Form 5
17-11-2014(229)
Rs. 20,000/-
As Per SRO/
Pack 14’s
Singulair 10mg
Tablet of Merck & Co.
Inc. USA
Myteka 10mg Tablet
Hilton Pharma Pvt.
Ltd. Karachi
New Licensee
Approved
4. -do- Cip 250mg Tablet
Each film coated Tablet
contains:-Ciprofloxacin
as Ciprofloxacin
HCl…250mg
(Quinolones Antibiotic)
(B.P Spec,s)
Form 5
17-11-2014(235)
Rs. 20,000/-
As Per SRO/
Pack 10’s
CIPROXIN 250mg
Tablet Bayer Australia
Limited
GETCIPRO 250mg
Tablet Getz Pharma
(Pvt.) Ltd. Karachi
New Licensee
Approved
5. -do- Cip 500mg Tablet
Each film coated Tablet
contains:-Ciprofloxacin
as Ciprofloxacin
HCl…500mg
(Quinolones Antibiotic)
(B.P Spec,s)
Form 5
17-11-2014
Rs. 20,000/-
As Per SRO/
Pack 10’s
CIPROXIN 500mg
Tablet Bayer Australia
Limited
GETCIPRO 500mg
Tablet Getz Pharma
(Pvt.) Ltd. Karachi
New Licensee
Approved
6. -do- Levof 250mg Tablet
Each film coated Tablet
contains:-
Levofloxacin (as
hemihydrate)…250mg
(Quinolones Antibiotic)
(USP Spec,s)
Form 5
17-11-2014(234)
Rs. 20,000/-
As Per SRO/
Pack 10’s
LEVAQUIN 250mg
Tablet Janssen Pharma
USA
LEFLOX 250mg
Tablet Getz Pharma
(Pvt.) Ltd Karachi
New Licensee
Approved
7. -do- Levof DS 500mg Tablet
Each film coated Tablet
contains:-
Levofloxacin (as
hemihydrate)…500mg
Form 5
17-11-2014(233)
Rs. 20,000/-
As Per SRO/
Pack 10’s
LEVAQUIN 500mg
Tablet Janssen Pharma
USA
LEFLOX 500mg
Approved
64
(Quinolones Antibiotic)
(USP Spec,s)
Tablet Getz Pharma
(Pvt.) Ltd Karachi
New Licensee
8. -do- Moxif 400mg Tablet
Each film coated Tablet
contains:-
Moxifloxacin (as
Moxifloxacin
HCl)…400mg
(Quinolones Antibiotic)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(237)
Rs. 20,000/-
As Per SRO/
Pack 5’s
VIGAMOX 400mg
Tablet Alcon Lab,
USA
MOXIGET 400mg
Tablet Getz Pharma
(Pvt.) Ltd.
New Licensee
Approved
9. -do- Mecob 500mcg Tablet
Each sugar coated
Tablet contains:-
Mecobalamin
(JP)…500mcg
(Co-enzyme Vitamin
B12)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(230)
Rs. 20,000/-
As Per SRO/
Pack 20’s
50’s & 100’s
METHYCOBAL
500mcg Tablet Eisai
Co Ltd. JAPAN
METHYCOBAL
500mcg Tablet Hilton
Pharma (Pvt.) Ltd
Karachi
New Licensee
Approved
10. -do- Trump 37.5/325mg
Tablet
Each film coated Tablet
contains:-
Tramadol HCl…37.5mg
Paracetamol…325mg
(Opiate
analogue/analgesic )
(USP Spec,s)
Form 5
17-11-2014(231)
Rs. 20,000/-
As Per SRO/
Pack 10’s
BNF: Tramacet
(Gru¨nenthal)
TONOFLEX Tablet
Sami Pharmaceuticals
Karachi
New Licensee
Approved
11. M/s Sigma
Pharma
International Pvt.
Limited E-50,
N.W.I.Z., Port
Qasim Karachi
(Capsule General:
No. F.6-6/2014-
Lic (M-237 dated
17-10-2014)
Coxib 200mg Capsule
Each Capsule Contains:-
Celecoxib…200mg
(Cox-2 Inhibitor)
(Manufacturer’s Spec.s)
Form 5
17-11-2014 (196)
Rs. 20,000/-
As Per SRO/
Pack 20’s
CELEBREX 200mg
Capsule of Pfizer
Laboratories USA
CELBEX 200mg
Capsule Getz Pharma
Pvt. Ltd. Karachi
New Licensee
Approved
65
12. -do- Coxib 100mg Capsule
Each Capsule Contains:-
Celecoxib…100mg
(Cox-2 Inhibitor)
(Manufacturer’s Spec.s)
Form 5
18-11-2014(Nil)
Rs. 20,000/-
As Per SRO/
Pack 20’s
CELEBREX 100mg
Capsule of Pfizer
Laboratories USA
CELBEX 100mg
Capsule Getz Pharma
Pvt. Ltd. Karachi
New Licensee
Approved
13. -do- Profile 20mg Capsule
Each Capsule Contains:-
Omeprazole enteric
coated Pellets 8.5%
equivalent to
Omeprazole…20mg
(Source of Pellets:
M/s Titan Laboratories
Private Limited Plot No.
E27/1, E27/2, MIDC,
Mahad Village Jite
District, Raigad,
Maharashtra, India) (Proton pump inhibitor)
(Manufacturer’s Spec.s)
Form 5
17-11-2014 (192)
Rs. 100,000/-
As Per SRO/
Pack 14’s
BNF: Losec
(AstraZeneca)
RISEK 20mg Capsule
Getz Pharma (Pvt.)
Ltd
New Licensee
1. Original Legalized
Copy of Valid
GMP certificate of
manufacturer of
Pellets is required.
Approved. Firm will
provide legalized
GMP of the
manufacturer of
pellets and then
registration letter will
be issued after
approval of Chairman,
RB.
14. -do- Profile 40mg Capsule
Each Capsule Contains:-
Omeprazole enteric
coated Pellets 8.5%
equivalent to
Omeprazole…40mg
(Source of Pellets:
M/s Titan Laboratories
Private Limited Plot No.
E27/1, E27/2, MIDC,
Mahad Village Jite
District, Raigad,
Maharashtra, India) (Proton pump inhibitor)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(193)
Rs. 100,000/-
As Per SRO/
Pack 14’s
BNF: Losec
(AstraZeneca)
RISEK 40mg Capsule
Getz Pharma (Pvt.)
Ltd
New Licensee
1. Original Legalized
Copy of Valid
GMP certificate of
manufacturer of
Pellets is required.
Approved. Firm will
provide legalized
GMP of the
manufacturer of
pellets and then
registration letter will
be issued after
approval of Chairman,
RB.
66
15. -do- Somep 40mg Capsule
Each Capsule Contains:-
Esomeprazole enteric
coated Pellets 22.50%
equivalent to
Esomeprazole…40mg
(Source of Pellets:
M/s Titan Laboratories
Private Limited Plot No.
E27/1, E27/2, MIDC,
Mahad Village Jite
District, Raigad,
Maharashtra, India)
(Proton pump inhibitor)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(191)
Rs. 100,000/-
As Per SRO/
Pack 14’s
NEXIUM 40mg
Capsule AstraZeneca
E-CAP 40mg
Capsule Brookes
Pharmaceutical
Laboratories
New Licensee
1. Original Legalized
Copy of Valid
GMP certificate of
manufacturer of
Pellets is required.
Approved. Firm will
provide legalized
GMP of the
manufacturer of
pellets and then
registration letter will
be issued after
approval of Chairman,
RB.
16. -do- Somep 20mg Capsule
Each Capsule Contains:-
Esomeprazole enteric
coated Pellets 22.50%
equivalent to
Esomeprazole…20mg
(Source of Pellets:
M/s Titan Laboratories
Private Limited Plot No.
E27/1, E27/2, MIDC,
Mahad Village Jite
District, Raigad,
Maharashtra, India)
(Proton pump inhibitor)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(190)
Rs. 100,000/-
As Per SRO/
Pack 14’s
NEXIUM 40mg
Capsule AstraZeneca
E-CAP 40mg
Capsule Brookes
Pharmaceutical
Laboratories
New Licensee
1. Original Legalized
Copy of Valid
GMP certificate of
manufacturer of
Pellets is required.
Approved. Firm will
provide legalized
GMP of the
manufacturer of
pellets and then
registration letter will
be issued after
approval of Chairman,
RB.
17. -do- Zith 250mg Capsule
Each Capsule contains:-
Azithromycin (as
Dihydrate)…250mg
(Macrolide Antibiotic)
(USP Spec,s)
Form 5
17-11-2014(194)
Rs. 20,000/-
As Per SRO/
Pack 6's & 10's
ZITHROMAX 250mg
Capsule Pfizer
Laboratories
ZETRO 250mg
Capsule Getz Pharma
(Pvt.) Ltd.
New Licensee
Approved
67
18. -do- Malrid Capsule
Each Capsule contains:-
Dihydroartemisinin…
40mg
Piperaquine
Phosphate… 320mg
(Anti-Malarial)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(195)
Rs. 20,000/-
As Per SRO/
Pack 8's
Not confirmed
DIPIP 40/320mg
Capsule Hilton
Pharma (Pvt.) Ltd
New Licensee
1. Availability in
SRA’s not
confirmed. Firm
has provided
international
availability in
Italy.
Deferred for views of
recommendations of
WHO.
19. -do- Tranex 500mg Capsule
Each Capsule contains:-
Tranexamic
Acid…500mg
(Haemostatic/
Fibrinolytic)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(197)
Rs. 20,000/-
As Per SRO/
Pack 20's & 100's
Not confirmed
XED 500mg Capsule
Indus Pharma
New Licensee
1. Availability in
SRA’s not
confirmed. Firm
has provided
international
availability in
Bangladesh.
Deferred for
confirmation of
formulation / strength
whether approved in
reference Stringent
Regulatory Agencies
or not.
20. -do- Flucap 150mg Capsule
Each Capsule contains:-
Fluconazole …150mg
(Antifungal)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(198)
Rs. 20,000/-
As Per SRO/
Pack 1's
CANESTEN 150mg
Capsule Bayer
Healthcare
FLUDERM 150mg
Capsule Nabiqasim
Industries (Pvt.) Ltd
New Licensee
Approved.
68
21. M/s Sigma
Pharma
International Pvt.
Limited E-50,
N.W.I.Z., Port
Qasim Karachi
(Sachet General:
No. F.6-6/2014-
Lic (M-237 dated
17-10-2014)
Onitum 2gm Sachet
Each Sachet contains:-
Strontium Ranelate… 2g
(Anti-osteoporotic)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(204)
Rs. 20,000/-
As Per SRO/
Pack 7’s
PROTELOS Sachet
Les Laboratoires
Servier Industrie
ONITA Sachet
PharmEVO
New Licensee
Approved.
22. -do- Monti 4mg Sachet
Each Sachet contains:-
Montelukast Sodium
equivalent to
Montelukast 4mg
(Bronchodilators &
Anti-asthma
(Leukotriene antagonist)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(218)
Rs. 20,000/-
As Per SRO/
Pack 14’s
Singulair (MSD
MONTIKA 4mg
Sachet Sami
Pharmaceutical (Pvt.)
Ltd
New Licensee
Approved.
23. -do- Malrid 15/120mg Sachet
Each Sachet contains:-
Dihydroartemisinin…
15mg
Piperaquine Phosphate
…120mg
(Anti-Malarial)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(206)
Rs. 20,000/-
As Per SRO/
Pack 16’s
Not confirmed
ARMIQIN Sachet
PharmEVO
New Licensee
1. Availability in
SRA’s not
confirmed. Firm
has provided
international
availability in
Taiwan
Deferred for views of
recommendations of
WHO.
24. -do- Citrosalt 4mg Sachet
Each Sachet contains:-
Sodium Bicarbonate…
1.716gm Sodium Citrate
Anhydrous… 0.613gm
Citric Acid
Anhydrous…0.702gm
Tartaric Acid…
0.856gm
(Antacids, Anti-
flatulents)
Form 5
17-11-2014(217)
Rs. 20,000/-
As Per SRO/
Pack 20’s & 100’s
Not confirmed
CITRO SODA Sachet
Abbott Laboratories,
Pakistan
New Licensee
1. Availability in
SRA’s not
Deferred for
confirmation of
approval in reference
Stringent Regulatory
Agencies.
69
(Manufacturer’s Spec.s) confirmed. Firm
has provided
international
availability in
India.
25. -do- Profile 20mg Sachet
Each Sachet contains:-
Omeprazole… 20mg
Sodium Bicarbonate…
1680mg
(Proton pump
inhibitor/antacid)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(206)
Rs. 20,000/-
As Per SRO/
Pack 10’s
FDA: Zegerid
RISEK INSTA
Powder 20mg Sachet
Getz Pharma (Pvt.)
Ltd
New Licensee
1. Formulation is
under review by
the Review
Committee of
DRB.
Deferred till review of
formulation by
Review Committee.
26. -do- Profile 40mg Sachet
Each Sachet contains:-
Omeprazole… 40mg
Sodium Bicarbonate
…1680mg
(Proton pump
inhibitor/antacid)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(212)
Rs. 20,000/-
As Per SRO/
Pack 10’s
FDA: Zegerid
RISEK INSTA
Powder 40mg Sachet
Getz Pharma (Pvt.)
Ltd
New Licensee
1. Formulation is
under review by
the Review
Committee of
DRB.
Deferred till review of
formulation by
Review Committee.
27. -do- ORES Sachet
Each Sachet contains:-
Sodium Chloride… 2.6g
Sodium Citrate…2.9g
Potassium Chloride…
1.50g
Glucose Anhydrous…
13.50g
(Electrolytes)
Form 5
17-11-2014(213)
Rs. 20,000/-
As Per SRO/
Pack 20's
BNF: Oral
Rehydration Salts
(Non-proprietary)
WHO Formulation
OEM Sachet Indus
Pharma Pvt. Ltd.
New Licensee
Approved.
70
(BP Spec,s)
28. -do- Cysteine Sachet
Each Sachet contains:-
Acetylcysteine …200mg
(Mucolytic Agent)
(Manufacturer’s Spec.s)
Form 5
17-11-2014 (210)
Rs. 20,000/-
As Per SRO/
Pack 30’s
Not confirmed (ACC
Sandoz Switzerland by
Firm)
MUCOLATOR
200mg Sachet Abbott
Laboratories
(Pakistan) Ltd
New Licensee
1. Availability in
SRA’s not
confirmed. Firm
has provided
international
availability in
Switzerland.
Deferred for
confirmation of
approval in reference
Stringent Regulatory
Agencies.
29. -do- Laxit Sachet
Each Sachet contains:-
Polyethylene Glycol
3350… 13.125g
Sodium Chloride…
0.3507g
Sodium Bicarbonate…
0.1785g
Potassium chloride…
0.0466g
(Laxatives)
(Manufacturer’s Spec’s)
Form 5
17-11-2014 (211)
Rs. 20,000/-
As Per SRO/
Pack 10’s
Not confirmed
MOVCOL Sachet
Genix Pharma Private
Limited
New Licensee
1. Availability in
SRA’s not
confirmed in same
strength.
Approved as it is BNF
approved formulation
30. -do- Gastolyte Sachet
Each Sachet contains:-
Rice Powder …6g
Sodium Citrate
…0.580g Sodium
Chloride …0.350g
Potassium Chloride…
0.3g
(Electrolytes)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(216)
Rs. 20,000/-
As Per SRO/
Pack
1 x 10’s
BNF: Dioralyte Relief
(Sanofi-Aventis)
GASTROLYTE
Sachet Sanofi-Aventis
Pakistan Limited
New Licensee
Approved.
71
31. M/s Sigma
Pharma
International Pvt.
Limited E-50,
N.W.I.Z., Port
Qasim Karachi
(Oral Dry Powder
Suspension
General: No. F.6-
6/2014-Lic (M-
237 dated 17-10-
2014)
Klar 125mg/5ml Dry
Suspnsion
Each 5ml contains:-
Clarithromycin…125mg
(Macrolide Antibiotic)
(USP Spec.s)
{Source of
Clarithromycin taste
masked Granules:
M/s Surge Lab10th KM
Faisalabad road
Sheikhupura}
Form 5
17-11-2014(222)
Rs. 20,000/-
As Per SRO/
Pack 30ml & 60ml
BNF . Klaricid
(Abbott)
(Klaricid (Abbott))
New Licensee
Approved
32. -do- Klar 250mg/5ml Dry
Suspnsion
Each 5ml contains:-
Clarithromycin…250mg
(Macrolide Antibiotic)
(USP Spec.s)
{Source of
Clarithromycin taste
masked Granules:
M/s Surge Lab10th KM
Faisalabad road
Sheikhupura}
Form 5
17-11-2014(223)
Rs. 20,000/-
As Per SRO/
Pack 60ml
BNF . Klaricid
(Abbott)
(Klaricid (Abbott))
New Licensee
Stability studies of
zone IV-A of
granules
Valid GMP
certificate.
Approved
33. -do- Fantin 15mg/90mg/5ml
Dry Suspnsion
Each 5ml contains:-
Artemether… 15mg
Lumefantrine… 90mg
(Antimalarial )
(Manufacturer’s Spec.s)
Form 5
17-11-2014(225)
Rs. 20,000/-
As Per SRO/
Pack 15ml
30ml & 60ml
ATRENAM
15/90mg/5ml Dry
Suspension Areneco
Pharma Belgium
ARTHEGET
15/90mg/5ml Dry
Suspension Getz
Pharma (Pvt.) Ltd.
Karachi
New Licensee
Approved.
34. -do- Fantin DS
30mg/180mg/5ml
Dry Suspnsion
Each 5ml contains:-
Artemether… 30mg
Form 5
17-11-2014(221)
Rs. 20,000/-
As Per SRO/
ATRENAM
30/180mg/5ml Dry
Suspension Areneco
Pharma
Approved.
72
Lumefantrine… 180mg
(Antimalarial )
(Manufacturer’s Spec.s)
Pack 30ml & 60ml Belgium ARTHEGET
30/180mg/5ml Dry
Suspension Getz
Pharma (Pvt.) Ltd.
Karachi
New Licensee
35. -do- Cip 250mg/5ml
Dry Suspnsion
Each 5ml contains:-
Ciprofloxacin (as
Ciprofloxacin HCl
Monohydrate) 250mg
( Quinolones Antibiotic
)
(Manufacturer’s Spec.s)
Form 5
17-11-2014(220)
Rs. 20,000/-
As Per SRO/
Pack 60ml
CIPROXIN Bayer
(Formulation is
different)
HIFLOX Hilton
Pharma (Pvt.) Ltd
Karachi
New Licensee
1. Formualtion is
under review by
the Review
Committee of
DRB.
Deferred till review of
formulation by
Review Committee
36. -do- Zith 200mg/5ml
Dry Suspnsion
Each 5ml contains:-
Azithromycin (as
Azithromycin
Dihydrate)…200mg
(Macrolide Antibiotic )
(USP Spec.s)
Form 5
17-11-2014(224)
Rs. 20,000/-
As Per SRO/
Pack 15ml, 22.5ml,
25ml, 30ml, &
60ml
BNF: Zithromax
(Pfizer)
ZETRO Getz Pharma
(Pvt.) Ltd Karachi.
New Licensee
Approved.
37. -do- Eryt 200mg/5ml
Dry Suspnsion
Each 5ml contains:-
Erythromycin Ethyl
succinate Monohydrate
equivalent to
Erythromycin… 200mg
( Macrolide Antibiotic
)
(USP Spec.s)
Form 5
17-11-2014(225)
Rs. 20,000/-
As Per SRO/
Pack 60ml
Not confirmed
ERYTHROCIN Indus
Pharma Karachi.
New Licensee
1. Availability in
same strength in
SRA’s not
confirmed. Firm
has provided
international
availability in
Deferred for
confirmation of
formulation approval
in reference Stringent
Regulatory Agencies
73
Jordan.
38. -do- Fosil 250mg/5ml
Dry Suspnsion
Each 5ml contains:-
Fosfomycin (as
Fosfomycin
Calcium)…250mg
(Anti Bacterial Agent )
(Manufacturer’s Spec.s)
Form 5
17-11-2014 (219)
Rs. 20,000/-
As Per SRO/
Pack 60ml
FOSFOCINA
Laboratories ERN,
Spain
MIFOS 250mg/5ml
Dry Suspension
Remington Pharma
Lahore
New Licensee
1. Availability in
same strength in
SRA’s not
confirmed. Firm
has provided
international
availability in
Spain.
Deferred for
confirmation of
formulation approval
in reference Stringent
Regulatory Agencies
39. -do- Flucap 50mg/5ml
Dry Suspnsion
Each 5ml contains:-
Fluconazole…50mg
(Antifungal)
(USP Spec.s)
Form 5
17-11-2014(227)
Rs. 20,000/-
As Per SRO/
Pack 35ml
BNF: Diflucan
(Pfizer)
FLUCANOL
50mg/5ml Dry
Suspension Rock
Pharma Nawshehra
New Licensee
Approved.
40. -do- Linz 100mg/5ml
Dry Suspnsion
Each 5ml contains:-
Linezolid 100mg
(Antibacterial )
(Manufacturer’s Spec.s)
Form 5
20-11-2014(Nil)
Rs. 20,000/-
As Per SRO/
Pack 60ml
BNF:
Zyvox(Pharmacia)
NEZOCIN
100mg/5ml Dry
Suspension Brookes
Pharma (Private)
Limited
New Licensee
Approved.
74
Evaluator – III
S/N Name and
address of
manufacturer
/ Applicant
Brand Name
(Proprietary name +
Dosage Form + Strength)
Composition
Pharmacological Group
Finished product
Specification
Type of Form
Initial date,
diary
Fee including
differential fee
Demanded Price
/ Pack size
Remarks on the
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
Recommendations
by the Evaluator
41. M/s MTI
Medical (Pvt)
Limited, 586-
587 Sunder
Industrial
Estate,
Raiwind Road
Lahore.
(Tablet
General)
LOFAMIN Tablet 250mg
Each film coated tablet
contains:
Levofloxacin as
hemihydarte…..250mg
Fluoroquinolone
Manufacture
Form-5
Dy No: 1258
dated 20-10-2014
20,000/-
As per SRO/
Pack of 10’s
Levaquin Tablet of
Janssen Pharms
(USFDA)
Leflox of Getz
Karachi.
The CLB in its 236th
meeting approved the
grant of DML by the
way of formulation
with sections namely:
a. Oral Liquid
General
b. Tablet General
c. Capsule General
d. Oral Dry Powder
suspension
General
Approved.
42. -do- LOFAMIN Tablet 500mg
Each film coated tablet
contains:
Levofloxacin as
hemihydarte…..500mg
Fluoroquinolone
Manufacture
Form-5
Dy No: 1262
dated 20-10-2014
20,000/-
As per SRO/
Pack of 10’s
Levaquin Tablet of
Janssen Pharms
(USFDA)
Leflox of Getz
Karachi.
Approved.
75
43. -do- TEMURIN Tablet 100mg
Each chewable tablet
contains:
Iron III Hydroxide
Polymatose Complex
equivalent to elemental
Iron…..100mg
Anti- Anemic
Manufacturer
(Word film coated has been
replaced with chewable as
firm applied as chewable)
Form-5
Dy No: 1018
dated 26-09-2014
20,000/-
As per SRO/
Pack of 1x10’s,
2x10’s
International
availability requires
confirmation.
Rubifer Chewable
Tablets of AGP (Pvt)
Limited, Karachi.
Approved.
44. -do- TEMURIN-F Tablet 100mg
Each chewable tablet
contains:
Iron III Hydroxide
Polymaltose Complex
equivalent to elemental
Iron…..100mg
Folic acid……0.35mg
Anti- Anemic
Manufacturer
(Word film coated has been
replaced with chewable as
firm applied as chewable)
Form-5
Dy No: 1261
dated 20-10-2014
20,000/-
As per SRO
Pack of 1x10’s,
2x10’s
International
availability requires
confirmation.
Rubifer-F Chewable
Tablet of AGP (Pvt)
Limited Karachi.
Deferred for product
specific inspection by
panel comprising of
Director DTL &
Area FID
45. -do- CYTO Tablet 250mg
Each film coated tablet
contains:-
Ciprofloxacin as
hydrochloride….250mg
Fluoroquinolone
BP
Form-5
Dy No: 1019
dated 26-09-2014
20,000/-
As per SRO
1x10’s
Cipro of Bayer Health
Care
Cipro of Bayer Health
Care Karachi
Approved.
76
46. -do- CYTO Tablet 500mg
Each film coated tablet
contains:-
Ciprofloxacin as
hydrochloride….500mg
Fluoroquinolone
BP
Form-5
Dy No: 1017
dated 26-09-2014
20,000/-
As per SRO/
Pack of 1x10’s
Cipro of Bayer Health
Care
Cipro of Bayer Health
Care Karachi
Approved.
47. -do- PRIZO Tablets 100mg
Each film coated tablet
contains:-
Flurbiprofen…..100mg
Cyclo-oxygenase Inhibitor,
Analgesic, Anti-
inflammatory
BP
Form-5
Dy No: 1054
dated 26-09-2014
20,000/-
As per SRO/
Pack of 3x10’s
Ansaid of Pharmacia
(USFDA)
Ansaid of Pfizer
Karachi
Approved.
48. -do- OSTIM Tablets 50mg
Each film coated tablet
contains:
Clomiphene Citrate…..50mg
Antioestrogen
USP
Form-5
Dy No: 1020
dated 26-09-2014
20,000/-
As per SRO/
Pack of 1x10’s,
2x10’s and
3x10’s
Serophene of EMD
Serno (USFDA)
Cerophene of Hilton
Pharma Karachi.
Deferred till decision
on the manufacturing
requirement for this
product.
49. -do- MOZEX Tablet 400mg
Each film coated tablet
contains:
Moxifloxacin as
HCL….400mg
Fluoroquinolone
Manufacturer
(Word film coated has been
omitted in the agenda so has
been added in the minutes)
Form-5
Dy No: 1046
dated 26-09-2014
20,000/-
As per SRO/
Pack of 5’s
Avelox Tablet of
Bayer Health Care
Avelox of Bayer
Health Care Karachi
Approved.
77
50. -do-
(Capsule
General)
ESTO Capsules 20mg
Each capsules contains:-
Esomeprazole Magnesium
Trihydrate enteric coated
pellets (22.5%) equivalent to
Esomeprazole……20mg
PPI
Manufacturer
Source: M/s Vision
Pharmaceuticals, Islamabad.
Form-5
Dy No: 1047
dated 26-09-2014
20,000/-
As per SRO/
1x10’s & 1x7’s
Nexium of
AstraZeneca USFDA
Esso Capsules of
Shaigan
Pharmaceuticals,
Islamabad.
Approved.
51. -do- ESTO Capsules 40mg
Each capsules contains:-
Esomeprazole Magnesium
Trihydrate enteric coated
pellets (22.5%) equivalent to
Esomeprazole………40mg
PPI
Manufacturer
Source: M/s Vision
Pharmaceuticals, Islamabad.
Form-5
Dy No: 1048
dated 26-09-2014
20,000/-
As per SRO/
1x10’s & 1x14’s
Nexium of
AstraZeneca USFDA
Esso Capsules of
Shaigan
Pharmaceuticals,
Islamabad.
Approved.
52. -do- AZOl Capsules 250mg
Each capsule contains:
Azithromycin as
dihydrate…..250mg
Macrolide
USP
Form-5
Dy No: 1050
dated 26-09-2014
20,000/-
As per SRO/
1x6’s & 1x10’s
Zithromax of Pfizer
(USFDA).
Zithromax of Pfizer
Karachi.
Approved.
53. -do- GRIBOL Capsules 150mg
Each capsule contains:
Fluconazole…..150mg
Antifungal
Manufacturer
Form-5
Dy No: 1260
dated 20-10-2014
20,000/-
As per SRO/
1x4’s
Diflucan of Pfizer
(USFDA)
Diflucan Of Pfizer
Karachi.
Approved.
54. -do- GOTEC Capsules 40mg
Form-5
Prilosec of
AstraZeneca
Approved.
78
Each capsule contains:
Omeprazole enteric coated
pellets (8.5%) equivalent to
Omeprazole ……40mg
PPI
BP
Source: M/s Vision
Pharmaceuticals, Islamabad.
Dy No: 1055
dated 26-09-2014
20,000/-
As per SRO/
1x10’s, 1x14’s
(USFDA)
Risek of Getz Karachi
55. -do- GOTEC Capsules 20mg
Each capsule contains:
Omeprazole enteric coated
pellets (8.5%) equivalent to
Omeprazole ……20mg
PPI
BP
Source: M/s Vision
Pharmaceuticals, Islamabad.
Form-5
Dy No: 1044
dated 26-09-2014
20,000/-
As per SRO/
1x10’s, 1x14’s
Prilosec of
AstraZeneca
(USFDA)
Risek of Getz Karachi
Approved.
56. -do-
Oral liquid
(General)
APRIN Syrup
Each ml contains:
Cetirizine
dihydrochloride ………1mg
Antihistamine
Manufacturer
Form-5
Dy No: 1051
dated 26-09-2014
20,000/-
As per SRO
Pack of 30ml
and 60ml bottle
Benadryl Allergy Oral
Syrup of McNeil
Products UK
Baydal of Bayer
Health Care Karachi.
Approved.
57. -do- APHOLAC Suspension
Each 5ml contains:
Lactulose…..3.35gm
Laxative
BP
Form-5
Dy No: 1052
dated 26-09-2014
20,000/-
As per SRO/
Pack of 120ml &
240ml bottle
Duphalac of Solvay
(USFDA)
Duphalac of Abbot
Pharma, Karachi
Firm has submitted
invoice of purchase of
Refractive Index
detector.
Deferred for:
1. confirmation of
dosage form &
verification of HPLC
equipped with RI
detector by area FID.
2. Fee for import.
3. Legalized GMP of
source.
4. Stability studies.
58. TEMURIN Syrup
Each 5ml contains:
Iron III Hydroxide
Polymatose Complex
Form-5
Dy No: 1053
dated 26-09-2014
Availability in SRA’s
need confirmation
Engfer Syrup of
English Pharma Lahore
Approved.
79
equivalent to elemental
Iron…….50mg
Anti-anemic
Manufacturer
20,000/-
As per SRO/
Pack of 60ml &
120ml bottle
59. -do-
(Oral Dry
Powder
Suspension
General)
AZOL Suspension
Each 5ml contains:
Azithromycin dihydrate
equivalent to Azithromycin
…..200mg
Macrolide
USP
Form-5
Dy No: 1257
dated 20-10-2014
20,000/-
As per SRO/
Pack of 15ml
bottle
Zithromax of Pfizer
(USFDA)
Zithromax of Pfizer
Karachi
Approved.
60. -do- CYTO Suspension
Each 5ml contains:
Ciprofloxacin as HCL taste
masked pellets 25%
equivalent to
Ciprofloxacin..…..250mg
Fluoroquinolone
Manufacturer
Form-5
Dy No: 1259
dated 20-10-2014
20,000/-
As per SRO/
60ml bottle
Not available in
SRA’s
Novidat of Sami
Pharma Karachi
Deferred till review of
formulation by
Review Committee.
Evaluator – III (Veterinary New DML)
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date,
diary
Fee including
differential fee
Demanded Price
/ Pack size
Remarks on the
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
Recommendations
by the Evaluators
61. M/s Izfaar
Pharmaceutical
TRIOZIN Injection
Form-5
Trisolizin of Star Labs
Lahore.
Deferred for
confirmation of TOC
80
Industries,
Lahore
Veterinary Liquid
Injection
(General
Antibiotic)
Each ml contains:
Sulphadiazine…..400mg
Trimethoprim……80mg
Antibiotic
Manufacturer
10-07-14 Dy. No:
64
20,000/-
Decontrolled/
50ml vial
The CLB in its 236th
meeting of
Registration Board
approved the grant of
DML with following
sections namely:
a. Veterinary Liquid
Injection (General
Antibiotic)
b. Veterinary Liquid
Injection (General)
analyzer & Liquid
Particle Counter.
62. -do- TYLOGEN Injection
Each ml contains:
Tylosin Tartrate….10mg
Gentamicin as
sulphate…..50mg
Antibiotic
Manufacturer
Form-5
03-07-14 Dy. No:
15
20,000/-
Decontrolled/
50ml vial
Tygent Injection of
Selmore
Pharmaceuticals
Lahore
Deferred for
confirmation of TOC
analyzer & Liquid
Particle Counter.
63. -do- OXY FAR LA Injection
Each ml contains:
Oxytetracycline as
Hydrochloride…….200
mg
Antibiotic
Manufacturer
Form-5
10-07-14 Dy. No:
63
20,000/-
Decontrolled/
100ml vial
Oxy-LA injection of
Selmore
Pharmaceuticals,
Lahore
Deferred for
confirmation of TOC
analyzer & Liquid
Particle Counter.
64. -do- OXY FAR Injection
Each ml contains:
Oxytetracycline as
Hydrochloride…….50m
g
Antibiotic
Manufacturer
Form-5
10-07-14 Dy. No:
63
20,000/-
Decontrolled/
50ml Vial
Oxy-5 injection of
Selmore
Pharmaceuticals,
Lahore
Deferred for
confirmation of TOC
analyzer & Liquid
Particle Counter.
65. -do- ENRO-100 Injection
Each ml contains:
Enrofloxacin….100mg
Fluoroqunolone
Form-5
03-07-14 Dy. No:
17
20,000/-
Enroxsel of Selmore
Pharmaceuticals
Lahore
Deferred for
confirmation of TOC
analyzer & Liquid
Particle Counter.
81
Antibacterial
Decontrolled/
50ml vial
66. -do- FLOXIN Injection
Each ml contains:
Oxytetracycline as
HCL…..300mg
Flunixin as
Meglumine……20mg
Antibiotic/ Analgesic,
Anti-inflammatory
Manufacturer
Form-5
03-07-14 Dy. No:
19
20,000/-
Decontrolled/
50ml vial
I-Fom of International
Pharma Labs Lahore
Deferred for
confirmation of TOC
analyzer & Liquid
Particle Counter.
67. -do- TYLOFAR Injection
Each ml contains:
Tylosin
Tartrate……200mg
Antibiotic
Form-5
03-07-14 Dy. No:
15
20,000/-
Decontrolled/
50ml vial
Tylosel of Selmore
Pharmaceuticals,
Lahore
Deferred for
confirmation of TOC
analyzer & Liquid
Particle Counter.
68. -do- Ketoxay LA
Each ml contains:
Oxytetracycline as
HCL…….200mg
Ketoprofen….30mg
Antibiotic/ Analgesic
Manufacturer
Form-5
03-07-14 Dy. No:
19
20,000/-
Decontrolled/
50ml vial
Oxyfen-LA of
Selmore
Pharmaceuticals,
Lahore
Deferred for
confirmation of TOC
analyzer & Liquid
Particle Counter.
69. -do- TYLOPRIM Injection
Each ml contains:
Sulphamethoxypyridazin
e……150mg
Trimethoprim……30mg
Tylosin tartrate…..50mg
Antibiotic
Manufacturer
Form-5
03-07-14 Dy. No:
15
20,000/-
Decontrolled/
50ml vial
Tylotrim of Selmore
Pharmaceuticals
Lahore
Deferred for
confirmation of TOC
analyzer & Liquid
Particle Counter.
70. -do- DICOTYL Injection
Each ml contains:
Form-5
03-07-14 Dy. No:
Bacticom of Selmore
Pharmaceuticals
Lahore
Deferred for
confirmation of TOC
analyzer & Liquid
82
Tylosin tartrate….50mg
Colistin
sulphate…..10mg
Dimetridazole…..100mg
Antibiotic/ Anti-
Protozoal
Manufacturer
17
20,000/-
Decontrolled/,
50ml vial
Particle Counter.
71. -do- IVERIN Injection
Each ml contains:
Ivermectin….10mg
Anthelmintic
BP
Form-5
03-07-14 Dy. No:
14
20,000/-
Decontrolled/
50ml vial
Actimec Injection of
Selmore
Pharmaceuticals
Lahore
Deferred for
confirmation of
Liquid Particle
Counter.
72. -do- PARACTIN Injection
Each ml contains:
Ivermectin….20mg
Anthelmintic
BP
Form-5
03-07-14 Dy. No:
14
20,000/-
Decontrolled/
50ml vial
Elvomec D/S of Elko
Karachi
Deferred for
confirmation of
Liquid Particle
Counter.
73. -do- MELOXAM Injection
Each ml contains:
Meloxicam…….7.5mg
Analgesic/ Anti-
inflammatory
BP
Form-5
03-07-14 Dy. No:
14
20,000/-
Decontrolled/ 50
ml vial
Calimox of Selmore
Pharma
Deferred for
confirmation of TOC
analyzer & Liquid
Particle Counter.
74. -do- B-Vita Injection
Each ml contains:
Cyanocobalamin…..125
mcg
Vitamin
USP
Form-5
03-07-14 Dy. No:
15
20,000/-
Decontrolled/
Pack of 50 ml
vial
B-Vita of Kakasian
Pharma Lahore
Deferred for
confirmation of TOC
analyzer & Liquid
Particle Counter.
75. -do- ADE-FAR Injection
Form-5
Nawan Laboratories
Karachi
Deferred for
confirmation of TOC
83
Each ml contains:
Vitamin
A…….100,000IU
Vitamin
D3……40,000IU
Vitamin E…….40mg
Vitamin and Growth
promoters
Manufacturer
03-07-14 Dy. No:
17
20,000/-
Decontrolled/
50ml vial
analyzer & Liquid
Particle Counter.
76. -do- VITOBION Injection
Each ml contains:
Thiamine HCL……5mg
Riboflavin……2.5mg
Pyridoxine
HCL……2.5mg
Nicotinamide……37.5m
g
Vitamin
Manufacturer
Form-5
03-07-14 Dy. No:
15
20,000/-
Decontrolled/ 50
ml vial
Thiaprin Injection of
Star Labs Karachi
Deferred for
confirmation of TOC
analyzer & Liquid
Particle Counter.
77. -do- HEPAFAR Injection
Each ml contains:
Phenoxy-2-methyl-2-
propionic acid…..100mg
Hepatoprotectant/ Liver
Tonic
Manufacturer
Form-5
03-07-14 Dy. No:
15
20,000/-
Decontrolled/
50ml vial
Hepaguard of Star
Labs Lahore
Deferred for
confirmation of TOC
analyzer & Liquid
Particle Counter.
78. -do- IMIDO-FAR Injection
Each ml contains:
Imidocarb
dipropionate……120mg
Antiprotozoal
Form-5
03-07-14 Dy. No:
15
20,000/-
Decontrolled/
50ml vial
IMIPRO of Selmore
Pharmaceuticals,
Lahore
Deferred for
confirmation of TOC
analyzer & Liquid
Particle Counter.
79. -do- AAVIL Injection
Each ml contains:
Pheniramine
maleate…..11.35mg
Form-5
03-07-14 Dy. No:
15
20,000/-
Anril Injection of
Syman Pharma Lahore
Deferred for
confirmation of TOC
analyzer & Liquid
Particle Counter.
84
Antihistamine
Manufacturer
Decontrolled/
50ml vial
80. -do- ATRO Injection
Each ml contain:
Atropine
Sulphate…..1mg
Anti-muscarinic
BP
Form-5
03-07-14 Dy. No:
15
20,000/-
Decontrolled/
Pack of 50ml vial
Atrovet Injection of
Selmore
Pharmaceuticals
Lahore
Deferred for
confirmation of TOC
analyzer & Liquid
Particle Counter.
85
Case No.04. Grant of registrationsfor additional sectionsof already licensed manufacturers.
Evaluator – II
S/N Name and address of
manufacturer /
Applicant
Brand Name
(Proprietary
name + Dosage
Form +
Strength)
Composition
Pharmacological
Group
Finished
product
Specification
Type of Form
Initial date,
diary
Fee including
differential fee
Demanded
Price / Pack
size
Remarks on the
formulation (if
any) including
International
status in stringent
drug regulatory
agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
Decision
81. M/s Pharmatec
Pakistan (Pvt.) Limited,
D-86/A, S.I.T.E.,
Karachi-75700.
(Cream/Oint General:
No. F.6-6/2014-Lic
(M-237 dated 14-10-
2014)
Adagel Gel
Contains:-
Adapalene
(B.P)…0.1%w/w
Benzoyl Peroxide
(B.P)…2.5%w/w
(Anti-acne
Preperation)
(Manufacturer’s
Spec.s)
Form 5
13-10-2014
(31)
Rs. 20,000/-
As Per
SRO/15gm,
30gm
BNF: Epiduo
(Galderma)
ADAPLUS
(BIOGEN
PHARMA,Islamab
ad)
Grant of additional
section
Cream/Ointment
(General)
recommended.(24-
07-2014)
Approved.
86
82. -do- Pamulin
Ointment
Contains:-
Retapamulin…1.
0%w/w
(Antibiotic and
chemotherapeutic
for
dermatological
use)
(Manufacturer’s
Spec.s)
Form 5
13-10-2014
(34)
Rs. 50,000/-
As Per
SRO/5gm,15g
m
BNF: Altargo
(GSK)
Altapam
Ointment of M/s
Atco Lab, Regn
No 061764
Grant of additional
section
Cream/Ointment
(General)
recommended.(24-
07-2014)
1. Me-too status
has been given as
Altapam Ointment
of M/s Atco Lab
(Reg. No 061764)
that needs
confirmation.
Pricing of
formulation has
been done in 9th
PAC.
Approved
83. M/s Sami
Pharmaceuticlas (Pvt.)
Limited, F-95, S.I.T.E.
Karachi-Pakistan
Tablet (Psychotropic)
Section (No. F.6-
5/2014-Lic (M-236)
dated 8th Sep, 2014.
Pralzo 0.25mg
Tablets
Each tablet
contains:-
Alprazolam
(USP)…0.25mg
(Benzodiazepine)
(USP Spec.s)
Form 5
09-09-2014
(240)
Rs. 20,000/-
Rs.157.47/30’s
BNF: Alprazolam
(Non-proprietary)
XANAX (PFIZER
LABORATORIES
LTD.,Karachi)
Very good, Panel
recommends all the
additional sections
as per approved
layout plan. (24-06-
14)
1. Alprazolam is a
controlled drug
substance.
Approved.
84. -do- Pralzo 0.5mg
Tablets
Form 5
09-09-2014
BNF: Alprazolam
(Non-proprietary)
Approved.
87
Each tablet
contains:-
Alprazolam
(USP)…0.5mg
(Benzodiazepine)
(USP Spec.s)
(239)
Rs. 20,000/-
Rs.157.47/30’s
XANAX (PFIZER
LABORATORIES
LTD.,Karachi)
Very good, Panel
recommends all the
additional sections
as per approved
layout plan. (24-06-
14)
1. Alprazolam is a
controlled drug
substance.
85. -do-
Tablet (General)
Section (No. F.6-
5/2014-Lic (M-236)
dated 8th Sep, 2014.
Gasicol
Chewable Tablets
Each Chewable
tablet contains:-
Sodium
Alginate(BP)…5
00mg
Potassium
Bicarbonate
(BP)…100mg
(Antacid)
(Manufacturer’s
Spec.s)
Form 5
03-04-2014
(201)
Rs. 20,000/-
Rs. 5 per
Tablet, Rs.
80/16’s
BNF: Gaviscon
Advance
Not confirmed
Very good, Panel
recommends all the
additional sections
as per approved
layout plan. (24-06-
14)
1. Verification of
photocopy of
fee receipt is
required.
2. Me-too status
needs
confirmation.
Deferred for application on
Form -5D alongwith
requisite fee & other codal
formalities.
86. -do- Solfy 5mg
Tablets
Each film coated
tablet contains:-
Solifenacin
Succinate…5mg
(Muscarinic
antagonist)
(Manufacturer’s
Spec.s)
Form 5
21-10-2014
(72)
Rs. 20,000/-
As per PRC
BNF: Vesicare
(Astellas)
Fenaso (Highnoon)
Very good, Panel
recommends all the
additional sections
as per approved
layout plan. (24-06-
14)
Approved.
88
87. -do- Urigo 80mg
Tablets
Each film coated
tablet contains:-
Febuxostat……
……….…80mg
(Xanthine
Oxidase
Inhibitor)
(Manufacturer’s
Spec.s)
Form 5
21-10-2014
(73)
Rs. 20,000/-
As per PRC
FDA: Uloric
Zurig (Getz)
Very good, Panel
recommends all the
additional sections
as per approved
layout plan. (24-06-
14)
Approved.
88. -do- Urigo 40mg
Tablets
Each film coated
tablet contains:-
Febuxostat…40m
g
(Xanthine
Oxidase
Inhibitor)
(Manufacturer’s
Spec.s)
Form 5
21-10-2014
(71)
Rs. 20,000/-
As per PRC
FDA: Uloric
Zurig (Getz)
Very good, Panel
recommends all the
additional sections
as per approved
layout plan. (24-06-
14)
Approved.
89. -do-
Capsule (General)
Section (No. F.6-
5/2014-Lic (M-236)
dated 8th Sep, 2014.
Beritex 150mg
Capsules
Each capsule
contains:-
Polysaccharide
Iron Complex
equivalent to
Elemental
Iron…150mg
(Iron compound)
(Manufacturer’s
Spec.s)
Form 5
09-09-2014
(241)
Rs. 20,000/-
As per PRC
Not confirmed
Ferricure (S. J. &
G)
Very good, Panel
recommends all the
additional sections
as per approved
layout plan. (24-06-
14)
1. Availability in
SRA’s not
confirmed.
Firm has
provided
international
availability of
un approved
products in
USA, Canada,
Approved.
89
Evaluator – III
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of
Form
Initial
date, diary
Fee
including
differential
fee
Demanded
Price /
Pack size
Remarks on
the
formulation
(if any)
including
International
status in
stringent
drug
regulatory
agencies /
authorities
Me-too status
GMP status
as depicted in
latest
inspection
report (with
date) by the
Evaluator
Recommendations
by the Evaluator
Decision
90. M/s Rasco
Pharma, 5.5
Km Raiwind
Road, Lahore
Liquid Injection
General (Small
Volume Vial)
PARA-RAS Infusion
Each 100ml vial
contains;
Paracetamol
(BP)…..1000mg
Antipyretic/ Analgesic
Manufacturer
Form-5
Dy No: 659
dated 22-
09-2014
20,000/-
As per
SRO
1x 100ml
PERFALGAN
10 mg/ml,
solution for
infusion (100
ml vial
contains 1000
mg
paracetamol)
of BMS UK
Provas of
Firm has submitted
the invoices of
purchase of Liquid
Particle counter and
TOC analyzer.
Approved. Area FID
will confirm
instalation &
operational
qualifications of TOC
& Liquid Particle
Counter and then
registration letter will
be issued after
approval of
Chairman, RB.
UK.
90
Sami Karachi
The
inspection of
firm was
carried out on
03-06-2014
by the panel
of inspectors
and
recommended
the renewal of
DML and
additional
section
namely Liquid
Injection
General
(Small
Volume Vial)
91. -do- LEVOFLOXA Infusion
Each 100ml vial
contains:
Levofloxacin
hemihydarte equivalent
to Levofloxacin
USP…..500mg
Quinolone
Manufacturer
Form-5
Dy No: 660
dated 22-
09-2014
20,000/-
As per
SRO
1x 100ml
Tevanic of
Sanofi
Aventis
(BNF)
Levocil of
CCL Pharma
Lahore.
Approved. Area FID
will confirm
instalation &
operational
qualifications of TOC
& Liquid Particle
Counter and then
registration letter will
be issued after
approval of
Chairman, RB.
92. -do- LEVOFLOXA Infusion
Each 100ml vial
contains:
Levofloxacin
hemihydarte equivalent
to Levofloxacin
USP…..250mg
Quinolone
Manufacturer
Form-5
Dy No: 665
dated 22-
09-2014
20,000/-
As per
SRO
1x 100ml
250mg
levofloxacin
(as
hemihydarte)
in 50ml
solution
(Tavanic of
sanofi)
Levocil of
CCL Pharma
Lahore
Deferred for
confirmation of
approval by the
reference Stringent
Regulatory Agencies
for this strength /
volume.
91
93. -do- CIP-RX Infusion
Each 100ml vial
contains:
Ciprofloxacin lactate
equivalent to
Ciprofloxacin
USP….400mg
Quinolone
USP
Form-5
Dy No: 656
dated 22-
09-2014
20,000/-
As per
SRO
1x 100ml
Ciprofloxacin
2 mg/ml
Solution for
Infusion
400mg/200ml
vial of
Hospira UK
Limited
Novidat of
Sami Karachi
Deferred for
confirmation of
approval of
formaulation in
Stringent Regulatory
Agencies in the
same strength.
94. -do- CIP-RX Infusion
Each 100ml vial
contains:
Ciprofloxacin lactate
equivalent to
Ciprofloxacin
USP….200mg
Quinolone
USP
Form-5
Dy No: 660
dated 22-
09-2014
20,000/-
As per
SRO
1x 100ml
Ciprofloxacin
2 mg/ml
Solution for
Infusion
200mg/100ml
vial of
Hospira UK
Limited
Novidat of
Sami Karachi
Approved. Area FID
will confirm
instalation &
operational
qualifications of TOC
& Liquid Particle
Counter and then
registration letter will
be issued after
approval of
Chairman, RB.
95. -do- LINZO Infusion
Each 100ml contains:
Linezolid….200mg
Oxazolidinone
Manufacturer
Form-5
Dy No: 654
dated 22-
09-2014
20,000/-
As per
SRO
1x 100ml
Zyvox of
Pfizer USA
Nezocin of
Brookes
Pharma
Approved. Area FID
will confirm
instalation &
operational
qualifications of TOC
& Liquid Particle
Counter and then
registration letter will
be issued after
approval of
Chairman, RB.
96. -do- RESGYL Infusion
Each 100ml contains:
Metronidazole…500mg
Antiprotozoal
Manufacturer
Form-5
Dy No: 657
dated 22-
09-2014
20,000/-
As per
SRO
1x 100ml
Flagyl of
Sanofi
(USFDA)
Metrozine of
Searle Karachi
Approved. Area FID
will confirm
instalation &
operational
qualifications of TOC
& Liquid Particle
Counter and then
registration letter will
be issued after
approval of
Chairman, RB.
92
97. -do- RE-VED Infusion
Each 100ml contains:
Ofloxacin HCL
equivalent to
Ofloxacin……200mg
Quinolone
Manufacturer
Form-5
Dy No: 658
dated 22-
09-2014
20,000/-
As per
SRO
1x 100ml
Teravid of
Sanofi USA
Loxat of Siza
Lahore
Approved. Area FID
will confirm
instalation &
operational
qualifications of TOC
& Liquid Particle
Counter and then
registration letter will
be issued after
approval of
Chairman, RB.
98. -do- MOXILINE Infusion
Each 250ml vial
contains:
Moxifloxacin HCL
equivalent to
Moxifloxacin……400mg
Quinolone Antibiotic
Manufacturer
Form-5
Dy No: 662
dated 22-
09-2014
20,000/-
As per
SRO
1x 250ml
Avelox of
Bayer Health
Care USA
Moxiget of
Getz Karachi
Applied volume is
250ml however the
approval of section
is for Liquid
Injection General
(Small Volume
Vial)
Approved. Area FID
will confirm
instalation &
operational
qualifications of TOC
& Liquid Particle
Counter and then
registration letter will
be issued after
approval of
Chairman, RB.
99. M/s Arsons
Pharmaceuticals
Industries (Pvt)
Limited, Lahore
(Tablet
Psychotropic)
RELAXIM Tablet 3mg
Each tablet contains:
Bromazepam…….3mg
Benzodiazepine
Manufacturer
Form-5
23-09-14
Dy. No:
793
20,000/-
As per
SRO
3x10’s
Lexotan
Tablets of
Roche (TGA
Approved)
Tensium
Tablets of
Werrick
Pharma
Islamabad.
The
inspection of
the firm was
conducted on
08-05-2014
by the panel
of inspectors
and
recommended
the renewal of
DML and
grant of
additional
section of
tablets
Approved with
change in applied
brand name.
93
psychotropic.
100. -do- ARVOTRIL Tablets
0.5mg
Each tablet contains:
Clonazepam……0.5mg
Benzodiazepine
BP
Form-5
Dy No: 788
dated 23-
09-2014
20,000/-
As per
SRO
5x10’s
Clonazepam
Tablet of Teva
(USFDA)
Clonzil of
English
Pharma
Lahore
Approved with
change in applied
brand name.
101. -do- ARVOTRIL Tablets
2mg
Each tablet contains:
Clonazepam……2mg
Benzodiazepine
BP
Form-5
Dy No: 790
dated 23-
09-2014
20,000/-
As per
SRO
3x10’s
Clonazepam
Tablet of Teva
(USFDA)
Clonzil of
English
Pharma
Lahore
Approved with
change in applied
brand name.
102. -do- ARTIVAN Tablets 1mg
Each tablet contains:
Lorazepam……1mg
Benzodiazepine
BP
Form-5
Dy No: 792
dated 23-
09-2014
20,000/-
As per
SRO
10x10’s
Ativan of
Pfizer
(USFDA)
Ativan of
Pfizer Karachi
Approved with
change in applied
brand name.
94
103. -do- ARTIVAN Tablets 2mg
Each tablet contains:
Lorazepam……2mg
Benzodiazepine
BP
Form-5
Dy No: 791
dated 23-
09-2014
20,000/-
As per
SRO
10x10’s
Ativan of
Pfizer
(USFDA)
Ativan of
Pfizer Karachi
Approved with
change in applied
brand name.
104. -do- XALLIUM Tablets 5mg
Each tablet contains:
Diazepam………5mg
Benzodiazepine
BP
Form-5
Dy No: 794
dated 23-
09-2014
20,000/-
As per
SRO
3x10’s
Diazeoam of
Wockhardt
UK
Valium of
Martin Dow
Karachi
Approved with
change in applied
brand name.
105. -do- ARMICUM Tablet
7.5mg
Each tablet contains:
Midazolam as
meleate……7.5mg
Benzodiazepine
Manufacturer
Form-5
Dy No: 794
dated 23-
09-2014
20,000/-
As per
SRO
3x10’s
Hypnovel
tablets of
Roche New
Zealand
Dormicum of
Martin Dow
Karachi
Approved with
change in applied
brand name.
5. Left-over agenda (245)
a) Remaining application of previously approved new sections
Evaluator - II
95
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date, diary
Fee including
differential fee
Demanded Price
/ Pack size
Remarks on the
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
Decision
106. M/s Herbion
Pakistan (Pvt)
Ltd., Kahuta
Road, industrial
Triangle, Humak,
Rawalpindi-
Islamabad.
EsNovex/AciNovex/
GastriNovex
Capsules 20mg
Each capsule
contains:-Enteric
coated pellets of
Esomeprazole
Magnesium
Trihydrate
eq. to
Esomeprazole…20m
g
( Antipeptic
Ulcerants / Proton
Pump Inhibitor)
(Manufacturer’s
Spec.s)
{Source of Pellets:
M/s Glukem
Pharmaceuticals (P)
Ltd Plot # 205/2A, 1st
Floor , IDA, Phase-II,
Cherlapally,
Hyderabad-Andhra
Pradesh, India}
Form 5
02-05-2014
Dy.No.2076
Rs.20,000/=+Rs.
80,000/- (05-09-
2014)
Rs.200.00/
2x7’s
Nexium of
AstraZeneca
Esso of Shaigan
Pharmaceuticals
Islamabad.
Grant of DML
recommended (23-24th
January 2014)
1. Valid and
legalized GMP
Certificate of
Source, COA and
stability studies
according to zone
IV-a of pellets are
required.
The stability & COA
have been provided
by the applicant
before the meeting of
the Board.
Approved. Firm will
provide legalized GMP of
the manufacturer of pellets
and then registration letter
will be issued after
approval of Chairman, RB.
107. -do- EsNovex/AciNovex/
GastriNovex
Capsules 40mg
Each capsule
contains:-Enteric
coated pellets of
Esomeprazole
Form 5
02-05-2014
Dy.No.2077
Rs.20,000/- +
Rs. 80,000/- (05-
09-2014)
Nexium of
AstraZeneca
Esso of Shaigan
Pharmaceuticals
Islamabad.
Approved. Firm will
provide legalized GMP of
the manufacturer of pellets
and then registration letter
will be issued after
approval of Chairman, RB.
96
Magnesium
Trihydrate
eq. to
Esomeprazole …40
mg
( Antipeptic
Ulcerants / Proton
Pump Inhibitor)
(Manufacturer’s
Spec.s)
{Source of Pellets:
M/s Glukem
Pharmaceuticals (P)
Ltd Plot # 205/2A,
1st Floor , IDA,
Phase-II,
Cherlapally,
Hyderabad-Andhra
Pradesh, India}
Rs.371.00/2x7’s
Grant of DML
recommended (23-24th
January 2014)
1. Valid and
legalized GMP
Certificate of
Source, COA and
stability studies
according to zone
IV-a of pellets are
required.
The stability & COA
have been provided
by the applicant
before the meeting of
the Board.
108. -do- OmeNovex /
SecNovex /
PeptiNovex
Capsules 20mg
Each capsule
contains:-
Omeprazole enteric
coated Pellets eq. to
Omeprazole
…20mg
( Antipeptic
Ulcerants / Proton
Pump Inhibitor)
(Manufacturer’s
Spec.s)
{Source of Pellets:
M/s Vision
Pharmaceuticals, Plot No.224, Street
No.1, I-10/3,
Industrial Area,
Islamabad.}
Form 5
02-05-2014
Dy.No.2078
Rs.20,000/=
Rs.290.00/
2x7’s
Losec (Astrazeneca)
Omega(Ferozsons)
Grant of DML
recommended (23-24th
January 2014)
Approved.
97
109. -do- OmeNovex /
SecNovex /
PeptiNovex
40mg Capsules
Each capsule
contains:-
Omeprazole enteric
coated Pellets
eq. to
Omeprazole…
40mg
( Antipeptic
Ulcerants / Proton
Pump Inhibitor)
(Manufacturer’s
Spec.s)
{Source ofPellets:
M/s Vision
Pharmaceuticals, Plot
No.224, Street No.1,
I-10/3, Industrial
Area, Islamabad.}
Form 5
02-05-2014
Dy.No.2079
Rs.20,000/=
Rs.354.00/
2x7’s
Losec (Astrazeneca)
Omega(Ferozsons)
Grant of DML
recommended (23-24th
January 2014)
Approved.
110. -do- FluNovex / CF-
Novex / TheraNovex
Extra Tablets
Each film coated
tablet contains:-
Paracetamol BP
….…..650mg
Chlorphenirmine
Maleate
BP………………..…
…..4mg
Phenylephrine HCl
BP…10mg
(Analgesic +
Decongestant
Combination)
(Manufacturer’s
Spec.s)
Form 5-D
24-02-2014
Dy.No.194
Rs.20,000+Rs.
30,000/- (07-05-
14)
Rs.230.00/
10x10’s
Not confirmed
Form 5-D
Grant of DML
recommended (23-24th
January 2014)
1. The firm had
applied on Form 5
, after evaluation
the Firm applied
on Form 5-D and
submitted
additional fee of
Rs. 30,000/-
2. International
availability not
confirmed in
stringent DRS’s.
Deferred for confirmation
of approval in reference
Stringent Regulatory
Agencies. It will be
followed by assessment of
stability studies and expert
opinions by Brig Aslam,
Dr.Rehana Kauser and
Dr.Shazli Manzoor.
111. -do- VitaNovex /
CilaNovex /
BonNovex
Form 5
26-02-2014
Dy.No.211
Not confirmed
Not confirmed
Deferred for approval in
reference Stringent
Regulatory Agencies &
98
Suspension
Each 5ml contains:-
Ossein Mineral
Complex …250mg
Vitamin D … 400 i.u
(Calcium-Phosphorus
Supplements)
(Manufacturer’s
Spec.s)
Rs.20,000
Rs.144.00/
60ml
Grant of DML
recommended (23-24th
January 2014)
1. International
availability not
confirmed in
stringent DRA’s.
2. Me-too status not
confirmed.
3. Firm has claimed
that they possess
Atomic Absorption
(PerkinElmer- A
Analyst 300)
spectrophometer
and has submitted
that it can be
verified by area
FID.
me-too status alongwith
installational &
operational qualification
of atomic absorption
spectrophotometer by area
FID.
99
Evaluator – I
S/N Name and
address of
Manufacturer /
Applicant
Brand Name
(Proprietary
name + Dosage
form + Strength)
Composition
Pharmacological
Group
Finished product
specification
Type of Form
Initial date,
diary.
Fee including
differential fee
Demanded
Price / Pack
size
Internationa
l status in
stringent
regulatory
agencies
Me-too
status
GMP status
as depicted
in inspection
report
(dated)
Remarks /
Observations
Decision
112. M/s Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot
No. E-145 – E-
149, North
Western
Industrial Zone,
Port Qasim,
Karachi.
Acen Effervescent
Tablet 200mg
Each effervescent
tablet contains:
N-acetylcysteine
…………..200mg
(Manufacturer’s
Specs)
Mucolytic agent
Form-5D
New License
28-05-2014
804 R&I
Rs. 800 / per
10’s
Rs. 50,000/-
ACC™ 200
effervescent
tablets
N-
acetylcystein
e 200mg
South Africa
References and
data of various
international
clinical studies
have been provided
along with 06
months accelerated
and real time
stability summary.
Deferred for
approval in
reference
Stringent
Regulatory
Agencies to
establish safety &
efficacy of
product.
113. M/s Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot
No. E-145 – E-
149, North
Western
Industrial Zone,
Port Qasim,
Karachi.
Glucort S.R. Tablet
5mg Each enteric
coated tablet
contains:-
Beclomethasone
Dipropionate ...
5mg
(Manufacturer’s
Specs)
Corticosteroid
Form-5D
New License
28-05-2014
808 R&I
Rs. 1,000 / per
10’s
Rs. 50,000/-
CLIPPER
Gastro-
resistant
prolonged
release tablet
5mg
MHRA
References and
data of various
international
clinical studies has
been provided
along with 06
months accelerated
and real time
stability summary.
Firm has also
submitted
undertaking to
submit comparative
dissolution profile
with established
brand before
marketing the
product.
Deferred for
expert opinions by
Brig Aslam,
Dr.Rehana Kauser
and Dr.Shazli
Manzoor and
evaluation of
stability studies by
Incharge, PEC.
100
114. M/s Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot
No. E-145 – E-
149, North
Western
Industrial Zone,
Port Qasim,
Karachi.
Lafelax Liquid
Sachet
Each 15ml sachet
contains:-
Lactulose………6
7% w/v
(USP
Specification)
Laxative
Source: M/s
Fresenius Kabi,
Austria
Form-5D
New License
28-05-2014
811 R&I
Rs. 250 / per
10’s
Rs. 50,000/-
28/05/2014
Rs. 50,000/-
24/09/2014
Total fee: Rs.
100,000/-
LAEVOLAC
10g/15ml
Sachet
MHRA
References and
data of various
international
clinical studies /
literature have been
provided along
with 06 months
accelerated and real
time stability
summary.
GMP certificate of
the source of
Lactulose dated 13-
02/2012 with the
statement that this
certificate reflects
the status of
manufacturer at the
time of inspection
(31-01-2012) and
should not be relied
upon to reflect the
compliance status if
more than three
years have elapsed
since the date of
that inspection.
Deferred for
confirmation of
same strength
internationally,
evaluation of
stability studies,
confirmation of
HPLC equipped
with RI detector &
legalized GMP of
source.
115. M/s Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot
No. E-145 – E-
149, North
Western
Industrial Zone,
Port Qasim,
Karachi.
Diolyte Rice
Sachet
Each sachet
contains:-
Rice Powder…6g
Sodium
Citrate……. 0.58g
Sodium Chloride
………….. 0.35g
Potassium Chloride
…………… 0.3g
(Manufacturer’s
Specs)
Form 5
New License
05-05-2014
662 R&I
As per PRC
10’s
Rs. 20,000/-
DIAROLYT
E
GASTROLY
TE
Sanofi
Approved with
change in brand
name.
101
ORS
116. M/S Pharma
Lord (Pvt) Ltd.,
12 Km, Lahore
Road, Layyah.
Tablet (General)
Capsule
(General)
Oral Dry Powder
Suspension
(General)
CPRO 125mg/5ml
Suspension
Dry Suspension
Each reconstituted
5ml contains:
Ciprofloxacin
………..... 125mg
(Anti-infective /
Quinolone)
Reference
formulation:
CIPRO Oral
Suspension (M/s
Bayer HealthCare
Pharmaceuticals
Inc.)
Ciprofloxacin Oral
Suspension is
available in 5% (5
g ciprofloxacin in
100 mL) and 10%
(10 g ciprofloxacin
in 100 mL)
strengths.
Ciprofloxacin Oral
Suspension is a
white to slightly
yellowish
suspension with
strawberry flavor
which may contain
yellow-orange
droplets. It is
composed of
ciprofloxacin
microcapsules and
diluent which are
Form 5
Rs. 125/- per
60ml
R&I diary No.
and date not
available
Rs.20,000
(Duplicate)
NOVIDAT
125mg/5ml
Sami
Panel
inspection
report for
grant of
DML dated
14th
December,
2012
attached.
1. Under
international
availability Cipro
of M/s Bayer, Italy
has been
mentioned.
2. Role of
ingredients has not
been provided.
3. Ciprofloxacin
25% granules had
been proposed
earlier. However,
now firm has
proposed dry
powder suspension
containing
Ciprofloxacin
(base) with water
as diluent which is
different from the
reference
international
brand*.
4. Copy of latest
GMP report
required.
Deferred for
review of
formulation.
102
mixed prior to
dispensing. The
components of the
suspension have
the following
compositions:
Microcapsules–
ciprofloxacin,
povidone,
methacrylic acid
copolymer,
hypromellose,
magnesium
stearate, and
Polysorbate 20.
Diluent–medium-
chain triglycerides,
sucrose, lecithin,
water, and
strawberry flavor.
103
Evaluator – III
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date, diary
Fee including
differential fee
Demanded Price /
Pack size
Remarks on the
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
Decision
117. M/s Faas
Pharmaceuticals
(Pvt) Limited, F-
748/ L S.I.T.E.
Karachi
(Tablet General)
Ciploxin Tablet
250mg
Each film coated tablet
contains:
Ciprofloxacin as
HCL…..250mg
Anti-Infective
USP
Form-5
Dy No:977 dated
12-06-2014
20,000/-
As per SRO
Cipro of Byaer Health
Care
Cipro of Bayer
Healthcare Karachi
Inspection of the firm
was conducted on 18-
03-2014 by the area
FID and GMP
compliance was found
satisfactory.
Approved.
118. -do- Ciploxin Tablet
500mg
Each film coated tablet
contains:
Ciprofloxacin as
HCL…..500mg
Anti-Infective
USP
Form-5
Dy No:975 dated
12-06-2014
20,000/-
As per SRO
Cipro of Byaer Health
Care
Cipro of Bayer
Healthcare Karachi
Approved.
119. -do- Levoquin Tablet
250mg
Each film coated tablet
contains:
Levofloxacin as
hemihydarte…..250mg
Form-5
Dy No:976 dated
12-06-2014
20,000/-
As per SRO
Levaquin Approved
USFDA
Leflox of Getz Pharma
Karachi
Approved.
104
Anti-Infective
Manufacturer
120. -do- Levoquin Tablet
500mg
Each film coated tablet
contains:
Levofloxacin as
hemihydarte…..500mg
Anti-Infective
Manufacturer
Form-5
Dy No:974 dated
12-06-2014
20,000/-
As per SRO
Levaquin Approved
USFDA
Leflox of Getz Pharma
Karachi
Approved.
121. -do-
Capsule (General)
Omezole-D Capsule
Each capsule
contains:-
Blended pellets of
Omeprazole 20mg
EC….20mg
Domperidone IR
….10mg
Anti-Ulcer and Anti-
Emetic
Manufacturer
Source: M/s Glukem
Pharmaceuticals, Plot
No. 205/2A, IDA,
Phase II, Chedapally,
Hyderabad, India
Form-5
Dy No:974 dated
12-06-2014
100,000/-
As per SRO
Not available in
stringent SRA,s
Me too status is not
submitted by the firm.
a. Evidence of
approval of same
dosage form and
strength in FDA,
TGA, EMA,
MHLW, and
Health Canada is
required.
b. GMP certificate
of the source
(which shall be
legalized) and
stability studies
as per ZONE-IV
A needs to be
submitted.
Deferred till review of
formulation.
122. M/s Martin Dow
Limited, Plot No.
37, Sector 19,
Korangi Industrial
Area, Karachi
Sparta Sachet
Each sachet conatins:-
L-Ornithine –L-
Aspartate……3gm
Cholagogues and
Hepatic Protectors\
Manufacturer
Form-5
Dy No. 1067 dated :
30-06-2014
As per brand leader
price/ Pack of 5,10
& 30’s
Hepa-MerzMerz
Pharmaceuticals
Germany
Hepa-Merz of Brookes
Pharma, Karachi.
Deferred for confirmation
of approval in reference
Stringent Regulatory
Agencies & me too status.
105
123. -do- Olyte Sachet
Each sachet contains:-
Precooked Rice
Powder ……6gm
Sodium
citrate…..0.58gm
Sodium
chloride…..0.35gm
Potassium
chloride……0.30gm
Form-5
Dy No. 1069 dated :
30-06-2014
As per brand leader
price/ Pack of 6,10
& 20’s
Doalyte Relief Black
current sachet of
Aventis Pharma UK
Diarolyte of Sanofi
Avnetis Karachi
Approved.
124. -do- Evrease Sachet
Each sachet contains:
Mebeverine as
Hydrochloride:
135mg
Physillium
Husk…..3.5gm
Antispasmodic and
Laxative
Manufacturer
Form-5
Dy No. 1070 dated :
30-06-2014
Rs.155.52 per pack
of 10’s
Rs. 310.50 per pack
of 20’s
Rs.465.75 per pack
of 30’s
Fybogel Mebeverine
of Reckitt Benkiser
UK
Ispamer Sachet of
Getz, Karachi
Approved.
125. M/s Elite Pharma
(Pvt) Limited, 9.5
Km Sheikhupura
Road Lahore
Flucolite Infusion
50ml
Each ml contains:-
Fluconazole……2mg
Antifungal
Manufacturer
Form-5
Dy No. 885 dated :
25-11-2013
20,000/-
Price not submitted
/Pack of 100ml of
1’s
Diflucan of Pfizer.
Diflucan of Pfizer
Labs Karachi
Evidence of
availability of TOC is
required as BP
specifications are
claimed.
Panel inspection of the
firm was conducted on
28-01-13 and the
panel recommended
the liquid injectable
infusion (100ml)
Deferred for confirmation
of installation and
performance qualification
of TOC analyser & Liquid
Particle Counter by Area
FID.
106
126. -do- Percemol Infusion
1gm/100ml
Each 100ml conatins:-
Paracetamol……1gm
Analgesic
Manufacturer
Form-5
Dy No. 883 dated :
25-11-2013
20,000/-
Price not submitted
/Pack of 100ml of
1’s
Perfalgan of BMS, UK
Provas of SAMI
Pharmaceuticals
Karachi
Evidence of
availability of TOC is
required as BP
specifications are
claimed.
Deferred for confirmation
of installation and
performance qualification
of TOC analyser & Liquid
Particle Counter by Area
FID.
127. -do- Capronic Infusion
50mg/ml
Each ml contains:-
Aminocaproic
acid…..50mg
Hemostatis
Form-5
Dy No. 883 dated :
25-11-2013
20,000/-
Price not submitted
/Pack of 100ml of
1’s
Not available in
SRA,s.
Me too is not provided
by the company.
Evidence of
availability of TOC is
required as BP
specifications are
claimed.
Deferred for confirmation
of following:
1. Installation and
performance qualification
of TOC analyser & Liquid
Particle Counter by Area
FID.
2. Me too status & approval
by referenece Stringent
Regulatory Agencies.
128. -do- Elite Reserbelakta
Each ml contains:-
Sorbitol…..200mg
Sodium
Lactate…..1.9mg
So+dium
chloride…..6mg
Calcium
chloride…..0.1mg
Potassium
Chloride……0.3mg
Magnesium
Chloride…..0.2mg
Hyperosmoler
complex and infusion
solution
Manufacturer
Form-5
Dy No. 884 dated :
25-11-2013
20,000/-
Price not submitted
/Pack of 400ml of
1’s
Not available in
stringent SRA’s. Firm
has submitted the
applied product is
available in Ukraine
(Saorbilactum infusion
of Yuria Pharma)
which also needs
verification.
Firm submitted that
product is not
available locally.
Evidence of
availability of TOC is
required as BP
specifications are
claimed.
Deferred for confirmation
of folowing:
1. Installation and
performance qualification
of TOC analyser & Liquid
Particle Counter by Area
FID.
2. Me too status & approval
by referenece Stringent
Regulatory Agencies.
129. -do- Elite Reserbelakta
Each ml contains:-
Sorbitol…..200mg
Sodium
Lactate…..1.9mg
Sodium
Form-5
Dy No. 888 dated :
25-11-2013
20,000/-
Not available in
stringent SRA’s. Firm
has submitted the
applied product is
available in Ukraine
(Saorbilactum infusion
of Yuria Pharma)
Deferred for confirmation
of folowing:
1. Installation and
performance qualification
of TOC analyser & Liquid
Particle Counter by Area
FID.
107
chloride…..6mg
Calcium
chloride…..0.1mg
Potassium
Chloride……0.3mg
Magnesium
Chloride…..0.2mg
Hyperosmoler
complex and infusion
solution
Manufacturer
Price not submitted
/Pack of 200ml of
1’s
which also needs
verification.
Firm submitted that
product is not
available locally.
Evidence of
availability of TOC is
required as BP
specifications are
claimed.
2. Me too status & approval
by referenece Stringent
Regulatory Agencies.
b) Routine applications
Evaluator – II
S/N Name and address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date, diary
Fee including
differential fee
Demanded Price /
Pack size
Remarks on the
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
Decision
130. M/s Maple
Pharmaceuticals (Pvt.)
Ltd., 147/23, Korangi
Industrial Area,
Karachi.
Faxim-E 200mg
Tablet
Each film coated
Tablet contains:-
Rifaximin
(B.P)…200mg
(Antibacterial)
(Manufacturer’s
Spec.s)
Form-5
15-07-2010
(N/A)
Rs.8,000/-+Rs. 12,000
(14-05-2013)
As per PAC
BNF: Xifaxanta
(Norgine)
Nimixa (Getz Pharma)
Overall cGMP
measures are followed
in the Firm (31-03-
2014)
1. Verification of
Approved. Reference
will be sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If confirmed,
then Chairman, RB
will permit issuance of
registration letter.
108
photocopies of fee
challan is
required.
131. -do- Faxim 550mg Tablet
Each Tablet
contains:-Rifaximin
(B.P)…550mg
(Antibacterial)
(Manufacturer’s
Spec.s)
Form-5
15-07-2010
(N/A)
Rs.8,000/-+Rs. 12,000
(25-07-2013)
As per PAC
BNF: Xifaxanta
(Norgine)
Nimixa (Getz Pharma)
Overall cGMP
measures are followed
in the Firm (31-03-
2014)
1. Verification of
photocopies of fee
challan is
required.
Approved. Reference
will be sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If confirmed,
then Chairman, RB
will permit issuance of
registration letter.
132. M/s Sami
Pharmaceuticlas (Pvt.)
Limited, F-95, S.I.T.E.
Karachi-Pakistan
Neege 20mg Tablets
Each delayed release
Tablet contains:-
Pantoprazole Sodium
Sesuiquihydrate
equivalent to
Pantoprazole
(USP)…20mg
(Proton Pump
Inhibitor) USP
Spec.s)
Form 5
06-07-2010
Rs.8,000/ (69)
+Rs. 12000 (10-05-
2013)
As Per PRC
BNF. Pantoprazole
(Non-proprietary)
Zentro (Bosch)
Good (28-11-2013)
Very good (24-06-
2014) Grant of
Additional sections
Satisfactory (07-11-
2013) Routine
1. Verification of
photocopy of fee
of Rs. 12000/- is
required.
Approved. Reference
will be sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If confirmed,
then Chairman, RB
will permit issuance of
registration letter.
109
1. The Routine applications checked by the Field Officers before establishment of Cell
Evaluator - II
S/N Name and
address of
manufacturer/
Applicant
1. Brand
Name
2. Dosage
Form
3.
Composition
4.
Pharmacologi
cal
group
1.Type of
Form
2. Type of
application
3.
Demanded
Price / Pack
size
4. Initial
date, diary.
5. Date on
which fee
becomes
complete
according to
type of
application
/or Form
(total Fee)
1. Finished
Product
Specification
2. Me-too status
Comments /
observation on
the product (if
any)
Decision
Registration-II
133. M/s Barrett
Hodgson
Pakistan Pvt.
Ltd. F/423,
SITE, Karachi
1.DutaBar
2.Capsule
3.Each
Capsule
contain:
Dutasteride…
……….0.5mg
4.Alpha-
Reductase
Inhibitors
1.Form5
2.Routine
3. Rs.
1200/20’s
4.28/09/2010
Dy. No. 1738
Form 5
Rs. 8000/-
(Original)
21-5-2013
Rs.12,000/-
(Photo copy)
Me too confirmed
Advodart of GSK
FDA : Avodart
(GSK)
Deferred for
confirmation of
formualtion in soft
gelatin capsule form.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
134. -do- 1.MindSet
2.Capsules
3.Each
Capsule
contains:
Ziprasidone
……….20mg
4.Atypical
1.Form5
2.Routine
3. Rs.
900/14’s
4.28/09/2010
Dy. No. 1742
Form 5
Rs. 8000/-
Me too status
confirmed.
FDA : Geodon
(Pfizer)
Approved with
change in applied
brand name.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
110
Anti-
Psychotropic
Agent
(Original)
21-5-2013
Rs.12,000/-
(Photo copy)
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
135. -do-
1.MindSet
2.Capsules
3.Each
Capsule
contains:
Ziprasidone…
…….40mg
4.Atypical
Anti-
Psychotropic
Agent
1.Form5
2.Routine
3. Rs.
1500/14’s
4.28/09/2010
Dy. No. 1741
Rs. 8000/-
(Original)
21-5-2013
Rs.12,000/-
(Photo copy)
Me too status
confirmed.
FDA : Geodon
(Pfizer)
Approved with
change in applied
brand name.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
136. -do-
1.MindSet
2.Capsules
3.Each
Capsule
contains:
Ziprasidone
……….60mg
4.Atypical
Anti-
Psychotropic
Agent
1.Form5
2.Routine
3. Rs.
2100/14’s
4.28/09/2010
Dy. No. 1740
Rs. 8000/-
(Original)
21-5-2013
Rs.12,000/-
(Photo copy)
Ziprox of Nabi
qasim
FDA : Geodon
(Pfizer)
Approved with
change in applied
brand name.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
137. -do-
1.MindSet
2.Capsules
3.Each
Capsule
contains:
Ziprasidone…
…….80mg
4.Atypical
Anti-
Psychotropic
Agent
1.Form5
2.Routine
3. Rs.
2800/14’s
4.28/09/2010
Dy. No. 1739
Rs. 8000/-
(Original)
21-5-2013
Rs.12,000/-
(Photo copy)
Me too status
confirmed
FDA : Geodon
(Pfizer)
Approved with
change in applied
brand name.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
111
138. M/s Macter
International Ltd.
F-216, SITE,
Karachi
1.Amlotel
2.Tablet
3.Each tablet
contains:
Telmisartan…
…………….4
0mg
Amlodipine…
…………..….
5mg
4.antihyperten
sive
1.Form5
2.Routine
3.14’s / As
per PRC
4.22/09/2010
Dy. No. 1709
Rs. 8000/-
(Original)
22-5-2013
Rs.12,000/-
(Not
attached)
Me too confirmed FDA: Generic
(TORRENT
PHARMS LTD)
Approved.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
139. -do- 1.Amlotel
2.Tablet
3.Each tablet
contains:
Telmisartan…
…………….8
0mg
Amlodipine…
…………..….
5mg
4.antihyperten
sive
1.Form5
2.Routine
3.14’s / As
per PRC
4.22/09/2010
Dy. No. 1708
Rs. 8000/-
(Original)
22-5-2013
Rs.12,000/-
(Not
attached)
Me too confirmed FDA: Generic
(TORRENT
PHARMS LTD)
Approved.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
140. -do- 1.Amlotel
2.Tablet
3.Each tablet
contains:
Telmisartan…
…….40mg
Amlodipine…
………10mg
4.antihyperten
sive
1.Form5
2.Routine
3.14’s / As
per PRC
4.22/09/2010
Dy. No. 1710
Rs. 8000/-
(Original)
22-5-2013
Rs.12,000/-
(Not
attached)
Me too confirmed FDA: Generic
(TORRENT
PHARMS LTD)
Approved.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
141. -do- 1.Amlotel
2.Tablet
3.Each tablet
contains:
Telmisartan…
…………….8
0mg
Amlodipine…
…………..….
10mg
4.antihyperten
sive
1.Form5
2.Routine
3.14’s / As
per PRC
4.22/09/2010
Dy. No. 1707
Rs. 8000/-
(Original)
22-5-2013
Rs.12,000/-
(Not
attached)
Me too status
confirmed
FDA: Generic
(TORRENT
PHARMS LTD)
Approved.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
112
142. -do- 1.Prophed
2.Suspension
3.Each 5ml
contains:
Ibuprofen.100
mg
Pseudoephedri
ne
HCI……15mg
4.Pain reliever
/fever reducer
nasal
decongestant)
1.Form5
2.Routine
3. 60ml/As
per PRC
4.22/09/2010
Dy. No. 1711
Rs. 8000/-
(Original)
22-5-2013
Rs.12,000/-
(Not
attached)
Rovinac of Rock
pharmaceutical
Int. avail not
confirmed in Str
DRAs.
Psychotropic
precursor
(For
Psychotropic
Precursors,
there is no
requirement
for dedicated /
separate
manufacturing
facility)
Deferred for
confirmation of
approval in reference
Stringent Regulatory
Agencies.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan.
143. M/s Nabiqasim
Industries Pvt
Ltd. 17/24,
Korangi
industrial Area,
Karachi.
1.Qutex
2.Tablet
3.Each film
coated tablet
contains:
Quetiapine
fumarate eq to
quetiapine.100
mg
4.anti
psychotic,
dibenzothiaze
pine)
Specs:
NabiQasim
1.Form5
2.Routine
3. 10’s, 30’s/
As per PRC
4.16/09/2010
Dy. No. 1699
Rs. 8000/-
(Original)
14-5-2013
Rs.12,000/-
(Photo copy)
Me too status
confirmed
FDA: Generic
(DR. REDDYS
LABS LTD)
Approved.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
144. -do- 1.Bepcor
2.Tablet
3.Each film
coated tablet
contains:
Bosentan (as
monohydrate)
…………...12
5mg
4.Pulmonary
arterial
hypertension)
(PAH),
systemic
sclerosis with
ongoing
digital ulcer
disease
1.Form5D
2.Routine
3. Rs.
30,000/10’s
4.16/09/2010
Dy. No. 1690
Rs. 15000/-
(Original)
14-5-2013
Rs.5000/-
(Photo copy)
1. It is a me too
2. At the time of
filing application,
the drug was new.
The firm submitted
Form 5-D with fee
Rs. 15,000/-. Now
the drug has
become registered.
The firm has
submitted the from
5.
FDA: Tracleer Approved.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
113
Specs:
NabiQasim
145. -do- 1.Qrist
2.Tablets
3.Each
extended
release tablet
contains:
Desvenlafaxin
e succinate eq
to
desvenlafaxine
……….50mg
4.Antidepressa
nt
Specs:
NabiQasim
1. Form 5
2.Routine
3. 10’s, 14’s,
/
As per PRC
4.16/09/2010
Dy. No. 1689
Rs. 8000/-
(Original)
14-5-2013
Rs.12,000/-
(Photo copy)
1.Me too status
confirmed
Denla XR
50mg&100mg of
M/s Semos
Pharma,
(Reg.No.070433&0
70434)
2.The firm has
submitted the
undertaking
regarding
submission of
comparative
dissolution profile
before marketing of
the product
FDA : Khedezla Approved.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
146. -do- 1.Qrist
2.Tablets
3.Each
extended
release tablet
contains:
Desvenlafaxin
e succinate eq
to
desvenlafaxine
………..….10
0mg
4.antidepressa
nt
Specs:
NabiQasim
1. Form 5
2.Routine
3.
10’s,14’s/As
per PRC
4.16/09/2010
Dy. No. 1693
Rs. 8000/-
(Original)
14-5-2013
Rs.12,000/-
(Photo copy)
1.Me too status
confirmed
Denla XR
50mg&100mg of
M/s Semos
Pharma,
(Reg.No.070433&0
70434)
2.The firm has
submitted the
undertaking
regarding
submission of
comparative
dissolution profile
before marketing of
the product
FDA: Kheedezla Approved.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
147. -do- 1.Qutex
2.Tablet
3.Each film
coated tablet
contains:
Quetiapine
fumarate eq to
quetiapine..25
mg
4.anti
psychotic,
dibenzothiaze
1. Form 5
2.Routine
3.
10’s,30’s/As
per PRC
4.16/09/2010
Dy. No. 1698
Rs. 8000/-
(Original)
14-5-2013
Rs.12,000/-
(Photo copy)
Me too status
confirmed
FDA: Seroquel Approved.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
114
pine
Specs:
NabiQasim
148. -do-
1.Qutex
2.Tablet
3.Each film
coated tablet
contains:
Quetiapine
fumarate eq to
quetiapine.200
mg
4.anti
psychotic,
dibenzothiaze
pine
Specs:
NabiQasim
1. Form 5
2.Routine
3. 10’s, 30’s /
As per PRC
4.16/09/2010
Dy. No. 1695
Rs. 8000/-
(Original)
14-5-2013
Rs.12,000/-
(Photo copy)
Me too status
confirmed
FDA: Seroquel Approved.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
149. -do- 1.Bepcor
2.Tablet
3.Each film
coated tablet
contains:
Bosentan (as
monohydrate)
……..62.5mg
4.Pulmonary
arterial
hypertension
(PAH)
Specs:
NabiQasim
1. Form 5
2.Routine
3. Rs.
19000/10’s
4.16/09/2010
Dy. No. 1696
Rs. 15000/-
(Original)
14-5-2013
Rs.5000/-
(Photo copy)
1. It is a me too.
2. The firm has
now submitted
form 5.
FDA: Tracleer Approved.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
Registration-V
115
150. M/s Care
Pharmaceuticals,
8Km, Thokor
Raiwind Road,
Lahore
1.Sinocare
2.Cream
3.Each gm
contains:
Fluocinolone
acetonide..2.5
mg
4.Corticosteroi
d
1.Form5
2.Routine
3.Rs.50/15g
m,
Rs.90/30gm
4.30-09-2010
Dy.No.4032
Rs.8000/-
Rs.12,000/-
13-5-2013
Reply has been
received.
FDA: Generic
(Taro)
Deferred for
confirmation of
steroidal section.
151. -do- 1.Fusidcare
2.Cream
3.Each gm
contains:
Fusidic Acid
(2%)…….20
mg
4.Antibacterial
1.Form5
2.Routine
3.Rs.65/5gn,
Rs.165/15gm
4.30-09-2010
Dy.No.4033
Rs.8000/-
15-05-2013
Rs.12,000/-
Reply is still
awaited.
The firm was
communicated
twice. They have
stated that they are
no more interested
in the product
registration.
BNF: Fucidin
(Leo)
Last reminder will be
issued to the firm for
rectification opf
shortcomings.
152. -do- 1.Clomezole
2.Cream
3.Each gm
contains:
Clotrimazole
………….10
mg
4.Antifungal
1.Form5
2.Routine
3.
Rs.41/10gn,
Rs.70/20gm
4.30-09-2010
Dy.No.4029
Rs.8000/-
15-05-2013
Rs.12,000/-
Reply is still
awaited.
The firm was
communicated
twice. They have
stated that they are
no more interested
in the product
registration.
FDA: Generic
(Taro)
Last reminder will be
issued to the firm for
rectification opf
shortcomings.
153. M/s CCL
Pharmaceuticals,
Pvt. Ltd.
62-Industrial
Estate, Kot
Lakhpat, Lahore
1.Cip
2.Suspension
3.Each 5ml
contains:
Ciprofloxacin
hydrochloride
eq. to
ciprofloxacin
…..................1
25mg
4.Antibiotic.
1.Form5
2.Routine
3.60ml/ Price
not
mentioned
4.06-09-2010
Rs.8000/-
(Photo copy)
20-05-2013
20-05-2013
Rs.12,000/-
(Original)
FDA: Cipro
(Different
formulation)
The originator’s
(M/s Bayer)
formulation
contains
ciprofloxacin in
base form,
however the
firm has
submitted that a
number of
products in
Pakistan are
registered in
which
ciprofloxacin is
Deferred for review
of formulation by
Review Committee.
116
present in HCl
form. The firm
has also
provided
labeling and
outer packaging
of Novidate
(product of Sami
pharmaceuticals,
Karachi) which
confirms the
stance of the
firm.
154. M/s Schazoo
Pharmaceuticals
Laboraories Pvt.
Ltd. Kaolawala
Stop, 20, KM
Jaranwala Road,
District
Shehikhupura.
1.Cavrex
2.Tablet
3.Each film
coated tablet
contains:
Entecavir as
monohydrate
(M.S)……1
mg
4.Anti viral.
1.Form5
2.Routine
3.Rs.15,000/
30’s
4.24-09-2010
Rs.8000/-
(Original)
28-05-2013
Rs.12,000/-
(Original)
Tacavair of M/s
Consolidated
chemical Lab.
FDA: Baraclude
Me too status
confirmed
Approved.
155. -do- 1.Ceretek
2.Injection
3.Each 1ml
contains:
Haloperidol as
lactate…5mg
4.Anti
Psychotic
1.Form5
2.Routine
3.Rs.300/(2x
5) 1ml
Ampoule
4.24-09-2010
Rs.8000/-
(Original)
28-05-2013
Rs.12,000/-
(Original)
FDA: Generic
(Sagent Pharms)
Me too status
confirmed
Deferred for
confirmation of
installation and
operational
qualification of TOC
analyser & Liquid
Particle Counter by
area FID.
156. -do- 1.Ceretek
2.Tablet
3.Each tablet
contains:
Haloperidol
Usp……….20
mg
4. Anti
Psychotic
1.Form5D
2.Routine
3.Rs.300/3x1
0’s
4.24-09-2010
Rs.8000/-
(Original)
28-05-2013
Rs.12,000/-
(Original)
1. It is new drug.
2. Differential fee
of Rs. 30,000/- is
required to be
deposited by the
applicant.
FDA: Generic
(Sandoz)
The firm has
been asked for
submission of
fee. Her
responses still
awaited.
Deferred for
submission of
differential fee,
assessment of
stability studies &
opinion by the
experts.
Registration – II
117
157. M/s Genix
Pharma (Pvt.)
Ltd;
44, 45-B,
Korangi Creek
Road,
Karachi
Diphos Dry
Suspension
Each 5ml
contains:
Dihydroartemi
sinin………15
mg
Piperaquine
Phosphate…
…...…120mg
1.Form5
2.Routine
3. 30 ml Rs.
250/-
60 ml Rs.
500/-
80 ml Rs.
667/-
4.14-09-2010
5.Dy. No.72
Rs.8,000/-
Rs.12,000/-
21-05-2013
Me too confirmed Int. avail not
confirmed in
Stringent DRAs.
The firm has
submitted
reference of Me
too as Poart
susp. of Neutro
pharma (62770)
Deferred for views
of recommendations
of WHO.
158. -do- Diphos DS
Sachet
30/240mg
Each Sachet
contains:
Dihydroartemi
sinin
(Ph.I)….30mg
Piperaquine
Phosphate
Anhydrous…
….….. 240mg
1.Form5
2. Routine
3. per sachet
Rs. 45/-
10’s Rs.450/-
16’s Rs.
720/-
4.14-09-2010
5.Dy. No.64
Rs.8,000/-
Rs.12,000/-
(21-5-2013)
1. Me too status
needs confirmation
Int. avail not
confirmed in Str
DRAs.
Deferred for views
of recommendations
of WHO.
159. -do- 1.Diphos
2. Syrup
3.Each 5ml
contains:
Dihydroartemi
sinin……..15
mg
Piperaquin
Phosphate
………120mg
4.Anti
Malarial
1.Form5-D
2. Routine
3. 30 ml Rs.
250/-
60 ml Rs.
500/-
80 ml Rs.
667/-
4.14-09-2010
Dy. No.73
Rs.8,000/-
Rs.12,000/-
(21-5-2013)
1. Me too status
needs confirmation
Int. avail not
confirmed in Str
DRAs.
Deferred for views
of recommendations
of WHO.
118
160. -do- 1.Diapil
2.Tabs
3.Each film
coated tablet
contains:
Saxagliptin
HCl e.q to
Saxagliptin…
…….…5mg
4.Anti Diabetc
1.Form5D
2.Routine
3. Rs.
4500/10’s
Rs. 9000/20’s
Rs.
13500/30’s
4.14/09/2010
Dy. No. 1684
Rs. 15000/-
Rs.12,000/-
21-5-2013
Gliplyza 5mg
Tablet, Regn
no.076316, M/s
Macter int, Karachi
FDA: Onglyza Approved
161. -do- 1.Diapil
2.Tablet
3.Each film
coated tablet
contains:
Saxagliptin
HCl e.q to
Saxagliptin…
……..……2.5
mg
4. Anti
Diabetc
1.Form5D
2.Routine
3. Rs.
2500/10’s
Rs. 5000/20’s
Rs. 7500/30’s
4.14/09/2010
Dy. No. 1681
Rs. 15000/-
Rs.12,000/-
21-5-2013
Gliplyza 2.5mg
Tablet, Regn
no.076316, M/s
Macter int,
Karachi.
FDA: Onglyza Approved
162. -do- 1.Diphos DS
2.Tablet
3.Each Tablet
contains:
Dihydroartemi
sinin
(Ph.I)…….80
mg
Piperaquine
Phosphate
(M.S) 640mg
4.Anti
Malarial
1.Form-5 D
2.Routine
3. Rs.800/8’s
4.14/09/2010
Dy. No. 67
(Moh)
Rs. 8000/-
Rs.12,000/-
21-5-2013
Me too status needs
confirmation.
Int. avail not
confirmed in Str
DRAs.
Deferred for views
of recommendations
of WHO.
163. -do- 1.Diphos DS
2.Suspension
3.Each 5ml
contains:
Dihydroartemi
sinin
1.Form-5
2.Routine
3. Rs.
450/10’s
Rs. 720/16’s
4.16/09/2010
Me too status needs
confirmation.
Int. avail not
confirmed in Str
DRAs.
Deferred for views
of recommendations
of WHO.
119
(PhI)….30mg
Piperaquine
Phosphate
Anhydrous…
……..…240m
g
4.Anti
Malarial
Dy. No. 69
(Moh)
Rs. 8000/-
Rs.12,000/-
21-5-2013
164. M/s Noa Hemis
Pharmaceuticals,
Plot No. 154,
Sector-23, Korangi
Industrial Area,
Karachi-74900
Loxicam 4mg
Tablet
Each film coated
tablet contains:
Lornoxicam
…………4 mg
(NSAID)
(Manufacturer’s
Spec.s)
Form-5
30-7-2010
Dy.No.1507
Rs.8000/-+Rs.
12000/- (10-05-
13)
Rs.1200/-/10’s
The formulation
found to be EMA
approved but
appeared as not
confirmed in the
agenda erroneously.
Xefast (Pharmevo)
Good (09-06-2014)
2. Verification of
photocopy of fee
of Rs. 8000/- is
required.
3. International
availability in
stringent DRA,s
not confirmed.
Approved (as found
approved by EMA).
Reference will be sent
to B & A Division,
DRAP for verification
of photocopy of fee
challan. If confirmed,
then Chairman, RB
will permit issuance of
registration letter.
165. -do- Loxicam-DS 8mg
Tablet
Each film coated
tablet contains:
Lornoxicam
…………8 mg
(NSAID)
(Manufacturer’s
Spec.s)
Form-5
30-7-2010
Dy.No.1505
Rs.8000/-
+Rs. 12000/-
(10-05-13)
Rs.2300/-/10’s
The formulation
found to be EMA
approved but
appeared as not
confirmed in the
agenda erroneously.
Xefast (Pharmevo)
Good (09-06-2014)
1. Verification of
photocopy of fee
of Rs. 8000/- is
required.
2. International
Approved (as found
approved by EMA).
Reference will be sent
to B & A Division,
DRAP for verification
of photocopy of fee
challan. If confirmed,
then Chairman, RB
will permit issuance of
registration letter.
120
availability in
stringent DRA,s
not confirmed.
166. -do- Resipa 1mg Tablet
Each film coated
tablet contains:
Risperidone …1
mg
(Antipsychotic)
(Manufacturer’s
Spec.s)
Form-5
30-7-2010
Dy.No.1500
Rs.8000/-+Rs.
12000/- (14-05-
13)
As per PRC
BNF : Risperdal
(Janssen)
Risperdal
(Janssen)
Good (09-06-2014)
1. Verification of
photocopy of fee
of Rs. 8000/- is
required.
Approved. Reference
will be sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If confirmed,
then Chairman, RB
will permit issuance of
registration letter.
167. -do- Resipa 2mg Tablet
Each film coated
tablet contains:
Risperidone…2 mg
(Antipsychotic)
(Manufacturer’s
Spec.s)
Form-5
30-7-2010
Dy.No.1509
Rs.8000/-+Rs.
12000/- (14-05-
13)
As per PRC
BNF : Risperdal
(Janssen)
Risperdal
(Janssen)
Good (09-06-2014)
1. Verification of
photocopy of fee
of Rs. 8000/- is
required.
Approved Reference
will be sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If confirmed,
then Chairman, RB
will permit issuance of
registration letter.
168. -do- Resipa 3mg Tablet
Each film coated
tablet contains:
Risperidone ...3 mg
(Antipsychotic)
(Manufacturer’s
Spec.s)
Form-5
30-7-2010
Dy.No.1503
Rs.8000/-+Rs.
12000/- (14-05-
13)
As per PRC
BNF : Risperdal
(Janssen)
Risperdal
(Janssen)
Good (09-06-2014)
1. Verification of
photocopy of fee
of Rs. 8000/- is
required.
Approved Reference
will be sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If confirmed,
then Chairman, RB
will permit issuance of
registration letter.
121
169. -do- Gasiton 50mg
Tablet
Each tablet
contains:
Itopride
Hydrochloride……
…….50 mg
(Gastroprokinetic)
(Manufacturer’s
Spec.s)
Form-5
30-7-2010
Dy.No.1508
Rs.8000/-+Rs.
12000/- (10-05-
13)
As per PRC
Not confirmed
GANATON
(ABBOTT)
Good (09-06-2014)
1. Verification of
photocopy of fee
of Rs. 8000/- is
required.
2. International
availability in
stringent DRA,s
not confirmed.
3. Formulation is
under review by
the review
committee.
Deferred for review
of formulation by
Review Committee.
170. -do- Etecav 0.5 mg
Tablet
Each film coated
tablet contains:
Entecavir (as
monohydrate)……
……...0.5 mg
(Anti Viral)
(Manufacturer’s
Spec.s)
Form-5
30-7-2010
Dy.No.1506
Rs.8000/-+Rs.
12000/- (10-05-
13)
As per PRC
BNF : Baraclude
(Bristol-Myers
Squibb)
Centauru S
(Ferozsons)
Good (09-06-2014)
1. Verification of
photocopy of fee
of Rs. 8000/- is
required.
2. Amount of active
drug is very less
(500mcg), may be
considered for
Product specific
inspection.
Deferred for product
specific inspection by
panel comprising of
Director DTL Karachi,
DDG (E & M) & area
FID.
171. -do- Proxat 20mg Tablet
Each film coated
tablet contains:
Paroxetine (as
Form-5
30-7-2010
Dy.No.1504
Rs.8000/-+Rs.
BNF : Seroxat (GSK)
Seroxat (GSK)
Good (09-06-2014)
Approved. Reference
will be sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If confirmed,
122
HCl)…..…20 mg
(Antidepressant,
selective serotonin
reuptake inhibitor)
(B.P Spec.s)
12000/- (10-05-
13)
As per PRC
1. Verification of
photocopy of fee
of Rs. 8000/- is
required.
then Chairman, RB
will permit issuance of
registration letter.
172. -do- Muscolex 4mg
Capsule
Each capsule
contains:
Thiocolchicoside…
…..4 mg
(Muscle relaxant)
(Manufacturer’s
Spec.s)
Form-5
30-7-2010
Dy.No.1502
Rs.8000/-+Rs.
12000/- (10-05-
13)
As per PRC
Not confirmed
Muscoril (Searle)
Good (09-06-2014)
1. Verification of
photocopy of fee
of Rs. 8000/- is
required.
2. International
availability in
stringent DRA,s
not confirmed.
3. Formulation is
under review by
the review
committee.
Deferred for review of
formulation by
Review Committee.
173. -do- Gabagyl 200mg
Capsule
Each capsule
contains:
Gabapentin………
……...200 mg
(Anticonvulsant)
(Manufacturer’s
Spec.s)
Form-5
30-7-2010
Dy.No.1510
Rs.8000/-+Rs.
12000/- (10-05-
13)
As per PRC
Gebapentin in 200mg
strength Not found in
FDA & UK
Gabin of PharmEvo
Good (09-06-2014)
1. Verification of
photocopy of fee
of Rs. 8000/- is
required.
2. International
availability in
stringent DRA,s
not confirmed.
Deferred for
confirmation of
approval in reference
Stringeny Regulatory
Agencies.
174. -do- Zofen 0.25mg/5ml Form-5 BNF : Sanomigran Rejected on the
grounds that the
123
Syrup
Each 5ml contains:
Pizotifen( as
Hydrogen
Maleate)…………
………………..0.2
5 mg
(Appetite
stimulant)
(Manufacturer’s
Spec.s)
30-7-2010
Dy.No.1501
Rs.8000/-+Rs.
12000/- (10-05-
13)
As per PRC
(Novartis)
Not confirmed
Good (09-06-2014)
1. Verification of
photocopy of fee
of Rs. 8000/- is
required.
2. The firm has
applied the
formulation as
appetite stimulant
which is not
rational.
applicant applied the
formulation for wrong
pharmacological
indication.
124
2. Veterinary applications
S/N Name of
Applicant
Name of Drug(s) /
Composition
Price/Pack
Size
Shelf Life Date of
application
receiving.
Decision
175. M/s. Nawan
Laboratories
(Pvt) Ltd.,
Karachi.
Pameron Injection
Each ml contains:-
Methampyrone…
…………100mg
Chlorpheniramine
Maleate…..1mg
Caffeine……10mg
(Antipyretic and
Analgesic).
Decontrolled
10ml
50ml
100ml
2 years 24-12-2010
Rs.8000 + Rs.
12000 =
Rs.20,000/-
Deferred for confirmation
of installation and
operational qualification of
TOC analyser and Liquid
Particla Counter, Me-too
status & GMP status of the
firm.
176. M/s. Mallard
Pharmaceutic
als (Pvt) Ltd.,
Multan.
Shina Gold Drench
Each ml contains:-
Oxyclozanide……
….…..62.50mg
Oxfendazole……
…….…25mg
Cobalt
Sulphate…..2mg
Sodium
Selenite……0.5mg
(Anthelmentic).
Decontrolled
100ml
250ml
500ml
1000ml
2.5 Liter
2 years 15-12-2010
Rs.8000 + Rs.
12000 =
Rs.20,000/-
Deferred for name change,
Me-too & GMP status of
the firm.
177. M/s. Mallard
Pharmaceutic
als (Pvt) Ltd.,
Multan.
Shinazan Plus
Drench
Each ml contains:-
Oxyclozanide……
……...30mg
Levamisole
Decontrolled
100ml
150ml
250ml
500ml
2 years 15-12-2010
Rs.8000 + Rs.
12000 =
Rs.20,000/-
Deferred for name change,
Me-too & GMP status of
the firm.
125
HCI………...15mg
Cobalt
Sulphate………....
0.75mg
Sodium
Selenite……..…..0
.35mg
Vitamin
K……………....3
mg
(Anthelmentic).
1000ml
2.5 Liter
178. M/s. Mallard
Pharmaceutic
als (Pvt) Ltd.,
Multan.
Shina Fax Liquid
Each ml contains:-
Oxfendazole……
…..22.65mg
Zinc
Sulphate………2.6
mg
(Anthelmentic).
Decontrolled
100ml
250ml
450ml
500ml
1000ml
2.5 Liter
2 years 15-12-2010
Rs.8000 + Rs.
12000 =
Rs.20,000/-
Deferred for name change,
Me-too & GMP status of
the firm.
179. M/s. Mallard
Pharmaceutic
als (Pvt) Ltd.,
Multan.
Shina Zole 12.5%
SC Liquid
Each ml contains:-
Albendazole……
………..125mg
Sodium Selenite
………..1.67mg
Cobalt
Sulphate…………
0.50mg
(Anthelmentic).
Decontrolled
30ml
100ml
250ml
500ml
1000ml
2.5 Liter
2 years 15-12-2010
Rs.8000 + Rs.
12000 =
Rs.20,000/-
Deferred for name change,
Me-too & GMP status of
the firm.
126
180. M/s. Sanna
Laboratories,
Faisalabad.
Sanoxicam
Injection
Each ml contains:-
Meloxicam...7.5mg
(Analgesic).
Decontrolled
10ml
30ml
50ml
100ml
2 years 30-12-2010
Rs.8000 + Rs.
12000 =
Rs.20,000/-
Deferred for Me-too &
GMP status of the firm.
181. M/s. Sanna
Laboratories,
Faisalabad.
SCS-Forte
Injection
Each ml contains:-
Colistin
Sulphate……...1
MIU
(Polymyxin
Antibiotic).
Decontrolled
50ml
100ml
2 years 30-12-2010
Rs.8000 + Rs.
12000 =
Rs.20,000/-
Deferred for Me-too &
GMP status of the firm.
182. M/s. Sanna
Laboratories,
Faisalabad.
Sanacol-50 Water
Soluble Powder
Each gram
contains:-
Colistin
Sulphate…….50,0
0,000 IU
(Polymyxin
Antibiotic).
Decontrolled
100gm
300gm
500gm
1 Kg
2 years 30-12-2010
Rs.8000 + Rs.
12000 =
Rs.20,000/-
Deferred for Me-too &
GMP status of the firm.
183. M/s. Sanna
Laboratories,
Faisalabad.
ECS-150 Oral
Liquid
Each 100ml
contains:-
Enrofloxacin
…………10gm
Colistin
Sulphate…50,000,
000 IU
(Antibiotic).
Decontrolled
100ml
500ml
1 Liter
2 years 30-12-2010
Rs.8000 + Rs.
12000 =
Rs.20,000/-
Deferred for Me-too &
GMP status of the firm.
127
Evaluator – I
S. N Name and
address of
Manufacturer /
Applicant
Brand Name
(Proprietary
name + Dosage
form + Strength)
Composition
Pharmacological
Group
Finished product
specification
Type of Form
Initial date,
diary.
Fee including
differential fee
Demanded
Price / Pack
size
International
status in
stringent
regulatory
agencies
Me-too status
GMP status as
depicted in
inspection
report (dated)
Remarks /
Observations
Decision
184. M/s Ray Pharma
(Pvt.) Ltd, S-58,
S.I.T.E.
Extension
Hawksbay
Road, Karachi
Raylox Tablet
Film Coated
Tablet
Each Film Coated
Tablet Contains.
Levofloxacin as
Hemihydrate
..........750mg
(Quinolone group
Antibacterial)
Manufacturers
Specifications
Form 5
10’s /Rs.299/-
Dy. No. Not
mentioned
(Duplicate
Dossier)
Dossier dated
29-06-2010
Rs.8000/- (17-
05-2010)
Dy. No. Not
mentioned
Rs.12,000/-
dated 26-09-
2013 (Fee
challans are
duplicate)
Total
Rs.20,000/-
LEVAQUIN
750mg Film
coated tablet
US FDA
LEFLOX
750mg
Getz
Inspection report
dated 06/05/2014
good level of
GMP compliance
reported.
Approved.
185. M/s Ray Pharma
(Pvt.) Ltd, S-58,
S.I.T.E.
Extension
Hawksbay
Road, Karachi
Rayart DS Tablet
Tablet
Each Tablet
Contains.
Artemether
Form 5
8’s /Rs.264/-
Dy. No. Not
mentioned
(Duplicate
ARTHEGET
40/240mg tablet
Getz
Inspection report
dated 06/05/2014
good level of
Approved
128
……….40mg
Lumefantrine……
.240mg
(Anti Malarial)
Manufacturers
Specifications
Dossier)
Dossier dated
29-06-2010
Rs.8000/- (17-
05-2010)
Dy. No. Not
mentioned
Rs.12,000/-
dated 26-09-
2013 (Fee
challans are
duplicate)
Total
Rs.20,000/-
GMP compliance
reported.
186. M/s Ray Pharma
(Pvt.) Ltd, S-58,
S.I.T.E.
Extension
Hawksbay
Road, Karachi
Rayart Tablet
Tablet
Each Tablet
Contains.
Artemether
……….80mg
Lumefantrine……
.480mg
(Anti Malarial)
Manufacturers
Specifications
Form 5
4’s /Rs.220/-
Dy. No. Not
mentioned
(Duplicate
Dossier)
Dossier dated
19-07-2010
Rs.8000/- (17-
05-2010)
Dy. No. Not
mentioned
Rs.12,000/-
dated 26-09-
2013 (Fee
challans are
duplicate)
Total
Rs.20,000/-
ARTHEGET
80/480mg tablet
Getz
Inspection report
dated 06/05/2014
good level of
GMP compliance
reported.
Approved.
187. M/s Ray Pharma
(Pvt.) Ltd, S-58,
S.I.T.E.
Extension
Rayaz Tablet
Tablet
Form 5
3’s /Rs.160/-
Dy. No. Not
ZITHROMAX
500mg tablets
US FDA
Approved.
129
Hawksbay
Road, Karachi
Each Film Coated
Tablet Contains.
Azithromycin as
dihydrate
………………….
500mg
(Macrolide
Antibiotic)
Manufacturers
Specifications
mentioned
(Duplicate
Dossier)
Dossier dated
29-06-2010
Rs.8000/- (17-
05-2010)
Dy. No. Not
mentioned
Rs.12,000/-
dated 26-09-
2013 (Fee
challans are
duplicate)
Total
Rs.20,000/-
AZOMAX
500mg tablet
Novartis
Inspection report
dated 06/05/2014
good level of
GMP compliance
reported.
188. M/s Macter
International
(Pvt.) Ltd. F-
216, S.I.T.E.,
Karachi
Micam
Tablet
Each film coated
tablet Contains:-
Lornoxicam
…..4mg
(Analgesic and
anti-
inflammatory)
Form 5
5’s and 10’s/As
Per PRC
Dy No 255 R&I
dated 23-07-
2010 Rs.8000/-
Rs.12,000/-
22-05-2013
VICTRA
4mg tablet
Scitech
Lornoxicam
4mg f/c tablet
EMA
Inspection report
dated 10-04-2014
considered to be
operating at
satisfactory level
of GMP.
Capsule section
mentioned in
inspection report.
Approved.
189. M/s Bosch
Pharmaceutical,
221, Bosch
House, Sector
23, Korangi
Industrial Area,
Karachi.
Falgan
500mg/50ml
Infusion
Each Vial
Contains.
Paracetamol
….(B.P)
500mg/50ml
Form 5-D
1,s /Rs.60/-
Dy
No.1386/R&I
dated 22-07-
2010/
Rs.15,000/-
PERFALGAN
10mg/ml (50ml
Vial)
MHRA
Injectable Liquid
section granted
vide letter No. F.
2-4/91-Lic (Vol-
II) (M-196).
Routine GMP
1. Copy of
cashiers’ cheque
amounting to
168,000/- (Rs.
12,000/- each for
14 products,
including Falgan
500mg/50ml).
However, the
cheque or the
covering is not
endorsed by STO
Deferred for
rectification of
following
shortcomings in the
dossier:
1. Copy of
cashiers’ cheque
amounting to
168,000/- (Rs.
12,000/- each for
14 products,
including Falgan
500mg/50ml). The
130
(Analgesics and
Antipyretics)
(Manufacturer’s
Specs)
Copy of cashiers
cheque
amounting to
168,000/- (Rs.
12,000/- each
for 14 products,
including Falgan
500mg/50ml).
However, the
cheque or the
covering is not
endorsed by
STO and is also
not the
prescribed fee
for Form-5D
applications.
inspection report
dated 12-08-2014
cGMP level rated
as good.
and is also not the
prescribed fee for
Form-5D
applications.
2. Pyrogen free
distilled water has
been mentioned in
the master
formulation
whereas, the
reference brand
contains WFI for
which evidence of
TOC analyzer and
liquid particle
counter is required.
However, firm has
provided copies of
operator’s manual
of particle counter
only, as evidence.
3. Stability
summary at 30 C
and 65% RH for
only one batch of
3,000/- vials
submitted.
cheque or the
covering is not
endorsed by STO
and is also not the
prescribed fee for
Form-5D
applications.
2. Pyrogen free
distilled water has
been mentioned in
the master
formulation
whereas, the
reference brand
contains WFI for
which evidence of
TOC analyzer and
liquid particle
counter is
required.
However, firm has
provided copies of
operator’s manual
of particle counter
only, as evidence.
Confirmation from
FID is required for
the Installational
& Operation
Qualification of
liquid particle
counter & TOC
analyzer.
3. Stability
summary at 30 C
and 65% RH for
only one batch of
3,000/- vials
submitted. Which
is required to be as
per WHO
guidelines.
190. M/s Pakistan
Pharmaceutical
Products (Pvt)
Ltd. D-122,
Sindh Industrial
Trading Estate,
Karachi
Pioglit 15mg +
2mg Tablet
Tablet
Each Tablet
Form 5
Dy. No. Not
mentioned / R&I
date not
mentioned
(Covering letter
Glibetic
15/2mg
ICI
Inspection report
dated 13-02-2013
Evidence of
approval of same
formulation by
stringent regulatory
authority e.g.,
FDA, TGA,
MHLW, EMA and
Deferred for
confirmation of
approval in
reference
Stringent
Regulatory
Agencies.
131
Contains.
Pioglitazone..
…..…. 15mg
Glimepiride..
…….. 2mg
(Anti-
Hyperglycemic)
dated
07/07/2010)
Rs.8000/-
(19/07/2010)
Rs.12,000/-
(15/05/2013) fee
challans are
duplicate
Total
Rs.20,000/-
14’s / Rs. 10 per
tablet
and 03-06-2014
considered to be
operating at
satisfactory level
of GMP.
Health Canada
required.
191. M/s Pakistan
Pharmaceutical
Products (Pvt)
Ltd. D-122,
Sindh Industrial
Trading Estate,
Karachi
Glitter 4mg Tablet
Tablet
Each Tablet
Contains.
Glimepiride ……..
4mg
(Anti-
Hyperglycemic)
Form 5
Dy. No Not
mentioned / R&I
dated not
mentioned
(Covering letter
dated
20/07/2010)
Rs.8000/-
(22/07/2010)
Rs.12,000/-
(15/05/2013)
fee challans are
duplicate
Total
Rs.20,000/-
20’s As per PRC
Amaryl
MHRA
Amaryl
Sanofi-Aventis
Inspection report
dated 13-02-2013
and 03-06-2014
considered to be
operating at
satisfactory level
of GMP.
Approved.
192. M/s Pakistan
Pharmaceutical
Products (Pvt)
Ltd. D-122,
Sindh Industrial
Trading Estate,
Karachi
Glitter 3mg Tablet
Tablet
Each Tablet
Contains.
Glimepiride ……..
Form 5
Dy. No. Not
mentioned / R&I
dated not
mentioned
(Dossier dated
20/07/2010)
Amaryl
MHRA
Amaryl
Sanofi-Aventis
Inspection report
Approved.
132
3mg
(Anti-
Hyperglycemic)
Rs.8000/-
(22/07/2010)
Rs.12,000/-
(15/05/2013)
fee challans are
duplicate
Total
Rs.20,000/-
20’s / As per
PRC
dated 13-02-2013
and 03-06-2014
considered to be
operating at
satisfactory level
of GMP.
193. M/s Pakistan
Pharmaceutical
Products (Pvt)
Ltd. D-122,
Sindh Industrial
Trading Estate,
Karachi
Glitter 2mg Tablet
Tablet
Each Tablet
Contains.
Glimepiride ……..
2mg
(Anti-
Hyperglycemic)
Form 5
Dy. No. Not
mentioned / R&I
dated not
mentioned
(Dossier dated
20/07/2010)
Rs.8000/-
(22/07/2010)
Rs.12,000/-
(15/05/2013)
fee challans are
duplicate
Total
Rs.20,000/-
20’s / As per
PRC
Amaryl
MHRA
Amaryl
Sanofi-Aventis
Inspection report
dated 13-02-2013
and 03-06-2014
considered to be
operating at
satisfactory level
of GMP.
Approved.
194. M/s Pakistan
Pharmaceutical
Products (Pvt)
Ltd. D-122,
Sindh Industrial
Trading Estate,
Karachi
Glitter 1mg Tablet
Tablet
Each Tablet
Contains.
Glimepiride ……..
1mg
(Anti-
Form 5
Dy. No. Not
mentioned / R&I
dated not
mentioned
(Dossier dated
20/07/2010)
Rs.8000/-
(22/07/2010)
Amaryl
MHRA
Amaryl
Sanofi-Aventis
Inspection report
dated 13-02-2013
and 03-06-2014
considered to be
operating at
satisfactory level
Approved.
133
Hyperglycemic) Rs.12,000/-
(15/05/2013)
fee challans are
duplicate
Total
Rs.20,000/-
20’s / As per
PRC
of GMP.
6. Routine drug registration applications
Evaluator – II
S.No Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form + Strength)
Composition
Pharmacological Group
Finished product
Specification
Type of Form
Initial date, diary
Fee including
differential fee
Demanded Price /
Pack size
Remarks on the
formulation (if any)
including
International status in
stringent drug
regulatory agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
Decision
195. M/s Macter
International
(Pvt) Ltd. F-216,
S.I.T.E, Karachi.
Affient 5mg Tablet Each film coated tablet
contains: Prasugrel HCl eq. to Prasugrel…………….5
mg (Inhibitor of platelet activation and
aggregation)
(Manufacturer’s Spec.s)
Form 5
05‐7‐2010(54)
Rs.15000/‐ 22‐5‐2013
Rs.5,000/‐
Rs. 8.42/Tab
Rs. 118/14’s
Rs.236/28’s
BNF: Efient(Lilly)
Prasu (Amson)
Satisfactory level of
GMP compliance. (10-
04-14)
1. Verification of
photocopy of
differential fee (Rs.
5000/-) paid is
required.
2. The Firm had
applied on Form 5-
D initially but has
Approved.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
134
now submitted
Form 5.
3. Approval of section
/ manufacturing
facility of applied
drug from licensing
section is required.
The Firm has
submitted GMP
insp. Report dated
10-04-14 which
mentions Tablet
(General) Section.
196. -do- Affient 10mg Tablet Each film coated tablet
contains: Prasugrel HCl eq. to Prasugrel…………….10
mg (Inhibitor of platelet activation and
aggregation)
(Manufacturer’s Spec.s)
Form 5
05‐7‐2010(46)
Rs.15000/‐ 22‐5‐2013
Rs.5,000/‐
Rs. 14/Tab
Rs. 96/14’s
Rs.392/28’s
BNF: Efient(Lilly)
Prasu (Amson)
Satisfactory level of
GMP compliance. (10-
04-14)
1. Verification of
photocopy of
differential fee (Rs.
5000/-) paid is
required.
2. The Firm had
applied on Form 5-
D initially but has
now submitted
Form 5.
Approved.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
197. -do- Tamsyl Tablets Each Tablet contains: Etamsylate (B.P)….250mg (Antifibrinolytic, synthetic antihaemorrhagic and angioprotective) (Manufacturer’s Spec.s)
Form 5
05‐7‐2010(N/A)
Rs.15000/‐ 22‐5‐2013
Rs.5,000/‐
Rs. 7.5/Tab
Rs. 75/10’s
Rs.150/20’s
Not confirmed
Not confirmed
Satisfactory level of
GMP compliance. (10-
04-14)
1. Verification of
photocopies of fee
(Rs. 15000/- + Rs.
5000/-) paid is
required.
2. The Firm had
applied on Form 5-
Deferred for
confirmation of me
too status &
approval in reference
Stringent Regulatory
Agencies.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan.
135
D initially but has
now submitted
Form 5.
3. International
availability not
confirmed in same
strength.
4. Me-too status given
as Dicynone of
French
Pharmaceuticals
Group (Reg. No.
004229) needs
confirmation.
198. -do- Tamsyl Tablets Each Tablet contains: Etamsylate (B.P)….500mg (Antifibrinolytic, synthetic antihaemorrhagic and angioprotective) (Manufacturer’s Spec.s)
Form 5
05‐7‐2010(N/A)
Rs.15000/‐ 22‐5‐2013
Rs.5,000/‐
Rs. 15/Tab
Rs. 150/10’s
Rs.300/20’s
BNF: Dicynene
(Sanofi-Aventis)
Cytoplex of M/s AGP
Reg. No. 061420
(Me too status appeared
in agenda as not
confirmed erroneously)
Satisfactory level of
GMP compliance. (10-
04-14)
1. Verification of
photocopies of fee
(Rs. 15000/- + Rs.
5000/-) paid is
required.
2. The Firm had
applied on Form 5-
D initially but has
now submitted
Form 5.
Deferred for
confirmation of me
too status. Reference
will be sent to B &
A Division, DRAP
for verification of
photocopy of fee
challan.
199. -do- Valsitan Tablets Each film coated tablet
contains: Amlodipine (as besilate)…5mg Valsartan….160mg (Calcium Antagonist) (Manufacturer’s Spec.s)
Form 5
06‐7‐2010(N/A)
Rs.8000/‐ 22‐5‐2013 Rs.12,000/‐
AS per PRC
BNF: Exforge
(Novartis)
Exforge
(Novartis)
Satisfactory level of
GMP compliance. (10-
04-14)
Approved.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
136
1. Verification of
photocopies of fee
(Rs. 8000/- + Rs.
12000/-) paid is
required.
permit issuance of
registration letter.
200. -do- Valsitan Plus Tablets Each tablet contains: Amlodipine (as besilate)…10mg Valsartan….160mg (Calcium Antagonist) (Manufacturer’s Spec.s)
Form 5
06‐7‐2010(N/A)
Rs.8000/‐ 22‐5‐2013 Rs.12,000/‐
AS per PRC
BNF: Exforge
(Novartis)
Exforge
(Novartis)
Satisfactory level of
GMP compliance. (10-
04-14)
1. Verification of
photocopies of fee
(Rs. 8000/- + Rs.
12000/-) paid is
required.
Approved with
change in brand
name. Reference wil
be sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
201. -do- Alozin Tablets Each film coated extended release tablet contains: Ranolazine…1000mg
(anti‐ischemic And
antianginal) (Manufacturer’s Spec.s)
Form 5
06‐7‐2010(N/A)
Rs.8000/‐ 22‐5‐2013 Rs.12,000/‐
AS per PRC
FDA: Ranexa (Gilead)
Ranola (Highnoon)
Satisfactory level of
GMP compliance. (10-
04-14)
1. Verification of
photocopies of fee
(Rs. 8000/- + Rs.
12000/-) paid is
required.
Approved.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
202. -do- Tamsyl 2ml Injection Each 2ml ampoule
contains: Etamsylate……….250 mg (Antifibrinolytic synthetic antihaemorrhagic and angioprotective) (Manufacturer’s Spec.s)
Form 5-D
06‐7‐2010(N/A)
Rs.15,000/‐ 22‐5‐2013 Rs.5,000/‐
AS per PRC/4’s,
100’s
Not confirmed
Cytoplex of M/s AGP
Reg. No. 061419
(Me too status appeared
in agenda as not
confirmed at that time)
Satisfactory level of
GMP compliance. (10-
04-14)
1. Verification of
Deferred for
confirmation of
followings:
1. Installation and
performance
qualifications of
TOC analyser &
Liquid Particle
Counter by area FID.
2. Approval in
reference Stringent
Regulatory
Agencies.
137
photocopies of fee
(Rs. 15000/- + Rs.
5000/-) paid is
required.
2. The Firm had
applied on Form 5-
D initially but has
now submitted
Form 5.
3. Approval of section
/ manufacturing
facility of applied
drug from licensing
section is required.
The Firm has
submitted GMP
insp. Report dated
10-04-14 which
mentions Sterile
Products (Liquid
injections,
Opthalmic/Otic
drops).
4. International
availability not
confirmed.
5. Verification of
Total Organic
Testing Facility is
required.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan.
203. M/s. WelMark
Pharmaceuticals
Plot # 122,
Block-B, Phase-
V Industrial
Estate Hattar.
Rismek 3mg Tablets
Each film coated tablet
contains:-
Risperidone(USP)….3mg
(Antipsychotic)
(USP Spec.s)
Form 5
12-07-2010 (17)
Rs.8,000/
+Rs. 12000 (09-
05-2013)
As Per PRC
BNF. Risperdal
(Janssen)
Benzisox (Highnoon)
No conclusion of
inspection report,
recommendations of
some corrections (24-
05-14 routine GMP
inspection)
The Board considered
the above inspection
Approved.
138
report & satisfied with
the same.
204. -do- Welfam 40mg Tablets
Each tablet contains:-
Famotidine (USP)…40mg
(H2 receptor Blocker,
Antipeptic ulcerate)
(USP Spec.s)
Form 5
12-07-2010 (16)
Rs.8,000/
+Rs. 12000 (09-
05-2013)
As Per PRC/10’s
BNF: Famotidine (Non-
proprietary)
Acicon (Barrett
Hodgson)
No conclusion of
inspection report,
recommendations of
some corrections (24-
05-14 routine GMP
inspection)
The Board considered
the above inspection
report & satisfied with
the same.
1. BNF describes the
product as uncoated
while the Firm has
applied for the film
coated formulation.
Approved in
uncoated Tablets.
205. M/s Atco
Laboratories
Limited B-18,
S.I.T.E, Karachi.
Combinol-D Sugar Free
Syrup
Each 5ml contains:-
Dextromethorphan
Hydrobromide
(B.P)…10mg
Ephedrine Hydrochloride
(B.P)…7.5mg
Chlorphenamine Maleate
(B.P)…4mg
Terpin Hydrate (USP)…
3.5 mg
Ammonium Chloride
(B.P)…90mg
(Bronchodilator)
(Manufacturer’s Spec.s)
Form 5
06-07-2010
Rs.8,000/ (N/A)
+Rs. 12000 (22-
05-2013)
Rs. 38/- Per 120ml
bottle
Not confirmed
Combinol-D Syrup
(Atco Laboratories)
Good level of GMP
(18-06-2014)
1. Verification of
photocopies of fee
(Rs. 8000/- + Rs.
12000/-) paid is
required.
2. Approval of section
/ manufacturing
facility of applied
drug from licensing
section was asked.
The Firm has
submitted GMP
Deferred for review
of formulation by
Review Committee.
139
insp. Report dated
18-06-14 which
mentions Oral
Liquid
(Syrup/Suspension)
section Non
Antibiotic.
3. International
availability of
formulation in
SRA’s not
confirmed.
4. Formulation
contains Ephedrine
Hydrochloride, a
controlled drug
substance.
206. M/s Nenza
Pharmaceuticals,
33 A Industrial
Estate
Hayatabad
Peshawar
NenKast 5mg Tablets
Each Chewable Tablet
contains:-
Montulekast Sodium
Equivalent to
Montelukast(B.P)…5mg
(Antiasthmatic)
(Manufacturer’s Spec.s)
Form 5
16-07-2010
Rs.8,000/ (80)
+Rs. 12000 (23-
05-2013)
As Per SRO/- 14’s
BNF: Singulair (MSD)
Montiget (Getz)
No conclusion
regarding GMP of the
Firm, some minor
observations at which
the management was
agreed to rectify.
(routine GMP 10-04-
2014)
The Board considered
the above inspection
report & satisfied with
the same.
Approved.
207. -do- Nenmether DS Tablets
Each Tablet contains:-
Artemether…40mg
Lumefantrine…240mg
(Antimalarial)
(USP Salmous Spec.s)
Form 5
16-07-2010
Rs.8,000/ (79)
+Rs. 12000 (23-
05-2013)
As Per SRO/- 8’s
WHO approved
formulation
A-Fantrine 40/240 by
M/s Atco
No conclusion
regarding GMP of the
Firm, some minor
observations at which
the management was
agreed to rectify.
Approved.
140
(routine GMP 10-04-
2014)
The Board considered
the above inspection
report & satisfied with
the same.
208. M/s PharmEvo
(Private Limited
Plot #A-29,
North West
Industrial Zone,
Port Qasim,
Karachi-75020
Evorox 1.5g Injection
(Powder for reconstitution)
Each Vial contains:-
Cefuroxime Sodium
equivalent to Cefuroxime
(USP) …1.5g
(Antibiotic)
(USP Spec.s)
Form 5
06-07-2010, Rs.
8000/- + Rs.
12,000 (22-05-
2013)
As per PRC
BNF: Zinacef (GSK)
Zecef (Bosch)
Good, GMP compliance
(01-04-14) Provincial
Drug Inspector.
The firm later on
submitted inspection
report dated 20.03.2013
conducted by DRAP.
The Board considered
the above inspection
report & satisfied with
the same.
1. Verification of
copies of fee
challans is required.
2. Evidence of
approval of
technical staff from
licensing section is
required.
(The firm
provided the
technical staff
approval but
missed
erroneously in
agenda).
3. Firm has submitted
inspection report of
provincial drug
inspector and has
informed that they
will submitt latest
inspection report of
FID when
Approved.
Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan. If
confirmed, then
Chairman, RB will
permit issuance of
registration letter.
141
inspection report
would be received.
209. M/s Maple
Pharmaceuticals
(Pvt.) Ltd.,
147/23, Korangi
Industrial Area,
Karachi.
Defrinac Plus Tablets
Each film coated tablet
contains:-
Dexibuprofen
(M.S)…300mg
Pseudoephidrine
Hydrochloride(B.P)…60mg
(NSAID+Decongestant)
(Manufacturer’s Spec.s)
Form 5-D
01-07-
2010(11)Rs.8,000/-
+Rs. 12,000 (25-
07-2013)+Rs.
30,000/- (01-12-
2014)
Rs. As per PRC
/3×10’s
Form 5-D
Overall cGMP
measures are followed
in the Firm (31-03-
2014)
1. The Firm had
applied on Form 5,
but after evaluation
the Firm has
deposited
differential fee for
application on Form
5-D. Form 5-D is
incorrect.
2. Verification of fee
of Rs. 12000/- is
required.
3. Formulation
contains controlled
drug substance.
Deferred for last
reminder for
correction in form 5-
D alongwith stability
studies. Reference
will be sent to B &
A Division, DRAP
for verification of
photocopy of fee
challan.
210. -do- Fastofen Tablets
Each film coated tablet
contains:-
Ibuprofen lysinate…342mg
(NSAID)
(Manufacturer’s Spec.s)
Form-5
05-07-
2010(44)Rs.8,000/-
+Rs. 12,000 (14-
05-2013) Rs.
30,000/- (01-12-
2014)
Rs. As per PAC
/30’s
Form 5-D
Overall cGMP
measures are followed
in the Firm (31-03-
2014)
1. The Firm had
applied on Form 5,
but after evaluation
the Firm has
deposited
differential fee for
application on Form
5-D. Form 5-D is
incorrect.
2. Verification of fee
of Rs. 12000/- is
required.
Deferred for last
reminder for
correction in form 5-
D alongwith stability
studies. Reference
will be sent to B &
A Division, DRAP
for verification of
photocopy of fee
challan.
211. M/s Nabiqasim Misocot 50 mg Tablets Form 5 BNF: Arthrotec Deferred for Product
142
Industries (Pvt)
Ltd. 17/24,
Korangi
Industrial Area,
Karachi.
Each tablet contains:-
Diclofenac Sodium
(B.P)…50mg
Misoprostol…200mcg
(NSAIDs)
(Manufacturer’s Spec.s)
01/07/10(Nil)
Rs.8000/-
+Rs.12000/-
(14/05/13)
As per PRC
/10’s,20’s
(Pharmacia)
Arthrotec (Pfizer)
Good GMP compliance
(18-12-13)
1. Verification of
photocopies of fee
submitted is
required.
2. Other strength of
the product Misocot
75 mg Tablets has
already been
deferred for Product
specific inspection
by panel
comprising of
Director DTL,
DDG (E&M) and
area FID
specific inspection by
panel comprising of
Director DTL,
Karachi, DDG
(E&M) and area FID.
Reference will be
sent to B & A
Division, DRAP
for verification of
photocopy of fee
challan.
Evaluator – II
Applications checked by Evaluator IV (human)
S.No Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form + Strength)
Composition
Pharmacological Group
Finished product
Specification
Type of Form
Initial date, diary
Fee including
differential fee
Demanded Price /
Pack size
Remarks on the
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
Decision
212. M/s Pfizer
Pakistan Limited.
Zetamax Tablet
Each film coated tablet
Form 5
23-07-2010
International: BNF:
Azithromycin (Non-
Approved.
143
B-2, S.I.T.E.,
Karachi
contains
Azithromycin Dihydrate eq
to Azithromycin USP
……….500mg
Antibiotic
Finished product
specifications are USP
Dy. No. 264
Rs. 8000 + 12000
Rs 340/ 6’s
proprietary)
Local: Azitor of Macter Int
Pvt Limited Karachi
According to
inspection report
dated 16-05-2012,
factory premises and
manufacturing
operations were found
in line and good with
GMP compliance
standards at time of
inspection.
Latest inspection
report is required. The
firm later on
submitted inspection
report dated
09.09.2014 conducted
by DRAP.
The Board considered
the above inspection
report & satisfied
with the same.
According to BNF
Azithromycin has
been approved in UK
as Azithromycin
monohydrate hemi-
ethanolate in Tablet
dosage form.
213. -do- Zetamax Tablet
Each film coated tablet
contains
Azithromycin Dihydrate eq
to Azithromycin USP
……….250mg
Antibiotic
Finished product
specifications are USP
Form 5
05-07-2010
Dy. No. 37
Rs. 8000 + 12000
Rs 240/ 6’s
International: BNF:
Azithromycin (Non-
proprietary)
Local: Azitor of Macter Int
Pvt Limited Karachi
According to
inspection report
dated 16-05-2012,
factory premises and
manufacturing
operations were found
in line and good with
GMP compliance
standards at time of
Approved.
144
inspection.
Latest inspection
report is required. The
firm later on
submitted inspection
report dated
09.09.2014 conducted
by DRAP. The Board
considered the above
inspection report &
satisfied with the
same.
According to BNF
Azithromycin has
been approved in UK
as Azithromycin
monohydrate hemi-
ethanolate in Tablet
dosage form.
214. M/s Genome
Pharmaceuticals
(Pvt) Limited.,
Plot No. 16/I-
Phase IV,
Industrial Estate,
Hattar
Ovulin Tablet
Each tablet contains
Clomiphene Citrate USP
…… 50mg
Anti estrogen
Finished product
specifications are USP
Form 5
17-08-2010
Rs 20,000/-
As per PRC
BNF: Clomid
(Sanofi-Aventis)
Ovi-F (Merck)
Grant of GMP for
Export recommended
(27-12-13)
Deferred till decision
on the manufacturing
requirement for this
product.
215. M/s Rotexmedica
Pakistan (Pvt)
Ltd.,
Plot no 206 & 207,
Industrial triangle,
Kahuta Road,
Islamabad
Texpami Capsule
Each capsule contains
Pamidronate as disodium
USP ………..100 mg
(bone Resorption Inhibitor)
Finished product
specifications are
Manufacturer
Form 5
19-05-2010
Rs 8000 + 12000
10’s as per SRO
Not confirmed
Aminomux Cap
100mg by M/s
Seignior
A compliance report
was asked to be
submitted for follow
up inspection. (13-02-
14)
Firm has not given
international
availability. It is
required as it is part
of Form 5. Firm has
replied reference of
Deferred for
confirmation of
approval in reference
Stringent Regulatory
Agencies & latest
GMP report.
145
argentina.
Latest satisfactory
GMP inspection
report is required. A
compliance report
was asked to be
submitted for follow
up inspection. (13-02-
14)
216. M/s Macter
International (Pvt.)
Limited. F-216,
S.I.T.E., Karachi.
Zincasa Syrup 10 mg/ 5 ml
Each 5 ml contains
Zinc Sulphate Monohydrate
USP eq to elemental
Zinc……10 mg
Antidiarrheal
Finished Product
Specifications are
Manufacturer
Form 5
20-08-2010
Dy. No. 151
Rs. 8000 + 12000
As per PRC
Me too Zegen Syrup
10 mg/5ml by Genera
International
available in India,
China, Bangladesh
According to
inspection report
dated 10-04-2014,
firm was considered
to be operating at
satisfactory level of
compliance with
GMP guidelines.
International
availability in SRA’s
not confirmed. USP
mentions the
formulation as Oral
Solution with pH of
2.5to 4.5 while
Manuf. Spec.s for this
formulation has pH of
5 to 6.
Approved with USP
specification (as
formulation is WHO
recommended).
217. M/s Macter
International (Pvt.)
Limited. F-216,
S.I.T.E., Karachi.
Mclevo Infusion 250mg
Each 100 ml contains
Levofloxacin USP 250 mg
Broad Spectrum
Antibacterial Agent
Finished Product
Specifications are
Manufacturer
Form 5
21-07-2010
Dy. No. 1371
Rs. 8000 + 12000
Rs 500
FDA has not
approved strength of
2.5mg/ml. FDA
approved 5ml/ml with
Dextrose5%.
Firm has not
submitted undertaking
(The firm had
submitted the above
undertaking but was
Deferred for approval
in reference Stringent
Regulatory Agencies
in same strength &
volume along with
confirmation of
installation and
operational
qualifications of TOC
analyser & Liquid
Particle Counter by
146
erroneously missed
in the agenda)
According to
inspection report
dated 10-04-2014,
firm was considered
to be operating at
satisfactory level of
compliance with
GMP guidelines.
International: FDA
has not approved 2.5
mg/ml
Local: Bexus Inf
250mg/100ml by M/s
Shaigan
area FID.
218. M/s Macter
International (Pvt.)
Limited. F-216,
S.I.T.E., Karachi.
Mclevo Infusion 250mg
Each 50 ml contains
Levofloxacin 250 mg
Broad Spectrum
Antibacterial Agent
Finished Product
Specifications are
Manufacturer
Form 5
21-07-2010
Dy. No. 1371
Rs. 8000 + 12000
Rs 400/ 50 ml
Firm has not
submitted undertaking
(The firm had
submitted the above
undertaking but was
erroneously missed
in the agenda)
According to
inspection report
dated 10-04-2014,
firm was considered
to be operating at
satisfactory level of
compliance with
GMP guidelines.
International:
Levaquine 250mg/50
ml (FDA)
Local: Xeflox Inf
250mg/50ml by M/s
Helix
Deferred for
confirmation of
installation and
operational
qualifications of TOC
analyser & Liquid
Particle Counter by
area FID.
147
219. M/s Macter
International (Pvt.)
Limited. F-216,
S.I.T.E., Karachi.
Mclevo Infusion 750mg
Each 100 ml contains
Levofloxacin 750 mg
Broad Spectrum
Antibacterial Agent
Finished Product
Specifications are
Manufacturer
Form 5
21-07-2010
Dy. No. 1371
Rs. 8000 + 12000
Rs 800/ 100 ml
Firm has not
submitted undertaking
(The firm had
submitted the above
undertaking but was
erroneously missed
in the agenda)
According to
inspection report
dated 10-04-2014,
firm was considered
to be operating at
satisfactory level of
compliance with
GMP guidelines.
International: FDA
has not approved 7.5
mg/ml
Local: Bexus Inf
750mg/100ml by M/s
Shaigan
Deferred for approval
in reference Stringent
Regulatory Agencies
in same strength &
volume along with
confirmation of
installation and
operational
qualification of TOC
analyser & Liquid
Particle Counter by
area FID.
220. M/s Macter
International (Pvt.)
Limited. F-216,
S.I.T.E., Karachi.
Mclevo Infusion 500mg
Each 20 ml contains
Levofloxacin 500 mg
Broad Spectrum
Antibacterial Agent
Finished Product
Specifications are
Manufacturer
Form 5
21-07-2010
Dy. No. 1373
Rs. 8000 + 12000
Rs 500/ 20 ml
Firm has not
submitted undertaking
(The firm had
submitted the above
undertaking but was
erroneously missed
in the agenda)
According to
inspection report
dated 10-04-2014,
firm was considered
to be operating at
satisfactory level of
compliance with
GMP guidelines.
International:
Deferred for
verification of me too
status along with
confirmation of
installation and
operational
qualification of TOC
analyser & Liquid
Particle Counter by
area FID.
148
Levaquine 500mg/20
ml (FDA)
Local: Me too status
needs confirmation
221. M/s Macter
International (Pvt.)
Limited.
F-216, S.I.T.E.,
Karachi.
Kirin Tablet
Each film coated tablet
contains
Aliskirin hemifumarate
MS……150 mg
Hydrochlorothiazide USP
…..12.5 mg
Non peptide, direct rennin
inhibitor
Finished Product
Specifications are
Manufacturer
Form 5
30-08-2010
Dy. No. 191
Rs. 8000
As per PRC
1 × 14’s
Me too Co-Kiren
Tablet by Tabros
Pharma
International
Tekturna HCT tablet
(USA)
According to
inspection report
dated 10-04-2014,
firm was considered
to be operating at
satisfactory level of
compliance with
GMP guidelines.
Firm has not
submitted
undertaking.
(The firm had
submitted the above
undertaking but was
erroneously missed in
the agenda)
Approved.
222. M/s Macter
International (Pvt.)
Limited.
F-216, S.I.T.E.,
Karachi.
Mimin Tablet 200 mg
Each film coated tablet
contains
Rifaximin……..200 mg
Non systemic Antibiotic
Finished Product
Specifications are
Manufacturer
Form 5
30-08-2010
Dy. No. 196
Rs. 8000
As per PRC
1 × 10’s
Me too Xerifax
Tablet 200 mg
International
Xifaxan Tablet 200
mg (FDA)
According to
inspection report
dated 10-04-2014,
firm was considered
to be operating at
satisfactory level of
Approved.
149
compliance with
GMP guidelines.
Firm has not
submitted
undertaking.
(The firm had
submitted the above
undertaking but was
erroneously missed
in the agenda)
223. M/s Macter
International (Pvt.)
Limited.
F-216, S.I.T.E.,
Karachi.
Mirin Capsule 50 mg
Each capsule contains
Diacerein MS …..50 mg
Antirheumatics/ Pain
Management
Finished Product
Specifications are
Manufacturer
Form 5
30-08-2010
Dy. No. 198
Rs. 8000 + 12000
As per PRC
Me too Diora Capsule
50 mg by Getz
International
Diacerein Capsule 50
mg available in India.
EMA approved
Diacerein for rare
disease
(epidermolysis
bullosa).
According to
inspection report
dated 10-04-2014,
firm was considered
to be operating at
satisfactory level of
compliance with
GMP guidelines.
Firm has not
submitted
undertaking.
(The firm had
submitted the above
undertaking but was
erroneously missed in
the agenda)
Firm has given assay
Deferred for review
of formulation by
Review Committee.
150
limit for finished
product as 288-368
mg/capsule.
Firm has given assay
for tablets while
applied product is
capsule.
The firm has
submitted the correct
assay method with
correct limits.
224. M/s Macter
International (Pvt.)
Limited.
F-216, S.I.T.E.,
Karachi.
Micam Injection 8 mg
Each vial contains
Lornoxicam…….8 mg
Analgesic & Anti
inflammatory
Finished Product
Specifications are
Form 5
30-08-2010
Dy. No. 200
Rs. 8000 + 12000
As per PRC
Firm has not provided
reference of
specifications of
finished product.
The firm submitted
Finished Product
Specification as
Manufacturer’s
specifications
Firm has written
Glenmark as
reference to
specifications of
active raw material
for description,
identification,
solubility and Aydin/
Turkey for assay of
active raw material.
QC tests for injections
have not been
provided.
Me too Xefast tablet
8 mg by PharmEvo
International Xefo
powder for injection 8
Deferred for
confirmation of
installation and
operational
qualification of TOC
analyser & Liquid
Particle Counter by
area FID.
151
mg (EMA)
225. -do- Zincasa DS Syrup 20 mg/ 5
ml
Each 5 ml contains
Zinc Sulphate Monohydrate
USP eq to elemental
Zinc……20 mg
Antidiarrheal
Finished Product
Specifications are
Manufacturer
Form 5
20-08-2010
Dy. No. 151
Rs. 8000 + 12000
As per PRC
Me too Zegen Syrup
10 mg/5ml by Genera
International
available in India,
China, Bangladesh
According to
inspection report
dated 10-04-2014,
firm was considered
to be operating at
satisfactory level of
compliance with
GMP guidelines.
International
availability in SRA’s
not confirmed. USP
mentions the
formulation as Oral
Solution with pH of
2.5to 4.5 while
Manuf. Spec.s for this
formulation has pH of
5 to 6.
Approved with USP
specification as
formulation is WHO
recommended.
226. M/s Pharmatec
Pakistan (Pvt.)
Ltd.
D- 86/A., S.I.T.E.,
Karachi.
Alptec 0.25mg Tablet
Each tablet contains
Alprazolam USP
….0.25mg
Anxiolytic
Finished product
specifications are USP
Form 5
31-05-2013
Rs 60,000/-
3 × 10
International:
Alprazolam 0.25mg
(FDA)
Me too: Alloram 0.25
mg by M/s Global
According to
inspection report
dated 23-10- 2013,
firm was considered
to be operating at
good level of
compliance with
GMP guidelines.
Deferred for
confirmation of
segregated
manufacturing facility
for Narcotic Drugs
and Psychotropic
substances.
227. M/s Benson
Pharmaceuticals. Plot No 119, street
No 8, I-10/3,
Industrial area
Islamabad.
Moxi Tablet
Each film coated tablet
contains
Moxifloxacin (as
hydrochloride)
(USP...400mg
Form 5
09-06-2010
Rs 8000 + 12000
5’s as per SRO
BNF: Avelox (Bayer)
Local: Morax tab
400mg by M/s Global
Firm is operating at
Deferred for
provision of assay
method of Finished
Product.
152
(Fluroquinolone)
(Manufacturer’s Spec.s)
satisfactory level of
GMP compliance (15-
04-14)
Assay method had not
been given in
Finished Product
specifications.
228. -do-
Piclo Tablet
Each film coated tablet
contains
Piroxicam (as beta
cyclodextrin)……………20
mg
(NSAID)
(Manufacturer’s Spec.s)
Form 5
09-06-2010
Rs 8000 + 12000
5’s as per SRO
BNF:
Brexidol(Chiesi)
Local: Brexidol cap
20mg by M/s Genome
Firm is operating at
satisfactory level of
GMP compliance (15-
04-14)
Originator’s
formulation is
uncoated while the
Firm has applied Film
coated formulation.
Firm has not given
active raw material
specifications.
Finished product
specifications are
incomplete and
without reference.
Assay, identification,
dissolution methods
have not been
provided.
Deferred for
correction in coating
& speficication of
active material &
finished product.
229. M/s WnsFeild
Pharmaceuticals
Plot no. 122, Block
B, Phase V,
Industrial Estate,
Hattar
Venlax tablet 37.5 mg
Each extended release film
coated tablet contains
Venlafaxine (as HCl)
……..37.5 mg
(Anti depressant)
(B.P Spec.s)
Form 5
04-08-2010
Rs 20,000/-
Pack of 20’s
As fixed by Govt
BNF: Venlafaxine
(Non-proprietary)
Local: Zaxine (Araf
Pharma)
Grant of GMP
Certificate for Export
recommended (04-09-
14)
Approved with
change in brand
name.
230. -do- Venlax tablet 75mg Form 5 BNF: Venlafaxine Approved with
153
Each extended release film
coated tablet contains
Venlafaxine (as HCl)
……..75 mg
(Anti depressant)
(B.P Spec.s)
04-08-2010
Rs 20,000/-
Pack of 2 × 7’s
As fixed by Govt
(Non-proprietary)
Local: Zaxine (Araf
Pharma)
Grant of GMP
Certificate for Export
recommended (04-09-
14)
change in brand
name.
231. -do- Venlax tablet
Each film coated tablet
contains
Venlafaxine (as HCl)
(USP)……..50 mg
(Anti depressant)
(BP Spec.s)
Form 5
04-08-2010
Rs 20,000/-
Pack of 20’s
As fixed by Govt
FDA: Venlafaxine (as
HCl) by Teva
Amfax (Amson)
Grant of GMP
Certificate for Export
recommended (04-09-
14)
Approved with
change in brand
name.
232. -do- Artidoxin DS co-blister
Tablet
(i) 3Tablets of which Each
coblister tablet contains
Sulphadoxin USP ……..
500mg
Pyrimethamine USP
……..25mg
(USP Spec.s)
(ii) 6Tablets of which Each
tablet contains
Artisunate……100mg
(Antimalarial)
Finished product
specifications are
(Manufacturer’s Spec.s)
Form 5
04-08-2010
Rs 20,000/-
2 × 10’s tab
As fixed by Govt
International: Not
confirmed.
(Formulation is
found WHO
approved)
Local:Fansi Plus
(Wilshire)
Grant of GMP
Certificate for Export
recommended (04-09-
14)
International
availability in SRA’s
not confirmed. Firm
has provided
reference from China.
For verification of
Facility (Co-blister
Machine etc) Firm
has submitted that
they possesses the
Chinese made blister
machine which has
the capability of
blistering different
size of tablets
together I to one
Deferred for
confirmation of co-
blister facility by area
FID.
154
blister. The machie is
convertible from Alu
Alu to Alu PVC and
vice versa. The have
given undertaking
that they will procure
the specific dye for
the purpose if the
product is registered.
233. -do- Artidoxin co-blister Tablet
(i) 3Tablets of which Each
coblister tablet contains
Sulphadoxin USP ……..
500mg
Pyrimethamine USP
……..25mg
(USP Spec.s)
(ii) 6Tablets of which Each
tablet contains
Artisunate……50mg
(Antimalarial)
Finished product
specifications
are(Manufacturer’s Spec.s)
Form 5
04-08-2010
Rs 20,000/-
2 × 10’s tab
As fixed by Govt
International: Not
confirmed.
Local: Arteka of
Hemis
Grant of GMP
Certificate for Export
recommended (04-09-
14)
International
availability in SRA’s
not confirmed. Firm
has provided
reference from China.
Me-too status needs
confirmation. (Arteka
of Hemis), Pricing of
formulation has been
fixed in 19th PRC.
For verification of
Facility (Co-blister
Machine etc) Firm
has submitted that
they possesses the
Chinese made blister
machine which has
the capability of
blistering different
size of tablets
together I to one
blister. The machie is
convertible from Alu
Alu to Alu PVC and
vice versa. The have
given undertaking
that they will procure
the specific dye for
the purpose if the
product is registered.
Deferred for
confirmation WHO
recommended
formulation / Pack &
verification of co-
blister facility by area
FID.
155
234. -do- Winprid Tablet
Each film coated tablet
contains:-
Itopride HCl…..50mg
Gastroprokinetic
(Manufacturer’s Spec.s)
Form 5
04-08-2010
Rs 20,000/-
1 × 10’s tab
As fixed by Govt
International:
Ganaton
Local:Ganaton
(Abbot)
Grant of GMP
Certificate for Export
recommended (04-09-
14)
Formulation is under
review by the review
committee.
Deferred for review
of formulation by
Review Committee.
235. M/s Qintar
Pharmaceuticals,
14-A P.S.I.E.,
Lahore road,
Sargodha
HEMA Chewable (Sugar
Free) Tablets
Each chewable tablet
contains
Mecobalamin (J.P)…500
mcg
(Co enzyme type vitamin
B12)
(Manufacturer’s Spec.s)
Form 5
27-03-2010
Rs 8000 + 12000
Rs 178 for 20’s
Rs 267 for 30’s
Rs 890 for 100’s
International: Not
confirmed
Local: Hicobal
500mcg by M/s
Himont
Renewal of DML
recommended (08-10-
12)
International
availability not
confirmed in SRAs.
Firm has given
reference of
international
availability from
India.
Formulation given is
not of chewable
Tablets
Latest inspection
report is required.
Deferred for
confirmation of
approval of same
dosage form in
reference Stringent
Regulatory Agencies
and clarification of
formulation as not
given for applied
chewable dosage
form and submission
of latest GMP
inspection report.
236. -do-
Gexin Tablets
Each film coated tablet
contains:-
Gemifloxacin as
mesylate………… 320 mg
(Fluroquinolone)
(Manufacturer’s Spec.s)
Form 5
27-03-2010
Rs 8000 + 12000
Rs 625 for 7’s
International: FDA
Factive
Local: Actigem tab
320mg by M/s
Ferozsons
Renewal of DML
recommended (08-10-
12)
Latest inspection
report is required.
Deferred for
submission of latest
GMP inspection
report.
237. -do- Smart XR Tablets Form 5 International:ALLEGRA-
D 12 HOUR ALLERGY AND
Deferred for
156
Each film coated XR tablet
contains
Fexofenadine HCL (USP)
as immediate Layer…..60
mg
Pseudoephedrine HCL
(USP) as extended
release….. 120 mg
(Histamine H1 receptor
antagonist & adrenergic
vasoconstrictor)
Finished product
specifications are USP
27-03-2010
Rs 8000 + 12000
Rs 120 for 10’s
CONGESTION (Sanofi)
Local: Fexet D by
M/s Getz
Renewal of DML
recommended (08-10-
12)
Formulations is
specialized dosage
form, Product specific
inspection may be
carried out for the
product for
verification of facility
etc.
Confirmation of
section is required.
Latest inspection
report is required.
submission of latest
GMP inspection
report & product
specific inspection by
panel comprising of
DDG, Lahore and
area FID for
verification of
manufacturing &
testing facilities of the
applied formulation.
238. -do-
Rovax Tablet
Each film coated tablet
contains
Rosuvastatin Calcium eq to
Rosuvastatin….. ……..5mg
(Hypolipidaemics)
(Manufacturer’s Spec.s)
Form 5
27-03-2010
Rs 8000 + 12000
Rs 100 for 10’s
BNF: Crestor
(AstraZeneca)
Local: Rast 5mg by
M/s Tabros
Renewal of DML
recommended (08-10-
12)
Latest inspection
report is required.
Deferred for
submission of latest
GMP inspection
report.
239. -do-
Rovax Tablet
Each film coated tablet
contains
Rosuvastatin Calcium eq to
Rosuvastatin…..
……..10mg
(Hypolipidaemics)
(Manufacturer’s Spec.s)
Form 5
27-03-2010
Rs 8000 + 12000
Rs 180 for 10’s
BNF: Crestor
(AstraZeneca)
Local: Rast 5mg by
M/s Tabros
Renewal of DML
recommended (08-10-
12)
Latest inspection
report is required.
Deferred for
submission of latest
GMP inspection
report.
240. M/s Nenza
Pharmaceuticals,
Plot No. 33 A,
Flotin Tablet 20 mg
Each tablet contains
Fluoxetin HCl USP eq to
Form 5
15-07-2010
8000 + 12000
Me too Floxac tablet
20 mg by Schazo
Approved.
157
Phase- V,
Industrial Estate,
Hayatabad,
Peshawar.
Fluoxetin….
20 mg
(Antidepressant)
Finished product
specifications are USP
As fixed by govt
1 × 10 pack International Selfemra tablet 20 mg
(FDA)
No conclusion
regarding GMP of the
Firm, some minor
observations at which
the management was
agreed to rectify.
(Routine GMP 10-04-
2014).
The Board
considered the above
inspection report &
satisfied with the
same.
241. M/s Genix Pharma
(Pvt.) Ltd.
44, 45- B, Korangi
Creek Road,
Karachi.
Triptan Tablet
Each film coated tablet
contains
Frovatriptan (as Succinate
monohydrate)….. …2.5 mg
Anti migraine
Finished product
specifications are
Manufacturer.
Form 5 D
10-08-2010(52)
Rs 15000/-+ Rs.
12000/- (21-05-
13)+Rs. 23000/- 21-
11-2014
Rs. 200 per tablet
Pack of 10’s for Rs
2000/-
International:Frova
Tablet 2.5 mg (FDA)
Local: Form 5-D
Good GMP (30-04-
2014)
Verification of copy
of Rs.12000/- fee
challan is required.
No authentic
reference to clinical
use & doses given in
clinical part of dossier
Stability studies
conducted under Zone
IV A conditions as
per ICH/ WHO
guidelines, Clinical
data/ clinical trials are
required.
Reference of
specifications/testing
methods of finished
product is required.
Deferred for
rectification of
following
observations in the
dossier:
1. Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan.
2. No authentic
reference to clinical
use & doses given in
clinical part of dossier
3. Stability studies
conducted under Zone
IV A conditions as
per ICH/ WHO
guidelines, Clinical
data/ clinical trials are
required.
4. Reference of
specifications/testing
methods of finished
product is required.
242. M/s Genix Pharma
(Pvt.) Ltd.
44, 45- B, Korangi
Eltram Tablet
Each film coated tablet
contains
Form 5-D
10-08-2010
Rs 15000/-+ Rs.
International:
Promacta Tablet 50
mg (FDA)
Deferred for
rectification of
following observation
158
Creek Road,
Karachi.
Eltrambopag (as
olamine)….. …50 mg
Haematopoietic
Finished product
specifications are
Manufacturer.
12000/- (21-05-13)
Rs. 200 per tablet
Pack of 10’s for Rs
2000/-
Pack of 20’s for Rs
4000/-
Local: Not
confirmed.
Good GMP (30-04-
2014)
Verification of copy
of Rs.12000/- fee
challan is required.
Firm has requested to
change Form 5-D to
Form 5 as at the time
of initial application,
the product was new
but now it has
become me-too.
Form 5 is required.
Evidence of Me-too
status is required.
in the dossier:
1. Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan.
2. Form 5 is required.
3. Evidence of Me-
too status is required.
243. M/s Genix Pharma
(Pvt.) Ltd.
44, 45- B, Korangi
Creek Road,
Karachi.
Eltram Tablet
Each film coated tablet
contains
Eltrambopag (as
olamine)….. …25 mg
Haematopoietic
Finished product
specifications are
Manufacturer.
Form 5 D
10-08-2010
Rs 15000/-/-+ Rs.
12000/- (21-05-13)
Rs. 150 per tablet
Pack of 10’s for Rs
1500/-
Pack of 20’s for Rs
3000/-
International:
Promacta Tablet 50
mg (FDA)
Local:
Good GMP (30-04-
2014)
Verification of copy
of Rs.12000/- fee
challan is required.
Firm has requested to
change Form 5-D to
Form 5 as at the time
of initial application,
the product was new
but now it has
become me-too.
Form 5 is required.
Evidence of Me-too
status is required.
Deferred for
rectification of
following observation
in the dossier:
1. Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan
2. Form 5 is required.
3. Evidence of Me-
too status is required.
244. M/s Genix Pharma
(Pvt.) Ltd.
44, 45- B, Korangi
Creek Road,
Art-M Tablet
Each tablet contains
Artesunate …….60 mg
Pyronaridine Phosphate eq
Form 5 D
10-08-2010(52)
Rs 15000/-+ Rs.
12000/- (21-05-
International:
Local: Form 5-D
Deferred for
rectification of
following observation
in the dossier:
159
Karachi. to Pyronaridine…180 mg
Anti malarial
Finished product
specifications are
Manufacturer.
13)+Rs. 23000/- 21-
11-2014
Rs. 300 per tablet
Pack of 10’s for Rs
3000/-
Pack of 20’s for Rs
6000/-
Pack of 30’s for Rs
9000/-
Good GMP (30-04-
2014)
Verification of copy
of Rs.12000/- fee
challan is required.
No authentic
reference to clinical
use & doses given in
clinical part of dossier
Stability studies
conducted under Zone
IV A conditions as
per ICH/ WHO
guidelines, Clinical
data/ clinical trials are
required.
Reference of
specifications/testing
methods of finished
product is required.
Evidence of
Availability in
Stringent SRA’s is
required.
1. Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan.
2. No authentic
reference to clinical
use & doses given in
clinical part of dossier
3. Stability studies
conducted under Zone
IV A conditions as
per ICH/ WHO
guidelines, Clinical
data/ clinical trials are
required.
4. Reference of
specifications/testing
methods of finished
product is required.
5. Evidence of
Availability in
Stringent SRA’s is
required.
245. M/s Helix Pharma
(Pvt) Ltd.,
Hakimsons House,
A/ 56, S.I.T.E.,
Karachi
Primavera/ Omni Plus/
Ristor/ Omnita Omitag/
OSB Capsule
Each capsule contains
Omeprazole…..20mg
Sodium Bicarbonate
…….1100mg
(Strength has been
corrected as 1100 mg which
was typed as 110mg in the
agenda copy)
Proton Pump Inhibitor &
Antacid
(Manufacturer’s Spec.s)
Form 5
30-08-2010
Dy No 203
Rs 8000+Rs.
12000/- (22-07-13)
MRP of 10 capsules
as per PRC
International: Zegerid (FDA)
Local: Rapid (global)
Satisfactory GMP
compliance (11-08-
14)
Verification of copy
of Rs.12000/- fee
challan is required.
Deferred for review
of formulation by
Review Committee.
246. M/s AGP (Private)
Limited.
B-23, S.I.T.E.,
Karachi
Maxna Injection
Each ml contains
Tranexamic acid BP
……….100mg
Anti Fibrinolytic Agent
Form 5
30-08-2010
Rs. 8000 + 12000
As fixed by DPC
5 × 10 ml ampoules
International:
Local:
Satisfactory GMP
compliance (26-11-
13)
Deferred for
rectification of
following
observations in the
dossier:
160
Finished product
specifications are BP
Verification of copy
of fee challans is
required.
Verification of TOC
analyzer & liquid
particle counter is
required.
Confirmation of Me
too status in 1g/10ml
is required.
Letter of approval of
injection section is
required. Inspection
report dated 26-09-
2012 mentions
Injectable (Antibiotic,
Analgesic,
Spasmolytics etc)
Section.
1. Reference will be
sent to B & A
Division, DRAP for
verification of
photocopy of fee
challan.
2. confirmation of
installation and
operational
qualification for TOC
analyzer & liquid
particle counter by
area FID.
3. Confirmation of
Me too status in
1g/10ml is required.
4. Letter of approval
of injection section is
required.
247. M/s Bloom
pharmaceuticals
(Pvt) Ltd. Phase I
& II Industrial
Estate, Hattar
Surfen Plus Tablet
Each film coated tablet
Contains:
Hyoscine N
Butylbromide BP…………
10 mg
Paracetamol BP……
500mg
Anticholinergic &
Analgesic
(B.P Spec.s)
Form 5
05-08-2010
Rs 20,000/-
10 × 10’s tab
As per SRO
International:
Local: Buscopan
Plus Tablets
NO conclusion ,
routine GMP
inspection ,
Shortcomings have
been improved (25-
07-14)
International
availability has not
been written. It is
required as it is part
of Form 5.
Reference to finished
product specifications
has been given as B.P
while the formulation
is not included in B.P.
Undertaking on
desired format has not
been submitted.
Deferred for
rectification of
following
observations in the
dossier:
1. International
availability (in
Stringent Regulatory
Agencies) required as
part of Form 5.
2. Reference to
finished product
specifications has
been given as B.P
while the formulation
is not included in B.P.
3. Undertaking on
desired format has not
been submitted.
248. M/s Bloom Amalar Suspension Form 5 International: Deferred for
161
Pharmaceuticals
(Pvt) Ltd. Phase
I & II Industrial
Estate, Hattar
Each 5 ml contains
Artemether…..15mg
Lumefantrine…..90mg
Antimalarial
Finished product
specifications are
Manufacturer.
05-08-2010
Rs 20,000/-
As per SRO
30 ml & 60 ml
Local: Buscopan
Plus Tablets
NO conclusion ,
routine GMP
inspection ,
Shortcomings have
been improved (25-
07-14)
Firm has written that
“we will surrender
our already registered
product Benol
Capsule Reg No.
022525 in case of fast
track registration of
our this product
Amalar Suspension.”
No clarification has
been given in reply.
International
availability has not
been written. It is
required as it is part
of Form 5.
Active raw material
specifications have
been given as B.P
while these are not
included in B.P.
Undertaking on
desired format has not
been submitted.
rectification of
following
observations in the
dossier:
1. International
availability has not
been submitted.
2. Active raw material
specifications have
been given as B.P
while these are not
included in B.P.
3. Undertaking on
desired format has not
been submitted.
249. Rogen
Pharmaceuticals.
Plot No. 30, St No.
S-4
National Industrial
Zone (RCCI),
Rawat, Islamabad.
Olirag 10 mg Tablet
Each film coated tablet
contains:
Olanzapine 10 mg
(Tranquilizers, Sedative,
Hypnotics)
USP Specifications
Form 5
19-07-2010
20,000
As per SRO for 10’s
International:
Olanzapine 52 mg
(FDA)
Me too: Amprex
tablet 5 mg by
Amarant
The firm has rectified
the short-comings
conveyed to him.
Approved.
250. Rogen Olirag 5 mg Tablet Form 5 International: Approved.
162
Pharmaceuticals.
Plot No. 30, St No.
S-4
National Industrial
Zone (RCCI),
Rawat, Islamabad.
Each tablet contains:
Olanzapine 5 mg
(Tranquilizers, Sedative,
Hypnotics)
USP Specifications
19-07-2010
20,000
As per SRO for 10’s
Olanzapine 5 mg
(FDA)
Me too: Amprex
tablet 5 mg by
Amarant
251. Rogen
Pharmaceuticals.
Plot No. 30, St No.
S-4
National Industrial
Zone (RCCI),
Rawat, Islamabad.
Rocep 250 mg Capsule
Each capsule contains:
Ciprofloxacin HCL USP
250 mg
(Quinolone)
Finished product
specifications are
Manufacturer
Form 5
19-07-2010
20,000
As per SRO for 10’s
International: Not
approved by reference
DRAs
Local: Ciprocin cap
250mg by M/s
Miracle
Deferred for review
of formualation by
Review Committee.
252. Rogen
Pharmaceuticals.
Plot No. 30, St No.
S-4
National Industrial
Zone (RCCI),
Rawat, Islamabad.
Rocep 500 mg Capsule
Each capsule contains:
Ciprofloxacin HCL 500
mg
(Quinolone)
Finished product
specifications are
Manufacturer
Form 5
19-07-2010
20,000
As per SRO for 10’s
International: Not
approved by reference
DRAs
Local: Ciprocin cap
250mg by M/s
Miracle
Deferred for review
of formualation by
Review Committee.
253. Rogen
Pharmaceuticals.
Plot No. 30, St No.
S-4
National Industrial
Zone (RCCI),
Rawat, Islamabad.
Sulrog Tablet 25 mg
Each tablet contains:
Levosulpride 25 mg
(Antidepressant/
Gastroprokinetic)
Finished product
specifications are
Manufacturer
Form 5
19-07-2010
20,000
As per SRO for 20’s
International: Not
approved by reference
DRAs
Local: levopraid
tablet 25mg by M/s
Pacific
Deferred for review
of formualation by
Review Committee.
163
254. Rogen
Pharmaceuticals.
Plot No. 30, St No.
S-4
National Industrial
Zone (RCCI),
Rawat, Islamabad.
Sulrog Tablet 50 mg
Each tablet contains:
Levosulpride 50 mg
(Antidepressant/
Gastroprokinetic)
Finished product
specifications are
Manufacturer.
Form 5
19-07-2010
20,000
As per SRO for 20’s
International: Not
approved by reference
DRAs
Local: levopraid
tablet 50mg by M/s
Pacific
Deferred for review
of formualation by
Review Committee.
255. Rogen
Pharmaceuticals.
Plot No. 30, St No.
S-4
National Industrial
Zone (RCCI),
Rawat, Islamabad.
Sulrog Tablet 100 mg
Each tablet contains:
Levosulpride 100 mg
(Antidepressant/
Gastroprokinetic)
Finished product
specifications are
Manufacturer
Form 5
19-07-2010
20,000
As per SRO for 20’s
International: Not
approved by reference
DRAs
Local: levopraid
tablet 100mg by M/s
Pacific
Deferred for review
of formualation by
Review Committee.
256. Rogen
Pharmaceuticals.
Plot No. 30, St No.
S-4
National Industrial
Zone (RCCI),
Rawat, Islamabad.
Mecrogen 500 mcg Tablet
Each film coated tablet
contains
Macobalamin……..500
mcg
Vitamin B12
Finished product
specifications are
Manufacturer
Form 5
19-07-2010
20,000
As per SRO for 30’s
International:
Methycobal tablet
(Japan)
Local: levopraid
tablet 100mg by M/s
Pacific
Approved with sugar
coating.
164
Evaluator – II
Applications of impot checked by Evaluator – IV
S.No Name and address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form + Strength)
Composition
Pharmacological Group
Finished product
Specification
Type of Form
Initial date,
diary
Fee including
differential
fee
Demanded
Price / Pack
size
Remarks on the
formulation (if any)
including
International status in
stringent drug
regulatory agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report (with
date) by the Evaluator
Decision
257. M/s. Novartis Pharma
(Pvt) Ltd, Karachi. /
Product License
Holder:-
M/s. Novartis Pharma
Schweiz Ltd
Monbijoustrasse Bern,
Switzerland.
Manufacturing Site:-
M/s. Novartis Pharma
SAS, rue la Chapelle,
Huningue, France.
Sebivo Oral Solution
20mg/ml
Each ml of oral solution
contains: -
Telbivudine…………20mg
(Hepatitis B)
Form 5-A
11-11-2009
Diary No. 659
Rs.15000/-
12-02-2014
Rs.35000/-
Total
Rs.50,000/-
Demanded
Price/Pack
Size
Rs.3915/300ml
FDA: Tyzeka (Novartis)
New Application
N/A
Following objections
were raised on the
applications:
1. Firm has not provided
Studies like process
validation,
pharmaceutical
development studies,
validation of analytical
methods.
2.Firm has not provided
chromatographs for
sample and reference of
active ingredient,
benzoic acid,
degradation products in
analytical procedures
and stability studies.
3.Clinical trial data/
clinical data
Firm had objected on
these observations and
regarding limited time
period provided for
Approved
`(The firm submitted
the relevant portion
of CTD showing the
Process validation,
validation of
analytical method &
chromatograms of
sample and standard
of :
(i) API
(ii) Benzoic acid
(iii) Degradation
products.
The referred CTD
mentions same the
manufacturing site
as applied).
165
reply of these objections
but now has submitted
the reply of these
observations.
Assessment of reply
reveals that the Firm has
not submitted the
validation reports
regarding process and
analytical methods in a
prescribed manner viz.
without contents like
specificity, linearity,
precision, accuracy,
limit of detection, Range
, Robustness etc.
Further, the Firm has
also not submitted the
chromatograms of
sample and standard of :
(i) API
(ii) Benzoic Acid
(iii) Degradation
products.
258. Applicant:
M/s. Mehran Dental,
Karachi.
M No. Al Noor
Centre Randle Road,
ADJ-
ANKLESeriaHospital,
Karachi
Manufacturer:
M/s. Laboratorios
Zeyco S.A. DE C.V.
CAMINO A SANTA
ANA TEPETITLAN
NO. 2230 COLONIA
SANTA ANA
TEPETITLAN 45230
ZAPOPAN
JALISCO, Mexico.
FD Injection IV
Each 1.8ml ampoule
contains: -
Lidocaine HCl…36.0mg
Epinephrine…0.018mg
Local Anesthetic
/Adrenergic agonist
Finished product
specifications are USP
Form 5-A
17-02-2009
Diary No.153
Rs.15000/-
18-06-2013
Rs.85000/-
Rs.1200 /
1 x 10
cartridge in
each blister
Total 5 blister
in packet
Total 50 Pieces
of cartridges in
Packet
International:
Local:
Sole agency agreement
has been expired.
GMP certificate of
manufacturer has been
expired.
Firm has not provided
original & legalized
Certificate of
Pharmaceutical Product
with english translation.
Firm has not provided
long term stability
studies under zone IV A
conditions are ICH/
WHO guidelines.
Chromatograms in
analytical methods &
stability studies have not
been provided along
with data.
Firm gave reference of
USP for finished
product specifications
Deferred for
rectification of
following
observations in the
dossier:
1. Sole agency
agreement has been
expired.
2. GMP certificate
of manufacturer has
been expired.
3. Firm has not
provided original &
legalized Certificate
of Pharmaceutical
Product with english
translation.
4. Firm has not
provided long term
stability studies
under zone IV A
conditions are ICH/
WHO guidelines.
5. Chromatograms in
analytical methods
166
while given assay
method is not as same as
given in USP 35.
Firm has not provided
active raw material
specifications.
Firm has not provided
specifications of
primary packaging
material (glass vial).
Undertaking on desired
format has not been
submitted.
& stability studies
have not been
provided along with
data.
6. Firm gave
reference of USP for
finished product
specifications while
given assay method
is not as same as
given in USP 35.
7. Firm has not
provided active raw
material
specifications.
8. Firm has not
provided
specifications of
primary packaging
material (glass vial).
9. Undertaking on
desired format has
not been submitted.
259. Applicant:
M/s. Haroon Brothers,
1/ A,
KarimjeeBuilding,
Opposite HBL Napier
Rd Branch, Near
Denso Hall,
Karachi.
Manufacturer:
M/s. Pharma Stulln
GmbH Werksstrasse
3, D-92551 Stulln,
Germany.
Mydriaticum Stulln UD
Eye Drops
Each ml contains: -
Tropicamide Ph. Eur.
….…5mg
Ophthalmic Preparation /
Mydriatic & Cycloplegic
Finished product
specifications are
Form 5-A
30-04-2009
Rs.15000 +
Rs.85000 =
Rs.100000/
Rs.30/ Per Vial
(0.4ml),
depending on
pack size
Reply of the Firm needs
further evaluation.
Deferred for
evaluation of replies
submitted by the
firm.
260. Applicant:
M/s. Haroon Brothers,
1/ A,
KarimjeeBuilding,
Opposite HBL Napier
Rd Branch, Near
Denso Hall,
Karachi.
Manufacturer:
M/s. Penta
Arzneimittel GmbH
Blupan UD Eye Drops
Each ml contains: -
Sodium
Hyaluronate Ph. Eur.
…1.5057mg
Dexpanthenol (Vitamin
B5) USP….20.0000 mg
Ophthalmic Preparation
Finished product
Form 5-A
30-04-2009
Rs.15000 +
Rs.85000 =
Rs.100000/
Rs.36/ per vial
(0.5ml)
Reply of the Firm needs
further evaluation.
Deferred for
evaluation of replies
submitted by the
firm.
167
Werksstrasse 3,
Germany.
specifications are
Evaluator – III
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name
+ Dosage Form +
Strength)
Composition
Pharmacological Group
Finished product
Specification
Type of Form
Initial date,
diary
Fee including
differential
fee
Demanded
Price / Pack
size
Remarks on
the
formulation (if
any) including
International
status in
stringent drug
regulatory
agencies /
authorities
Me-too status
GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator
Recommendations
by the Evaluator
Decision
261. M/s Atco
Laboratories
(Pvt) Limited
Karachi.
ADVOCORT Fatty
Ointment 0.1%
Each gram contains:
Methylprednisolone
aceponate…….1mg
Synthetic corticosteroid
Manufacturer
Form-5
Dy. No: 126
dated 14th
October 2010
8,000/-
Rs. 95/- per
5gm tube
Rs. 176/- per
10gm tube
Rs. 250/- per
15gm tube
Advantan Fatty
Ointment of
CSL Limited
(TGA
Approved)
Advantan of
Bayer Pakistan
Karachi.
Inspection of
the firm was
conducted on
18-06-14 by the
area FID and
GMP
Compliance was
found good.
Firm has submitted
that they are in
process of
establishing the
steroidal section
facility. The firm
has also submitted
letter regarding
approval of
proposed layout
plan for Ointment
(Steroid) and Oral
Liquid Section
(General).
Deferred for
confirmation of
manufacturing
facility for
steroids.
168
262. -do- ADVOCORT Ointment
0.1%
Each gram contains:
Methylprednisolone
aceponate…….1mg
Synthetic corticosteroid
Manufacturer
Form-5
Dy. No: 125
dated 14th
October 2010
8,000/-
Rs. 95/- per
5gm tube
Rs. 176/- per
10gm tube
Rs. 250/- per
15gm tube
Advantan
Ointment of
CSL Limited
(TGA
Approved)
Advantan of
Bayer Pakistan
Karachi
Deferred for
confirmation of
manufacturing
facility for
steroids.
263. -do- ADVOCORT Lotion 0.1%
Each ml contains:
Methylprednisolone
aceponate…….1mg
Synthetic corticosteroid
Manufacturer
Form-5D
Dy. No: 127
dated 14th
October 2010
15,000/- dated
14-10-10
35000/- dated
05-12-13
Rs. 225/- 30ml
Rs. 330/- per
60ml
Advantan
Lotion of CSL
Limited (TGA
Approved)
Inspection of
the firm was
conducted on
18-06-14 by the
area FID and
GMP
Compliance was
found good.
a. Stability studies
needs to be
submitted as per
ICH/ WHO
guidelines.
b. Clinical trial
data is required
along with
clinical
justification.
Deferred for
followings:
1. Confirmation
of
manufacturing
facility for
steroids.
2. Stability
studies as per
ICH/ WHO
guidelines.
3. Clinical trial
data along with
clinical
justification.
264. M/s Linear
Pharma, Rawat
Islamabad.
PYRETIC Effervescent
Tablets 500mg
Each tablet contains:
Paracetamol….500mg
Analgesic/ Antipyretic
Manufacturer
Form-5
06-10-2010
Dy. No.9220
8,000/-
28-02-2014
Dy. No.595
12000/-
As per SRO/
Pack of 100’s
Paracetamol
effervescent
tablet of Accord
Health Care
UK.
Acetosol of
Shigan Pharma
Islamabad.
Inspection of
the firm was
conducted by
the area FID on
13-11-14 and
the was
complying the
GMP
Approved.
169
265. -do- MEFQUINE Tablets 250mg
Each tablet contains:
Mefloquine
Hydrochloride…..250mg
Antimalarial
Manufacturer
Form-5
06-10-2010
Dy. No.9226
8,000/-
28-02-2014
Dy. No.594
12000/-
As per SRO/
Pack of 25’s
Lariam Tablet
of Roche UK
Meflogen of
Genome
Pharmaceuticals
Approved.
266. -do- PENTO Capsule 40mg
Each capsule contains:
Pantoprazole sodium 22.5
% pellets equivalent to
Pantoprazole…..40mg
PPI
Manufacturer
Source: Vision
Pharmaceuticals Islamabad.
Form-5
06-10-2010
Dy. No.9226
8,000/-
28-02-2014
Dy. No.596
12000/-
As per SRO/
Pack of 14’s
Not available in
SRA’s
Pentoloc of
Aeries Pharma
Deferred for
review of
formulation.
267. M/s Innvotek
Pharmaceuticals
Islamabad.
LETRO Tablets
Each film coated tablet
contains:
Letrozole……2.5mg
Non steroidal aromatase
Inhibitor
USP
Form-5
Dy. No: 1037/
20-10-10
20,000/-
As per PRC/
Pack of 10’s
Femara of
Novartis
Femara of
Novartis
Karachi
Inspection of
the firm was
conducted on
04-07-14 by the
area FID and
GMP
compliance was
found
satisfactory.
Deferred till
decision on the
manufacturing
requirement for
this product.
170
268. -do- MILTEFO Capsules
Each capsule contains:
Miltefosine…..50mg
Antiprotozoal
Manufacturer
Form-5
Dy. No: 1036/
20-10-10
20,000/-
As per PRC/
Pack of 8x7’s
Impavido of
Knight Theraps
(USFDA)
Fosin Capsules
of Nimral Labs
Approved.
269. M/s Fedro
Pharmaceutical
Labs. Peshawar
RANIDOL Tablets 150mg
Each film coated tablet
contains:
Ranitidine as
hydrochloride……150mg
H2 Blocker
BP
Form-5
20-09-2010
Dy. No. 1148
20,000/-
As per SRO
1x10’s
Ranitidine
tablets of
Aurobindo
Pharma.
Zantac of GSK
a. Evidence of
approval of
section from
Drug Licensing
division is not
submitted.
b. Inspection of the
Firm was
conducted by
the area FID on
23-07-14 and
certain
shortcomings
were found,
which are
discussed with
the management
of which they
agreed to
rectify.
(“drainage line
found not
cleaned properly
in tablet section,
three blistering
and one
stripping
machines found
kept in one
room without
segregation and
advised to
provided
partition and AC
facilities to
control
temperature and
Deferred till
rectifications of
shortcomings as
mentioned in
GMP inspection
report dated
23.07.2014.
171
humidity.”)
270. -do- RANIDOL Tablets 300mg
Each film coated tablet
contains:
Ranitidine as
hydrochloride……300mg
H2 Blocker
BP
Form-5
20-09-2010
Dy. No. 1137
20,000/-
As per SRO
1x10’s
Ranitidine
tablets of
Aurobindo
Pharma.
Zantac of GSK
Deferred till
rectifications of
shortcomings as
mentioned in
GMP inspection
report dated
23.07.2014.
271. -do- FEKAST Tablets 4mg
Each film coated tablet
contains:
Montelukast as
sodium……4mg
Leukotriene Receptor
Antagonist
Manufacturer
Form-5
20-09-2010
Dy. No. 1138
20,000/-
As per SRO
2x7’s
Not found in
SRA’s, (applied
strength is
approved as
chewable
tablet.)
Me too status
needs
confirmation
Deferred till
rectifications of
shortcomings as
mentioned in
GMP inspection
report dated
23.07.2014.
272. -do- FEKAST Tablets 5mg
Each film coated tablet
contains:
Montelukast as
sodium……5mg
Leukotriene Receptor
Antagonist
Manufacturer
Form-5
20-09-2010
Dy. No. 1146
20,000/-
As per SRO
2x7’s
Not found in
SRA’s, applied
strength is
approved as
chewable tablet.
Me too status
needs
confirmation
Deferred till
rectifications of
shortcomings as
mentioned in
GMP inspection
report dated
23.07.2014.
273. -do- FEKAST Tablets 10mg
Each film coated tablet
contains:
Montelukast as
sodium……10mg
Leukotriene Receptor
Antagonist
Manufacturer
Form-5
20-09-2010
Dy. No. 1143
20,000/-
As per SRO
2x7’s
Motelukast of
Accord
Healthcare
Aerokast of
Barrett &
Hodgson (Pvt)
Limited Karachi
Deferred till
rectifications of
shortcomings as
mentioned in
GMP inspection
report dated
23.07.2014.
172
274. -do- FINFLEX-S Tablets 50mg
Each enteric coated tablet
contains:
Diclofenac Sodium
BP…….50mg
Antirehumatic
BP
Form-5
20-09-2010
Dy. No. 1147
20,000/-
As per SRO
2x10’s
Voltral of
Novartis
Fastaid of
Platinum
Pharma Karachi
Master formulation
submitted is of film
coated tablets
however applied
product is enteric
coated.
Deferred till
rectifications of
shortcomings as
mentioned in
GMP inspection
report dated
23.07.2014 &
rectification of
following
observation:
Master
formulation is of
film coated
tablets while
applied product
should be
enteric coated.
275. -do- FINFLEX-S Tablets 75mg
Each enteric coated tablet
contains:
Diclofenac Sodium
BP…….75mg
Antirehumatic
BP
Form-5
20-09-2010
Dy. No. 1142
20,000/-
As per SRO
2x10’s
Diclofenac
sodium of
Sandoz
(USFDA)
Fastaid of
Platinum
Pharma Karachi
Master formulation
submitted is of film
coated tablets
however applied
product is enteric
coated.
Deferred till
rectifications of
shortcomings as
mentioned in
GMP inspection
report dated
23.07.2014 &
rectification of
following
observation:
Master
formulation is of
film coated
tablets while
applied product
should be
enteric coated.
276. -do- FEDRACAM-BCD Tablets
20mg
Each tablet contains:
Piroxicam as Beta
Cyclodextrin……20mg
NSAID
Manufacturer
Form-5
20-09-2010
Dy. No. 1140
20,000/-
As per SRO
2x10’s
Brexidol of
Chesi (BNF)
Brexin of Chiesi
Karachi.
Master formulation
needs rectification
regarding quantity
of API.
Deferred till
rectifications of
shortcomings as
mentioned in
GMP inspection
report dated
23.07.2014 &
rectification of
following
observation:
Master
formulation
needs
rectification
regarding
173
quantity of API.
277. -do- CERIGEX-L Tablet 5mg
Each film coated tablet
contains:
Levocetirizine as
dihydrochloride…..5mg
Antihistamine
Manufacturer
Form-5
20-09-2010
Dy. No. 1139
20,000/-
As per SRO
Pack of 10’s
Levocetirizine
of Actavis UK
Alergocit of
Global Pharma
Islamabad.
Deferred till
rectifications of
shortcomings as
mentioned in
GMP inspection
report dated
23.07.2014
278. -do- DI- METHER Tablets
Each tablet contains:
Artemether ……40mg
Lumefantrine….240mg
Antimalarial
USP (Salmus)
Form-5
20-09-2010
Dy. No. 1145
20,000/-
As per SRO
Pack of 10’s
WHO
recommended
Formulation
Artem DS of
Hilton
Deferred till
rectifications of
shortcomings as
mentioned in
GMP inspection
report dated
23.07.2014
279. M/s Asian
Continental
(Pvt) Limited,
Karachi
FEVEREN 6 Plus
Suspension
Each 5ml contains:
Paracetamol……..250mg
Analgesic and Antipyretic
USP
Form-5
Dated: 08-10-
2010
8,000/-
Dated: 31-07-
2013
12000/-
As per SRO/
Pack of 1’s
90ml bottle
Calpol 6 Plus
(BNF)
Calpol 6 Plus
GSK Karachi
Inspection of
the firm was
conducted on
09-09-14 by the
area FID and
concluded that
the firm is
working at
acceptable level
of GMP
compliance.
Approved.
280. -do- ATIZA Syrup 2.5mg/ 5ml
Each 5ml contains
Levocetirizine
dihydrochloride……..2.5mg
Antihistamine
Manufacturer
Form-5
Dated: 12-10-
2010
8,000/-
Dated: 31-07-
2013
12000/-
As per SRO/
Pack of 1’s
90ml bottle
Xyzal Oral
Solution
(USFDA)
T-Day of
Novartis
Karachi
Approved.
174
281. -do- FEVEREN Tablet 500mg
Each tablet contains:
Pracetamol……500mg
Analgesic
Manufacturer
Form-5
Dy. No: 1916/
29-10-10
8,000/-
As per PRC
Panadol GSK
USA
Panadol GSK
Karachi
Approved.
282. -do- FEVEREN Extra Tablet
500mg
Each tablet contains:
Pracetamol……500mg
Caffiene…….65mg
Analgesic
Form-5
Dy. No: Not
provided
8,000/- dated
27-10-10
As per PRC
Panadol Extra
GSK USA
Panadol Extra
GSK Karachi.
Approved.
283. M/s Linear
Pharma, Rawat
Islamabad
FACAL Tablet
Each tablet contains:
Alfacalcidol….0.25mg
Elemental
Calcium…..50mg
Vitamin D supplement
Manufacturer
Form-5
Dy. No: 9229
dated 06-10-10
20,000/-
As per SRO/
Pack of 10’s
Not available in
SRA’s
Me too status
needs
confirmation.
Inspection of
the firm was
conducted by
the area FID on
13-11-14 and
the was
complying the
GMP
Deferred for
confirmation of
approval in
reference
Stringent
Regulatory
Agencies & me
too status.
284. -do- ALEND Tablets
Each tablet contains:
Alendronate as
sodium…..10mg
Biphosphonates
Manufacturer
Form-5
Dy. No: 1139
dated 03-11-10
20,000/-
As per SRO/
Pack of 10’s
Alendronic acid
of Accord
HealthCare UK
Alendrate of
Global Pharma
Approved.
285. -do- DOMELATE-C Tablet
Each tablet contains:
Domperidone as
meleate….15mg
Form-5
Dy. No: 1148
dated 03-11-10
Not available in
SRA’s
Me too status
needs
Deferred for
review of
formulation by
Review
Committee.
175
Cinnarizine……25mg
Antidopaminergic/
Antihistamine
Manufacturer
20,000/-
As per SRO/
Pack of 2x10’s
confirmation
286. -do- DIVAL Tablets
Each delayed release tablet
contains:
Divalproex
sodium…….500mg
Antiepileptic
USP
Form-5
Dy. No: 1147
dated 03-11-10
20,000/-
As per SRO/
Pack of
10x10’s
Depakote of
Abbive
Divarex of
Medera Pharma
Approved.
287. -do- DIVAL Tablets
Each delayed release tablet
contains:
Divalproex
sodium…….250mg
Antiepileptic
USP
Form-5
Dy. No: 1146
dated 03-11-10
20,000/-
As per SRO/
Pack of
10x10’s
Depakote of
Abbive
Divarex of
Medera Pharma
Approved.
288. -do- LINQUE Tablets
Each film coated tablet
contains:
Quetiapine Fumarate
equivalent to
Quetiapine….200mg
Hypnotic
Form-5
Dy. No: 1151
dated 03-11-10
20,000/-
As per SRO/
Pack of 3x10’s
Seroquel of
AstraZeneca
(USFDA)
Dequit of
Shaheen
Pharma
Approved.
289. -do- LINQUE Tablets
Each film coated tablet
contains:
Quetiapine Fumarate
equivalent to
Quetiapine….400mg
Hypnotic
Manufacturer
Form-5
Dy. No: 1150
dated 03-11-10
20,000/-
As per SRO/
Pack of 10’s
Seroquel of
AstraZeneca
(USFDA)
Dequit of
Shaheen
Pharma
Approved.
176
290. -do- ALMOVAL Tablets
Each film coated tablet
contains:
Amlodipine as
besylate……5mg
Valsartan….80mg
Antihypertensive
Manufacturer
Form-5
Dy. No: 1142
dated 03-11-10
20,000/-
As per SRO/
Pack of 14’s
Exforge of
Novartis
(USFDA)
Exforge of
Novartis
Karachi
Approved.
291. -do- AMEASAID Tablets
Each sugar coated tablet
contains:
Flurbiprofen….100mg
Antirheumatic
Manufacturer
Form-5
Dy. No: 1152
dated 03-11-10
20,000/-
As per SRO/
Pack of 30’s
Froben Tablet
of Abbot
HealthCare UK
Ansaid of Pfizer
Karachi
Approved (As
sugar coated
approved in
UK).
292. -do- ALDONATE Tablet
Each film coated tablet
contains:
Methyldopa….250mg
Antihypertensive
Manufacturer
Form-5
Dy. No: 1155
dated 03-11-10
20,000/-
As per SRO/
Pack of 100’s
Aldomet of
Aspen UK
Aldomet of
MSD
Approved.
293. -do- LINESTIN Tablet
Each film coated tablet
contains:
Ebastine……10mg
Antihistamine
Form-5
Dy. No: 1149
dated 03-11-10
20,000/-
As per SRO/
Pack of 10’s
Aerius of
Dermagen
Pharma
Islamabad
Approved.
294. -do- L-FENAC Capsule
Each capsule contains:
Acitretin…..10mg
Vitamin A Derivative
Form-5
Dy. No: 1136
dated 03-11-10
20,000/-
As per SRO/
Pack of 3x10’s
Acitretin
Capsules of
Genus
Pharmaceuticals
UK
Neotigason of
Roche Karachi
Approved.
177
295. -do- TOLFERID Tablet
Each film coated tablet
contains:
Tolterodine tartrate…..2mg
Urinary antispasmodic
Manufacturer
Form-5
Dy. No: 1153
dated 03-11-10
20,000/-
As per SRO/
Pack of 28’s
Detrusitol
Tablet of Pfizer
UK
Detrusitol
Tablet of Pfizer
Karachi
Approved.
296. -do- OFLOX Tablet
Each film coated tablet
contains:
Ofloxacin……200mg
Fluoroquinolone
Manufacturer
Form-5
Dy. No: 9221
dated 06-10-10
20,000/-
As per SRO/
Pack of 10’s
Terivid of
Sanofi UK
Treivid of
Sanofi Karachi
Approved.
297. -do- CITAL Tablet
Each chewable tablet
contains:
Escitalopram as
oxalate……10mg
Antidepressant
Manufacturer
Form-5
Dy. No: 9228
dated 06-10-10
20,000/-
As per SRO/
Pack of 10’s
Not available in
SRA’s
Me too status
needs
confirmation
Deferred for
approval in
reference
Stringent
Regulatory
Agencies & me
too status.
298. -do- LEVRINE Tablets
Each film coated tablet
contains:
Alverine Citrate…..60mg
Simethicone….300mg
Antispasmodic
Manufacturer
Form-5
Dy. No: 1140
dated 03-11-10
20,000/-
As per SRO/
Pack of 2x10’s
Not available in
SRA’s
Me too status
needs
confirmation.
Deferred for
approval in
reference
Stringent
Regulatory
Agencies & me
too status.
299. -do- TAMSIN Capsule
Each capsule contains:
Tamsulosin HCL as
modified release pellets
(0.2%) equivalent to
Tamsulosin……0.4mg
Alpha-1 Blocker
Manufacturer
Form-5
Dy. No: 1154
dated 03-11-10
20,000/-
As per SRO/
Pack of 10’s
Flomax MR
Capsules of
Boehringer
Inghelheim UK
Tamsolin of
Getz Karachi
Approved.
178
Source: Vision
Pharmaceuticals Islamabad
300. -do- LINAKSAT Tablets
Each film coated tablet
contains:
Montelukast as
sodium……10mg
Antihistamine
Manufacturer
Form-5
Dy. No: 9222
dated 06-10-10
20,000/-
As per SRO/
Pack of 30’s
Singulair of
MSD
Montiget of
Getz Karachi
Approved.
301. -do- GEMNILOX Tablets
Each film coated tablet
contains:
Gemifloxacin as
mesylate…..320mg
Quinolone
Manufacturer
Form-5
Dy. No: 1157
dated 03-11-10
20,000/-
As per SRO/
Pack of 7’s
Factive of LG
Life Sciences
(USFDA)
Factiflox of
Envoy Pharma
Approved.
302. -do- LINPRIDE Tablets
Each tablet contains:
Amisulpride…..50mg
Antipsycotic
Manufacturer
Form-5
Dy. No: 1141
dated 03-11-10
20,000/-
As per SRO/
Pack of 2x10’s
Solian Tablet
Solian Tablet of
Sanofi Karachi
Approved.
303. -do- DOB-C Capsules
Each capsule contains:
Calcium
dobisilate….500mg
Vasotherapeutic
Form-5
Dy. No: 1138
dated 03-11-10
20,000/-
As per SRO/
Pack of 2x10’s
Not available in
SRA’s
Doxium of AGP
Karachi
Deferred for
review of
formulation by
the Review
Committee.
304. M/s Caraway
Pharmaceuticals,
Islamabad.
ONDENLES Injection 8mg
Each ml contains:
Ondansetron hydrochloride
dihydrate equivalent to
Ondansetron……2mg
5HT-3 Antagonist
Form-5
Dy. No: 9773
dated 18th
October 2010
20,000/-
Zofran of GSK
Zofran of GSK,
Karachi
The inspection
of the firm was
conducted on
a. Evidence of
availability of
TOC and liquid
particle counter
is not provided
by the firm.
b. Latest
inspection
Deferred for the
followings:
1. Confirmation
of installation
and operational
qualifications of
TOC analyser
and liquid
179
USP
As per SRO 24-09-12 by the
panel of
inspectors and
they concluded
that the firm is
operating at
good level of
GMP
compliance.
report is
required.
particle counter
by FID.
2. Latest
inspection report
is required.
305. -do- ONDENLES Tablet 8mg
Each film coated tablet
contains:
Ondansetron hydrochloride
dihydrate equivalent to
Ondansetron……8mg
5HT-3 Antagonist
USP
Form-5
Dy. No: 9774
dated 18th
October 2010
20,000/-
As per SRO
Zofran of GSK
Zofran of GSK,
Karachi
Latest inspection
report is required.
Deferred for
latest GMP
status of the
firm.
306. M/s Genix
Pharma (Pvt)
Limited,
Karachi.
GRANI Tablet
Each film coated tablet
contains:
Granisetron HCL equivalent
to Granisetron…….1mg
Antiemetic
Manufacturer
Form-5
Dy. No: 1899
dated 29-10-10
8,000/-
Rs. 3250/-
Pack of 10’s
Rs. 6500/-
Pack of 20’s
Kytril Tablet of
Roche
Kytril Tablets
of Roche
Karachi
Inspection of
the firm was
conducted on
30-04-14 by the
area FID and
GMP
compliance is
rated as GOOD
Approved.
307. -do- GRANI Syrup
Each 5ml contains:
Granisetron HCL equivalent
to Granisetron…….1mg
Antiemetic
Manufacturer
Form-5
Dy. No: 1907
dated 29-10-10
8,000/-
Rs. 210/- Pack
of 30ml
Rs. 420/- Pack
of 60ml
Kytril Syrup of
Roche
Graniset Syrup
of SJ & G Fazul
Elahi Karachi
Approved.
180
Evaluator – III (Veterinary Cases)
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name
+ Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date,
diary
Fee including
differential fee
Demanded
Price / Pack
size
Remarks on the
formulation (if
any) including
International
status in
stringent drug
regulatory
agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
Recommendat
ions by the
Evaluators
Decision
308. M/s Noble
Pharma, Mirpur
Azad Kashmir
NOBI-LINCOL
Powder
Each 1gm contains:
Lincomycin
Sulphate…..100mg
Colistin
Sulphate……8,00,0
00IU
Antibacterial
Manufacturer
Form-5
Dy. No: 05
dated 02-10-10
20,000/-
Decontrolled/
100gm, 500gm
and 1kg
Vety Lincon
Powder of Leads
Pharma Karachi.
Approved.
309. -do- TRIDOX-TD Oral
Powder
Each 1000gm
contains:
Doxycycline
HCL……200gm
Tylosin
Tartrate…..100gm
Bromohexine
HCL…..5ogm
Colistin
sulphate…..48MIU
Form-5
Dy. No: 85
dated 08th
November 2010
20,000/-
Decontrolled/
100gm, 500gm,
and 1Kg
Pulmotin Water
Soluble Powder of
Attabak Pharma
Islmabad.
Approved.
181
Evaluator – III (Import applications)
S/N Name and
address of
manufacturer
/ Applicant
Brand Name
(Proprietary name
+ Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date,
diary
Fee including
differential fee
Demanded
Price / Pack
size
Remarks on
the
formulation
(if any)
including
International
status in
stringent
drug
regulatory
agencies /
authorities
Me-too status
GMP status
as depicted in
latest
inspection
report (with
date) by the
Evaluator
Recommendation
s by the
Evaluators
Decision
310. Applicant
M/s Bajwa
Sons, 129
Circular Road,
Lohari Lahore
Manufacturer
Shanghai
Transfusion
Technology
Co. Ltd.
Add: No.500
You Dong
Road,
Minhang,
Shanghai,
201100, P.R of
China
Famous Brand
Single Blood Bags
Each 100ml of
CPDA (Citrate
Phosphate Dextrose
Adenine Solution,
Anticoagulant)
contains:
Citric acid
monohydrate……0
.299g
Sodium citrate
dihydrate…………
2.63g
Sodium
biphosphate
monohydrate……0
.222g
Dextrose
monohydrate……..
3.19g
Adenine……….0.0
275g
Form-5A
Dy No: Not
provided
15000/- dated
08-10-10
Rs 150/ Blood
Bag of 250ml
Rs 150/ Blood
Bag of 450ml
Rs 160/ Blood
Bag of 500ml
a. Evidence of
Balance fee is
not submitted.
b. Stability studies
as per Zone-IV-
A conditions as
per ICH/ WHO
guidelines need
to be submitted.
c. Original
Legalized and
valid COPP as
per WHO format
or original and
legalized GMP
certificate along
with Free sale
certificate from
regulatory body
of country of
origin, needs to
be submitted.
d. Clinical trial
data is not
submitted.
Deferred for the
followings:
1. Evidence of
Balance fee is not
submitted.
2. Stability studies as
per Zone-IV-A
conditions as per
ICH/ WHO
guidelines need to be
submitted.
3. Original Legalized
and valid COPP as
per WHO format or
original and legalized
GMP certificate along
with Free sale
certificate from
regulatory body of
country of origin,
needs to be
submitted.
4. Clinical trial data is
not submitted.
5. Packaging material
182
Water for
Injection….Qs
Disposable
e. Packaging
material
specification are
not provided
specification has not
been provided
311. Applicant
M/s Bajwa
Sons, 129
Circular Road,
Lohari Lahore
Manufacturer
Shanghai
Transfusion
Technology
Co. Ltd.
Add: No.500
You Dong
Road,
Minhang,
Shanghai,
201100, P.R of
China
Famous Brand
Double Blood Bags
Each 100ml of
CPDA (Citrate
Phosphate Dextrose
Adenine Solution,
Anticoagulant)
contains:
Citric acid
monohydrate……0
.299g
Sodium citrate
dihydrate…………
2.63g
Sodium
biphosphate
monohydrate……0
.222g
Dextrose
monohydrate……..
3.19g
Adenine……….0.0
275g
Water for
Injection….Qs
Disposable
Form-5A
Dy No: 29 dated
08-10-10
15000/- dated
08-10-10
Rs 300/ Blood
Bag of 450ml
Rs 315/ Blood
Bag of 500ml
a. Evidence of
Balance fee is
not submitted.
b. Stability studies
as per Zone-IV-
A conditions as
per ICH/ WHO
guidelines need
to be submitted.
c. Original
Legalized and
valid COPP as
per WHO format
or original and
legalized GMP
certificate along
with Free sale
certificate from
regulatory body
of country of
origin, needs to
be submitted.
d. Clinical trial
data is not
submitted.
e. Packaging
material
specification are
not provided
Deferred for the
followings:
1. Evidence of
Balance fee is not
submitted.
2. Stability studies as
per Zone-IV-A
conditions as per
ICH/ WHO
guidelines need to be
submitted.
3. Original Legalized
and valid COPP as
per WHO format or
original and legalized
GMP certificate along
with Free sale
certificate from
regulatory body of
country of origin,
needs to be
submitted.
4. Clinical trial data is
not submitted.
5. Packaging material
specification has not
been provided
312. Applicant
M/s Bajwa
Sons, 129
Circular Road,
Lohari Lahore
Manufacturer
Shanghai
Transfusion
Technology
Co. Ltd.
Add: No.500
You Dong
Road,
Minhang,
Famous Brand
triple Blood Bags
Each 100ml of
CPD (Citrate
Phosphate Dextrose
Solution,
Anticoagulant)
contains:
Citric acid
monohydrate……0
.299g
Sodium citrate
dihydrate…………
2.63g
Form-5A
Dy No: Not
provided
15000/- dated
08-10-10
Rs 510/ Blood
Bag of 450ml
Rs 525/ Blood
Bag of 500ml
a. Evidence of
Balance fee is
not submitted.
b. Stability studies
as per Zone-IV-
A conditions as
per ICH/ WHO
guidelines need
to be submitted.
c. Original
Legalized and
valid COPP as
per WHO
format or
original and
Deferred for the
followings:
1. Evidence of
Balance fee is not
submitted.
2. Stability studies as
per Zone-IV-A
conditions as per
ICH/ WHO
guidelines need to be
submitted.
3. Original Legalized
and valid COPP as
per WHO format or
original and legalized
183
Shanghai,
201100, P.R of
China
Sodium
biphosphate
monohydrate……0
.222g
Dextrose
monohydrate……..
3.19g
Water for
Injection….Qs to
100ml
Each 100ml of
SAGM (Saline
Adenine Glucose
Mannitol, Red
Blood Cell
Preservative)
contains:
Dextrose
monohydrate…..0.
900g
Sodium
chloride…..0.877g
Adenine…….0.016
9g
D-
Mannitol…….0.52
5g
Water for
Injection….qs to
100ml
Disposable
legalized GMP
certificate
along with Free
sale certificate
from regulatory
body of country
of origin, needs
to be submitted.
d. Clinical trial
data is not
submitted.
e. Packaging
material
specification
are not
provided
GMP certificate along
with Free sale
certificate from
regulatory body of
country of origin,
needs to be
submitted.
4. Clinical trial data is
not submitted.
5. Packaging material
specification has not
been provided
313. Applicant
M/s Bajwa
Sons, 129
Circular Road,
Lohari Lahore
Manufacturer
Shanghai
Transfusion
Technology
Co. Ltd.
Add: No.500
You Dong
Road,
Minhang,
Shanghai,
Famous Brand
Quadruple Double
Blood Bags
Each 100ml of
CPD (Citrate
Phosphate Dextrose
Solution,
Anticoagulant)
contains:
Citric acid
monohydrate……0
.299g
Sodium citrate
dihydrate…………
2.63g
Form-5A
Dy No: Not
provided
15000/- dated
08-10-10
Rs 440/ Blood
Bag of 450ml
Rs 445/ Blood
Bag of 500ml
a. Evidence of
Balance fee is
not submitted.
b. Stability studies
as per Zone-IV-
A conditions as
per ICH/ WHO
guidelines need
to be submitted.
c. Original
Legalized and
valid COPP as
per WHO
format or
original and
legalized GMP
Deferred for the
followings:
1. Evidence of
Balance fee is not
submitted.
2. Stability studies as
per Zone-IV-A
conditions as per
ICH/ WHO
guidelines need to be
submitted.
3. Original Legalized
and valid COPP as
per WHO format or
original and legalized
GMP certificate along
184
201100, P.R of
China
Sodium
biphosphate
monohydrate……0
.222g
Dextrose
monohydrate……..
3.19g
Water for
Injection….Qs to
100ml
Each 100ml of
SAGM (Saline
Adenine Glucose
Mannitol, Red
Blood Cell
Preservative)
contains:
Dextrose
monohydrate…..0.
900g
Sodium
chloride…..0.877g
Adenine…….0.016
9g
D-
Mannitol…….0.52
5g
Water for
Injection….qs to
100ml
Disposable
certificate
along with Free
sale certificate
from regulatory
body of country
of origin, needs
to be submitted.
d. Clinical trial
data is not
submitted.
e. Packaging
material
specification
are not
provided
with Free sale
certificate from
regulatory body of
country of origin,
needs to be
submitted.
4. Clinical trial data is
not submitted.
5. Packaging material
specification has not
been provided
185
Case No.07. Remaining drug registration applications of previously approved new sections
Evaluator – I
M/s Stallion Pharmaceuticals (Pvt) Ltd, Lahore have informed that their 04 products were deferred in
244th meeting of Registration Board held on 8
th and 9
th May, 2014 due to confirmation of manufacturing
facility and that they are now under process of developing a dedicated Carbapenem facility and that the
04 deferred products may be considered of their approved manufacturing facility. The firm has requested
consideration of the following 04 products on priority basis (according to 10 products per section policy).
S.
N
Name and address
of Manufacturer /
Applicant
Brand Name
(Proprietary
name + Dosage
form + Strength)
Composition
Pharmacological
Group
Finished product
specification
Type of Form
Initial date,
diary.
Fee including
differential fee
Demanded Price
/ Pack size
International
status in
stringent
regulatory
agencies
Me-too status
GMP status as
depicted in
inspection
report (dated)
Remarks /
Observations
Decision
314. M/s. Stallion
Pharmaceuticals
(Pvt) Ltd, 581-
Sunder Industrial
Estate, Lahore
New License
1.Capsule.(Penicillin
)
2.Dry Powder
Suspension
(Penicillin)
3.Dry Powder
Injection (Penicillin)
Vide letter No. F. 1-
33/2009 – Lic dated
6th February, 2014
Fluclox Injection
500mg
Dry Powder
Injection
Each vial
contains:-
Flucloxacillin
Sodium (B.P) eq.
to Flucloxacillin
………………..
500mg
(Penicillin)
BP Specifications
Form-5
27-10-2014
1336 R&I
Rs. 20,000/-
Pack of one Rs.
90/-
Pack of 5 Rs.
450/-
Pack of 10 Rs.
900/-
FLOXAPEN
Injection 500mg
MHRA UK
A-FLOX
500mg Injection
Laderly
N/A (New
License)
Approved.
315. -do- Staclox Injection
Dry Powder
Injection
Form-5
27-10-2014
1337 R&I
AMPICLOX
250/250mg
Injection
MHRA
Approved.
186
Each vial
contains:-
Ampicillin
Sodium (B.P) eq.
to Ampicillin
………………..
250mg
Cloxacillin
Sodium (B.P) eq.
to Cloxacillin
250mg
(Penicillin)
Manufacturers
Specifications
Rs. 20,000/-
Pack of one Rs.
70/-
Pack of 5 Rs.
350/-
Pack of 10 Rs.
700/-
AMPICLOX
500mg Injection
Gsk
N/A (New
License)
316. -do- Flustal Injection
Dry Powder
Injection
Each vial
contains:-
Amoxicillin
Sodium (B.P) eq.
to
Amoxicillin……..
….. 250mg
Flucloxacillin
Sodium (B.P) eq.
to Flucloxacillin
…………………
250mg
(Penicillin)
Manufacturers
Specifications
Form-5
27-10-2014
1338 R&I
Rs. 20,000/-
Pack of one Rs.
144/-
Pack of 5 Rs.
720/-
Pack of 10 Rs.
1440/-
FLUMOX
250/250mg Inj
EIPICO, Egypt
Biflocin
500mg Inj
Zam Zam Corp
N/A (New
License)
1) Evidence of
approval of
same
formulation in
Egypt has been
provided
instead of
stringent
regulatory
authority e.g.,
FDA, TGA,
MHLW, EMA
and Health
Canada.
Deferred for
confirmation of
approval in
reference
Stringent
Reulatory
Agencies.
317. -do- Amoxi Injection
500mg (BP)
Dry Powder
Injection
Each Vial
Contains:
Amoxicillin
Sodium ( BP) eq.
Form-5
25-10-2013
643 R&I
Rs. 20,000/-
Rs. 90.0 / 1’s,
Amoxil 500 mg
Vial
MHRA
Amoxil 500 mg
GSK, Pakistan
N/A (New
Approved.
187
to
Amoxicillin ……
500mg
(Penicillin)
BP Specifications
Rs. 900.0 / 10’s
License)
Evaluator – II
The Registration Board has been granting 10 products per section to newly approved sections. Following
are the remaining products of the applicants as per above policy.
S/
N
Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date, diary
Fee including
differential fee
Demanded Price /
Pack size
Remarks on the
formulation (if any)
including International
status in stringent drug
regulatory agencies /
authorities
Me-too status
GMP status as depicted
in latest inspection
report (with date) by
the Evaluator
Decision
318. M/s Rogen
Pharmaceuticals
Plot No. 30 Street
No. # S-4 National
Industrial Zone
Rawat Islamabad.
Semi Solid
(Cream/Ointment)
General Section
(No. F. 1-27/2009-
Lic Dated 19-07-10
)
Efrog 13.9%Cream
Each gram contains:-
Eflornithine (as
eflornithine
Hydrochloride
…139mg
(Enzyme Inhibitor)
(Manufacturer’s
Spec.s)
Form 5
26/11/2014 Dy. No.
1907 Rs. 20000/-
As per SRO
BNF: Vaniqa (Almirall),
but in 11.5% strength
Vanika (Crystollite) 13.9
% , Depilus Cream (Atco)
in 11.5% strength but no
pricing
The company may be
issued cGMP Certificate
for export purpose. (09-
06-2014)
1. The product is
available in 11.5 %
Approved in 11.5 %
strength.
188
strength as per BNF.
In Pakistan product is
available in both
13.9% and 11.5 %
strengths but pricing
of 11.5 % strength
could not be traced.
The Firm has
submitted master
formulation of both
strength after
evaluation of initial
dossier and has
requested to grant
them registration of
any one strength.
319. M/s Faas
Pharmaceuticals
(Pvt.) Limited F-
784/L S.I.T.E.
Karachi
Sachet Section:
F. 2-2/2009-Lic
dated 15-02-2013
Antisec Sachet
Each Sachet
contains:-
Racecadotril
(B.P)…10mg
(Anti-Diarrheal)
(Manufacturer’s
Spec.s)
Form 5
29/10/2014 Dy. No.
117 Rs. 20000/-
As per SRO/1×10’s
BNF: Hidrasec (Abbott
Healthcare)
Not confirmed
Satisfactory level of GMP
compliance(18-03-14)
1. Me-too status needs
confirmation.
Deferred for confirmation
of me too status
otherwise the firm shall
apply on form 5-D with
fee & other codal
formalities.
320. -do- Antisec Sachet
Each Sachet
contains:-
Racecadotril
(B.P)…15mg
(Anti-Diarrheal)
(Manufacturer’s
Spec.s)
Form 5
29/10/2014 Dy. No.
116 Rs. 20000/-
As per SRO/1×10’s
Not confirmed
Not confirmed
Satisfactory level of GMP
compliance(18-03-14)
1. International
availability of
formulation in SRA’s
not confirmed.
2. Me-too status needs
confirmation.
Deferred for confirmation
of approval in reference
Stringent Regulatory
Agencies & me too
status.
189
321. -do- Antisec Sachet
Each Sachet
contains:-
Racecadotril
(B.P)…30mg
(Anti-Diarrheal)
(Manufacturer’s
Spec.s)
Form 5
29/10/2014 Dy. No.
115 Rs. 20000/-
As per SRO/1×10’s
BNF: Hidrasec (Abbott
Healthcare)
Not confirmed
Satisfactory level of GMP
compliance(18-03-14)
1. Me-too status needs
confirmation.
Deferred for confirmation
of me too status
otherwise the firm shall
apply on form 5-D with
fee & other codal
formalities.
322. -do- Uronol Sachet 3G
Each Sachet
contains:-
Fosfomycin (as
Tromethamine
…3gm
(Anti-bacterial)
(Manufacturer’s
Spec.s)
Form 5
29/10/2014 Dy. No.
114 Rs. 20000/-
As per SRO/1×10’s
Health Canada: Monurol
(Triton Pharma Inc.)
Not confirmed
Satisfactory level of GMP
compliance (18-03-14)
1. Me-too status needs
confirmation.
Deferred for confirmation
of me too status
otherwise the firm shall
apply on form 5-D with
fee & other codal
formalities.
323. -do- Ostrolife Sachet
Each Sachet
contains:-
Cholecalciferol
(USP)…60,000IU
(Vitamin)
(Manufacturer’s
Spec.s)
Form 5
29/10/2014 Dy. No.
276 Rs. 20000/-
As per SRO/1×10’s
Not confirmed
Not confirmed
Satisfactory level of GMP
compliance(18-03-14)
1. International
availability of
formulation in SRA’s
not confirmed.
2. Me-too status needs
confirmation.
Deferred for confirmation
of approval in reference
Stringent Regulatory
Agencies & me too
status.
324. -do- Oraltral Sachet
(Orange Flavor)
Each Sachet
contains:-
Sodium
Chloride…3.5g
Sodium Citrate
Dihydrate…2.9g
Potassium
Chloride…1.5
Glucose
Anhydrous…20g
(Electrolytes)
(Manufacturer’s
Spec.s)
Form 5
29/10/2014 Dy. No.
271 Rs. 20000/-
As per SRO/1×20’s
Not confirmed
Peditral (Searle)
Satisfactory level of GMP
compliance(18-03-14)
1. International
availability of
formulation in SRA’s
not confirmed. WHO
formulation is sodium
chloride 2.6 g,
potassium chloride
Approved as the
formulation is WHO
approved.
190
1.5 g, sodium citrate
2.9 g, anhydrous
glucose 13.5 g
325. -do- Oraltral Sachet
(Lemon and Lime
Flavor)
Each Sachet
contains:-
Sodium
Chloride…3.5g
Sodium Citrate
Dihydrate…2.9g
Potassium
Chloride…1.5
Glucose
Anhydrous…20g
(Anti-Malarial)
(B.P Spec.s)
Form 5
17/09/2014 Dy. No.
274 Rs. 20000/-
As per SRO/1×20’s
Not confirmed
Peditral (Searle)
Satisfactory level of GMP
compliance(18-03-14)
1. International
availability of
formulation in SRA’s
not confirmed. WHO
formulation is sodium
chloride 2.6 g,
potassium chloride
1.5 g, sodium citrate
2.9 g, anhydrous
glucose 13.5 g.
Approved as the
formulation is WHO
approved.
326. -do- Neomecta Sachet
Each Sachet
contains:-
Dioctahedral
Smectite…3000mg
(Anti-diarrhioeals)
(Manufacturer’s
Spec.s)
Form 5
17/09/2014 Dy. No.
275 Rs. 20000/-
As per SRO/1×30’s
Not confirmed
Smecta (Atco)
Satisfactory level of GMP
compliance(18-03-14)
1. International
availability of
formulation in SRA’s
not confirmed.
Deferred for review of
formulation by Review
Committee.
327. -do-
Capsule Section:
F. 2-2/2009-Lic
dated 15-02-2013
Itometic Capsule
Each capsule
contains:
Itopride
hydrochloride…150
mg
(as sustained release
pellets)
(Gastoprokinetic /
antiemetic)
(Manufacturer’s
Spec.s)
(Source of Pellets:
Form 5
17/09/2014 Dy. No.
270 Rs. 20000/-
As per SRO/1×10’s
Not confirmed
Ganaton OD (Abbott)
Satisfactory level of GMP
compliance(18-03-14)
1. Formulation is under
review by the Review
Committee.
2. Fee for import of
pellets, Legalized
Copy of Valid GMP
certificate of
Deferred for review of
formulation alongwith the
rectification of following
observations:
1. Fee for import of
pellets, Legalized Copy
of Valid GMP certificate
of manufacturer of
Pellets;
2. stability studies
according to zone of
Pakistan of Pellets are
required.
.
191
M/s Titan
Laboratories Private
Limited Plot No.
E27/1, E27/2, MIDC,
Mahad Village Jite
District, Raigad,
Maharashtra, India)
manufacturer of
Pellets; stability
studies according to
zone of Pakistan of
Pellets are required.
328. -do- Azobact Capsule
250mg
Each capsule
contains:
Azithromycine (As
dihydrate)
(USP)..250mg
(Anti-Infective)
(USP Spec.s)
Form 5
17/09/2014 Dy. No.
266 Rs. 20000/-
As per SRO/1×10’s
BNF : Zithromax
(Pfizer)
Azomax (Novartis)
Satisfactory level of GMP
compliance(18-03-14)
Approved.
329. -do- Pirotrin 20mg
Capsule
Each capsule
contains:
Piroxicam beta
cyclodextrin eq. to
Piroxicam……..20
mg
(Analgesic / anti-
rheumatic/ anti
pyretic)
(Manufacturer’s
Spec.s)
Form 5
17/09/2014 Dy. No.
267 Rs. 20000/-
As per SRO/1×10’s
BNF : Feldene (Pfizer)
Pirobet (Highnoon)
Satisfactory level of GMP
compliance(18-03-14)
Approved.
330. -do- Tamsol 0.4mg
Capsule
Each capsule
contains:-
Tamsulosin
hydrochloride(as
modified release
pellets)…….0.4 mg
(Anti BPH)
(USP Spec.s)
{Source: M/s Vision
Pharmaceuticals, Plot
No 224, Street No.
Form 5
17/09/2014 Dy. No.
268 Rs. 20000/-
As per SRO/1×10’s
BNF: Tamsulosin
hydrochloride (Non-
proprietary)
Tamsolin (Getz)
Satisfactory level of GMP
compliance (18-03-14)
1. Certificate of
Analysis, stability
studies according to
zone of Pakistan of
Pellets are required.
Approved. Firm will
provide Certificate of
Analysis and stability
studies of pellets
according to zone IV A
and Chairman, RB will
permit issuance of
registration letter.
192
Evaluator – III
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of
Form
Initial date,
diary
Fee
including
differential
fee
Demanded
Price / Pack
size
Remarks on
the
formulation (if
any) including
International
status in
stringent drug
regulatory
agencies /
authorities
Me-too status
GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator
Recommendations
by the Evaluator
Decision
331. M/s Wenovo
Pharmaceuticals,
Taxila
(Dry Powder Vial
Injectable)
CLARITHREM
Injection
Each vial contains:
Clarithromycin
….….500mg
Macrolide
BP
Form-5
Dy No: 864
dated 24-09-
2014
20,000/-
As fixed by
Govt.
Pack of 1’s
Klaricid of
Abbott UK
(Lyophilized
Powder)
Clariset of
Mediate
Pharma
Approved.
332. -do- LANSOP Injection
30mg
Each vial contains:
Lansoprazole……30mg
PPI
Manufacturer
Form-5
Dy No: 863
dated 24-09-
2014
20,000/-
As fixed by
Govt.
Pack of 1’s
Prevacid of
Takeds Pharm
(USFDA)
Lyophilized
Powder
Lansit of SJ &
G Fazul Elhahi
Karachi
Approved.
01, I-10/3 , Industrial
area, Islamabad}
193
333. -do- PANTOWEN Injection
Each vial contains:
Pantoprazole as
sodium…..40mg
PPI
Manufacturer
Form-5
Dy No: 862
dated 24-09-
2014
20,000/-
As fixed by
Govt.
Pack of 1’s
Protonix of
Wyeth
(USFDA)
Lyophilized
powder
Lesprot of
Nabiqasim
Karachi
Approved.
334. -do- AZINOV Injection
Each vial contains:
Azithromycin….500mg
Macrolide
Manufacturer
Form-5
Dy No: 862
dated 24-09-
2014
20,000/-
As fixed by
Govt.
Pack of 1’s
Zithromax of
Pfizer
(USFDA)
Lyophilized
Powder
Azimycin of
Medicina
Pharma Lahore
Approved.
335. -do-
(Capsule General)
WENOLOX Capsule
Each capsule contains:
Duloxetine as HCL
enteric coated pellets
(17%) eq. to
Duloxetine…..30mg
Antidepressant
Manufacturer
Source: Vision Pharma
Islamabad
Form-5
Dy No: 1277
dated 24-10-
2014
20,000/-
As per policy
of MOH
1x10’s
Cymbalta of
EliLilly
Netherlands
Duxafit of
Wnsfield Hattar
Approved.
336. -do-
WENOLOX Capsule
Each capsule contains:
Duloxetine as HCL
enteric coated pellets
(17%) eq. to
Duloxetine…..60mg
Antidepressant
Manufacturer
Form-5
Dy No: 1276
dated 24-10-
2014
20,000/-
As per policy
of MOH
1x10’s
Cymbalta of Eli
Lilly
Netherlands
Duxafit of
Wnsfield Hattar
Approved.
194
337. -do- GABANOV Capsules
Each capsule contains:
Gabapentin…..300mg
Anticonvulsant
USP
Form-5
Dy No: 1274
dated 24-10-
2014
20,000/-
As per policy
of MOH
1x10’s
Gabapentin
Capsules of
Sandoz UK
Nerogabin of
Merck
Approved.
338. -do- GABANOV Capsules
Each capsule contains:
Gabapentin…..400mg
Anticonvulsant
USP
Form-5
Dy No: 1275
dated 24-10-
2014
20,000/-
As per policy
of MOH
1x10’s
Gabapentin
Arrow 400mg
Hard Capsules
of Actavis UK
Nerogabin of
Merck
Approved
339. -do-
(Liquid Ampoule
SVP)
TRAMANOV Injection
Each 2ml ampoule
contains:
Tramadol
HCL……100mg
Synthetic opiate
analogue
Manufacturer
Form-5
Dy No: 1273
dated 23-10-
2014
20,000/-
As per policy
of MOH
Pack of 5’s &
10’s
Tramdol
Injection of
Beacon Pharma
UK
Lamadol of
Brooks Karachi
Evidence of
availability of TOC
analyzer and liquid
particle counter is
required.
Deferred for
confirmation of
installation and
operational
qualifications of
TOC analyser &
liquid Particle
Counter by Area
FID.
340. -do- WENOFEN Injection
Each 2ml of amber
glass ampoule contains:
Diclofenac
Sodium…..75mg
Lidocaine
HCl…..20mg
Analgesic, Local
anesthetic
Manufacturer
Form-5
Dy No: 1272
dated 23-10-
2014
20,000/-
As per policy
of MOH
Pack of 5’s &
10’s
Availability in
SRA’s needs
confirmation
Dinopen of
Global Pharma,
Islamabad.
Evidence of
availability of TOC
analyzer and liquid
particle counter is
required.
Deferred for
confirmation of
installation and
operational
qualifications of
TOC analyser &
liquid Particle
Counter by Area
FID.
195
Evaluator – III (Veterinary applications)
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date,
diary
Fee including
differential
fee
Demanded
Price / Pack
size
Remarks on the
formulation (if
any) including
International
status in
stringent drug
regulatory
agencies /
authorities
Me-too status
GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator
Remarks by the
Evaluator
Decision
341. M/s Noble
Pharma, Mirpur
Azad Kashmir
Liquid Injection
Section
(Veterinary)
Approved vide
letter No. F.5-
2/207 Lic dated:
18-02-13
Nobivec Injection 2%
Each ml contains:
Ivermectin……..20mg
Antiparasitic
BP
Form-5
Dy. No: 65
dated 20-07-14
20,000/-
Decontrolled/
Pack of 50ml
Elvomec D/S of
Elko Karachi
Inspection of the
firm was
conducted by
the area FID and
firm was found
GMP compliant.
Deferred for
confirmation of
installation and
operational
qualifications of
liquid Particle
Counter by Area
FID.
342. -do- Nobivec Injection 1%
Each ml contains:
Ivermectin……..10mg
Antiparasitic
BP
Form-5
Dy. No: 66
dated 20-07-14
20,000/-
Decontrolled/
Pack of 50ml
Actimec
Injection of
Selmore
Pharmaceuticals
Lahore.
Deferred for
confirmation of
installation and
operational
qualifications of
liquid Particle
Counter by Area
FID.
196
Case No.08. Registration applications of Pregabalin deferred in previous meetings of
Registration Board
Evaluator - I
Sr.
No.
Name and address
of Manufacturer /
Applicant
Brand Name
(Proprietary name
+ Dosage form +
Strength)
Composition
Pharmacological
Group
Finished product
specification
Type of Form
Initial date,
diary.
Fee including
differential fee
Demanded
Price / Pack
size
International
status in
stringent
regulatory
agencies
Me-too status
GMP status as
depicted in
inspection
report (dated)
Remarks /
Observations
Decision
343. M/S CCL
Pharmaceutical
(Pvt.) Ltd. 62-
Industrial Estate ,
Kot Lakhpat,
Lahore.
Achlin Capsule
25mg
Capsule
Each Capsule
Contains:
Pregabalin……25
mg
(Antiepileptics,
other antiepileptics)
Manufacturers
specifications
Form 5
14-11-2005
Rs.8000/-
Dy. No. Not
mentioned
14-02-2014
Dy. No.596
Rs.12000/-
14’s/ As Per
Brand Leader
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Panel inspection
for the grant of
GMP certificate
conducted on
06/11/2013,
12/12/2013 &
18/12/2013.
Capsule
(General) section
mentioned in
Issuance of /
Revalidation of
DML vide letter
No. F. 1-8/84-Lic
(Vol. II)
Approved.
344. M/S CCL
Pharmaceutical
Achlin Capsule
50mg
Form 5
LYRICA
Capsules (25, 50,
Approved.
197
(Pvt.) Ltd. 62-
Industrial Estate ,
Kot Lakhpat,
Lahore.
Capsule
Each Capsule
Contains:
Pregabalin……50
mg
(Antiepileptics,
other antiepileptics)
Manufacturers
specifications
14-11-2005
Rs.8000/-
Dy. No. Not
mentioned
14-02-2014
Dy. No.596
Rs.12000/-
14’s/ As Per
Brand Leader
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Panel inspection
for the grant of
GMP certificate
conducted on
06/11/2013,
12/12/2013 &
18/12/2013.
Capsule
(General) section
mentioned in
Issuance of /
Revalidation of
DML vide letter
No. F. 1-8/84-Lic
(Vol. II)
345. M/S CCL
Pharmaceutical
(Pvt.) Ltd. 62-
Industrial Estate ,
Kot Lakhpat,
Lahore.
Achlin Capsule
100mg
Capsule
Each Capsule
Contains:
Pregabalin……100
mg
(Antiepileptics,
other antiepileptics)
Manufacturers
specifications
Form 5
14-11-2005
Rs.8000/-
Dy. No. Not
mentioned
14-02-2014
Dy. No.596
Rs.12000/-
14’s/ As Per
Brand Leader
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Panel inspection
for the grant of
GMP certificate
conducted on
06/11/2013,
12/12/2013 &
18/12/2013.
Capsule
Approved.
198
(General) section
mentioned in
Issuance of /
Revalidation of
DML vide letter
No. F. 1-8/84-Lic
(Vol. II)
346. M/S NabiQasim
(Pvt) Ltd. 17/24,
Korangi Industrial
Area, Karachi-
Pakistan.
Preka Capsule
150mg
Capsule
Each Capsule
Contains:
Pregabalin……150
mg
(Anticonvulsant)
Manufacturers
Specifications
Form 5
24-04-2008
Rs.8000/-
Dy. No. Not
mentioned
09-09-2013
Rs.12000/-
Dy. No. not
mentioned
duplicate dossier
/
10’s, / Rs. 288/-
20’s / Rs. 547/-
30’s / 799/-
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Inspection report
dated 18-12-
2013. Capsule
section
mentioned in
report and cGMP
certificate.
Approved.
347. M/S NabiQasim
(Pvt) Ltd. 17/24,
Korangi Industrial
Area, Karachi-
Pakistan.
Preka Capsule
75mg
Capsule
Each Capsule
Contains:
Pregabalin……75
mg
(Anticonvulsant)
Manufacturers
Specifications
Form 5
24-04-2008
Rs.8000/-
Dy. No. Not
mentioned
09-09-2013
Rs.12000/-
Dy. No. not
mentioned
duplicate dossier
/
10’s / Rs.160/-
20’s / Rs. 304/-
30’s / Rs. 444/-
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Inspection report
dated 18-12-
2013. Capsule
section
mentioned in
report and cGMP
Approved.
199
certificate.
348. M/S NabiQasim
(Pvt) Ltd. 17/24,
Korangi Industrial
Area, Karachi-
Pakistan.
Preka Capsule
50mg
Capsule
Each Capsule
Contains:
Pregabalin……50
mg
(Anticonvulsant)
Manufacturers
Specifications
Form 5
24-04-2008
Rs.8000/-
Dy. No. Not
mentioned
09-09-2013
Rs.12000/-
Dy. No. not
mentioned
duplicate dossier
/
10’s / Rs.144/-
20’s / Rs. 273/-
30’s / Rs. 400/-
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Inspection report
dated 18-12-
2013. Capsule
section
mentioned in
report and cGMP
certificate.
Approved.
349. M/S NabiQasim
(Pvt) Ltd. 17/24,
Korangi Industrial
Area, Karachi-
Pakistan.
Preka Capsule
100mg
Capsule
Each Capsule
Contains:
Pregabalin……100
mg
(Anticonvulsant)
Manufacturers
Specifications
Form 5
24-04-2008
Rs.8000/-
Dy. No. Not
mentioned
09-09-2013
Rs.12000/-
Dy. No. not
mentioned
duplicate dossier
/
10’s / Rs.201/-
20’s / Rs. 382/-
30’s / Rs. 558/-
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Inspection report
dated 18-12-
2013. Capsule
section
mentioned in
report and cGMP
certificate.
Approved.
350. M/S Linz
Pharmaceuticals
(Pvt) Ltd., 31-G/H,
Sector 15 Korangi
Industrial Area,
Karachi-Pakistan.
Pegab 300mg
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……300
mg
Form 5
Covering letter
not attached.
Rs.8000/- Jul,
2008
Dy. No. Not
mentioned
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Approved.
200
(Anticonvulsant
Agent)
Manufacturers
specifications
28-05-2014
Rs.12000/-
Dy. No. 802
duplicate dossier
/
14’s/ Rs.390/-
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
dated 27-05-
2014. Capsule
section
mentioned. Panel
recommended
grant of renewal.
351. M/S Linz
Pharmaceuticals
(Pvt) Ltd., 31-G/H,
Sector 15 Korangi
Industrial Area,
Karachi-Pakistan.
Pegab 100mg
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……100
mg
(Anticonvulsant
Agent)
Manufacturers
specifications
Form 5
Covering letter
not attached.
Rs.8000/- Jul,
2008
Dy. No. Not
mentioned
28-05-2014
Rs.12000/-
Dy. No. Not
mentioned
14’s/ Rs.291/-
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
dated 27-05-
2014. Capsule
section
mentioned. Panel
recommended
grant of renewal.
Approved.
352. M/S Linz
Pharmaceuticals
(Pvt) Ltd., 31-G/H,
Sector 15 Korangi
Industrial Area,
Karachi-Pakistan.
Pegab 75mg
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……75
mg
(Anticonvulsant
Agent)
Manufacturers
specifications
Form 5
Covering letter
not attached.
Rs.8000/- Jul,
2008
Dy. No. Not
mentioned
28-05-2014
Rs.12000/-
Dy. No. Not
mentioned
14’s/ Rs.237/-
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
dated 27-05-
2014. Capsule
Approved.
201
section
mentioned. Panel
recommended
grant of renewal.
353. M/S Bosch 221,
Bosch House ,
Sector 23, Korangi
Industrial
Area,Karachi.
Gablin 100mg
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……100
mg
(Anticonvulsant
Agent)
Manufacturers
specifications
Form 5
Covering letter
not attached.
June, 2008
Rs.8000/-
Dy. No. Not
mentioned
28-05-2014
Rs.12000/-
803 R&I
14’s / Rs.291/-
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Inspection report
dated 12-08-
2014. Capsule
section approved
Approved.
354. M/S Bosch 221,
Bosch House ,
Sector 23, Korangi
Industrial
Area,Karachi.
Gablin 75mg
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……75
mg
(Anticonvulsant
Agent)
Manufacturers
specifications
Form 5
Covering letter
not attached.
June, 2008
Rs.8000/-
Dy. No. Not
mentioned
28-05-2014
Rs.12000/-
803 R&I
14’s/ Rs.237/-
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Inspection report
dated 12-08-
2014. Capsule
section approved
Approved.
355. M/S Bosch 221,
Bosch House ,
Sector 23, Korangi
Industrial
Area,Karachi.
Gablin 300mg
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……300
mg
Form 5
Covering letter
not attached.
June, 2008
Rs.8000/-
Dy. No. 803
28-05-2014
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
Approved.
202
(Anticonvulsant
Agent)
Manufacturers
specifications
Rs.12000/-
803 R&I
14’s/ Rs.390/-
75, 100 and
150mg)
Hilton
Inspection report
dated 12-08-
2014. Capsule
section approved
356. M/S Sami
Pharmaceutical
Pvt., Limited F-95,
S.I.T.E. Karachi.
Pregy 50mg
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……50
mg
(Anticonvulsant)
Manufacturer
Specifications
Form 5
Rs.8000/-
22-12-2009
Dy. No. not
mentioned
Rs.12000/- fee
challan is
missing
As per PRC
duplicate dossier
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
report dated 24-
06-2014. Panel
recommended
grant of
additional
sections. Capsule
section
mentioned.
Approved.
357. M/S Sami
Pharmaceutical
Pvt., Limited F-95,
S.I.T.E. Karachi.
Pregy 75mg
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……75
mg
(Anticonvulsant)
Manufacturer
Specifications
Form 5
Rs.8000/-
22-12-2009
Dy. No. not
mentioned
Rs.12000/-
29-07-2013
Dy. No. Not
mentioned
As per PRC
duplicate dossier
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
report dated 24-
06-2014. Panel
recommended
grant of
additional
Approved.
203
sections. Capsule
section
mentioned.
358. M/S Sami
Pharmaceutical
Pvt., Limited F-95,
S.I.T.E. Karachi.
Pregy 100mg
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……100
mg
(Anticonvulsant)
Manufacturers
specifications
Form 5
Rs.8000/-
22-12-2009
Dy. No. not
mentioned
Rs.12000/-
29-07-2013
Dy. No. Not
mentioned
As per PRC
Duplicate
dossier
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
report dated 24-
06-2014. Panel
recommended
grant of
additional
sections. Capsule
section
mentioned.
Approved.
359. M/S Sami
Pharmaceutical
Pvt., Limited F-95,
S.I.T.E. Karachi.
Pregy 150mg
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……150
mg
(Anticonvulsant)
Manufacturers
specifications
Form 5
Rs.8000/-
22-12-2009
Dy. No. not
mentioned
Rs.12000/-
29-07-2013
Dy. No. Not
mentioned
As per PRC
Duplicate
dossier
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
report dated 24-
06-2014. Panel
recommended
grant of
additional
sections. Capsule
section
mentioned.
Approved.
360. M/S AGP (Private)
Limited, B-23,
Hi-Gab Capsules
75mg
Form 5
LYRICA
Capsules (25, 50,
Approved.
204
S.I.T.E., Karachi Capsule
Each Capsule
Contains:
Pregabalin……75
mg
(Anti-Epileptic)
Manufacturers
specifications
Rs.8000/-
17-07-2009
Dy. No. not
mentioned
Rs.12000/-
19-03-2014
Dy. No. Not
mentioned
14’s / Rs.565/-
Duplicate
dossier
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
26/11/2013.
Capsule section
mentioned in FID
report.
361. M/S AGP (Private)
Limited, B-23,
S.I.T.E., Karachi
Hi-Gab Capsules
50mg
Capsule
Each Capsule
Contains:
Pregabalin……50
mg
(Anti-Epileptic)
Manufacturers
specifications
Form 5
Rs.8000/-
17-07-2009
Dy. No. not
mentioned
Rs.12000/-
19-03-2014
Dy. No. Not
mentioned
14’s / Rs.450/-
duplicate dossier
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
26/11/2013.
Capsule section
mentioned in FID
report.
Approved.
362. M/S AGP (Private)
Limited, B-23,
S.I.T.E., Karachi
Hi-Gab Capsules
200mg
Capsule
Each Capsule
Contains:
Pregabalin……200
mg
(Anti-Epileptic)
Manufacturers
Form 5
Rs.8000/-
17-07-2009
Dy. No. not
mentioned
Rs.12000/-
19-03-2014
Dy. No. Not
mentioned
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
SYNGAB
Capsules 200mg
Atco
Inspection report
Approved.
205
specifications 14’s / Rs.1225/-
duplicate dossier
dated
26/11/2013.
Capsule section
mentioned in FID
report.
363. M/S AGP (Private)
Limited, B-23,
S.I.T.E., Karachi
Hi-Gab Capsules
225mg
Capsule
Each Capsule
Contains:
Pregabalin……225
mg
(Anti-Epileptic)
Manufacturers
specifications
Form 5
Rs.8000/-
17-07-2009
Dy. No. not
mentioned
Rs.12000/-
19-03-2014
Dy. No. Not
mentioned
14’s / Rs.1370/-
duplicate dossier
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
Evidence of Me
too status
required
Inspection report
dated
26/11/2013.
Capsule section
mentioned in FID
report.
1) Evidence
of me too
status
required.
Deferred for
confirmation of
me too status.
364. M/S AGP (Private)
Limited, B-23,
S.I.T.E., Karachi
Hi-Gab Capsules
300mg
Capsule
Each Capsule
Contains:
Pregabalin ……
300mg
(Anti-Epileptic)
Manufacturers
specifications
Form 5
Rs.8000/-
17-07-2009
Dy. No. not
mentioned
Rs.12000/-
19-03-2014
Dy. No. Not
mentioned
14’s/Rs.1560/-
duplicate dossier
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
26/11/2013.
Capsule section
mentioned in FID
report.
Approved.
365. M/S AGP (Private)
Limited, B-23,
S.I.T.E., Karachi
Hi-Gab Capsules
100mg
Capsule
Each Capsule
Contains:
Pregabalin……100
mg
Form 5
Rs.8000/-
17-07-2009
Dy. No. not
mentioned
Rs.12000/-
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Approved.
206
(Anti-Epileptic)
Manufacturers
specifications
19-03-2014
Dy. No. Not
mentioned
14’s/Rs.735/-
duplicate dossier
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
26/11/2013.
Capsule section
mentioned in FID
report.
366. M/S AGP (Private)
Limited, B-23,
S.I.T.E., Karachi
Hi-Gab Capsules
25mg
Capsule
Each Capsule
Contains:
Pregabalin……25
mg
(Anti-Epileptic)
Manufacturers
specifications
Form 5
Rs.8000/-
17-07-2009
Dy. No. not
mentioned
Rs.12000/-
19-03-2014
Dy. No. Not
mentioned
14’s / Rs.270/-
duplicate dossier
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Inspection report
dated
26/11/2013.
Capsule section
mentioned in FID
report.
Approved.
367. M/S AGP (Private)
Limited, B-23,
S.I.T.E., Karachi
Hi-Gab Capsules
150mg
Capsule
Each Capsule
Contains:
Pregabalin……150
mg
(Anti-Epileptic)
Manufacturers
specifications
Form 5
Rs.8000/-
17-07-2009
Dy. No. not
mentioned
Rs.12000/-
19-03-2014
Dy. No. Not
mentioned
14’s/Rs.940/-
duplicate dossier
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
26/11/2013.
Capsule section
mentioned in FID
report.
Approved.
207
368. M/s Neutro Pharma
(Pvt) Ltd., 9.5 Km,
Sheikhupura Road,
Lahore
Gabin Capsules
300mg
Capsule
Each Capsule
Contains:
Pregabalin……300
mg
(GABA Analogue)
Manufacturers
Specifications
Form 5
Rs.8000/-
17-08-2009
Dy. No. not
mentioned
Rs.12000/-
07-07-2014
Dy. No. 66
As per PRC
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
to check GMP
compliance
conducted on
6th& 7
th January,
2014.
Approved.
369. M/s Atco
Laboratories
Limited, B-18,
S.I.T.E., Karachi
Syngab
Capsules75mg
Capsule
Each Capsule
Contains:
Pregabalin……75
mg
(Anti Epileptic)
Manufacturers
Specifications
Form 5
Rs.8000/-
29-04-2008
Dy. No. not
mentioned
Rs.12000/-
08-04-2014
Dy. No. not
mentioned
As per leader
price per 14’s
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 18-06-2014
Approved.
370. M/s Atco
Laboratories
Limited, B-18,
S.I.T.E., Karachi
Syngab Capsules
150mg
Capsule
Each Capsule
Contains:
Pregabalin……150
mg
(Anti Epileptic)
Manufacturers
Specifications
Form 5
Rs.8000/-
29-04-2008
Dy. No. not
mentioned
Rs.12000/-
08-04-2014
Dy. No. not
mentioned
As per leader
price per 14’s
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 18-06-2014
Approved.
208
371. M/s Atco
Laboratories
Limited, B-18,
S.I.T.E., Karachi
Syngab Capsules
300mg
Capsule
Each Capsule
Contains:
Pregabalin……300
mg
(Anti Epileptic)
Manufacturers
Specifications
Form 5
Rs.8000/-
22-04-2008
Dy. No. not
mentioned
Rs.12000/-
08-04-2014
Dy. No. not
mentioned
As per leader
price per 14’s
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 18-06-2014
Approved.
372. M/S Tabros
Pharma
L-20/B, F.B.
Industrial Area,
Karachi.
Grelin Capsule
75mg
Capsule
Each Capsule
Contains:
Pregabalin……75
mg
(Anti-Epileptic.)
Manufacturers
specifications
Form 5
Rs.8000/-
30-06-2008
Dy. No. Not
mentioned
Rs.12000/-
Dated 20-03-
2014
Dy. No. not
mentioned
14’s / Rs.1100/-
(Rs. 78.57 per
capsule)
(duplicate
dossier)
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
11/03/2014.
Overall
conditions noted
improved as
compared to last
visit.
Approved.
373. M/S Tabros
Pharma
L-20/B, F.B.
Industrial Area,
Karachi.
Grelin Capsule
100mg
Capsule
Each Capsule
Contains:
Pregabalin……100
mg
(Anti-Epileptic.)
Manufacturers
specifications
Form 5
Rs.8000/-
30-06-2008
Dy. No. Not
mentioned
Rs.12000/-
Dated.20-03-
2014
Dy. No. not
mentioned
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Approved.
209
14’s/Rs.1300/-
(duplicate
dossier)
Inspection report
dated
11/03/2014.
Overall
conditions noted
improved as
compared to last
visit.
374. M/S Tabros
Pharma
L-20/B, F.B.
Industrial Area,
Karachi.
Grelin Capsule
150mg
Capsule
Each Capsule
Contains:
Pregabalin……150
mg
(Anti-Epileptic.)
Manufacturers
specifications
Form 5
Rs.8000/-
30-06-2008
Dy. No. Not
mentioned
Rs.12000/-
Dated.20-03-
2014
Dy. No. not
mentioned
14’s/Rs.1600/-
(duplicate
dossier)
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
11/03/2014.
Overall
conditions noted
improved as
compared to last
visit.
Approved.
375. M/S Tabros
Pharma
L-20/B, F.B.
Industrial Area,
Karachi.
Grelin Capsule
300mg
Capsule
Each Capsule
Contains:
Pregabalin……300
mg
(Anti-Epileptic.)
Manufacturers
specifications
Form 5
Rs.8000/-
30-06-2008
Dy. No. Not
mentioned
Rs.12000/-
Dated.20-03-
2014
Dy. No. not
mentioned
14’s/Rs.2600/-
(duplicate
dossier)
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated
11/03/2014.
Overall
conditions noted
improved as
compared to last
Approved.
210
visit.
376. M/S Scotmann
Pharmaceuticals, 5-
D, I-10/3, Industrial
Area Islamabad.
Foxril Capsule
75mg
Capsule
Each Capsule
Contains:
Pregabalin……75
mg
(Anticonvulsant.)
Manufacturers
specifications
Form 5
Rs.8000/-
15-07-2008
Dy. No. 186
Rs.12000/-
Dated.08-07-
2014
Dy. No. 1244
14’s / Rs. 16.95
/ Capsule
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 12-04-
2013. Good
compliance.
Capsule section
mentioned in
panel inspection
report dated 02-
12-2008.
Approved.
377. M/S Scotmann
Pharmaceuticals, 5-
D, I-10/3, Industrial
Area Islamabad.
Foxril Capsule
100mg
Capsule
Each Capsule
Contains:
Pregabalin……100
mg
(Anticonvulsant.)
Manufacturers
specifications
Form 5
Rs.8000/-
15-07-2008
Dy. No.176
Rs.12000/-
Dated.08-07-
2014
Dy. No. 1244
14’s/Rs.20.85/C
apsule
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 12-04-
2013. Good
compliance.
Capsule section
mentioned in
panel inspection
report dated 02-
12-2008.
Approved.
378. M/S Scotmann
Pharmaceuticals, 5-
D, I-10/3, Industrial
Foxril Capsule
150mg
Capsule
Form 5
Rs.8000/-
LYRICA
Capsules (25, 50,
75, 100,
Approved.
211
Area Islamabad.
Each Capsule
Contains:
Pregabalin……150
mg
(Anticonvulsant.)
Manufacturers
specifications
15-07-2008
Dy No.181
Rs.12000/-
Dated.08-07-
2014
Dy. No. 1244
Rs.33.90/Capsul
e
14’s
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 12-04-
2013. Good
compliance.
Capsule section
mentioned in
panel inspection
report dated 02-
12-2008.
379. M/S OBS Pakistan
(Pvt.) Ltd. C-14,
S.I.T.E.,
Manghopir Road
Karachi-75700
Pregalin Capsule
Capsule
Each Capsule
Contains:
Pregabalin……150
mg
(Antiepileptics)
Manufacturers
specifications
Form 5
Rs.8000/-
18-10-2008
Not mentioned
Rs.12000/-
Dated.29-07-
2013 duplicate
dossier
Dy. No. not
mentioned
14’s/Rs.1300/-
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 06-03-
2014. GMP
satisfactory and
capsule section
mentioned in
report.
Approved.
380. M/S OBS Pakistan
(Pvt.) Ltd. C-14,
S.I.T.E.,
Manghopir Road
Karachi-75700
Pregalin Capsule
Capsule
Each Capsule
Contains:
Pregabalin……300
mg
(Antiepileptics)
Form 5
Rs.8000/-
18-10-2008
Not mentioned
Rs.12000/-
Dated.29-07-
2013 duplicate
dossier
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
Approved.
212
Manufacturers
specifications
Dy. No. not
mentioned
14’s/Rs.2200/-
300mg)
Getz
Inspection report
dated 06-03-
2014. GMP
satisfactory and
capsule section
mentioned in
report.
381. M/S OBS Pakistan
(Pvt.) Ltd. C-14,
S.I.T.E.,
Manghopir Road
Karachi-75700
Pregalin Capsule
Capsule
Each Capsule
Contains:
Pregabalin……75
mg
(Antiepileptics)
Manufacturers
specifications
Form 5
Rs.8000/-
18-10-2008
Not mentioned
Rs.12000/-
Dated.29-07-
2013 duplicate
dossier
Dy. No. not
mentioned
14’s/Rs.900/-
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 06-03-
2014. GMP
satisfactory and
capsule section
mentioned in
report.
Approved.
382. M/S Glitz Pharma
(Pvt.) Ltd; 265-
Industrial Triangle,
Kahuta Road
Islamabad.
P-Gab 75
Tablet
Each film coated
tablet Contains:
Pregabalin……75
mg
(Antiepileptics)
Manufacturers
specifications
Form 5
Rs.8000/-
31-12-2008
Dy. No.561
Rs.12000/-
Dated.08-07-
2014
Dy. No. 1239
10x2=20’s /As
Per SRO
Inspection report
dated 18-03-
2013.
Satisfactory GMP
and tablet section
mentioned.
1) Firm had
initially
applied on
Form 5 for
registration of
Pregabalin
75mg tablet.
Since the
product is not
me too, firm
was asked to
provide me
too reference
or application
on Form 5D.
Now, firm
has requested
to change the
particulars of
The request of the
firm has not been
acceded to by the
Board & the
Board rejected the
application of P-
Gab 75 Tablet
213
the file to
Pregabalin
Oral Solution
20mg/ml.
Firm has also
submitted that
additional fee
if any, will be
deposited.
383. M/S Glitz Pharma
(Pvt.) Ltd; 265-
Industrial Triangle,
Kahuta Road
Islamabad.
P-Gab 100
Tablet
Each tablet
Contains:
Pregabalin……100
mg
(Antiepileptics)
Manufacturers
specifications
Form 5
Rs.8000/-
31-12-2008
Dy. No.562
Rs.12000/-
Dated.08-07-
2014
Dy. No. 1235
10x2=20’s &
14’s /As Per
SRO
Inspection report
dated 18-03-
2013.
Satisfactory GMP
and tablet and
capsule section
mentioned.
1) Firm had
initially
applied on
Form 5 for
registration of
Pregabalin
100mg tablet.
Since the
product is not
me too, firm
was asked to
provide me
too reference
or application
on Form 5D.
Now, firm
has requested
to change the
particulars of
the file to
Pregabalin
300mg
capsules.
Firm has also
submitted that
additional fee
if any, will be
deposited.
The request of the
firm has not been
acceded to by the
Board & the
Board rejected the
application P-Gab
100, Tablet
384. M/S Glitz Pharma
(Pvt.) Ltd; 265-
Industrial Triangle,
Kahuta Road
Islamabad.
P-Gab 50
Tablet
Each tablet
Contains:
Pregabalin……50
mg
(Antiepileptics)
Form 5
Rs.8000/-
31-12-2008
Dy. No. 560
Rs.12000/-
Dated.08-07-
2014
Dy. No. 1233
Inspection report
dated 18-03-
2013.
Satisfactory GMP
and tablet section
mentioned.
1) Firm had
initially
applied on
Form 5 for
registration of
Pregabalin
100mg tablet.
Since the
product is not
me too, firm
The request of the
firm has not been
acceded to by the
Board & the
Board rejected the
application of P-
Gab 50, Tablet
214
Manufacturers
specifications
10x2=20’s /As
Per SRO
was asked to
provide me
too reference
or application
on Form 5D.
Now, firm
has requested
to change the
particulars of
the file to
Pregabalin
200mg
capsules.
Firm has also
submitted that
additional fee
if any, will be
deposited.
385. M/S Glitz Pharma
(Pvt.) Ltd; 265-
Industrial Triangle,
Kahuta Road
Islamabad.
P-Gab 150mg
Tablet
Each film coated
tablet Contains:
Pregabalin……150
mg
(Antiepileptics)
Manufacturers
specifications
Form 5
Rs.8000/-
31-12-2008
Dy. No.563
Rs.12000/-
Dated.08-07-
2014
Dy. No. 1234
10x2=20’s/As
Per SRO
Inspection report
dated 18-03-
2013.
Satisfactory GMP
and tablet section
mentioned.
1) Firm had
initially
applied on
Form 5 for
registration of
Pregabalin
100mg tablet.
Since the
product is not
me too, firm
was asked to
provide me
too reference
or application
on Form 5D.
Now, firm
has requested
to change the
particulars of
the file to
Pregabalin
150mg
capsules.
Firm has also
submitted that
additional fee
if any, will be
deposited.
The request of the
firm has not been
acceded to by the
Board & the
Board rejected the
application of P-
Gab 150mg
Tablet
386. M/S Glitz Pharma P-Gab 100 Form 5 LYRICA Approved.
215
(Pvt.) Ltd; 265-
Industrial Triangle,
Kahuta Road
Islamabad.
Capsule
Each capsule
Contains:
Pregabalin……100
mg
(Antiepileptics)
Manufacturers
specifications
Rs.8000/-
31-12-2008
Dy. No.559
Rs.12000/-
Dated.08-07-
2014
Dy. No. 1236
10x2=20’s &
14’s /As Per
SRO and Rs.
625/- per 20’s
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 18-03-
2013.
Satisfactory GMP
and tablet section
mentioned.
387. M/S Glitz Pharma
(Pvt.) Ltd; 265-
Industrial Triangle,
Kahuta Road
Islamabad.
P-Gab 75
Capsule
Each capsule
Contains:
Pregabalin……75
mg
(Antiepileptics)
Manufacturers
specifications
Form 5
Rs.8000/-
31-12-2008
Dy. No.557
Rs.12000/-
Dated.08-07-
2014
Dy. No. 1238
10x2=20’s &
14’s/As Per
SRO and Rs.
345/- per 20’s
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 18-03-
2013.
Satisfactory GMP
and tablet section
mentioned.
Approved.
388. M/S Glitz Pharma
(Pvt.) Ltd; 265-
Industrial Triangle,
Kahuta Road
Islamabad.
P-Gab 50
Capsule
Each capsule
Contains:
Pregabalin……50
mg
(Antiepileptics)
Manufacturers
Form 5
Rs.8000/-
31-12-2008
Dy. No.556
Rs.12000/-
Dated.08-07-
2014
Dy. No. 1237
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Approved.
216
specifications 10x2=20’s &
14’s/As Per
SRO
Getz
Inspection report
dated 18-03-
2013.
Satisfactory GMP
and tablet section
mentioned.
389. M/S Global
Pharmaceuticals
(Pvt.) Ltd., Plot No.
204-205, Industrial
Triangle, Kahuta
Road, Islamabad.
Pert 50 mg
Capsules
Capsule
Each capsule
Contains:
Pregabalin……50
mg
(Anticonvulsant)
Manufacturers
Specifications
Form 5
Rs.8000/- fee
challan not
attached
Rs.12000/-
Dated.05-06-
2014
Dy. No. 566
R&I
14’s As Per
SRO
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
cGMP certificate
dated 21-11-
2014.
Capsule section
mentioned in
inspection report
and GMP
certificate dated
31-05-2012 and
21-11-2014.
1) Rs. 8,000/-
fee challan
(duly
endorsed by
Statistical
Officer) has
not been
provided.
However,
copy of
extracts from
214th meeting
of
Registration
Board as
evidence of
fee
submission.
Approved.
Reference will be
sent to B & A
Division for
verification of fee
challan. In acse of
non-confirmation,
firm will deposit
the fee (Rs.8000/-
) and Chairman,
RB will permit for
issuance of
registration letter.
390. M/S Global
Pharmaceuticals
(Pvt.) Ltd., Plot No.
204-205, Industrial
Triangle, Kahuta
Road, Islamabad.
Pert 75 mg
Capsules
Capsule
Each capsule
Contains:
Pregabalin……75
mg
(Anticonvulsant)
Manufacturers
Specifications
Form 5
Rs.8000/- fee
challan not
attached
Rs.12000/-
Dated.05-06-
2014
Dy. No. 565
R&I
14’s As Per
SRO
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
cGMP certificate
dated 21-11-
2014.
Capsule section
mentioned in
1) Rs. 8,000/-
fee challan
(duly
endorsed by
Statistical
Officer) has
not been
provided.
However,
copy of
extracts from
214th meeting
of
Registration
Board as
evidence of
fee
submission.
Approved.
Reference will be
sent to B & A
Division for
verification of fee
challan. In acse of
non-confirmation,
firm will deposit
the fee (Rs.8000/-
) and Chairman,
RB will permit for
issuance of
registration letter.
217
inspection report
and GMP
certificate dated
31-05-2012 and
21-11-2014.
391. M/S Genome
Pharmaceutical
Private Limted,
Factory 16/1-Phase
IV, Industrial
Estate, Hattar.
Pregabanome-150
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……150
mg
(Gaba Analogue)
Manufacturers
specifications
Form 5
Rs.8000/-
09-08-2008
Dy. No.287
Rs.12000/-
16-06-2014
Dy. No. 258
As Per SRO
2x7’s (14)
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Panel inspection
for grant of GMP
dated 27-12-
2013.
Capsule General /
Antibiotic
mentioned.
Approved.
392. M/S Genome
Pharmaceutical
Private Limted,
Factory 16/1-Phase
IV, Industrial
Estate, Hattar.
Pregabanome-75
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……75
mg
(Gaba Analogue)
Manufacturers
specifications
Form 5
Rs.8000/-
09-08-2008
Dy. No.288
Rs.12000/-
16-06-2014
Dy. No. 258
As Per SRO
2x7’s (14)
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Panel inspection
for grant of GMP
dated 27-12-
2013.
Capsule General /
Antibiotic
mentioned.
Approved.
393. M/S Genome
Pharmaceutical
Private Limted,
Pregabanome-50
Capsule
Capsule
Form 5
Rs.8000/-
LYRICA
Capsules (25, 50,
75, 100,
Approved.
218
Factory 16/1-Phase
IV, Industrial
Estate, Hattar.
Each Capsule
Contains:
Pregabalin……50
mg
(Gaba Analogue)
Manufacturers
specifications
09-08-2008
Dy. No. 289
Rs. 12000/-
16-06-2014
Dy. No. 258
As Per SRO
2x7’s (14)
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Panel inspection
for grant of GMP
dated 27-12-
2013.
Capsule General /
Antibiotic
mentioned.
394. M/S Genome
Pharmaceutical
Private Limted,
Factory 16/1-Phase
IV, Industrial
Estate, Hattar.
Pregabanome-
100Capsule
Capsule
Each Capsule
Contains:
Pregabalin……100
mg
(Gaba Analogue)
Manufacturers
specifications
Form 5
Rs.8000/-
09-08-2008
Dy. No.286
Rs.12000/-
16-06-2014
Dy. No. 258
As Per SRO
2x7’s (14)
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Panel inspection
for grant of GMP
dated 27-12-
2013.
Capsule General /
Antibiotic
mentioned.
Approved.
395. M/s Noa Hemis
Pharmaceuticals
Plot No.154,
Sector-23, Korangi
Industrial
Area,Karachi
Gabatil-75mg
Capsule
Each Capsule
Contains:
Pregabalin
……75mg
(Anti epileptic)
Manufacturers
specifications
Form 5
Rs.8000/-
22-07-2008
Dy. No. not
mentioned
Rs.12000/-
19-06-2014
1609 R&I
10’s, 14’s/15%
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Approved.
219
less then brand
leader
DDG and FID
inspection report
dated 09-06-2014
GMP compliance
considered good.
Capsule section
mentioned in
GMP inspection
reports.
396. M/s Noa Hemis
Pharmaceuticals
Plot No.154,
Sector-23, Korangi
Industrial
Area,Karachi
Gabatil-150mg
Capsule
Each Capsule
Contains:
Pregabalin
……150mg
(Anti epileptic)
Manufacturers
specifications
Form 5
Rs.8000/-
22-07-2008
Dy. No. not
mentioned
Rs.12000/-
19-06-2014
1609 R&I
10’s, 14’s / 15%
less then brand
leader
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
DDG and FID
inspection report
dated 09-06-2014
GMP compliance
considered good.
Capsule section
mentioned in
GMP inspection
reports.
Approved.
397. M/s Noa Hemis
Pharmaceuticals
Plot No.154,
Sector-23, Korangi
Industrial
Area,Karachi
Gabatil-300mg
Capsule
Each Capsule
Contains:
Pregabalin
……300mg
(Anti epileptic)
Manufacturers
specifications
Form 5
Rs.8000/-
22-07-2008
Dy. No. not
mentioned
Rs.12000/-
19-06-2014
1609 R&I
10’s, 14’s / 15%
less then brand
leader
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
DDG and FID
inspection report
dated 09-06-2014
Approved.
220
GMP compliance
considered good.
Capsule section
mentioned in
GMP inspection
reports.
398. M/S Sharooq
Pharmaceuticals
(Pvt) Ltd. 21-KM
Ferozepur Road,
Lahore.
Gabmor Capsule
Capsule
Each Capsule
Contains:
Pregabalin……300
mg
(Antiepileptic)
Manufacturers
specifications
Form 5
Rs.8000/-
19-01-2009
Not mentioned
Rs.12000/-
Dated.19-06-
2014 duplicate
dossier
Dy. No. 1286
14’s/As per PRC
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
after non-
compliance
report and grant
of GMP
certificate dated
28-03-2014.
GMP issued and
capsule section
mentioned.
Approved.
399. M/S Sharooq
Pharmaceuticals
(Pvt) Ltd. 21-KM
Ferozepur Road,
Lahore.
Gabmor Capsule
Capsule
Each Capsule
Contains:
Pregabalin……75
mg
(Antiepileptic)
Manufacturers
specifications
Form 5
Rs.8000/-
19-01-2009
Not mentioned
Rs.12000/-
Dated.19-06-
2014 duplicate
dossier
Dy. No. 1281
14’s,10’s/As per
PRC
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
after non-
compliance
report and grant
of GMP
certificate dated
28-03-2014.
Approved.
221
GMP issued and
capsule section
mentioned.
400. M/S Sharooq
Pharmaceuticals
(Pvt) Ltd. 21-KM
Ferozepur Road,
Lahore.
Gabmor Capsule
Capsule
Each Capsule
Contains:
Pregabalin………
………..…150mg
(Antiepileptic)
Manufacturers
specifications
Form 5
Rs.8000/-
19-01-2009
Not mentioned
Rs.12000/-
Dated.19-06-
2014 duplicate
dossier
Dy. No. 1282
14’s, 10’s/As
per PRC
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
after non-
compliance
report and grant
of GMP
certificate dated
28-03-2014.
GMP issued and
capsule section
mentioned.
Approved.
401. M/s Rasco Pharma,
5.5Km Raiwind
Road Lahore.
Pregab Capsule
300mg
Capsule
Each Capsule
Contains:
Pregabalin
….……300mg
(Anticonvulsant)
Manufacturers
specifications
Form 5
Rs.8000/-
25-07-2009
Dy. No. Not
mentioned
Rs.12000/-
20-06-2014
Dy. No. 1296
Rs.630/-, 1x14
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
dated 03-06-2014
where panel
recommended
grant of renewal
of DML. Capsule
section
mentioned in said
report.
Approved.
222
402. M/s Rasco Pharma,
5.5Km Raiwind
Road Lahore.
Pregab Capsule
150mg
Capsule
Each Capsule
Contains:
Pregabalin
……150mg
(Anticonvulsant)
Manufacturers
specifications
Form 5
Rs.8000/-
25-07-2009
Dy. No. Not
mentioned
Rs.12000/-
20-06-2014
Dy. No. 1295
Rs.350/-, 1x14
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
dated 03-06-2014
where panel
recommended
grant of renewal
of DML. Capsule
section
mentioned in said
report.
Approved.
403. M/s Rasco Pharma,
5.5Km Raiwind
Road Lahore.
Pregab Capsule
50mg
Capsule
Each Capsule
Contains:
Pregabalin
……50mg
(Anticonvulsant)
Manufacturers
specifications
Form 5
Rs.8000/-
25-07-2009
Dy. No. Not
mentioned
Rs.12000/-
20-06-2014
Dy. No. 1294
Rs.175/-, 1x14
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
dated 03-06-2014
where panel
recommended
grant of renewal
of DML. Capsule
section
mentioned in said
report.
Approved.
404. M/s WnsFeild
Pharmaceuticals,
Plot#122, Block-A,
Phase-V, Industrial
Lyricowin 75
Capsule
Each capsule
Form 5
Rs.8000/-
19-04-2009
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
Approved.
Reference will be
sent to B & A
Division for
223
Estate, Hattar Contains:
Pregabalin
……75mg
(Anticonvulsants)
Manufacturer’s
specifications
In agenda,
erroneously
dosage form with
brand name
written as Tablet
instead of
Capsule. The firm
actually
mentioned dosage
form as capsule in
form 5.
Dy. No. Not
mentioned
Rs.12000/-
19-06-2014
Dy. No. 259
As per SRO
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel report
dated 04-09-
2014. Panel
recommends
grant of GMP
and capsule
section
mentioned.
verification of fee
challan for
capsule dosage
form. If
confirmed, then
Chairman, RB
will permit for
issuance of
registration letter.
Otherwise case
will be placed
before the Board
for decision.
405. M/s Pakistan
Pharmaceuticals
Products (Pvt) Ltd.
D-122, Sindh
Industrial Trading
Estate, Karachi.
Gablin 150mg
Capsule
Capsule
Each capsule
Contains:
Pregabalin
……150mg
(Anticonvulsants)
Form 5
Rs.8000/-
17-06-2009
(Challan
submission date)
Dy. No. Not
mentioned
Rs.12000/-
26-07-2013
Dy. No. not
mentioned
Covering letter
is not attached
Rs.25/Capsule
/not mentioned
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 13-02-2013
and 03-06-2014
considered to be
operating at
satisfactory level
of GMP.
Approved.
406. M/s Pakistan
Pharmaceuticals
Products (Pvt) Ltd.
D-122, Sindh
Industrial Trading
Estate, Karachi.
Gablin 75mg
Capsule
Capsule
Each capsule
Contains:
Pregabalin
……75mg
Form 5
Rs.8000/-
17-06-2009
Dy. No. Not
mentioned
Rs.12000/-
26-07-2013
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
Approved.
224
(Anticonvulsants)
Dy. No. not
mentioned
Covering letter
is not
attached
Rs.25/Capsule
/not mentioned
100, 150 and
300mg)
Getz
Inspection report
dated 13-02-2013
and 03-06-2014
considered to be
operating at
satisfactory level
of GMP.
407. M/s Pakistan
Pharmaceuticals
Products (Pvt) Ltd.
D-122, Sindh
Industrial Trading
Estate, Karachi.
Gablin 300mg
Capsule
Capsule
Each capsule
Contains:
Pregabalin
……300mg
(Anticonvulsants)
Form 5
Rs.8000/-
17-06-2009
Dy. No. Not
mentioned
Rs.12000/-
26-07-2013
Dy. No. not
mentioned
Covering letter
is not attached
Rs.25/Capsule
/not mentioned
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 13-02-2013
and 03-06-2014
considered to be
operating at
satisfactory level
of GMP.
Approved.
408. M/s Danas
Pharmaceuticals
(Private) Limited,
Islamabad.
Gabfast
Capsule300mg
Capsule
Each capsule
Contains:
Pregabalin
……300mg
(Gaba analogue)
Form 5
Rs.8000/-
08-12-2009
Dy. No. 57
Rs.12000/-
05-06-2014
Dy. No. 555
10’s/As Per
SRO
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
cGMP certificate
dated 28-01-
2014. Capsule
section
mentioned.
Approved.
225
409. M/s Danas
Pharmaceuticals
(Private) Limited,
Islamabad.
Gabfast
Capsule75mg
Capsule
Each capsule
Contains:
Pregabalin
……75mg
(Gaba analogue)
Form 5
Rs.8000/-
08-12-2009
Dy. No. 55
Rs.12000/-
05-06-2014
Dy. No. 555
10’s/As Per
SRO
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
cGMP certificate
dated 28-01-
2014. Capsule
section
mentioned.
Approved.
410. M/s Danas
Pharmaceuticals
(Private) Limited,
Islamabad.
Gabfast
Capsule150mg
Capsule
Each capsule
Contains:
Pregabalin
……150mg
(Gaba analogue)
Form 5
Rs.8000/-
08-12-2009
Dy. No. 56
Rs.12000/-
05-06-2014
Dy. No. 555
10’s/As Per
SRO
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
cGMP certificate
dated 28-01-
2014. Capsule
section
mentioned.
Approved.
411. M/S Sami
Pharmaceutical
Pvt., Limited F-95,
S.I.T.E. Karachi.
Pregy 25mg
Capsule
Capsule
Each Capsule
Contains:
Pregabalin……25
mg
(Anticonvulsant)
Manufacturer
Specifications
Form 5
Rs.8000/-
07-09-2010
Dy. No. not
mentioned
Rs.12000/-
10-05-2013
duplicate dossier
Dy. No. Not
mentioned
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Approved.
226
As per PRC Panel inspection
report dated 24-
06-2014. Panel
recommended
grant of
additional
sections. Capsule
section
mentioned.
412. M/S Weather Folds
Pharmaceuticals,
Plot No.69/2,
Phase-II, Industrial
Area, Hattar, KPK
Gabalin 50mg Cap
Capsule
Each Capsule
Contains:
Pregabalin……50
mg
(Analgesic /
Anticonvulsant
Activity)
Manufacturers
specifications
Form 5
Rs.8000/-
29-12-2010
Dy. No. Not
mentioned
Rs.12000/-
Dated.11-07-
2014
Dy. No. 323
As per SRO
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Panel inspection
report dated 04-
09-2014. Panel
recommended
grant of GMP
certificate.
Capsule section
approved.
Approved.
413. M/S Weather Folds
Pharmaceuticals,
Plot No.69/2,
Phase-II, Industrial
Area, Hattar, KPK
Gabalin 100mg
Cap
Capsule
Each Capsule
Contains:
Pregabalin……100
mg
(Analgesic /
Anticonvulsant
Activity)
Manufacturers
specifications
Form 5
Rs.8000/-
29-12-2010
Dy. No. Not
mentioned
Rs.12000/-
Dated.11-07-
2014
Dy. No. not
mentioned
As per SRO
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Panel inspection
report dated 04-
09-2014. Panel
recommended
grant of GMP
Approved.
227
certificate.
Capsule section
approved.
414. M/S Lowitt Pharma
(pvt.) Ltd. 24-
Hayatabad
Industrial Estate
Peshawar.
P-Gablin
150Capsule
Oral Capsule
Each Capsule
Contains:
Pregabalin……150
mg
(Gaba Analogue,
Anticonvulsant.An
algasic)
Manufacturers
specifications
Form 5
Rs.8000/-
22-03-2010
(Endorsement
date)
Dy. No. Not
mentioned
Rs.12000/- (for
tablet)
Dated 22-05-
2014
Dy. No. Not
mentioned
Both pack size
and price as Per
SRO
Duplicate
Dossier
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Inspection report
dated 21-08-
2014. Overall
firm in good
working
condition.
Capsule section
mentioned in
inspection report
and revised
layout plan
approval dated
13-12-2013.
1) Balance
fee Rs.
12,000/- has
been
submitted for
tablet dosage
form.
Approved.
Reference will be
sent to B & A
Division for
verification of fee
challan for
capsule dosage
form. In acse of
non-confirmation,
firm will deposit
the fee
(Rs.12000/-) and
Chairman, RB
will permit for
issuance of
registration letter.
415. M/S Lowitt Pharma
(pvt.) Ltd. 24-
Hayatabad
Industrial Estate
Peshawar.
P-Gablin
50Capsule
Oral Capsule
Each Capsule
Contains:
Pregabalin……50
mg
(Gaba Analogue,
Anticonvulsant.An
algasic)
Manufacturers
specifications
Form 5
Rs.8000/-
22-03-2010
(Endorsement
date)
Dy. No. Not
mentioned
Rs.12000/-
Dated. 22-05-
2014
Dy. No. Not
mentioned
Both pack size
and price as Per
SRO
Duplicate
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Inspection report
dated 21-08-
2014. Overall
firm in good
working
condition.
Approved.
228
Dossier Capsule section
mentioned in
inspection report
and revised
layout plan
approval dated
13-12-2013.
416. M/S Lowitt Pharma
(pvt.) Ltd. 24-
Hayatabad
Industrial Estate
Peshawar.
P-Gablin
100Capsule
Oral Capsule
Each Capsule
Contains:
Pregabalin……100
mg
(Gaba Analogue,
Anticonvulsant.An
algasic)
Manufacturers
specifications
Form 5
Rs.8000/-
22-03-2010
(Endorsement
date)
Dy. No. Not
mentioned
Rs.12000/-
Dated.21-05-
2014
Dy. No. Not
mentioned
Both pack size
and price as Per
SRO
Duplicate
Dossier
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50,
75, 100 and
150mg)
Hilton
Inspection report
dated 21-08-
2014. Overall
firm in good
working
condition.
Capsule section
mentioned in
inspection report
and revised
layout plan
approval dated
13-12-2013.
Approved.
417. M/s Rogen
Pharmaceuticals
Plot#30, S-4,
National Industrial
Zone, Rawat,
Islamabad.
P-Roglin 75mg
Capsule
Capsule
Each capsule
Contains:
Pregabalin
……75mg
(Anti-epileptic)
Manufacturers
specifications
Form 5
Rs.8000/-
02-06-2010
Dy. No. 4754
Rs. 12000/-
16-06-2014
Dy. No.735
10’s/As Per
SRO
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
report dated 09-
06-2014. Tablet /
Approved.
229
capsule section
mentioned.
General Capsule
section
mentioned on the
report.
418. M/s Focus & Rulz
Pharmaceuticals
(Pvt) Ltd. Plot
No.4, Industrial
Triangle, Kahuta
Road, Islamabad.
Pregab 75mg
Capsule
Capsule
Each capsule
Contains:
Pregabalin
……75mg
(Analgesic and
Anticonvulsant)
Manufacturers
specifications
Form 5
Rs.8000/-
61 R&I
28-06-2010
Fee Rs.12000/-
challans form is
missing
14’s/As Per
SRO
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
report dated 27-
03-2014. Capsule
section approved.
Approved. Firm
will provide
verified challan of
Rs.12000/- and
Chairman will
authorize issuance
of registration
letter.
419. M/s Focus & Rulz
Pharmaceuticals
(Pvt) Ltd. Plot
No.4, Industrial
Triangle, Kahuta
Road, Islamabad.
Pregab 50mg
Capsule
Capsule
Each capsule
Contains:
Pregabalin
……50mg
(Analgesic and
Anticonvulsant)
Manufacturers
specifications
Form 5
Rs.8000/-
62 R&I
28-06-2010
Fee Rs.12000/-
challans form is
missing
14’s/As Per
SRO
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Panel inspection
report dated 27-
03-2014. Capsule
section approved.
Approved. Firm
will provide
verified challan of
Rs.12000/- and
Chairman will
authorize issuance
of registration
letter.
420. M/s Amarant
Pharmaceuticals
(Pvt) LTD 158-D,
Toro Gadap Road,
Super highway,
Karachi.
Gabalin Capsule
50mg
Capsule
Each filled Capsule
Contains:
Pregabalin……50
mg
Form 5
Rs.8000/-
22-11-2010
Dy. No. not
mentioned
Rs.52,000/-
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Approved.
230
(Anticonvulsant)
Manufacturers
specifications
(fast track)
19-11-2012
Dy. No. Not
mentioned
Rs.36/- capsule
duplicate dossier
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 08-08-2014
observed that
management is
taking serious
measures to
rearrange and
upgrade their
whole
manufacturing,
quality control
and storage
facilities as per
approved layout
plan.
421. M/s Amarant
Pharmaceuticals
(Pvt) LTD 158-D,
Toro Gadap Road,
Super highway,
Karachi.
Gabalin Capsule
75mg
Capsule
Each filled Capsule
Contains:
Pregabalin……75
mg
(Anticonvulsant)
Manufacturers
specifications
Form 5
Rs.8000/-
22-11-2010
Dy. No. not
mentioned
Rs.52,000/-
(fast track)
19-11-2012
Dy. No. Not
mentioned
Rs.71/- capsule
duplicate dossier
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 08-08-2014
observed that
management is
taking serious
measures to
rearrange and
upgrade their
whole
manufacturing,
quality control
and storage
facilities as per
approved layout
plan.
Approved.
422. M/s Amarant Gabalin Capsule Form 5 LYRICA Approved.
231
Pharmaceuticals
(Pvt) LTD 158-D,
Toro Gadap Road,
Super highway,
Karachi.
100mg
Capsule
Each filled Capsule
Contains:
Pregabalin……100
mg
(Anticonvulsant)
Manufacturers
specifications
Rs.8000/-
22-11-2010
Dy. No. not
mentioned
Rs.52,000/-
(fast track)
18-11-2012
Dy. No. Not
mentioned
Rs.89/- capsule
duplicate dossier
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 08-08-2014
observed that
management is
taking serious
measures to
rearrange and
upgrade their
whole
manufacturing,
quality control
and storage
facilities as per
approved layout
plan.
423. M/s Amarant
Pharmaceuticals
(Pvt) LTD 158-D,
Toro Gadap Road,
Super highway,
Karachi.
Gabalin Capsule
150mg
Capsule
Each filled Capsule
Contains:
Pregabalin……150
mg
(Anticonvulsant)
Manufacturers
specifications
Form 5
Rs.8000/-
22-11-2010
Dy. No. not
mentioned
Rs.52,000/-
(fast track)
19-11-2012
Dy. No. Not
mentioned
Rs.107/- capsule
duplicate dossier
LYRICA
Capsules (25, 50,
75, 100,
150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75,
100, 150 and
300mg)
Getz
Inspection report
dated 08-08-2014
observed that
management is
taking serious
measures to
rearrange and
upgrade their
whole
Approved.
232
manufacturing,
quality control
and storage
facilities as per
approved layout
plan.
9. Contract manufacturing applications
Evaluator – II (Application checked by Evaluator - IV)
S.No Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary
name + Dosage
Form + Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date,
diary
Fee including
differential
fee
Demanded
Price / Pack
size
Remarks on the
formulation (if
any) including
International
status in stringent
drug regulatory
agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
Decision
424. M/s Safe
Pharmaceuticals
(Pvt.) Ltd.
Plot No. C-1-20,
Sector 6-B,
North Karachi
Industrial Area,
Karachi
For
M/s Amarant
Pharmaceuticals
(Pvt.) Ltd.
158, D. Tore,
Gadap Road,
Super Highway,
Karachi.
Impulse Injection
500 mcg/ml
Each 1 ml
ampoule contains
Mecobalamin
(J.P)…..500 mcg
(Co-enzyme type
Vitamin B12)
(Manufacturer’s
Spec.s)
Form 5
Not mentioned
Rs 150,000
1 ml × 10’s
International:
Methycobal Inj by
M/s Eisai Co., Ltd.
Tokyo
Me too:Elgin Inj by
M/s Novartis
According to
inspection report
dated 20-08-2014 of
M/s Safe
Pharmaceuticals;
GMP compliance
level of firm is rated
as good.
Only Form 5 of the
application has been
evaluated. Rest of
Deferred for rectification of
following observation in the
dossier:
1. Reference will be sent to B &
A Division for verification of
challan.
2. Confirmation of installation
and operational qualifications
for TOC analyzer and liquid
particle counter by the area FID.
233
the conditions of
policy matters have
not been evaluated .
Verification fee
challan is required.
Evidence of TOC
analyzer and liquid
particle counter is
required. Firm has
replied that these are
under the process of
procurement.
425. -do- Moxina Infusion
400 mg/ 250 ml
Each vial (250 ml)
contains
Moxifloxacin (as
HCl) (USP)….
400 mg
Quinolone
(Manufacturer’s
Spec.s)
Form 5
Not mentioned
Rs 150,000
As per PAC
International:
Avelox Inf (FDA)
Me too: Moxiget
Inf 400mg/250ml
According to
inspection report
dated 20-08-2014 of
M/s Safe
Pharmaceuticals;
GMP compliance
level of firm is rated
as good.
Only Form 5 of the
application has been
evaluated. Rest of
the conditions of
policy matters have
not been evaluated .
Verification fee
challan is required.
Evidence of TOC
analyzer and liquid
particle counter is
required. Firm has
replied that these are
under the process of
procurement.
Deferred for rectification of
following observation in the
dossier:
1. Reference will be sent to B &
A Division for verification of
challan.
2. Confirmation of installation
and operational qualifications
for TOC analyzer and liquid
particle counter by the area FID.
426. -do-
Quvoxin Injection
500 mg/ 100 ml
Each vial (100ml)
contains
Levofloxacin
(USP)…. 500 mg
Quinolone
Form 5
Not mentioned
Rs 150,000
As per PAC
International:
Levaquine
500mg/100ml
(FDA)
Me too: Raylox Inf
500mg/100ml by
M/s Ray
Deferred for rectification of
following observation in the
dossier:
1. Reference will be sent to B &
A Division for verification of
challan.
234
(Manufacturer’s
Spec.s)
According to
inspection report
dated 20-08-2014 of
M/s Safe
Pharmaceuticals;
GMP compliance
level of firm is rated
as good.
Only Form 5 of the
application has been
evaluated. Rest of
the conditions of
policy matters have
not been evaluated .
Verification fee
challan is required.
Evidence of TOC
analyzer and liquid
particle counter is
required. Firm has
replied that these are
under the process of
procurement.
2. Confirmation of installation
and operational qualifications
for TOC analyzer and liquid
particle counter by the area FID.
427. -do-
Amadrol Injection
100 mg/ 2 ml
Each 2 ml
contains
Tramadol HCl
(B.P) …..100 mg
Non Narcotic
analgesic
(Manufacturer’s
Spec.s)
Form 5
Not mentioned
Rs 150,000
2 ml × 5’s
As per PAC
International:
Zamadol Inj
50mg/ml (100mg
ampoule) in UK
Me too: Tramadol
Inj 50mg/ml by M/s
Highnoon
Latest GMP
inspection report of
contract giver is
required.
According to
inspection report
dated 20-08-2014 of
M/s Safe
Pharmaceuticals;
GMP compliance
level of firm is rated
as good.
Only Form 5 of the
application has been
evaluated. Rest of
the conditions of
policy matters have
Deferred for rectification of
following observation in the
dossier:
1. Reference will be sent to B &
A Division for verification of
challan.
2. Confirmation of installation
and operational qualifications
for TOC analyzer and liquid
particle counter by the area FID.
235
not been evaluated .
Verification fee
challan is required.
Evidence of TOC
analyzer and liquid
particle counter is
required. Firm has
replied that these are
under the process of
procurement.
428. -do-
Amblum Injection
Each ml ampoule
contains
Artemether……80
mg
(Anti malarial)
(Manufacturer’s
Spec.s)
Form 5
Not mentioned
Rs 150,000
1 × 5 ampoule
As per PAC
International:
Artem Inj in China
Me too: Artem Inj
by M/s Hilton
According to
inspection report
dated 20-08-2014 of
M/s Safe
Pharmaceuticals;
GMP compliance
level of firm is rated
as good.
Only Form 5 of the
application has been
evaluated. Rest of
the conditions of
policy matters have
not been evaluated .
Verification fee
challan is required.
Formulation was
Deferred in the light
of recommendations
by Malaria Control
Programme in M-
245 of DRB.
Deferred in the light of
recommendation of National
Malaaria Control programme &
for rectification of following
observation in the dossier:
1. Reference will be sent to B &
A Division for verification of
challan.
2. Confirmation of installation
and operational qualifications
for TOC analyzer and liquid
particle counter by the area FID.
429. M/s Caraway
Pharmaceuticals
Plot No. 12,
street # N-3,
National
Industrial Zone,
Rawat,
Islamabad.
For
M/s Amarant
Pharmaceuticals
(Pvt.) Ltd.
158, D. Tore,
Amant- D
Injection
Each ml contains
Cholecalciferol
BP …..5 mg
Vitamin
Finished product
specifications are
B.P
Form 5
Not mentioned
Rs 150,000
As per PAC
International:
Required
Me too: Calciferol
Inj by M/s Global
Good level of GMP
compliance (24-09-
2012)
Only Form 5 of the
application has been
evaluated. Rest of
the conditions of
policy matters have
not been evaluated .
Deferred for rectification of
following observation in the
dossier:
1. Reference will be sent to B &
A Division for verification of
challan.
2. Confirmation of installation
and operational qualifications
for TOC analyzer and liquid
particle counter by the area FID.
236
Gadap Road,
Super Highway,
Karachi.
Verification fee
challan is required.
International
availability not
confirmed in SRA’s.
Letter of approval of
injection section is
required. Inspection
report dated 24-09-
12 mentions
Ampoule and Vial
sections.
Labeling
information has
been given for
malaria.
3. Evidence of approval in
reference Stringent Regulatory
Agencies.
4. Approval of manufacturing
facility by Licensing section.
5. Correction in labeling as
submitted label mentions the
use of formulation in malaria.
430. -do-
Amta- Rose
Injection
Each ampoule
(5ml) contains
Iron Sucrose 420
mg eq to
elemental Iron …..
100mg
Haematinic
Finished product
specifications are
USP
Form 5
Not mentioned
Rs 150,000
As per PAC
International:
Venofer Inj (FDA)
Me too: Merofer
JInj by M/s Bosch
Good level of GMP
compliance (24-09-
2012)
Only Form 5 of the
application has been
evaluated. Rest of
the conditions of
policy matters have
not been evaluated .
Verification fee
challan is required.
Initially on Form 5,
firm mentioned
quantity of active as
420 mg/ ampoule, in
reply firm
mentioned it as
1873 mg/ ampoule.
Clarification is
required. No
clarification is
provided in second
reply.
Letter of approval of
injection section is
required. Not
provided in second
reply. Inspection
Deferred for rectification of
following observation in the
dossier:
1. Reference will be sent to B &
A Division for verification of
challan.
2. Confirmation of installation
and operational qualifications
for TOC analyzer and liquid
particle counter by the area FID.
3. Initially on Form 5, firm
mentioned quantity of active as
420 mg/ ampoule, in reply firm
mentioned it as 1873 mg/
ampoule. Clarification is
required. No clarification is
provided in second reply.
4. Letter of approval of
injection section is required.
Not provided in second reply.
Inspection report dated 24-09-
12 mentions Ampoule and Vial
sections.
237
report dated 24-09-
12 mentions
Ampoule and Vial
sections.
Evidence of TOC
analyzer and liquid
particle counter is
required. Not
provided in replies.
Evaluator – III
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological Group
Finished product
Specification
Type of Form
Initial date,
diary
Fee including
differential fee
Demanded
Price / Pack
size
Remarks on the
formulation (if
any) including
International
status in stringent
drug regulatory
agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
Recommendations
by the Evaluator
Decision
431. Contract Giver
M/s Dyson
Research Labs,
Lahore.
Contract
Acceptor
M/s McOlson
Research
Laboratories,
Sheikhupura.
OD-CEF Injection 500mg
Each vial contains:
Ceftriaxone sodium
equivalent to
Ceftriaxone…..500mg
Cephalosporin
USP
Form-5
Dy No: 2437
dated: 15-04-
2013
1,42,000/- dated
15-04-13
8,000/- dated
18-05-09
As per SRO
Pack of 1’s
Inspection of M/s
McColson
Research Labs
conducted on 26-
08-14 and 11-09-
14 by the panel of
inspectors and
recommends the
grant of renewal of
DML to the firm
The applications
have been
evaluated as per
Form-5. However
the formalities as
per contract
manufacturing
policy may be
fulfilled by the
concerned section
before issuance of
registration letter.
Approved.
Firm will
provide
undertakings &
agreement as
per approved
contract policy
and Chairman
will permit
issuance of
registration
letter.
Permission will
be valid till
30.06.2015).
238
432. Contract Giver
M/s McOlson
Research
Laboratories,
Sheikhupura.
Contract
Acceptor
M/s Dyson
Research Labs,
Lahore.
AZIBAC Suspension
200mg
Each 5ml after
reconstitution contains:
Azithromycin dihydrate
equivalent to
Azithromycin
USP…..200mg
Macrolide Antibiotic
USP
Form-5
Dy No: 2430
dated: 15-04-
2013
50,000/- dated
15-04-13
1,00,000/- dated
14-05-13
As per SRO
Inspection of the
M/s Dyson
Research Labs
Sheikhupura was
conducted on 26-
09-14 by the area
FID and overall
hygiene and
condition is found
good.
Approved.
Firm will
provide
undertakings &
agreement as
per approved
contract policy
and Chairman
will permit
issuance of
registration
letter.
Permission will
be valid till
30.06.2015).
433. Contract Giver
M/s Masfa
Industries (Pvt)
Limited, Lahore
Contract
Acceptor
M/s McOlson
Research
Laboratories,
Sheikhupura.
M-XIME Suspension
100mg/5ml
Each 5ml contains:
Cefixime trihydraye
equivalent to
Cefixime…..100mg
Cephalosporin
USP
Form-5
Dy No: 2430
dated: 15-04-
2013
1,50,000/-
As per SRO
Inspection of M/s
McColson
Research Labs
conducted on 26-
08-14 and 11-09-
14 by the panel of
inspectors and
recommends the
grant of renewal of
DML to the firm
Approved.
Firm will
provide
undertakings &
agreement as
per approved
contract policy
and Chairman
will permit
issuance of
registration
letter.
Permission will
be valid till
30.06.2015).
434. Contract Giver
M/s Masfa
Industries (Pvt)
Limited, Lahore
Contract
Acceptor
M/s McOlson
Research
Laboratories,
Sheikhupura.
M-XIME Capsule 400mg
Each capsule contains:
Cefixime as
Trihydrate…..400mg
Cephalosporin
USP
Form-5
Dy No: 2405
dated: 15-04-
2013
1,50,000/-
As per SRO
Pack of 5’s
Inspection of M/s
McColson
Research Labs
conducted on 26-
08-14 and 11-09-
14 by the panel of
inspectors and
recommends the
grant of renewal of
DML to the firm
Approved.
Firm will
provide
undertakings &
agreement as
per approved
contract policy
and Chairman
will permit
issuance of
registration
letter.
Permission will
be valid till
30.06.2015).
239
435. Contract Giver
M/s Arsons
Pharmaceutical
Industries,
Lahore.
Contract
Acceptor
M/s Friends
Pharma (Pvt)
Limited, Lahore
for
MECOFOL Injection
Each1ml ampoule
contains:
Mecobalamin……500mcg
Co-Enzyme Vitamin B-12
IP
Form-5
Dy No: 2383
dated 12-04-13
1,50,000/-
As per SRO
Pack of 1’s
Inspection of M/s
Friends Pharma
Lahore was
conducted by the
panel of inspectors
on 21-05-14
concluded the firm
GMP compliant.
Liquid Injection
(general) section
approval vided
letter No. F.1-18/
93-Lic (Vol-II)
(M-227) dated 17-
06-11.
Evidence of
availability of
TOC and liquid
particle counter
is not provided.
Deferred for
confirmation
of installation
and
operational
qualifications
for TOC
analyser &
Liquid
Particle
Counter by
Area FID.
436. Contract Giver
M/s M/s Unison
Chemical
Works Lahore.
Contract
Acceptor
M/s English
Pharmaceuticals
Lahore
ESUN Injection 40mg
Each vial contains:
Sterilized Esomeprazole
Sodium lyophilized
equivalent to
Esomeprazole…..40mg
PPI
Manufacturer
Form-5
Dy No: 3160
dated 17-05-13
1,50,000/-
As per SRO
Nexium of
AstraZeneca
Nexium of BMS
The inspection M/s
English
Pharmaceuticals
Lahore was
conducted on 14-
11-2012 and 15-
11-2012 by the
area FID and found
GMP complaint
a. Quantity of API
in master
formulation
needs
rectification.
b. Latest GMP
Inspection
report of M/s
English Pharma
is required.
Deferred for
rectification of
following
observations:
1. Quantity of
API in master
formulation
needs
rectification.
2. Latest
GMP
Inspection
report of M/s
English
Pharma is
required.
437. Contract Giver
M/s M/s Unison
Chemical
Works Lahore.
Contract
Acceptor
M/s English
Pharmaceuticals
Lahore
U-MIP Injection 40mg
Each vial contains:
Sterilized Omeprazole
Sodium lyophilized
equivalent to
Omeprazole…..40mg
PPI
Manufacturer
Form-5
Dy No: 3161
dated 17-05-13
1,50,000/-
As per SRO
Losec Infusion of
AstraZeneca
Risek of Getz
Pharma
The inspection M/s
English
Pharmaceuticals
Lahore was
conducted on 14-
11-2012 and 15-
11-2012 by the
area FID and found
GMP complaint
a. Quantity of
API in master
formulation
needs
rectification
b. Latest GMP
Inspection
report of M/s
English
Pharma is
required.
Deferred for
rectification of
following
observations:
1. Quantity of
API in master
formulation
needs
rectification.
2. Latest
GMP
Inspection
report of M/s
English
Pharma is
required.
240
438. Contract Giver
M/s Dyson
Research Labs,
Lahore.
Contract
Acceptor
M/s English
Pharmaceuticals
Lahore
BEMOX Infusion
Each 250ml contains:
Moxifloxacin as
hydrochloride…….400mg
Fluoroquinolone
Manufacturer
Form-5
Dy No: 2417
dated: 15-04-
2013
1,50,000/-
As per SRO
Avelox of Bayer
HealthCare Inc
Molox Infusion of
CCL Pharma
a. Specifications
of API needs to
be submitted. b. Under finished
product
specifications
assay method
needs to be
submitted. c. Evidence of
facility of TOC
analyzer and
particle counter
needs to be
submitted.
d. Latest GMP
Inspection
report of M/s
English Pharma
is required.
Deferred for
rectification of
following
observations:
1.
Specifications
of API needs to
be submitted. 2. Under
finished
product
specifications
assay method
needs to be
submitted. 3.
Confirmation
of installation
and operational
qualifications
for TOC
analyzer and
particle
counter. 4. Latest
GMP
Inspection
report of M/s
English
Pharma is
required.
439. Contract Giver
M/s Dyson
Research Labs,
Lahore.
Contract
Acceptor
M/s English
Pharmaceuticals
Lahore
DYPENEM Injection
500mg
Each vial contains:
Meropenem trihydrate
equivalent to
Meropenem……500mg
Penicillin Antibiotic
Manufacturer
Form-5
Dy No: 2411
dated: 15-04-
2013
50,000/-dated
15-04-13
100,000 dated
14-05-13
As per SRO
Meronem of
AstraZeneca
Demonem of
Rotex Medica
a. Evidence of
approval of
manufacturing
facility for
applied product
needs to be
submitted
b. Latest GMP
Inspection
report of M/s
English Pharma
is required.
Deferred for
rectification of
following
observations:
1. Evidence of
approval of
manufacturing
facility for
applied product
needs to be
submitted 2. Latest GMP
Inspection
report of M/s
English
Pharma is
required.
241
440. Contract Giver
M/s Dyson
Research Labs,
Lahore.
Contract
Acceptor
M/s English
Pharmaceuticals
Lahore
DYPENEM Injection 1g
Each vial contains:
Meropenem trihydrate
equivalent to
Meropenem……1g
Penicillin Antibiotic
Manufacturer
Form-5
Dy No: 2412
dated: 15-04-
2013
50,000/-dated
15-04 -13
100,000 dated
14-05-13
As per SRO
Meronem of
AstraZeneca
Demonem of
Rotex Medica
a. Evidence of
approval of
manufacturing
facility for
applied product
needs to be
submitted
b. Latest GMP
Inspection
report of M/s
English Pharma
is required.
Deferred for
rectification of
following
observations:
1. Evidence of
approval of
manufacturing
facility for
applied product
needs to be
submitted 2. Latest GMP
Inspection
report of M/s
English
Pharma is
required.
Case No.10. Replies of deferred applications
Evaluator – I
Case No. a: -
The following two products, namely Effiflox 125mg/5ml and Effiflox 250mg/5ml, of M/s
Sami Pharmaceuticals (Pvt) Ltd., Karachi were deferred in the 242nd
meeting of the Registration
Board held on 24th
– 25th
February, 2014 for confirmation of approved dosage form (dry powder
suspension or solution) by stringent regulatory bodies.
2. The firm has now submitted that they have prepared the drugs against LEVAQUIN of
M/s Janssen Pharma – USA as oral solution and in parallel conducted accelerated stability
studies. The firm has also submitted revised Form – 5 and requested the Board to grant
registration as oral solution.
3. It is pertinent to mention that evidence of approval of 250mg / 5ml strength by stringent
regulatory agencies was not submitted by the firm instead comments of some local prescribers in
favor of the same have been submitted.
S/N Name and
address of
manufacturer /
Applicant
1. Brand Name
2. Dosage Form
3. Composition
4.
Pharmacologic
al group
1.Type of
Form
2. Type of
application
3. Demanded
Price / Pack
size
4. Initial date,
1.Finished
Product
Specification
2. Facility where
drug has to be
manufactured
with status
whether
Decision in 242nd
Meeting of
Registration
Board
Decision
242
diary.
5. Date on
which fee
becomes
complete
according to
type of
application
/or Form
approved by
CLB or not
3. Last GMP
inspection
report with date
& status.
441.
M/s Sami
Pharmaceuticals
(Pvt) Ltd., F-95,
Off. Hub River
Road, S.I.T.E.,
Karachi.
1. EFFIFLOX
125 mg/5ml
2. Dry powder
suspension 3.
Each 5ml of
reconstituted
suspension
contains:
Levofloxacin
Hemihydrate
MS eq. to
Levofloxacin
……………..
125mg
4.
Fluroquinolone.
1. Form-5
2. Fast track
3. As per
PAC, 60ml.
4. 20/04/2011,
264 (R&I)
5. 24/04/2013
Rs.60,000/-
1. Manufacturers
specification.
2. Dry powder
suspension
General
Antibiotic
available as per
inspection report
dated 02/05.2013.
3. cGMP report
dated 02/05/2013
is provided
wherein good
level of GMP
compliance is
reported.
Deferred for
confirmation of
approved dosage
form (dry powder
suspension or
solution) by
stringent
regulatory bodies.
The Board did not
accede the request
of firm for change
in dosage form &
deferred the
instant application
for review of
formulation by
Incharge, PEC..
442. M/s Sami
Pharmaceuticals
(Pvt) Ltd., F-95,
Off. Hub River
Road, S.I.T.E.,
Karachi.
1. EFFIFLOX
250 mg/5ml
2. Dry powder
suspension
3. Each 5ml of
reconstituted
suspension
contains:
Levofloxacin
Hemihydrate
MS eq. to
Levofloxacin
……………..
250mg
4.
Fluroquinolone.
1. Form-5
2. Fast track
3. As per
PAC, 60ml. 4.
20/04/2011,
263 (R&I)
5. 24/04/2013
Rs.60,000/-
1. Manufacturers
specification.
2. Dry powder
suspension
General
Antibiotic
available as per
inspection report
dated 02/05.2013.
3. cGMP report
dated 02/05/2013
is provided
wherein good
level of GMP
compliance is
reported.
Deferred for
confirmation of
approved dosage
form (dry powder
suspension or
solution) by
stringent
regulatory bodies.
The Board did not
acceed the request
of firm for change
in dosage form &
deferred the
instant application
for review of
formulation by
Incharge, PEC.
243
Case No. b:
Following registration application of M/s Arson Pharmaceutical Industries (Pvt) Ltd., Lahore was
deferred in the 243rd
meeting of the Registration Board for status of license in light of inspection report
dated 15-04-2013.
2. The firm has now submitted copy of panel inspection report dated 08/05/2014 for renewal of
Drug Manufacturing License and Grant of additional section (Tablet Psychotropic). The panel in its
aforesaid report reached on the following recommendations:
a. Recommend the renewal of Drug Manufacturing License of the firm M/s Arson
Pharmaceutical Industries (Pvt) Ltd., Multan Road Lahore.
b. Recommend the grant of license to the additional tablet Psychotropic Section.
3. The firm has also submitted a copy of certificate of current Good Manufacturing Practices dated
19-08-2014 wherein it is reported that firm is found complying with cGMP in terms of process control,
maintenance of equipment and area, documentation etc. as per provisions of Drugs Act, 1976 and rules
framed there under.
443. M/s Arsons
Pharmaceutical
Industries (Pvt) Ltd.
22 Km Multan
Road off 4 Km
Defence Road,
Lahore
Anomaly Case:
Capsule (General
Antibiotic)
Vide letter No. F. 1-
14/95 – Lic (Vol I)
(M – 227) dated
13th June, 2011
DOXICYCLINE
100mg Capsules
Capsule
Each Capsule
contains:-
Doxycycline as
Hyclate…..100 mg
Tetracycline
As Per
SRO 10 x
10’s
Form-5
28-09-2012
2280 R&I
Rs.20,000/-
Vibramycin
100mg
Capsules
US FDA
DOTUR
100mg
Capsule
Novartis
Deferred for
status of lisence
in light of
inspection report
dated 15-04-2013
Decision: The Board approved the registration of application.
244
Case No. c: -
Following registration application of M/s A’raf (Pvt) Ltd., Lahore was deferred in the 242nd
meeting of the Registration Board for expert opinion of Dr.Rizwan Taj, PIMS and Brig Jehangeer
Saleem. Now, the firm has informed that same product is already registered in the 214th meeting of the
Registration Board having registration No. 062765 to the firm M/s Schazoo Zaka.
2. In light of above, firm has requested for registration of their product and to change it to XR.
444.
M/s A’RAF (Pvt)
Ltd. (Former M/s
Remedy
Pharmaceutical Pvt
Limited), 23 Km
Raiwind Road
Lahore.
1. Zaxine SR
150mg tablets 2.
Sustained release
film coated tablet
3. Each tablet
contains:
Venlafaxine as
Hydrochloride
……. 150mg
4. Serotonin and
Noradrenaline
Reuptake
Inhibitors.
1. Form-5 D
2. Fast track
3. Rs. 1100/-
per 14’s 4.
30/07/2013,
9209 (R&I)
5. Rs.60,000/-
Rs. 90,000/-
1. B.P. specifications.
2. General Tablet
section available as
per inspection report
dated 19/01/2012.
3. GMP report dated
19/01/2012 attached.
The formulation is
found available in
UK
Deferred for expert
opinion of
Dr.Rizwan Taj,
PIMS; Brig
Jehangeer Saleem
Decision: The Board approved the registration of the product & acceded to the request of
the firm for change in nomenclature from SR to XR.
245
Evaluator - I
S/
N
Name and address
of manufacturer /
Applicant
Brand Name
(Proprietary
name + Dosage
Form + Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date,
diary
Fee including
differential fee
Demanded
Price / Pack
size
Decision of
Previous
Meeting
Remarks on the
formulation (if
any) including
International
status in
stringent drug
regulatory
agencies /
authorities
Me-too status
GMP status as
depicted in
latest inspection
report (with
date) by the
Evaluator
Decision
445. M/s. P.D.H.
Pharmaceuticals,
Lahore
Pyrox-B Tablets
Each tablet
contains:-
Piroxicam Beta
Cyclodextrin
equivalent to
Piroxicam ….
20mg
(NSAID)
Manufacturers
specifications
Form-5
Fast Track
28/8/2013 9991
R&I
28/8/2013
(Rs. 60,000/-)
Rs.265.22 per
2x10’s
Deferred for
final reminder
for completion
of Form 5
1. An
undertaking /
commitment
regarding the
submission of
following, as
per decision of
the
Registration
Board, may be
submitted:
a) Label claim
and prescribing
information
being same as
approved by
reference drug
agencies e.g.,
FDA, TGA,
MHLW, EMA
Brexidol, Cheisi,
BNF
Brexin 20mg,
Cheisi
Inspection report
dated 30/09/2014
provided. Firm
showed
improvement
regarding
previous
shortcomings /
observations.
Approved.
246
and Health
Canada.
2. Several
observations
have been
made by the
area FID in the
inspection
report dated
05/03/2014
regarding
validation of
HVAC,
frequency of In
Process testing,
differential
pressure
maintenance,
old machinery
like fluid bed
dryer, mixer,
granulator to
be replaced
with latest
version etc.
446. M/s. P.D.H
Pharmaceuticals
(Pvt) Ltd., 19 Km,
Ferozpur Road,
Lahore.
Giostatin 10mg
Tablets
Each film coated
tablet contains:-
Rosuvastatin
Calcium
equivalent to
Rosuvastatin
……………..
10mg
Statins
Manufacturers
specifications
Form 5
Fast Track
12/4/2013 798
R&I
13/11/2013
(Rs. 60,000/-)
Rs.250/10’s
Deferred for
final reminder
for completion
of Form 5
1. An
undertaking /
commitment
regarding the
submission of
following, as
per decision of
the
Registration
Board, may be
submitted:
a) Label claim
and prescribing
information
being same as
approved by
reference drug
agencies e.g.,
FDA, TGA,
MHLW, EMA
and Health
Canada.
2. Several
Crestor 10mg,
FDA
Rosutrol 10mg,
Pfizer
Inspection report
dated 30/09/2014
provided. Firm
showed
improvement
regarding
previous
shortcomings /
observations.
Approved.
247
observations
have been
made by the
area FID in the
inspection
report dated
05/03/2014
regarding
validation of HVAC,
frequency of In
Process testing,
differential
pressure
maintenance,
old machinery
like fluid bed
dryer, mixer,
granulator to
be replaced
with latest
version etc.
447. M/s. P.D.H
Pharmaceuticals
(Pvt) Ltd., 19 Km,
Ferozpur Road,
Lahore.
Esogerd 20mg
Capsule
Enteric coated
pellets
Each capsule
contains:-
Esomeprazole
Magnesium
trihydrate enteric
coated pellets
equivalent to
Esomeprazole
…………..…
20mg
Anti-ulcer
Manufacturers
specifications
Source: M/s
Vision
Pharmaceuticals,
Islamabad
Form 5
Fast Track
12/11/2013 788
R&I
12/11/2013
(Rs. 60,000/-)
Rs.231/ 2x7’s
Deferred for
final reminder
for completion
of Form 5
1. An
undertaking /
commitment
regarding the
submission of
following, as
per decision of
the
Registration
Board, may be
submitted:
a) Label claim
and
prescribing
information
being same as
approved by
reference drug
agencies e.g.,
FDA, TGA,
MHLW, EMA
and Health
Canada.
2. Several
observations
Nexium 20mg
Capsules, FDA
Nexum 20mg,
Capsules
Inspection report
dated 30/09/2014
provided. Firm
showed
improvement
regarding
previous
shortcomings /
observations.
FID mentioned
that automatic
capsule filling
machine should
be provided in
capsule filling
area.
Approved.
248
have been
made by the
area FID in
the inspection
report dated
05/03/2014
regarding
validation of
HVAC,
frequency of
In Process
testing,
differential
pressuremaint
enance, old
machinery like
fluid bed
dryer, mixer,
granulator to
be replaced
with latest
version etc.
448. M/s. P.D.H
Pharmaceuticals
(Pvt) Ltd., 19 Km,
Ferozpur Road,
Lahore.
Esogerd 40mg
Capsule
Enteric coated
pellets
Each capsule
contains:-
Esomeprazole
Magnesium
trihydrate enteric
coated pellets
equivalent to
Esomeprazole
………………
40mg
Anti-ulcer
Manufacturers
specifications
Source: M/s
Vision
Pharmaceuticals,
Islamabad
Form 5
Fast Track
12/11/2013 788
R&I
12/11/2013
(Rs. 60,000/-)
Rs.360/ 2x7’s
Deferred for
final reminder
for completion
of Form 5
1. An
undertaking /
commitment
regarding the
submission of
following, as
per decision of
the
Registration
Board, may be
submitted:
a) Label claim
and prescribing
information
being same as
approved by
reference drug
agencies e.g.,
FDA, TGA,
MHLW, EMA
and Health
Canada.
2. Several
Nexium 40mg
Capsules, FDA
Nexum 40mg,
Capsules
Inspection report
dated 30/09/2014
provided. Firm
showed
improvement
regarding
previous
shortcomings /
observations.
FID mentioned
that automatic
capsule filling
machine should
be provided in
capsule filling
area.
Approved.
249
observations
have been
made by the
area FID in the
inspection
report dated
05/03/2014
regarding
validation of
HVAC,
frequency of In
Process testing,
differential
pressure
maintenance,
old machinery
like fluid bed
dryer, mixer,
granulator to
be replaced
with latest
version etc. 449. M/s Zanctok
Pharmaceutical
Laboratories, F/5
S.I.T.E Area,
Hyderabad
Genelor
Syrup
Each 5ml
Contains:
Desloratadine……
………….2.5mg
Antihistamine
Manufacturers
specifications
Form5
Routine
23/07/2010
Dy. No. 1411
Rs. 8000/-
13-05-2013
Rs. 12000/-
60ml,120ml/As
per PRC
Deferred for
confirmation
of me too
status
Firm has
informed that due
to typographic
error the strength
was typed as
5mg/10ml and
that they have
corrected the
strength to
2.5mg/5ml. A
revised Form-5
has been
submitted by the
firm.
Clarinex
0.5mg/ml, Syrup,
FDA
Desora 0.5mg/ml
Syrup,
Continental
Pharma
Approved.
250
450. M/s Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot No.
E-145 – E-149,
North Western
Industrial Zone,
Port Qasim,
Karachi.
Relevo Sachet
20mg
Each sachet
contains:
Piroxicam beta-
cyclodextrin 191.2
mg eq. to
Piroxicam
………… 20mg
(Manufacturer’s
Specs)
NSAIDs
Form-5D
New License
28-05-2014
810 R&I
Rs. 150 / per
10’s
Rs. 50,000/-
Deferred for
evidence of
approval of
same
formulation by
reference drug
agencies e.g.,
FDA, TGA,
MHLW, EMA
and Health
Canada.
BREXIN
PULVER
20mg powder
Torrex-Chiesi
Pharma,Austria
BREXIN
20mg granules
for oral solution
(Sachet)
Promedica, Italy
Deferred for
evaluation of
stability data &
expert opinion by
the following:
1. Dr.Abid
Farooki, PIMS
2.Brig.Mushtaq,
MH
3.Dr.fareedullah
Zimri, NIRM
451. M/s Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot No.
E-145 – E-149,
North Western
Industrial Zone,
Port Qasim,
Karachi.
Gastocon Liquid
Sachet
Each 10ml sachet
contains:
Sodium alginate
(BP) 500 mg
Sodium bicarbonate
(BP) 267mg
Calcium carbonate
(BP)…. 160 mg
(BP Specifications)
Reflux suppressant
/ Antacid
Form-5D
New License
28-05-2014
809 R&I
Rs. 100 / per
10’s
Rs. 50,000/-
Deferred for:
1) Evidence of
approval of
same
formulation by
reference drug
agencies e.g.,
FDA, TGA,
MHLW, EMA
and Health
Canada.
2) Stability
data.
Now following
reference in
terms of evidence
of international
availability has
been submitted:
GAVISCON
Liquid Sachet
MHRA
Deferred for
evaluation of
stability data &
expert opinion by
the following:
1.Brig.Amjad
Salamat
2.Dr.Najam,
Shifa
3.Prof.Umer,
RMC
452. M/s
GlaxoSmithKline
Pakistan limted, F-
268 S.I.T.E.,
Karachi
Panadol Sinus
Caplets
Caplets
Each Caplet
Contains:
Paracetamol…500
mg
Phenylephrine
Hcl. 5.00mg
Form 5-D (Fast
Track)
Rs.8,000/-
09-12-2010
Dy. No. not
mentioned
Rs.60,000/-
20-03-2013
Dy. No. not
Registration
Board referred
Panadol sinus
Caplets to
Pharmaceutica
l Evaluation
Cell for
scrutinization
in light of
check list
approved by
BENYLIN
COLD & SINUS
500/5mg
Health Canada
Inspection dated
07-01-2014, 21-
01-2014 & 19-
02-2014. Well
maintained /
retained unit
Deferred for
evaluation of
stability data
which should be
performed at the
applicant’s site &
expert opinion by
the following:
1.Brig.Aslam
2.Dr.Shazli
Manzor
251
mentioned
Rs.82,000/-
19-11-2013
Dy. No. not
mentioned
Rs.300/-100’s
Registration
Board.
reported. Tablet
section
mentioned in
report.
1. In terms of
Prescribing
information (PI),
Patient
Information
Leaflet (PIL) and
Summary of
product
characteristics
(SmPC) as
approved by
Drug regulatory
agencies or
authorities of
country of origin
or FDA, EMA,
TGA, etc., firm
has submitted
international data
sheet for the
product.
2. Data of
stability studies
conducted on
three pilot
batches at
25C/60%RH,
30C/60%RH,
30C/75%RH and
40C/75%RH.
However, it is
pertinent to
mention that the
batches were
manufactured in
Sydney, Australia
as the raw
material and
pharmaceutical
development was
carried out in
firms R&D
center in
Australia.
3.Dr.Rehana
Kauser, PIMS
252
Evaluator – II
S/
N
Name and address
of manufacturer /
Applicant
Brand Name
(Proprietary
name + Dosage
Form +
Strength)
Composition
Pharmacologic
al Group
Finished
product
Specification
Type of Form
Initial date,
diary
Fee including
differential fee
Demanded
Price / Pack
size
Decision of
Previous
Meeting
Remarks on the
formulation (if
any) including
International
status in
stringent drug
regulatory
agencies /
authorities
Me-too status
GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator
Decision
453. M/s Herbion Pakistan
(Pvt) Ltd., Kahuta
Road, industrial
Triangle, Humak,
Rawalpindi-
Islamabad.
LacNovex /
LaxNovex /
ConstiNovex
3.35g Syrup
Each 5ml
contains:-
Lactulose
(BP)………3.35
g
(Laxative)
(B.P Spec.s)
{Source of
Lactulose: M/s
Fresenius Kabi
Austria GmbH
EstermannstraB
e 17 4020 Linz}
Form 5
26-02-2014
Dy.No.208
Rs.20,000+
Rs.80,000/-(05-
09-2014)
Rs.170.00/
120ml
Deferred for
confirmation of
1. Source &
Fee.
2. Testing
facility by DDG
DRAP and FID
(M-243)
BNF 61
(Lactulose
(Non-
proprietary)
DUPHALAC(H
IGHNOON
LABORATORI
ES LTD.)
Grant of DML
recommended
(23-24th January
2014)
1. The firm has
Approved. Firm will
provide legalized
GMP of source of
lactulose and
Chairman, RB will
permit issuance of
registration letter.
253
deposited fee
of Rs.
80,000/- and
requested for
fixation of
source i.e.
M/s Fresenius
Kabi Austria
GmbH
Estermannstr
aBe 17 4020
Linz.
2. Valid and
legalized
GMP
Certificate of
Source, COA
and stability
studies
according to
zone IV-a of
lactulose are
required.
(The firm has
submitted
COA &
Stability
studies)
3. Confirmation
of testing
facility by
DDG DRAP
and FID.
(The
inspection
report by
area FID &
DDG dated
02.12.2014
confirms the
testing
facility).
254
454. -do- MonteNovex /
AzmaNovex /
LeukoNovex
5mg Chewable
Tablets
Each chewable
tablet contains:-
Montelukast
Sodium BP eq.
to
Montelukast…5
mg
(Antiasthmatic
Agent
(Leukotriene
Receptor
antagonist)
(Manufacturer’s
Spec.s)
Form 5
24-02-2014
Dy.No.201
Rs.20,000
Rs.400.00/
14’s
Deferred for
correction in
master
formulation.
BNF 61:
(Singulair
(MSD)
Aerokast
(Barrett
Hodgson)
Grant of DML
recommended
(23-24th January
2014)
1. The firm has
corrected
master
formulation.
Approved.
455. -do-
MonteNovex /
AzmaNovex /
LeukoNovex
10mg Chewable
Tablets
Each chewable
tablet contains:-
Montelukast
Sodium BP eq.
to
Montelukast…
…….10mg
(Antiasthmatic
Agent
(Leukotriene
Receptor
antagonist)
(Manufacturer’s
Spec.s)
Form 5
24-02-2014
Dy.No.197
Rs.20,000
Rs.460.00/
14’s
Deferred for
correction in
master
formulation and
confirmation of
international
availability
Not confirmed
Aerokast
(Barrett
hodgson) not in
chewable
dosage form
Grant of DML
recommended
(23-24th January
2014)
1. The firm has
corrected
master
formulation.
2. Reference of
International
availability
has been
given from
India and
Bangladesh.
3. Reference of
5mg
Rejected on the
grounds that the
efficacy & safety of
the said formulation
has not been
established in
chewable dosage
form.
255
chewable
tablets has
been given
from Health
Canada.
Formulation
is in film
coated
dosage form
in Health
Canada.
456. -do- Neemplast
Plaster
Contains:-
Acrinol………
…10.4%
(Disinfectant
and Antiseptic)
(Manufacturer’s
)
Form 5
17-03-2014
Dy.No.251
Rs.20,000
Rs. 25/
19×72mm (10
strips)
Rs.
35/19×72mm
(20 strips)
Rs.
160/19×72mm
(100 strips)
Rs.
720/19×72mm
(500 strips)
Deferred for
confirmation of
me too status
and international
availability.
Not confirmed
Saniplast
(Uniferoz
Karachi)
Grant of DML
recommended
(23-24th January
2014)
1. The firm has
provided
reference of
Saniplast of
Uniferoz for
both
international
availability
and me-too
status.
2. International
availability
not
confirmed in
stringent
DRS’s.
3. Discussion
is requested
from
honorable
Drug
Deferred for
verification that the
said formulation is
registered in which
category in the
reference Stringent
Regulatory Agencies
whether as an OTC
or Pharmaceutical.
256
Registration
Board about
the status of
formulation
that whether
it is a drug
or HOTC
product.
S/
N
Name and address
of manufacturer /
Applicant
Brand Name
(Proprietary
name + Dosage
Form +
Strength)
Composition
Pharmacologic
al Group
Finished
product
Specification
Type of Form
Initial date,
diary
Fee including
differential fee
Demanded
Price / Pack
size
Decision of
Previous
Meeting
Remarks on the
formulation (if
any) including
International
status in
stringent drug
regulatory
agencies /
authorities
Me-too status
GMP status as
depicted in
latest inspection
report (with
date) by the
Evaluator
Decision
457. M/s. Simz
Pharmaceuticals (Pvt)
Ltd, 574-575 Sundar
Industrial Estate,
Raiwind Road
Lahore.
Ibusim DS
200mg
Liquid
Suspension
Each 5ml
contains:-
Ibuprofen
(B.P)…..200mg
(Antirheumatic,
anti-
inflammatory)
(B.P Spec.s)
Form-5
Rs.20,000/-10-
2-2014
Rs.60.00/90ml
Deferred for
confirmation
of
international
availability.
(M-244)
Health Canada:
Advil Pediatric
Drops
Brufen DS
(Abbot)
GMP compliant
(22-11-2013)
1. The product
was deferred
because the Firm
had not provided
the International
Approved.
257
availability
especially in
FDA, EMA,
Health Canada,
TGA & MHLW
for same generic,
dosage form &
strength with
reference is
required. Firm
had provided
Dolan Fp Forte
from Phillipine.
Later on same
formulation was
approved in M-
245 for M/s
Titles Pharma
Karachi because
international
availability was
confirmed. The
Firm has
requested to
consider their
application for
registration.
458. M/s. Cibex (Private)
Ltd. F-405, SITE,
Karachi
Batema-F Syrup
Each 15ml
contains:
Iron Protein
Succinylate
800mg
equivalent to
elemental
iron…40mg
Folic
Acid…5mg
(Anti-Anaemic)
(Manufacturer’s
Spec.s)
Form-5
30-04-2014
(611)
Rs.20,000/-
As per
SRO/60ml,
120ml
Deferred for
confirmation
of Me-Too &
International
(especially in
Stringent
Regulatory
Agencies)
registration
Status.
(M-245)
Not confirmed
Sucrofer-F
Syrup
(Nexpharm)
Grant of DML
recommended
(22-10-2013)
1. The Firm has
submitted
that the
product is
already
available
locally
manufactured
by CCL
under the
Approved
258
license of
Nexpharm
and the
product is
although not
available in
SRA,s but
DRAP has
granted
registration
to several
companies.
The Firm has
requested for
product
registration.
459. -do- Cimora 20mg
Capsule
Each Capsule
contains:
Esomeprazole
Magnesium
Trihydrate
enteric coated
pellets equivalent
to
Esomeprazole…
20mg
(Anti-Ulcerant)
(Manufacturer’s
Spec.s)
Form-5
30-04-2014
(625)
Rs.20,000/-
As per
SRO/14
Capsules
Deferred for
rectification
of following
observation:
1. Fee for
import.
2. Legalized
and Valid
GMP
3. Certificate
of Analysis
4. Stability
Studies
according to
zone assigned
to Pakistan.
(M-245)
BNF: Nexium
(AstraZeneca)
C-ESO (Crown
Pharmaceuticals
)
Grant of DML
recommended
(22-10-2013)
1. The Firm has
submitted
documents
for source of
pellets, M/s
Surge Lab
(Pvt. ) Ltd.
10th K.M
Faisalabad
Road ,
Sheikhupura.
2. cGMP
certificate
has been
issued to M/s
Surge for
Enteric
coated
Approved
259
Evaluator – III
Cases deferred in M-245 meeting
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name
+ Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date, diary
Fee including
differential fee
Demanded Price
/ Pack size
Decision in
245th
of
Registration
Board.
Remarks on
the
formulation (if
any) including
International
status in
stringent drug
regulatory
agencies /
authorities
Me-too status
GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator
Decision
Pellets/Granu
les and Taste
Masked
Granules/
Pellets.
3. Approval by
CLB for
manufacturin
g of
Esomeprazol
e enteric
coated pellets
by M/s Surge
submitted.
260
460. M/s Cibex (Pvt)
Limited Karachi.
KATAFEN Rapid
Gel 1%
Each gram contains:-
Diclofenac
diethylamine….10mg
Anti-Rheumatic
Manufacturer
Form-5
Dated 30/04/14
Dy No: 602
20,000/-
Pack of 1’s, 20gm
& 50gm/ As per
PRC
Deferred for
submission of
finished
product
specifications
The firm has
submitted the
finished
product
specifications
of applied
product.
Approved.
461. -do- MYBINA Plus
Ointment
Each gram contains:-
Polymyxin B
sulphate….5000IU
Bacitracin…500IU
Neomycin…3.5mg
Lidocaine….40mg
Antibacterial
Manufacturer
Form-5
Dated 30/04/14
Dy No: 605
20,000/-
Pack of 1’s, 20gm
tube/ As per PRC
Deferred for
rectification of
following
observations:
Under finished
product
specifications
assay method
is not
submitted.
The firm has
submitted the
assay method
under finished
product
specifications
of applied
product.
Approved.
462. M/s.Shawan
Pharmaceuticals,
Plot #37, Road:
NS-1, National
Industrial Zone,
Rawat Islamabad.
DEXPRO Tablet
300mg
Each film coated
Tablet contains:
Dexibuprofen …..
300mg
NSAID
Manufacturer
Form 5
Fast Track
Dy. No.5246
dated 16-08-2013
Rs.60,000/-
As per SRO
Pack of 10’s
Deferred for
review
committee for
review of
formulation
Seractil of
Genus (BNF-61)
Dexib of Tabros
Pharma Karachi
Inspection of the
firm was
conducted on 23
July 2013 and
GMP
compliance is
found GOOD
Approved.
Cases deferred in M-242 meeting
261
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name
+ Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date, diary
Fee including
differential fee
Demanded Price
/ Pack size
Decision in 242nd
of Registration
Board.
Remarks on the
formulation (if
any) including
International
status in
stringent drug
regulatory
agencies /
authorities
Me-too status
GMP status as
depicted in
latest inspection
report (with
date) by the
Evaluator
Decision
463. M/s Medwell
Pharmaceuticals,
Lawrencepur
BETADINE Scrub
Each 5ml contains:
Povidone-
Iodine…….7.5%
Disinfectant
BP
Form-5
Dy.No: 6382
dated: 07-10-2013
60,000/-
As per SRO/
50ml, 60ml and
450ml bottle
Deferred as the
firm has not
completed the
requisite
documentation per
Form-5
Pyodine of
Brookes Pharma
Karachi
The inspection of
firm was carried
out on 01-04-
2014 by the area
FID and GMP
compliance was
found good.
Approved.
262
Veterinary cases
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name
+ Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date,
diary
Fee including
differential
fee
Demanded
Price / Pack
size
Decision in 242nd
of Registration
Board.
Remarks on
the
formulation (if
any) including
International
status in
stringent drug
regulatory
agencies /
authorities
Me-too status
GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator
Decision
464. M/s Jfrin
Pharmaceuticals,
Lasbella
Balochistan
JF COLAMINE
Oral Powder
Each 100gm
contains:
Tylosin
Tartrate…..100mg
Doxycycline
HCL…..200mg
Phenyl
Butazone….12gm
Bromohexine
HCL….05gm
Colistin
Sulphate…..500MIU
Antibiotic
Manufacturer
Form-5
Dy.No: 866
dated: 24-07-
2013
60,000/-
Decontrolled/
Jar of 100,
500, 1000gm
Deferred as the
firm has not
completed the
requisite
documentation
per Form-5
Broncofas of
Zakfas
Pharmaceuticals
Rejected as the
formulation
contains banned
drug that is Phenyl
Butazone.
263
Case No. 11. NEW APPLICATIONS IN LEIU OF REJECTED ONES
Evaluator - III
Two products of M/s Hiranis Pharmaceuticals are rejected in the 243rd
meeting of Registration Board as
the safety and efficacy has not been established in the stringent SRA’s. The firm has submitted new
applications in lieu of the rejected products. The detail is tabulated below:
Sr.
No.
Products Discussed in M-
243
Decision in M-243 New Products applied
1. Acebro Capsule
(Acebrophylline 100mg)
Rejected as safety and
efficacy of formulation has
not been established in
stringent regulatory
authorities.
Fungisaf Capsule
(Fluconazole 150mg)
2. Acebro syrup
(Acebrophylline 50mg/
5ml)
Rejected as safety and
efficacy of formulation has
not been established in
stringent regulatory
authorities.
Levopearl oral suspension
125mg/5ml (Levofloxacin)
264
The detail of new products is follows:
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date,
diary
Fee including
differential fee
Demanded Price
/ Pack size
Remarks on the
formulation (if
any) including
International
status in
stringent drug
regulatory
agencies /
authorities
Me-too status
GMP status as
depicted in
latest inspection
report (with
date) by the
Evaluator
Recommendations
by the Evaluator
Decision
465. M/s Hiranis
Pharmaceuticals
Karachi
FUNGISAF Capsule
150mg
Each capsule contains
Fluconazole…..150mg
Triazole Antifungal
Manufacturer
Form-5
Dy No: 807 dated
28-07-14
20,000/-
As per PRC
Diflucan Pfizer
Inc
Diflucan of
Pfizer Karachi
Approved.
466. -do- LEVOPEARL Oral
Solution
Each 5ml contains:
Levofloxacin
(USP)….125mg/ 5ml
Quinolone
Manufacturer
Form-5
Dy. No: 2067
dated:16-12-2013
20,000/-
As per PRC
Levaquin Oral
Solution of
Janssen
(USFDA)
The product was
initially considered
as dry oral
suspension in 243rd
meeting of
Registration Board
and deferred with
following decision:
“Deferred for
confirmation of
formulation”
The firm then
revised the
formulation as Oral
Solution which was
product again
The Board did
not accede to the
request of firm
for change in
dosage form &
deferred the
instant
application for
review of
formulation by
Incharge, PEC.
265
considered in 244th
meeting of
Registration Board
and deferred with
decision:
“Deferred as the
Registration Board
has already granted
ten products in
liquid syrup section
(general)”
The firm has now
requested to
consider applied
formulation in lieu
of the rejected
product (Acebro
syrup
(Acebrophylline
50mg/ 5ml) in
243rd
meeting of
RB
266
Item No. VI Miscellaneous Cases - Pharmaceutical Evaluation & Registration Division.
Registration-I
Case No.01. Drugs deferred by Registration Board for expert opinion.
a. Strefen Lozenges - M/s. Reckitt Benckiser Healthcare International, Karachi.
Following drugs deferred for expert opinion. Accordingly product was referred to expert
for views. Comments are as under:-
S. No. Name of Indenter/
Manufacturer
Name of drug (s)/
Composition
& Therapeutic Group
Demanded
Price/Pack
Shelf Life Date of
application
receiving
& fee.
1. M/s. Reckitt Benckiser
Healthcare
International,
Karachi. /
M/s. Notting Site,
Nottingham,
Nottinghamshire,
United Kingdom.
Strefen Lozenge
Each one lozenge
contains:-
Flurbiprofen
BP……………..8.75mg
Price not
mentioned.
03 years 04-06-2012
Rs.15000 +
Rs.35000 =
Rs.50,000/-
Dr. M.Ehsan-ul-Haq,
MBBS, DTCD, FCPS,
(Physician (Medicine),
Federal Govt. Services
Hospital, Islamabad.
Prof. Dr. Ejaz Hussain
Malik,
Nishtar Medical Institution,
Multan.
Brig. (R) Prof. Dr.
Muzammil Hasan Najmi,
Chairman, Department of
Pharmacology/Associate
Dean, Basic Sciences
Division, Foundation
University, Medical College,
Rawalpindi. The drug Strefen Lozenge
containing flurbiprofen BP 8.75
can be useful addition to the list
of pharmaceutical available in
the country. Since the amount of
the active principle is quite small.
It is les likely to cause untoward
dose-related side effects. The
lozenge formulation of this
compound is already in use in the
world market. However the
therapeutic efficacy and the
I have gone through the literature
of Flurbiprofen. The only is good
and sample and recommended
for registration.
Awaited.
267
social acceptance in our
population can only be accessed
when it is used in our country.
The drug is intended for local use
and has small amount of the
active principle and thus is
expected to be cost effective.
Decision: Registration Board approved registration of Strefen Lozenge as per detail
mentioned in the case. The approval is subject to inspection of manufacturer abroad as per
import policy, verification of storage facilities and price fixation / calculation by the pricing
Division etc.
b. AminoFluid ® Infusion Solution 1000ml - M/s Otsuka Pakistan Ltd., Distt. Lasbella
Registration Board in its 238th
meeting deferred following products for expert opinion.
Accordingly products were referred for views. Comments are as under:-
S.
No.
Name of
Indenter/
Manufacturer
Name of drug (s)/
Composition
& Therapeutic Group
Demanded
Price/Pack
Shelf
Life
Date of
application
receiving
& fee.
1. M/s Otsuka
Pakistan Ltd.,
Distt. Lasbella. /
M/s. PT. Otsuka
Indonesia,
Lawang, Malang.
Indonesia.
AminoFluid ® Infusion Solution
1000ml
Each 150ml contains:-
L-Leucine…...………………2.100g
L-Isoleucine……………...…1.200g
L-Valine..………………...…1.200g
L-Lysine hydrochloride…….1.965g
(L-Lysine Equivalent)….....(1.573g)
L-Threonine...........................0.855g
L-Tryptophen……………….0.300g
L-Methionine.………………0.585g
L-Cystoine………………….0.150g
L-Phenylalanine…………….1.050g
L-Tyrosine..………………...0.075g
L-Arginine………………….1.575g
L-Histidine………………….0.750g
L-Alanine…………………...1.200g
L-Proline….………………...0.750g
LSerine ……………………..0.450g
Gylcine……...........................0.885g
Rs.4201/Per
1000ml Soft
bags.
02
years
27-09-2012
Rs.50,000/-
268
L-Aspartic acid……………..0.150g
L-Glutamic acid….................0.150g
Dipostassium phosphate…....0.458g
Water for injection ad….........150ml
(Clinical Parrenteral Nutrition).
2. M/s Otsuka
Pakistan Ltd.,
Distt. Lasbella. /
M/s. PT. Otsuka
Indonesia,
Lawang, Malang.
Indonesia.
Kidmin ® Injection
Each 1000ml contains:-
L-Leucine………………….…14.0g
L-Isoleucine………………...…9.0g
L-Valine……………………...10.0g
L-Lysine acetate………………7.1g
(free base)…………………..(5.05g)
L-Threonine…...........................3.5g
L-Tryptophan……………….....2.5g
L-MEthionine…………………3.0g
L-Phenylalanine…………….....5.0g
L-Cysteine….…………………1.0g
L-Tyrosin……………………...0.5g
L-Arginine…..………………...4.5g
L-Histidine………………...…..3.5g
L-Alanine………………...……2.5g
L-Proline…………………...….3.0g
L-Serine……………………….3.0g
L-Aspartic acid..........................1.0g
L-Glutamic acid……………….1.0g
(Clinical Parentertal Nutrition).
Rs.1708/
Per 200ml
bag
02
years
18-10-2012
Rs.15000 +
Rs.35000 =
Rs.50,000/-
3. M/s Otsuka
Pakistan Ltd.,
Distt. Lasbella. /
M/s. PT. Otsuka
Indonesia,
Lawang, Malang.
Indonesia.
Amiparen ® Injection
Each 500ml contains:-
L-Leucine…...………………..7.00g
L-Isoleucine……………….....4.00g
L-Valine……………………...4.00g
Lysine Acetate……………….7.40g
(L-Lysine equivalent)…....…(5.25g)
L-Threonine………………….2.85g
L-Tryptophan...........................1.00g
L-Methionine...........................1.95g
L-Phenylalanine……………...3.50g
L-Cysteine…………………...0.50g
Total free amino acids……50.00g
Essential amino acids (E)…..29.55g
Nonessential amino acids (N)20.45g
Total nitrogen………………..7.84g
L-Tyrosine…...........................0.25g
L-Arginine...…………………5.25g
L-Histidine…………………...2.50g
L-Alanine…………………….4.00g
L-Proline…..…………………2.50g
Rs.2512/
Per 500ml
Bag
02
years
24-09-2012
Rs.15000 +
Rs.35000 =
Rs.50,000/-
269
L-Serine…...…………………1.50g
Aminoacetic acid………….…2.95g
L-Aspartic Acid.......................0.50g
L-Glutamic acid.......................0.50g
Water for injection……ad 500mL
(Clinical Parenteral Nutrition).
In charge Intensive Care Unit
(ICU),
Pakistan Institute of Medical Sciences,
Islamabad.
In charge Intensive Care Unit
(ICU),
Military Hospital,
Rawalpindi.
I have evaluated the data provided by Otsuka Pakistan
Limited concerning AminoFluid ® 1000ml dual
chamber soft bags, Kidmin ® Injection 200ml soft bag
and Amiparen ® Injection 500ml soft bag. I have
found that the scientific data supports the therapeutic
efficacy and favorable safety profile. I recommended
that this drug be registered according to the drug
authority regulations.
Awaited
Decision: Brig. Aslam Khan, Member Registration Board / Incharge Intensive Care
Unit (ICU), Military Hospital, Rawalpindi also recommended the appled formulations.
Thus Registration Board approved registration of AminoFluid ® Infusion Solution 1000ml,
Kidmin ® Injection and Amiparen ® Injection as per detail mentioned in the case. The
approval is subject to inspection of manufacturer abroad as per import policy, verification
of storage facilities and price fixation / calculation by the pricing Division etc.
c. Propilen Surgical Suture with Needle - M/s. Nishat Surgical Hyderabad
Registration Board in its 243rd
meeting deferred following products for expert opinion.
Accordingly products were referred for views. Comments are as under:-
S.
No.
Name of
Indenter/
Manufacturer
Name of drug (s)/
Composition
& Therapeutic Group
Demanded
Price/Pack
Shelf
Life
Date of
application
receiving &
fee.
1. M/s. Nishat
Surgical
Hyderabad Sindh
Pakistan
manufactured by
M/s. Dogsan
Propilen Surgical Suture with
Needle
As per PRC 05
years
26-03-2012
Rs.100,000/-
270
Tibbi Malzeme
Sanayi A.S.
Trabzon Turkey.
2. -do- Silk Non Absorbable Surgical
Sutures
As per PRC 05
years
26-03-2012
Rs.100,000/-
3. -do- Pegelak and Pegelak Rapid
Synthetic Absorbable
Surgical Sutures with Needle
As per PRC 05
years
26-03-2012
Rs.100,000/-
4. -do- Tektel Non Absorbable
Surgical Sutures with Needle
As per PRC 05
years
26-03-2012
Rs.100,000/-
5. -do- Pedesente Synthetic
Absorbable Surgical Sutures
with Needle
As per PRC 05
years
26-03-2012
Rs.100,000/-
6. -do- Pegesorb and Pegesorb Rapid
Synthetic Absorbable
Surgical Sutures with Needle
As per PRC 05
years
26-03-2012
Rs.100,000/-
Professor Tanwir Khaliq,
Professor of Surgery,
Department of General
Surgery, Pakistan Institute
of Medical Sciences,
Islamabad.
Dr. I.U Baig, FCPS FRCS,
Consultant Surgeon & HOD,
Federal Government
Polyclinic, Islamabad.
Lt. Col. Dr. Farhan Ahmad
Majeed, Surgeon, Combined
Military Hospital,
Rawalpindi
We have used the surgical
sutures in our procedures. The
tissue penetration, needle,
suture strength, pliability and
knotting quality have been
found satisfactory.
Samples of sutures supplied
by M/s. Nishat Surgical
Hyderabad Sindh Pakistan
manufactured by M/s. Dogsan
Tibbi Malzeme Sanayi A.S.
Trabzon Turkey were
used/tested by me and by my
surgeons at FGPC and our
observations regarding the
surgical sutures are :
1.Sterile packing is good.
2.Tensile strength of sutures
of their appropriate types and
sizes is good.
3.Needle anchorage is fine.
4.Needle quality is good.
5.Tissue reaction to sutures is
according to standard.
6.No allergic reaction to
Surgical sutures of M/s.
Nishat Surgical Hyderabad
Sindh Pakistan are of
unsatisfactory quality,
specially size of needle is
dispropertmat with thread size
(dia).
271
suture material.
7.No postoperative infections
nooted.
In light of above observations
I recommend sutures namely;
Propilen, Silk, Pegalak and
Pegalak Rapi, Tektel,
Pedesente and Pegesorb and
Pegesorb Rapid.
Decision: Registration Board deferred the case due to the comments of Lt. Col. Dr.
Farhan Ahmad Majeed, Surgeon, Combined Military Hospital, Rawalpindi as he
mentioned “unsatisfactory quality, specially size of needle is dispropertmat with thread size
(dia)”. The Board decided to send these observations of Lt. Col. Dr. Farhan Ahmad Majeed
to the following experts for further pratical evaluation:
Col. Dr.Bilal Umair, Surgeon, CMH.
Dr.Mamoon Rasheed, Surgeon, Shifa Int Hospital, Islamabad.
d. Azarga Eye Drop Suspension 5ml - M/s. Ali Gohar & Co. (Pvt) Ltd., Karachi
Registration Board in its 244th
meeting deferred following products for expert opinion.
Accordingly products were referred for views. Comments are as under:-
S.
No.
Name of
Indenter/
Manufacturer
Name of drug (s)/
Composition
& Therapeutic Group
Demanded
Price/Pack
Shelf
Life
Date of
application
receiving &
fee.
1. Applicant:
M/s. Ali Gohar &
Co. (Pvt) Ltd.,
Karachi. /
Manufacturer:
M/s. S.A. Alcon-
Couvreur N.V.
Rijksweg 14,
2870 Puurs,
Belgium.
Azarga Eye Drop Suspension
5ml
Each ml contains:-
Brinzolamide......10mg
Timolol...............4mg
(Beta Blocking agents).
Finished product
specifications are
Manufacturer.
Rs.1400/
5ml Eye
Drops packs
24
months
02-03-2010
Rs.50, 000/-
272
Prof. Dr. M. Daud Khan,
Principal & Dean,
Pak International Medical
College, Hayatabad,
Peshawar.
Prof.Dr. Ali Raza,
Head of Eye Department,
RMC and Allied Hospitals,
Rawalpindi.
Maj. Gen. Mazhar Ishaq,
Commandant,
Armed Forces Institute of
Opthalmology,
The Mall, Rawalpindi.
Alcon International is the
leading international
pharmaceutical company
dealing with Ophthalmic
drugs and devices. Alcon
drugs are known for quality,
safety and efficacy. Azarga
Eye Drops, which is a
combination of a beta blocker
and carbonic anhydrase
inhibitor. It is registered by
FDA and has many studies in
support of its safety, efficacy
and effectiveness. The price
seems to be reasonably
comparable to other anti-
glaucoma drugs. I therefore
recommend that the drug may
kindly be registered in
Pakistan.
I have reviewed the literature
& references relating to the
above mentioned product with
regard to its safety, efficacy &
cost effectiveness. Azarga
(Brinzolamide, Timolol) is
most comfortable Eye Drops
preferred by patient then
Dorzolomide/Timolol
combination. I have gone
through all references which
have been published in
renowned International
Medical Journals on regular
intervals. As you all know that
Glaucoma is a second leading
cause of irreversible blindness
worldwide & as well as in
Pakistan & patient has to use
lifelong. So it needs excellent
tolerability & efficacy both.
We need this product in
Pakistan for the preservation
of sight and prevention of
blindness with Glaucoma. I
always trust the quality of
innovative products & Brands.
I highly recommend this drug
for registration & made
available in Pakistan.
Azarga (Brinzolamide,
Timolol) is already being used
internationally for the
management of Glaucoma &
all references given by them
have been published in peer
reviewed international
Medical Journals on regular
basis. It has a very good
efficacy and is well tolerated
by the patients.
Therefore in the light of data
provided I recommend this
drug for registration in
Pakistan.
Decision: Registration Board approved registration of Azarga Eye Drop Suspension
5ml as per detail mentioned in the case. The approval is subject to inspection of
manufacturer abroad as per import policy, verification of storage facilities and price
fixation / calculation by the pricing Division etc.
273
e. Hidrasec 10mg, 30mg Sachet and and Hidrasec Capsule 100mg
Registration Board in its 245th
meeting deferred following products for expert opinion.
Accordingly products were referred for views. Comments are as under:-
S.
No.
Name of Indenter/
Manufacturer
Name of drug (s)/
Composition
& Therapeutic Group
Demanded
Price/Pack
Shelf
Life
Date of
application
receiving &
fee.
1. M/s. Abbott
Laboratories
(Pakistan) Limited,
Karachi. /
M/s. Laboratoires
SOPHARTEX 21
Rue du Pressoir
Vernouillet,
France.
Hidrasec 10mg Sachet
Each sachet contains:-
Racecadotril……10mg
(Anti-Diarrheal).
Rs.1046.30/Per
16 Sachets
24
months
29-04-2013
Rs.100,000/-
2. M/s. Abbott
Laboratories (Pakistan)
Limited,
Karachi. /
M/s. Laboratoires
SOPHARTEX 21 Rue
du Pressoir
Vernouillet, France.
Hidrasec 30mg Sachet
Each sachet contains:-
Racecadotril….30mg
(Anti-Diarrheal).
Rs.1046.30/Per
16 Sachets
24
months
29-04-2013
Rs.100,000/-
3. M/s. Abbott
Laboratories
(Pakistan) Limited,
Karachi. /
M/s. Laboratoires
SOPHARTEX 21
Rue du Pressoir
Vernouillet,
France.
Hidrasec 100mg
Capsules
Each capsule contains:-
Racecadotril….100mg
(Anti-Diarrheal).
Rs.654/
Per 10
Capsules
24
months
29-04-2013
Rs.100,000/-
Prof.Dr. Rauf Niazi,
Head of Unit-2
Pakistan Institute of Medical
Sciences,
Islamabad.
Prof.Dr. Syed Irfan Ahmed,
Professor of Medicine,
RMC & Allied Hospitals,
Benazir Bhutto Hospital,
Murree Road, Rawalpindi.
Brig.Amjad Salamat,
Military Hospital,
Rawalpindi.
I strongly recommend
registration of that Raceadotril
(acetorphan), Capsules and
Hidrasec is recommended for
registration for the treatment
of diarrhea in conjunction with
Awaited.
274
Sachets, however if the price
of the drug can be brought
down, keeping in mind the
economic status of our
population these drugs would
be very useful addition, to
present drugs, available to
treat acute secretory diarrhea
and reduce morbidity of this
common condition. I highly
recommend registration of the
drug, on fast track basis.
ORS. However it should not
be used to treat infections.
Even in Cholera, which
requires antibiotics and
intravenous saline, it should
be used with caution as severe
fluid depletion can be a “Pre-
renal” cause of renal failure.
Hidrasec has a renal mode
excretion. Also no studies
have been conducted
comparing its safety profile
with Zinc or probiotics. Hence
it can not be claimed superior
to these modes of treatment.
Decision: Registration Board deferred the case for evaluation of clinical data by the
following experts:
Brig.Amjad Salamat MH, Rawalpindi.
Prof.Syed Irfan, BBH.
Prof.Rauf Niazi, PIMS.
Case No. 02. Registration of solvents for Oncodex (Docetaxel) Injection - M/s. PharmEvo
(Pvt) Ltd, Karachi.
Drug Registration Board in 236th meeting held on 20th November, 2012 approved the
registration of following drugs in the name of M/s. PharmEvo (Pvt) Ltd, Karachi manufactured
by M/s. Jiangsu Aosaikang Pharmaceutical Co., Ltd., 699-Kejian Road, Jiangning Science Park,
Nanjing, China subject to inspection of manufacturer abroad:-
S. No. Name of drug (s) & composition.
1. Oncodex 20mg Injection.
Each vial contains:-
Docetaxel……………20mg.
2. Oncodex 40mg Injection.
275
Each vial contains:-
Docetaxel……………40mg.
3. Oncodex 80mg Injection.
Each vial contains:-
Docetaxel……………80mg.
4. Oncotaxel 100mg Injection.
Each vial contains:-
Paclitaxel……………100mg.
In compliance of Drug Registration Board’s decision, inspection of the manufacturer
M/s. Jiangsu Aosaikang Pharmaceutical Co., Ltd., 699-Kejian Road, Jiangning Science Park,
Nanjing, China has been carried out by the nominated panel comprising Dr. Obaidullah, Deputy
Director General (Registration) and Mr. Abdullah, Deputy Drugs Controller (RRR), Drug
Regulatory Authority of Pakistan. M/s. PharmEvo (Pvt) Ltd, Karachi was advised to submit
separate solvent application for each product. The panel of inspector has recommended the
registration of the above said products. The storage facility of the importer has already been
verified by the area FID.
In response to our latter M/s. PharmEvo (Pvt) Ltd, Karachi have informed that same
solvent with same composition is being used in all three strengths of docetaxel range with final
concentration of the diluted solution equivalent to 10mg/ml. Below is a self-explanatory chart
depicting the fill range, approximate extractable volume and final concentration of the product
i.e. 10mg/ml:-
PRODCUT
NAME
DILUENT 13%
(W/W)
ETHANOL IN
WATER FOR
INJECTION
FILL RANGE
(ML)
APPROXIMATE
EXTRACTABLE
VOLUME OF
DILUENT WHEN
ENTIRE
CONTENTS ARE
WITHDRAWN
(ML)
CONCENTRATION
OF THE INITIAL
DILUTED
SOLUTION
(MG/ML
DOCETAXEL)
DOCETAXEL
20MG INJECTION
3.88 – 3.08 ml 1.8 ml 10mg/ml
DOCETAXEL
40MG INJECTION
3.60 – 3.86 ml 3.66 ml 10mg/ml
DOCETAXEL
80MG INJECTION
6.96 – 7.70 ml 7.1 ml 10mg/ml
276
M/s. PharmEvo (Pvt) Ltd, Karachi was again advised to submit separate solvent
application for each strength. In response, M/s. PharmEvo (Pvt) Ltd, Karachi has submitted
separate solvent application for each three strengths.
Decision: Registration Board approved the request of the firm for registration of the
solvents for already registered Docetaxel range of products.
Case No.03. Drugs deferred by Registration Board for submission of documents.
a. Caflam 50mg Sachets - M/s. Novartis Pharma, Karachi.
Drug Registration Board deferred the following applications for registration of drugs in
its 243rd
meeting and decided as mentioned against each. Accordingly, firm was advised to
provide the same information and the firm has submitted the required information as follows:-
S.# Name of
Manufacturer /
Importer.
Name of Drug (s)
Composition &
Therapeutic
Group.
Demanded
Price &
Pack Size.
Shelf
Life
Decision Reply of
the firm.
1. M/s. Novartis Pharma
(Pakistan) Limited,
Karachi /
M/s. Mipharm S.p.A.,
Milan, Italy.
Caflam 50mg Sachets
Each sachet contains:-
Diclofenac
potassium……50mg
(Non-steroidal anti-
inflammatory drug
(NSAID) Analgesic.
Rs.198/
Per packs
of 9’s
Rs.22/Per
Sachet
02
years
Deferred for
submission
of COPP
from
regulatory
authority of
Italy
The firm has
provided
COPP of
Italy attested
by Pakistan
Embassy.
Decision: Registration Board approved registration of Caflam 50mg Sachets as per
detail mentioned in the case. The approval is subject to inspection of manufacturer abroad
as per import policy, verification of storage facilities and price fixation / calculation by the
pricing Division etc.
277
b. Fluimucil A 600mg Effervescent Tablets - M/s. Angelini Pharmaceuticals (Pvt) Ltd.,
Lahore.
Drug Registration Board in its 244th
meeting held on 22-23rd
July, 2014 considered and
deferred the application of “Fluimucil A 600mg Effervescent Tablets (Acetylcysteine
600mg)” applied by M/s. Angelini Pharmaceuticals (Pvt) Ltd., Lahore imported from M/s.
Zambon Switzerland Ltd., Cadempino, Switzerland for submission of safety and efficacy data of
the drug along with complete clinical trial data of the formulation.
Name of Importer /
Manufacturer.
Name of Drug (s)
Composition & Therapeutic
Group.
Demanded
Price & Pack Size.
Shelf Life
M/s. Angelini
Pharmaceuticals (Pvt)
Ltd., Lahore /
M/s. Zambon Switzerland
Ltd., Cadempino,
Switzerland.
Fluimucil A 600mg
Effervescent Tablets.
Each tablets contains:-
Acetylcysteine........600mg.
(Mucolytics).
Rs.561.41/Per
packs of 10
effervescent
tablets.
Rs.56.14/Per
effervescent
tablets.
03 years
Accordingly, M/s. Angelini Pharmaceuticals (Pvt) Ltd., Lahore was advised to provide
the same. The firm has submitted the documents safety and efficacy data, which needs
deliberation by the Board.
Decision: Registration Board deferred the case for evaluation of clinical data by the
following experts:
Brig. Aslam Khan, Member registration Board
Abdul Lateef Shaikh, Director Pharmacy, AKUH, Karachi.
Dr.Shazli Manzoor, Pulmonologist, Quaid-e-Azam Int Hospital, Islamabad.
278
Case No. 04. Registration of imported – Inspections of manufacturing units abroad
thereof.
a. Withdrawal of registration applications - M/s. Barrett Hodgson Pakistan (Private)
Limited, Karachi.
Drug Registration Board in its 228th
meeting held on 12th
- 13th
October, 2010 approved
the registration of following drugs in the name of M/s. Barrett Hodgson Pakistan (Private)
Limited, Karachi manufactured by M/s. Yangtze River Pharmaceutical (Group) Jiangsu, China,
subject to inspection of manufacturer abroad:-
S. No. Name of Drug (s) Composition.
1. PacliBar Injection 30mg.
Each 5ml vial contains:-
Paclitaxel………30mg USP Specs.
2. PacliBar Injection 100mg.
Each 16.7ml vial contains:-
Paclitaxel………100mg USP Specs.
Dr. Muhammad Khalid Khan, Director, DTL, KPK / Member Drug Registration Board
and Mrs. Rohi Obaid, DDC, DRAP, Karachi was nominated for inspection of M/s. Yangtze
River Pharmaceutical (Group) Jiangsu, China. Accordingly, M/s. Barrett Hodgson Pakistan
(Private) Limited, Karachi was informed for arranging the inspection.
In response, M/s. Barrett Hodgson Pakistan (Private) Limited, Karachi have informed
that their principal M/s. Yangtze River Pharmaceutical (Group) Jiangsu, China is no more
interested in getting these products registered in Pakistan due to much delay in the process.
Therefore, the firm has requested for withdrawing the cases for registration of the above
mentioned products.
Decision: Registration Board acceded to request of the firm about withdrawl of above
registration applications.
279
b. Registration of imported drugs – Comments of panel of inspectors.
Drug Registration Board in its 236th
meeting held on 20th
November, 2012 approved the
registration of following drugs for import in the name of M/s. Sind Medical Stores, Karachi
manufactured by M/s. Boryung Pharmaceutical Co. Ltd., Singil-dong, Wonnam-dong, Chongro-
ku, Seoul, Korea, subject to inspection of manufacturer abroad:-
S. No. Name of Drug (s) &
Composition.
Fee
deposited.
Price approved by the Price
Advisory Committee.
1. A.D. Mycin Injection 10mg.
Each 5ml vial contains:-
Doxorubicin HCI…….10mg.
Rs.100,000 Rs.430.00/Per vial.
2. A.D. Mycin Injection 50mg.
Each 25ml vial contains:-
Doxorubicin HCI…….50mg.
Rs.100,000 Rs.1716.00/Per vial.
3. E.P. Mycin Injection 10mg.
Each 5ml vial contains:-
Epirubicin HCI……10mg.
Rs.100,000 Rs.670.00Per vial.
4. E.P. Mycin Injection 50mg.
Each 25ml vial contains:-
Epirubicin HCI…....50mg.
Rs.100,000 Rs.2500.00/Per vial.
5. Neotabine Injection 1gm.
Each vial contains:-
Gemcitabine HCI….1.14gm.
Rs.100,000 Rs.8330.00/Per vial.
6. Neotabine Injection 200mg.
Each vial contains:-
Gemcitabine HCI….228mg.
Rs.100,000 Rs.1675.00/Per vial.
In compliance, inspection of the manufacturer abroad M/s. Boryung Pharmaceutical Co. Ltd.,
Singil-dong, Wonnam-dong, Chongro-ku, Seoul, Korea, has been carried out by the nominated
panel comprising Dr. Saifur-Rehman Khattak, Director, CDL, Karachi and Mr. Salateen Waseem
Philip, ADC (Licensing), Drug Regulatory Authority of Pakistan, Islamabad.
280
The panel of inspectors has recommended the registration of the above said products with the
remarks that registration of the applied products is recommended however import to Pakistan
should be allowed only after confirmation of successful execution of the desired improvement.
The storage facility of the importer has already been verified by the Area FID.
With reference to the inspection report Dr. Saifur-Rehman Khattak, Director, CDL, Karachi
and Mr. Salateen Waseem Philip, ADC (Licensing), Drug Regulatory Authority of Pakistan,
Islamabad were requested to inform about type of short coming pointed out whether these are
critical in nature affecting the quality of the product or suggestive / advisory nature for further
processing the case.
In response, Dr. Saifur-Rehman Khattak, Director, CDL, Karachi have informed that the firm
was thoroughly inspected for facilities regarding the production, quality control and storage of
their products (Anti-Cancer Injections) intended for registration in Pakistan. The risk based
assessment of the facilities of the firm identified a number of critical, major and minor
observations which can adversely affect the quality of the products intended for registration in
Pakistan. They has further clarified that the observation No.1,2,4,6 and 10 are the critical
observations which need be rectified in any stance along with the other stated observations
before importing these products in Pakistan.
The panel informed that the certain observations are very critical and can affect the quality of
the product which is very serious threat for the patients to whom use these products. It should be
the duty of the panel of experts should gave the clear recommendation in light of observation, in
light of these serious observations the panel also recommended these products in final
recommendation, which is not understandable.
Decision: Regiastration Board discussed the inspection report in detail and keeping in
view nature of the observations being critical rejected the following applications of M/s.
Sind Medical Stores, Karachi manufactured by M/s. Boryung Pharmaceutical Co. Ltd.,
Singil-dong, Wonnam-dong, Chongro-ku, Seoul, Korea;
S. No. Name of Drug (s) &
Composition.
1. A.D. Mycin Injection 10mg.
281
Each 5ml vial contains:-
Doxorubicin HCI…….10mg.
2. A.D. Mycin Injection 50mg.
Each 25ml vial contains:-
Doxorubicin HCI…….50mg.
3. E.P. Mycin Injection 10mg.
Each 5ml vial contains:-
Epirubicin HCI……10mg.
4. E.P. Mycin Injection 50mg.
Each 25ml vial contains:-
Epirubicin HCI…....50mg.
5. Neotabine Injection 1gm.
Each vial contains:-
Gemcitabine HCI….1.14gm.
6. Neotabine Injection 200mg.
Each vial contains:-
Gemcitabine HCI….228mg.
c. Registration of imported drug – Issuance of registration letter after inspection of
manufacturer abroad.
i. M/s. Laderly Bio-Tech Pharma, Karachi
Drug Registration Board in its 244th
meeting held on 22-23rd
July, 2014 approved the
registration of following drugs in the name of M/s. Laderly Bio-Tech Pharma, Karachi,
manufactured by M/s. CSPC Pharmaceutical Co., Ltd., No. 188 Gongnong Road, Shijiazhuang
City, P R China, subject to inspection of manufacturer abroad, verification of storage facilities
and price fixation / calculation etc as per policy:-
S.#
Name of drug (s)/Composition. Fee deposited. Prices approved by
the Price
Recommendatory
Committee
1. Meropeon Injection 0.5gm.
Each vial contains: -
Meropenem USP…… 0.5gm.
Rs.100000 Rs.600/Per vial
2. Meropeon Injection 1gm.
Each vial contains: -
Meropenem USP …… 1gm.
Rs.100000 Rs.1100/Per vial.
Inspection of the manufacturer abroad M/s. CSPC Zhongnuo Pharmaceutical
282
(Shijiazhuang) Co., Ltd., 188 Gongnong Road, Shijiazhuang City, Hebei Province, China has
already been carried out by the nominated panel comprising Dr. Obaidullah, Deputy Director
General (Registration) and Mr. Abdullah, Deputy Drugs Controller (RRR), Drug Regulatory
Authority of Pakistan. The panel of inspectors has recommended the registration of the above
said products.
Decision: Registration Board considered the inspection report of the panel and
approved the registration of above products.
ii. M/s. Pak China International, Karachi.
Drug Registration Board in its 245th meeting held on 29-30th September, 2014 approved
the registration of following drug in the name of M/s. Pak China International, Karachi
manufacture by M/s. Zheijing Chimin Pharmaceutical Co. Ltd, 888 Beiyuan Road, Huangyan,
Zhejiang, P.R. China and exported by M/s. Ningbo Tisun Biochemi Company Ltd. Ningbo,
China subject to inspection of manufacturer abroad, verification of storage facilities and price
fixation / calculation etc as per policy:-
S.#
Name of drug (s)/Composition.
1. Sodium Ringer Lactate Injection.
Each 500ml bottle contains:-
Sodium Chloride….......................3.0gm.
Sodium Lactate, Anhydrous……1.55gm.
Potassium Chloride .....................0.15gm.
Calcium Chloride............................0.1gm.
Inspection of the manufacturer abroad M/s. Zheijing Chimin Pharmaceutical Co. Ltd, 888
Beiyuan Road, Huangyan, Zhejiang, P.R. China has already been carried out by the nominated
panel comprising Dr. Obaidullah, Deputy Director General (Registration) and Mr. Abdullah,
Deputy Drugs Controller (RRR), Drug Regulatory Authority of Pakistan. The panel of inspectors
has recommended the registration of the above said product.
Decision: Registration Board considered the inspection report of the panel and
approved the registration of above products.
283
Case No. 05. Change of manufacturing site of imported registered drug.
a. Duac Gel (Reg. No.043090) - M/s. GlaxoSmithKline Pakistan Limited, Karachi.
M/s. GlaxoSmithKline Pakistan Limited, Karachi have requested to approve the change
of source of manufacturing & supply of their registered imported drug “Duac Gel (Reg.
No.043090)” from M/s. Stiefel Laboratories, Ireland to M/s. Glaxo Operations UK Limited,
Barnard Castle, UK.
The firm has deposited fee Rs.50000/- and submitted following supporting documents:-
i) Original legalized CPP from new source.
ii) Supporting letter from endorsing source change.
iii) Copy of initial registration letter.
iv) Copy of transfer of registration letter in the name of M/s. GSK Pakistan Ltd.,
Karachi.
M/s. GlaxoSmithKline Pakistan Limited, Karachi was advised to submit the balance fee
as per revised “Schedule-F” for change of source of Duac Gel (Reg. No.043090) and status of
registration with EMA, US-FDA, Japan & Australia.
In response, M/s. GlaxoSmithKline Pakistan Limited, Karachi has submitted required fee
as per revised fee structure given in SRO 1117 (I) 2012.
The firm M/s. GlaxoSmithKline Pakistan Limited, Karachi has submitted legalized
Certificate of Pharmaceutical Product of “Duac Gel” issued by Australian Regulatory Authority.
The firm has submitted the all document and required fee as per approved policy of the
Drug Registration Board.
Decision: Registration Board approved request of M/s. GlaxoSmithKline Pakistan
Limited, Karachi for change in manufacturing site of Duac Gel (Reg. No.043090) from M/s.
Stiefel Laboratories, Ireland to M/s. Glaxo Operations UK Limited, Barnard Castle, UK.
Case No.06 Transfer of registered drugs.
a. M/s. Getz Pharma (Pvt) Limited, Karachi.
M/s. Getz Pharma (Pvt) Limited, Karachi have requested for transfer of registration of the
under-mentioned registered imported drugs from the name of previous importer M/s. Abbott
Laboratories (Pakistan) Limited, Karachi to their name as a result of agreement between M/s.
AbbVie Inc & M/s. Getz Pharma (Pvt) Limited, Karachi: -
284
S. No. Reg. No. Name of Drugs. Name of Manufacturer.
1. 015532 Survanta Suspension 8ml. M/s. Abbvie Inc., North Chicago, IL 60064,
USA.
2. 059025 Survanta Suspension 4ml. -do-
3. 011081 Forane Liquid for Inhalation
100ml. Manufactured by:-
M/s. Aescia Queenborough Limited, U.K.
Marketing Authorization Holder:-
M/s. Abbvie Limited, U.K.
4. 027374 Sevorane Volatile Liquid for
Inhalation 250ml.
-do-
M/s. Getz Pharma (Pvt) Limited, Karachi have deposited required fee
Rs.100000x4=400000/- and submitted the following documents:-
i) Legalized CoPP / GMP Certificate of Survanta Suspension 4ml.
ii) Legalized CoPP of Forane Liquid for Inhalation 100ml.
iii) Legalized GMP Certificate of Forane Liquid for Inhalation 100ml.
iv) Legalized CoPP of Sevorane Volatile Liquid for Inhalation 250ml.
v) Legalized GMP Certificate of Sevorane Volatile Liquid for Inhalation 250ml.
vi) Legalized Termination letter from M/s. AbbVie.
vii) Legalized Authorization letter from M/s. AbbVie
viii) No Objection Certificate from M/s. Abbott Laboratories (Pakistan) Limited,
Karachi.
ix) Registration applications on Form-5-A.
x) Copy of NOC for CRF.
Decision: Registration Board decided as follows:
Cancellation of above registrations from M/s. Abbott Laboratories (Pakistan)
Limited, Karachi.
Grant of above registrations in name of M/s. Getz Pharma (Pvt) Limited, Karachi.
Chairman, Registration Board will permit issuance of registration letter after
evaluation / completion of Form 5A as per check list approved by Registration
Board, comments of Cost & Pricing Division about MRP of the drug and
compliance of Import Policy for Finished Drugs.
285
b. Xenetix 350mg/ml Solution for Injection - M/s. A & Z Health Services, Rawalpindi
M/s. A & Z Health Services, Rawalpindi have requested for transfer of registration of a
registered drug “Xenetix 350mg/ml Solution for Injection (Reg. No.027353)” manufactured by
M/s. Guerbet France from the name of previous agent M/s. Digital Imaging Systems (Pvt) Ltd.,
Lahore to their name for finish import. They have deposited fee Rs.15000/- and submitted their
distribution agreement and previous agent dismissal notice. Since NOC of the former agent M/s.
Digital Imaging Systems (Pvt) Ltd., Lahore was not available. Therefore, as per practice in
vogue M/s. Digital Imaging Systems (Pvt) Ltd., Lahore were asked on 25th
May 2009 either to
submit their NOC in this regard or provide their fresh agency agreement (if any) with the
manufacturer abroad. Thereafter a reminder was issued on 01-07-2009 but they did not respond.
Then a show cause notice was issued to them on 29th
July 2009 to submit reply within 15 days
but they did not respond at all. Copy of this notice was also endorsed to DDG (E&M) Lahore to
ensure delivery to M/s. Digital Imaging Systems (Pvt) Ltd., Lahore. In response, Federal
Inspector of Drugs, Lahore, Mr. Asim Rauf has informed that despite personal visit of Drugs
Controller Officers to M/s. Digital Imaging Systems (Pvt) Ltd., Lahore on 03-03-2010 and
written reminder thereafter, the firm did not respond to the queries sought.
M/s. A & Z Health Services, Rawalpindi was advised to deposit balance fee as per
revised fee Schedule-F. In response, the firm have deposited the balance fee Rs.35000/-.
The firm has applied for the renewal neither on time nor after the expiry of the time till to
date. Therefore, the registration is not valid and cannot be transferred.
Decision: Registration Board did not accede to request of firm as registration of the
drug is not valid.
Case No. 07. Transfer of registrations and change of manufacturing site - M/s. Abbott
Laboratories (Pakistan) Limited, Karachi
M/s. Abbott Laboratories (Pakistan) Limited, Karachi have requested for transfer of
registration of the under-mentioned registered imported drugs from the name of previous
importer M/s. Highnoon Laboratories Ltd., Lahore to their name due to an International
Acquisition of the Pharmaceutical Section of Solvay with all associated companies has been
acquired by the Abbott group since February 15, 2010: -
286
S# Reg. No. Name of Drugs. Existing Name of
Manufacturer.
New Name of
Manufacturer.
1. 018552 Physiotens 0.2mg
Tablets.
M/s. Eli Lilly S.A.,
Spain.
Manufactured by:
M/s. Rottendrof Pharma
GmbH, Germany.
Packed by: -
M/s. Abbott Healthcare
SAS, France.
2. 018551 Physiotens 0.3mg
Tablets.
-do- -do-
3. 018550 Physiotens 0.4mg
Tablets.
-do- -do-
They have deposited required fee and following supporting documents: -
i) Original NOC of the previous importer M/s. Highnoon Laboratories Ltd., Lahore.
ii) Copy of the acknowledgement of last renewal of registration of the products
applied by the previous importer M/s. Highnoon Laboratories Ltd., Lahore.
iii) Copies of acknowledgement of receipt issued by the German National authority
BfArM & a notification submitted by the Solvay to the Germany authority for the
change in manufacturer name to M/s. Rottendrof Pharma GmbH, Germany.
iv) Copy of NOC for CRF.
Drug Registration Board in its 239th
meeting held on 12th
September, 2013 approved the
transfer of registration of Physiotens Tablet from M/s. Highnoon to M/s. Abbott Laboratories
(Pakistan) Ltd. Karachi along-with the change in manufacturing site from M/s. Eli Lilly S.A.,
Spain to M/s. Rottendrof Pharma GmbH, Germany, while the packaging site of the finished
products will be M/s. Abbott Healthcare SAS, France. The Board advised to provide site master
file of both sites and panel will inspect the manufacturing sites as well to comply the provisions
of import policy. The Board authorized its chairman to accord approval for issuance of letter
after compliance of aforementioned provisions.
As per decision of the Drug Registration Board M/s. Abbott Laboratories (Pakistan)
Limited, Karachi have submitted site master files of both sites attested by an authorized person
of the company.
M/s. Abbott Laboratories (Pakistan) Limited, Karachi was again advised to submit the
Form-5 (A), legalized CoPP’s of both Germany and French sources.
287
In response, M/s. Abbott Laboratories (Pakistan) Limited, Karachi have submitted Form
5(A) and following documents for an intermediate International Change of Manufacturing from
M/s. Rottendrof Pharma GmbH, Germany to M/s. Abbott Healthcare SAS, France:-
i) CoPP of the M/s. Abbott Healthcare SAS, France legalized by Pakistan Embassy.
ii) GMP of the regulatory authority for the manufacturing site legalized by Pakistan
Embassy.
iii) Justification of Change.
M/s. Abbott Laboratories (Pakistan) Limited, Karachi have also submitted that both
manufacturing and release site will be M/s. Abbott Healthcare SAS, France.
This case was discussed in 239th
meeting of the Drug Registration Board for the change
of manufacturing site from M/s. Eli Lilly S.A., Spain to M/s. Rottendrof Pharma GmbH,
Germany & packaging at M/s. Abbott Healthcare SAS, France. Meanwhile the firm requested
that all the manufacturing and packaging steps will be carried out at “M/s. Abbott Healthcare
SAS, France” and for which they have submitted documents as per SOP. Under the Drugs Act,
1976 there is no provision for transfer of registration from one company to another.
Decision: Registration Board referred above formulations for c onsideration of Review
Committee.
Case No.08 Change in name of manufacturer.
a. Rocaltrol Capsules 0.25mcg and 0.5mcg - M/s. Martin Dow Limited, Karachi.
M/s. Martin Dow Limited, Karachi has requested to approve the change of
manufacturer name of their following registered imported drugs as follows:-
S# Reg. No. Name of Drug (s) Current Name of
Manufacturer.
New Proposed Name
of Manufacturer.
1. 015557 Rocaltrol Capsules
0.25mcg.
M/s. R.P Scherer GmbH,
Germany.
M/s. Catalent
Germany Eberbach
GmbH,
Gammelsbacher
Strasse 2
69412 Eberbach /
Baden, Germany.
288
2. 015556 Rocaltrol Capsules
0.5mcg.
-do- -do-
The firm have deposited required fee Rs.100000x2=200000/- and submitted following
supporting documents:-
i) Copy of registration letter.
ii) Copy of transfer of registration letter.
iii) Copy of change in manufacturing site.
iv) Copy of NOC for CRF clearance.
v) Original and legalized CoPP as per WHO format.
M/s. Martin Dow Limited, Karachi was advised to provide CoPP issued from German
authority as the above said products are being manufactured in Germany and Certificate of Swiss
Medica is irrelevant.
In response, M/s. Martin Dow Limited, Karachi have submitted that Rocaltrol Capsules
0.25mcg & 0.5mcg are imported in finished form from M/s. F. Hoffmann-La Roche Ltd.,
Switzerland, under contract manufacturing arrangement with M/s. R.P Scherer GmbH,
Germany. M/s. F. Hoffmann-La Roche Ltd., Switzerland holds marketing authorization for
Rocaltrol range and M/s. R.P Scherer GmbH, Germany is just a contract manufacturer of
Rocaltrol. M/s. R.P Scherer GmbH, Germany does not hold marketing authorization of Rocaltrol
in Germany as such German authorities cannot issue CoPP for the product not marketed by the
company in Germany.
The firm has further submitted that they have submitted CoPP of Rocaltrol Capsules
0.25mcg & 0.5mcg issued from Swiss authorities, as the finish product is supplied from
Switzerland which indicates M/s. R.P Scherer (new name Catalaent) as manufacturing site.
The firm has also informed that only the name of manufacturer of Rocaltrol Capsules is
changed from “R.P. Scherer GmbH & Co. KG” to “Catalent Germany Eberbach GmbH”. The
physical address of the facility, the manufacturing process and quality controls for the capsules
as well as the personnel producing & testing of the capsules remains unchanged.
The manufacturing site of the product “Rocaltrol Capsules” is located in Germany but the
firm has submitted CoPP of Swiss Medica and not of German Authorities. The same was asked
them but they have not provided the same. The CoPP of country of origin is mandatory for such
approval.
289
Decision: The Board deferred the case and advised the firm to submit the legalized
document issued by German regulatory authorities for following confirmations:
Above referred products are being contract manufactured at Catalent Germany
Eberbach GmbH.
It is only change of title / name of the firm and rest of facilities including address is
same as of previous manufacturer.
Case No.09 Exemption from the Drugs (Labeling & Packing) Rules, 1976.
a. Kytril (Granisetron) Ampoule 3mg/3ml, Reg. No.020691 - M/s. Roche Pakistan
Limited, Karachi.
M/s. Roche Pakistan Limited, Karachi have informed that “Kytril Ampoule 3mg/3ml
(Reg. No.020691)” was registered in the name of M/s. SmithKline & French Pakistan Limited,
Karachi on February 10, 1998 and the registration was subsequently transferred to M/s. Roche
Pakistan Limited, Karachi on July 25, 2001 after the global acquisition of this brand by their
principal M/s. F. Hoffmann La-Roche Basel, Switzerland. Due to the low volumes of the imports
/ sales, (approx 2000 packs / anum) M/s. Roche Pakistan Limited had applied for exemption
from the Drugs (Labeling & Packing) Rules 1986 and the exemption was granted on November
10, 2004. Furthermore, for necessary compliance to the Drugs (Labeling & Packing) Rules 1986,
i.e. (after imports of the consignment) the information, i.e. Pak Reg. No., Price and Urdu
instructions are being overprinted on the secondary carton using an ink-jet printer.
Recently M/s. Roche Pakistan Limited, Karachi have imported a consignment of “Kytril
Ampoules” in Islamabad, (1000 packs) and have been advised by the concerned ADC to paste
stickers for compliance to the Drugs (Labeling & Packing) Rules 1986 on the individual
ampoules of the 5’s pack. Following find few facts which would reveal that individual ampoule
sticker pasting would be detrimental to the 5’s pack and the product:-
i) It’s a Neo-top secondary carton, (5’s pack) with perforated seal, and if open once the
temper evident seal / integrity of the pack would be compromised.
ii) Pasting of stickers is not possible due to the limited space available on the 3ml
ampoule as the sticker would mask the primary label, hiding the critical information
on the primary label, (ampoule photo attached).
290
iii) There would be high risk of ampoule breakage during the excessive handling of the
pack after opening it and while carrying out the manual process of sticker pasting.
Considering the above mentioned facts M/s. Roche Pakistan Limited, Karachi have
requested for an exemption of overprinting of the primary label (ampoule), since the secondary
label (carton) is being duly complied with the requirement of the Drugs (Labeling & Packing)
Rules 1986 by ink-jet printing.
M/s. Roche Pakistan Limited, Karachi have deposited required fee Rs.5000/- and
submitted following supporting documents:-
i) Copy of transfer of registration letter.
ii) Copy of initial registration letter.
iii) Copy of letter exemption from Drugs (Labeling & Packing) Rules 1986.
iv) Copy of last renewal status.
v) Copy of labels.
Kytril Ampoules (Reg. No.020691) is an 5HT3-antagonist used as antienetic, available in
3ml ampoule, which cannot be allowed to sell without complying full requirement of the Drugs
(Labeling & Packing) Rules 1986.
Decision: The Board after detailed deliberations decided that M/s Roche Pakistan Ltd,
Karachi may be permitted for ink-ject printing of Urdu version only of the ampules of
Kytril Ampoules (Reg. No. 020691) in any licensed manufacturing unit having facility for
this purpose. The firm will provide NOC of any licensed manufacturing unit and case will
be processed for approval for issuance of letter. The firm will comply the rest of the
labeling requirements under the Drugs (Labeling & Packaging) Rules, 1986 before import.
Case No.10 Extension in shelf life of registered drugs.
a. Alimta 100mg Injection, Regn. No.066174 and Alimta 500mg Injection, Regn.
No.043068.
M/s. Eli-Lilly Pakistan (Private) Limited, Karachi have requested to approve the
extension of shelf life of their following registered imported drugs from 24 months to 36 months.
As the current stability studies conducted on this product confirms that the product is well stable
291
when tested at 36 months time interval:-
S. No. Reg. No. Name of Product.
1. 066174 Alimta 100mg Injection.
2. 043068 Alimta 500mg Injection.
The firm has deposited required fee Rs.5000x2=10,000/- and submitted following
supporting documents:-
i) Copy of registration letter of Alimta 100mg Injection.
ii) Original CoPP of Alimta 100mg Injection attested by Pakistan Embassy having
approved shelf life of 36 months.
iii) Copy of registration letter of Alimta 500mg Injection.
iv) Copy of the acknowledgement of last renewal of registration of Alimta 500mg
Injection.
v) Original CoPP of Alimta 500mg Injection attested by Pakistan Embassy having
approved shelf life of 36 months.
vi) Copies of Stability Studies.
M/s. Eli-Lilly Pakistan (Private) Limited, Karachi was advised to clarify whether
stability data conducted for Zone-IV is approved by US-FDA or otherwise. In response, M/s. Eli-
Lilly Pakistan (Private) Limited, Karachi have submitted that previously provided stability data
was conducted for Zone-IV and approved by FDA. They have further submitted that original
CPPs issued by the FDA mentioning 36 months shelf life. These CPPs issued by the FDA
specifically for Pakistan for Alimta 100mg & 500mg on the basis of submitted Zone-IV stability
data. Therefore, Zone IV stability data should be considered as approved by the FDA.
As per practice in vogue views of following experts regarding extension of shelf lives of
the products has been obtained:-
S. No. Name of Expert.
Opinion
1. Prof. Dr. Zafar Iqbal,
Chairman, Department of Pharmacy,
University of Peshawar,
Peshawar.
Recommended
2. Dr. Farzana Chowdhary,
Director, Department of Pharmacy,
University of Veterinary & Animal
Sciences, Lahore.
Extension in shelf-lives is recommended
on condition that they will be available
only in hospitals / institutions specialized
for the treatment of cancer.
292
3. Jamil Anwar,
Director,
Drugs Testing Laboratory,
Punjab, Lahore.
Recommended
M/s. Eli-Lilly Pakistan (Private) Limited, Karachi was advised to clarify as these
“Pemetrexed” containing products are meant for malignant pleural mesotheliona, which indicate
it is a specialized product for tertiary care institution. The one of the expert indicate these
products should be available only in hospitals / institutions specialized for the treatment of
cancer. Therefore, you are advice to inform this office about mode of sale whether it is selling to
institution / hospitals or also available in retail out lets as well.
In response, M/s. Eli-Lilly Pakistan (Private) Limited, Karachi have confirm that Alimta
(pemetrexed) is indicated for Nonsquamous Non-Small Cell Lung Cancer-NSCLC and
malignant Pleural Mesothelioma. Alimta 500mg and 100mg formulations are registered in
Pakistan since 2006 and 2010 respectively. They would like to inform that at the time of
registration, no restrictions were imposed on the availability of Alimta. They have authorized
their distributor to provide Alimta to hospitals / institutions specialized for the treatment of
Cancer based on tenders / orders and to the very selective licensed outlets in Pakistan.
Decision: Registration Board after deliberations approved the request of the firm for
increase in shelf life.
Case No.11. Resemblance of brand name – Personal hearing thereof.
M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore have informed about resemblance of
brand name of imported drug “OZOL-40 Infusion (Reg. No.044854)” imported by M/s. United
International, Karachi with the brand name of their already registered locally manufactured drug
“O-Zole Capsules 40mg (Reg. No.043642)”. M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore
submitted that they are facing problems in marketing the product, time and again, and it will be
even more aggravated if the situation continues. Therefore they have humbly requested to take a
check on the situation and to strictly instruct M/s. United International, Karachi to change their
brand name as early as possible, so that they could continue marketing their product smoothly
293
and without apprehensions.
Accordingly, M/s. United International, Karachi was advised to propose at least three
distinguished alternate names of their drug other than the existing name. Also, submit an
undertaking that the new proposed brands do not have resemblance with any already registered
drug.
In response, M/s. United International, Karachi have submitted that they had been
granted the registration of product “OZOL-40 Infusion (Reg. No.044854)” on 9th
February,
2007, i.e. more than seven years before and the said product is already being marketed by them
for more than seven years, therefore, their product is strongly recognized and accepted by their
prevailing customers in the market with the said name since they have incurred substantial
marketing expenditures to create awareness among the customers about the product with the said
brand name. They have therefore requested to consider the additional fact that the nature of the
products being traded by them and that by M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore is
different, meaning that the product traded by them is an Injection whereas the product traded by
M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore is a capsule. M/s. United International,
Karachi has requested to continue trading of the said product with the same brand name, keeping
in view the these facts.
Registration Board took serious note of firm for not complying the instructions for
change of brand name. The Board decided to suspend the import of “OZOL-40 Infusion (Reg.
No.044854)” imported by M/s. United International, Karachi immediately and call the firm’s
representative in next meeting for personal hearing.
Accordingly, the importer M/s. United International, Karachi has been advised to suspend
the import of “OZOL-40 Infusion (Reg. No.044854)” imported by them immediately, till the
change of name of the product and called for personal hearing in this meeting.
Decision: The representative of the firm did not appear before the Board and informed
that they are willing to change the name of their product in light of the directions of the
Board. The Board accepts the request of the firm and authorized its Chairman for decision
on the change of name request of the firm.
294
Case No.12. Veterinary drugs deferred by Registration Board for expert opinion.
Registration Board in its 243rd
meeting held on 08th
-09th
May, 2014 referred all
veterinary applications to a committed comprises of Dr. Muhammad Arshad, Member
Registration Board, Dr. Muhammad Ashraf, UVAS, Lahore and Head of Pharmacology
Department Arid University Rawalpindi for expert opinion. The recommendations of expert are
as under:-
S. No. Name of Importer/
Manufacturer.
Name of Drug (s)/Composition. Recommendations
of Dr. Muhammad
Ashraf, UVAS,
Lahore
Recommendations
of Dr. Muhammad
Arshad, Member
R.B
Recommendatio
ns of Head of
Pharmacology
Department
Arid University
Rawalpindi
1. M/s. Ghazi Brothers,
Karachi-75350 /
Product License
Holder:-
M/s. Agrovet Market
S.A., San Luis, Lima,
Peru.
Manufacturer Under
Product License
Holder:-
M/s. Pharmadix Corp.
S.A.C. Urbanizacion La
Aurora-Ate Lima 3-
Peru.
Metri-CEF 3 Intrauterine
Suspension
Each 30ml contains:-
Cephalexin monohydrate
(Base)……………….....600mg
Neomycin sulfate
(Base)…………………1.02gm
Cloxacillin
benzathine...1.50gm
Vitamin A……….....30.000 IU
Recommended He endorsed the
recommendations
of Dr. Muhammad
Ashraf.
Dr. Mazhar ul
Haq
Wrote to this
office “I am
unable to put
my opinion on
said drugs due
to certain
unavoidable
reasons.
2. M/s. Ghazi Brothers,
Karachi-75350 /
Product License
Holder:-
M/s. Agrovet Market
S.A., San Luis, Lima,
Peru.
Catofos B9 + B12 Injectable
Solution
Each ml contains:-
Butaphosphan…………100mg
Vitamin B9 (Folic Acid)..15mg
Vitamin B12
(Cyanocobalamin)…….0.05mg
Recommended
295
Manufacturer Under
Product License
Holder:-
M/s. Pharmadix Corp.
S.A.C. Urbanizacion La
Aurora-Ate Lima 3-
Peru.
(Vitamin and Mineral).
3. M/s. Ghazi Brothers,
Karachi. /
M/s. Vetanco S.A.
Buenos Aires,
Argentina.
Ketoxilen Injection
Each 100ml contains:-
Oxytetracycline………...20gm
Ketoprofen………………3gm
(Antibiotic/Anti-
inflammatory).
Recommended
4. M/s. Ghazi Brothers,
Karachi. /
M/s. Cheilbio Co. Ltd.,
Moknae-Dong, Ansan-
Si, Gyeonggi-Do,
Korea.
Geslong Injection
Each ml of solution contains:-
Metoclopramide HCI……5mg
(Antiemetic/ Gastroprokinetic).
Recommended
5. M/s. Ghazi Brothers,
Karachi. /
M/s. Cheilbio Co. Ltd.,
Moknae-Dong, Ansan-
Si, Gyeonggi-Do,
Korea.
Cheil Tonocomp Injection
Each ml of solution contains:-
Toldimfos sodium……200mg
Recommended
6. M/s. Ghazi Brothers,
Karachi. /
M/s. Cheilbio Co. Ltd.,
Moknae-Dong, Ansan-
Si, Gyeonggi-Do,
Korea.
Seletoco Injection
Each ml of solution contains:-
Vitamin E acetate……..100mg
Sodium Selenite…………1mg
(Nutritional additive).
Recommended
7. M/s. Ghazi Brothers,
Karachi. /
M/s. Cheilbio Co. Ltd.,
Moknae-Dong, Ansan-
Si, Gyeonggi-Do,
Korea.
Procillin-LA Injection
Each ml contains:-
Pencillin G
Benzathine ………1,00,000 IU
Penicillin G
Procaine…………1,00,000 IU
Dihydrostreptomycin
sulfate…200mg
(Antibacterial).
Recommended
8. M/s. Ghazi Brothers,
Karachi. /
M/s. Cheilbio Co.
Ltd.Gyeonggi-Do,
Korea.
Oxyneo Powder
Each 1 Kg contains:-
Oxytetracycline Quaternary
Ammonium Salts………110gm
Neomycin sulfate…...…110gm
(Antibiotic).
Potential of
misuse on feed
additive & drug
interaction.
9. M/s. Ghazi Brothers, Oxyone Powder Potential of
296
Karachi. /
M/s. Cheilbio Co.
Ltd.Gyeonggi-Do,
Korea.
Each 1 Kg contains:-
Oxytetracycline Quaternary
Ammonium Salts……….200g
(Antibiotic).
misuse on feed
additive & drug
interaction.
10. M/s. Ghazi Brothers,
Karachi. /
M/s. Hebei Yuanzheng
Pharmaceutical Co.
Ltd., Shijiazhuang City,
Hebei Province, China.
Cefquin Suspension for
Injection
Each ml contains:-
Cefquinome (as sulfate)..25mg
(Antibiotic).
Recommended
11. M/s. Ghazi Brothers,
Karachi. /
M/s. Hebei Yuanzheng
Pharmaceutical Co.
Ltd., Shijiazhuang City,
Hebei Province, China.
Isomedium Powder for
parental administration
Each sachet contains:-
Isometamedium chloride
hydrochloride…………..…1g
(Antiprotozoal).
Recommended
12. M/s. Ghazi Brothers,
Karachi. /
M/s. Hebei Yuanzheng
Pharmaceutical Co.
Ltd., Shijiazhuang City,
Hebei Province, China.
Oxybiotic LA 30% Solution
for Injection
Each ml contains:-
Oxytetracycline (as
dihydrate)…………….300mg
(Antibiotic).
Recommended
13. M/s. Ghazi Brothers,
Karachi. /
M/s. Hebei Yuanzheng
Pharmaceutical Co.
Ltd., Shijiazhuang City,
Hebei Province, China.
Bupaquone Solution for
Injection
Each ml contains:-
Buparvaqone…………...50mg
(Antiprotozoal).
Recommended
14. M/s. Orient Animal
Health (Pvt) Ltd.,
Karachi. /
M/s. Univet Ireland
Ltd. Tullyvin, Cootehill,
Co. Cavan, Ireland.
Unimox LA Injection
Each ml contains:-
Amoxicillin (as Amoxicillin
Trihydrate) Ph. Eur…...150mg
(Antibacterial).
Recommended -
15. M/s. Orient Animal
Health (Pvt) Ltd.,
Karachi. /
M/s. Univet Ireland
Ltd. Tullyvin, Cootehill,
Co. Cavan, Ireland.
Unicycline LA Injection
Each ml contains:-
Oxytetracycline (as
Oxytetracycline Dihydrate Ph.
Eur)…………………...200mg
(Antibacterial).
Recommended (Stability Study
of zone IV not
provided)
16. M/s. Orient Animal
Health (Pvt) Ltd.,
Karachi. /
M/s. Univet Ireland
Ltd. Tullyvin, Cootehill,
Co. Cavan, Ireland.
Multivit Injection
Each 1 ml contains:-
Vitamin B1…………….10mg
Vitamin B2………...……5mg
Vitamin B6…….………..3mg
Vitamin B12………....0.05mg
Nicotinamide………..…35mg
D-Panthenol…….……...25mg
Recommended COPP of
Ireland not
provided.
297
Vitamin A…………15,000 IU
Vitamin D3………....1,000 IU
Vitamin E…………........10mg
(Multivitamins).
17. M/s. Orient Animal
Health (Pvt) Ltd.
Karachi. /
M/s. V.M.D. N.V,
Hoge Mauw, Arendonk-
Belgium.
Promycin-1000 Injectable
Solution
Each ml contains:-
Colistin
Sulphate………..1,000,000 IU
(Polypeptide Antibiotic).
Recommended (Mnf. In France
then packaging
in Belgium;
COPP of
France)
18. M/s. Orient Animal
Health (Pvt) Ltd.,
Karachi. /
M/s. V.M.D. N.V,
Hoge Mauw, Arendonk-
Belgium.
Promycin-4800 Water Soluble
Powder
Each gram contains:-
Colistin Sulphate…4,800,000
IU
(Polypeptide Antibiotic).
Recommended (Mnf. In France
then packaging
in Belgium;
COPP of
France)
19. M/s. Marush (Pvt) Ltd.,
Lahore. /
M/s. Univet Ltd.
Tullyvin, Cootehill, Co.
Cavan, Ireland.
Ubroloxin ® Intramammary
Suspension
Each 1 injector with 10g
(12ml) contains:-
Cefalexin
monohydrate...................200mg
Kanamycin
monosulfate……………133mg
(Corresponds to 100,000 I.U).
(Pharmaceuticals).
Recommended
20. M/s. U.M. Enterprises,
Karachi-74900/
M/s. Qilu Animal
Health Products Co.
Ltd., Jinan, Shandong,
China.
Flumeglu 5gm Injection
Each 100ml contains:-
Flunixin Meglumine equivalent
to 5.0g of Flunixin.
(Non-steriod, Ant-
inflammatory drug).
Recommended
21. M/s. U.M. Enterprises,
Karachi-74900/
M/s. Qilu Animal Health
Products Co. Ltd., Jinan,
Shandong, China.
Cefent 1gm Injection
Each 25ml vial contains:-
Ceftiofur Sodium equivalent to
1.0g Ceftiofur.
(B.Lactum Antibiotics).
Recommended
22. M/s. U.M. Enterprises,
Karachi-74900/
M/s. Qilu Animal
Health Products Co.
Ltd., Jinan, Shandong,
China.
Cefent 4gm Injection
Each 100ml vial contains:-
Ceftiofur Sodium equivalent to
4.0g Ceftiofur.
(B.Lactum Antibiotics).
Recommended
23. M/s. U.M. Enterprises,
Karachi-74900/
Ceftihyde 5gm Injection
Each 100ml contains:-
Recommended
298
M/s. Qilu Animal
Health Products Co.
Ltd., Jinan, Shandong,
China.
Ceftiofur Hydrochloride
equivalent to 5.0g Ceftiofur.
(B.Lactum Antibiotics).
24. M/s. Siddiqui Pharma
(Pvt) Ltd., Multan. /
M/s. KBNP, INC,
Dugok-ri, Sinam,
Yesan, Chungnam,
Korea.
Ciroxin 10% Oral Solution
Each Liter contains:-
Ciprofloxacin…………100g
(Antibiotics).
Recommended
25. M/s. Siddiqui Pharma
(Pvt) Ltd., Multan. /
M/s. KBNP, INC,
Dugok-ri, Sinam,
Yesan, Chungnam,
Korea.
Kenoxin 10% Oral Solution
Each Liter contains:-
Enrofloxacin……100g
(Antibiotics).
Recommended
26. M/s. Siddiqui Pharma
(Pvt) Ltd., Multan. /
M/s. KBNP, INC,
Dugok-ri, Sinam,
Yesan, Chungnam,
Korea.
Noroxin 200 Oral Solution
Each Liter contains:-
Norfloxacin…………200g
(Antibiotics).
Recommended
27. M/s. Mustafa Brothers
Faisalabad. /
M/s. Laboratorio
Centrovet Santiago,
Chile.
Cefalexine Injectable
Suspension 15%
Each 10ml contains: -
Cefalexine ….150/ml
(Beta lactam Antibiotic)
Recommended
28. M/s. Mustafa Brothers
Faisalabad. /
M/s. Laboratorio
Centrovet Santiago,
Chile.
Ceftiofur Hydrochloride
Injectable Suspension 5%
Contains:
Ceftiofur
Hydrochloride…………...50mg
(Antibiotic)
Recommended
29. M/s. Ghazi Brothers,
Karachi. /
M/s. CEVASA S.A.
Buenos Aires,
Argentina.
Sulfyvit Water Soluble Powder
Each 100gm contains:-
Sodium
sulfaquinoxaline………..15gm
Sodium
sulfamethazine………….14gm
Sodium
sulfadimethoxine………...2gm
Trimethoprim …………...6gm
More chances of
their misuse, drug
interaction and
development of
resistance. It is
better to have
separate products
for specific
purpose. Need
299
Prednisolone………...0.004gm
Vitamin A……....…300,000IU
Vitamin E……………..200 IU
Vitamin D3……..…..60.000IU
Vitamin C……………….2gm
Vitamin K3……………..1gm
Excipients……..…………..q.s
(Antibiotic, steroids Vitamin).
experimental
verification for
such combination,
30. M/s. Fartal
Pharmaceuticals,
Karachi. /
M/s. Laboratorios
Microsules Uruguay
S.A. Canelones,
Uruguay.
Ivermic M.O. Injectable
Suspension
Each ml contains:-
Ivermectin………..……1,000g
Zinc Sulphate 7H20…...0,043g
Magnesum Chloride
6H20…………………...0,650g
Copper Chloride
2H20…………………...0,004g
Magnesium Hypophosphite
6H20…………………..2,670g
Potassium Iodide……...0.030g
Vitamin B12…………..0,010g
Histidine HCI…………0,420g
Valine……….………..0,420g
Arginine HCI………….0,510g
Methionine……………0,420g
Threonine……………..0,500g
Sodium monobasic
glutamate……………....0,840g
(Endectocide, organic
More chances of
their misuse, drug
interaction and
development of
resistance. It is
better to have
separate products
for specific
purpose.
31. M/s. International
Chempharma (Pakistan)
Lahore. /
M/s. Biopharmachemie
Co Ltd TangNhon Phu
Vietnam.
CTC Plus Water Soluble
Powder
Contains:-
Chlortetracycline……5500mg
Vitamin A……………2400IU
Potassium Chloride…..760mg
Vitamin B12………...280mcg
Lysine…………………60mg
(Antibiotic)
More chances of
their misuse, drug
interaction and
development of
resistance. It is
better to have
separate products
for specific
purpose.
32. M/s. Better Traders
International,
Faisalabad. /
M/s. Kepro B.V.
Maagdenburgstraat,
Holland.
Thiacol 10% Oral Solution
Each ml contains:-
Thiamphenicol……….100mg
(Broad Spectrum
Antimicrobial Agent).
Recommended
33. M/s. Ani Cure
Veterinary Services,
Rawalpindi. /
Nemovit Water Soluble
Powder
Each gm contains: -
More chances of
their misuse, drug
interaction and
300
M/s. Interchemie
Werken ”De Adelaar”
B.V. Metaalweg, CG
Venray, Holland.
Neomycin
Sulpahte……………..…40mg
Oxytetracycline HCl…...60mg
Vitamin A……………7500IU
Vitamin D3,
Cholecalciferol………..1500IU
Vitamin E, a-tocopherol
acetate…………………....5mg
Vitamin B1….thiamine
hydrochloride……….....…1mg
Vitamin B2,
riboflavine………….….....2mg
Vitamin B6, pyridoxine
hydrochloride………….....2mg
Vitamin B12,
cyanocobalamin……….....7.5µ
Vitamin C, Ascorbic
acid..25mg
Ca-pantothenate……….7.5mg
Vitamin K3, menadione
sodium bisulfite………….5mg
Nicotinamide…………….5mg
Folic Acid…………..…300µg
DL-Methionine…………30mg
L-Lysine
hydrochloride…………...50mg
development of
resistance. It is
better to have
separate products
for specific
purpose.
34. M/s. Ani Cure
Veterinary Services,
Rawalpindi. /
M/s. Interchemie
Werken ”De Adelaar”
B.V. Metaalweg, CG
Venray, Holland.
Aliseryl Water Soluble Powder
Each gm contains: -
Erythromycin
thiocyanate…………..…35mg
Oxytetracycline HCl…...50mg
Streptomycin Sulphate…35mg
Colistin
Sulphate……….…..200,000IU
Vitamin A, retinol
acetate…………………3000IU
Vitamin D3,
cholecalciferol………1500IU
Vitamin E, a-tocopherol
acetate…….……………..2mg
Vitamin B1, thiamine
hydrochloride…………….2mg
Vitamin B2,
riboflavine…..4mg
Vitamin B6, pyridoxine
hydrochloride…………….2mg
Vitamin B12,
cyanocobalamin………..10µg
Vitamin C, Ascorbic
More chances of
their misuse, drug
interaction and
development of
resistance. It is
better to have
separate products
for specific
purpose.
301
Acid..20mg
Ca-
pantothenate…………10mg
Vitamin K3, menadione
sodium
bisulfite…………………..2mg
Nicotinamide……….…..20mg
Inositol……………….….1mg
35. M/s. Seignior Pharma
Karachi./
M/s. Instituto
Rosenbusch S.A. de
Biologia Experimental
Agropecuaria, San Jose
1469 (1136) Buenos
Aires, Argentina.
Ceftiofur LPU Injectable
Each 100ml vial contains: -
Ceftiofur HCL…………50mg
Excipients…………..…100ml
(Antibiotic)
Recommended
36. M/s. Seignior Pharma,
Karachi. /
M/s. Instituto
Rosenbusch S.A. de
Biologia Experimental
Agropecuaria, San Jose
1469 (1136) Buenos
Aires, Argentina.
Florfenicol 30% Rosenbusch
Injectable
Each 100ml vial contains:-
Florfenicol………...…...30gm
Excipients q.s……....…100ml
(Antibiotic)
Recommended
37. M/s. Bio-Labs (Pvt)
Ltd., Islamabad.
Bio-Enrocol-A Liquid
Each 100ml contains:-
Enrofloxacin………...…..10%
Colistin Sulphate………..3.5%
Amantadine…………….....4%
(Antibiotic, Anti-viral).
Contains
“Amantadine”
which is antiviral
drug for flu and
may have drug
interaction and
resistance problem
so should not be
used in these
combinations.
38. M/s. Bio-Labs (Pvt)
Ltd., Islamabad.
Coliflox 20% Liquid
Each 100ml contains:-
Enrofloxacin……………20gm
Colistin Sulphate…50,000,000
i.u.
(Quinolones).
Recommended
39. M/s. Leads Pharma
(Pvt) Ltd., Islamabad.
Virex CRD Powder
Contains:-
Contains
“Amantadine”
302
Tylosin Tartrate……….....10%
Doxycycline HCI…….…..22%
Colistin Sulphate……….…4%
Amantadine HCI………….3%
(Antibiotic).
which is antiviral
drug for flu and
may have drug
interaction and
resistance
problem so should
not be used in
these
combinations.
40. M/s. Elko Organization
(Pvt) Ltd., Karachi.
Fe-Zole SC 5% Oral
Suspension
Each ml contains:-
Fenbendazole………..….50mg
Elemental Selenium…....1.6mg
Elemental Cobalt.............10mg
(Anthelmintic).
Recommended
41. Noble Pharma Mirpur
Azad Kashmir.
ENTRO-5 Powder
Each 1000gm contains:-
Tylosin Tartrate BP……..10%
Doxycycline Hyclate USP20%
Colistin Sulphate…...450 MIU
Bromhexine HCI………0.5%
Neomycin SO4…………3.6%
(Antibacterial).
Drug which are
“Me too” like
drugs with minor
modifications
which may or
may not be
considered.
42. M/s. Mallard
Pharmaceuticals (Pvt)
Ltd., Multan.
Centrum Liquid
Each 100ml contains:-
Enrofloxacin HCI…...7500mg
Sulphamethoxypyridazine……
……………………7500mg
Sulphamethazine……5000mg
Trimethoprim………2500mg
(Antibiotic).
Drug which are
“Me too” like
drugs with minor
modifications
which may or
may not be
considered.
43. M/s. Intervac (Pvt) Ltd,
Sheikhupura Road,
Sheikhpura.
Tilmodox Liquid
Each 100ml contains:-
Tilmicosin Phosphate….15gm
Doxycycline HCI………15gm
(Antibiotic).
Tissue resistance.
44. M/s. Intervac (Pvt)
Limited, Lahore.
Amprobit Liquid
Each liter contains:-
Amprolium HCI………250gm
Ethopabate……………..16gm
(Anticoccidial).
Recommended
303
45. M/s. Attabak
Pharmaceutical,
Islamabad.
Tylothrodox Powder
Each 1000gm contains:-
Doxycycline HCl……..…100g
Tylosin tartrate …………..50g
Amantadine HCl ………...40g
Erythromycin thiocyanate..60g
(Antibacterial, Antiviral).
Contains
“Amantadine”
which is antiviral
drug for flu and
may have drug
interaction and
resistance
problem so
should not be
used in these
combinations.
46. M/s. Attabak
Pharmaceutical,
Islamabad.
Spiralinc-B Powder
Each 100gm powder contains:-
Lincomycin HCI…………..5g
Spectinomycin HCI……..7.5g
Spiramycin adipate...........2.5g
Bromhexine HCI………...0.5g
(Antibacterials).
Recommended
47. M/s. D-Maarson
Pharmaceuticals,
Rawat, Islamabad.
CRD-555 Water Soluble
Powder
Each 1000g contains:-
Doxycycline HCl ............200g
Tylosin tartrate ………....100g
Colistin sulphate……500MIU
Amantadine HCl ………..40g
Drug which are
“Me too” like
drugs with minor
modifications
which may or
may not be
considered.
48. M/s. Symans
Pharmaceuticals (Pvt)
Ltd. Lahore.
SPZ-Plus Feed Additive Oral
Each 100gm contains:-
Procaine Penicillin
B.P…1200mg
Streptomycine Sulphate
B.P……………………3600mg
Zinc Bacitracin B.P…5200mg
Colistin Sulphate B.P.500 MIU
(Antimicobial).
Recommended
49. M/s. Symans
Pharmaceuticals (Pvt)
Ltd. Lahore.
Cipro Plus Solution
Each Liter Contains:-
Ciprofloxacin…………200gm
Contains
“Amantadine”
which is antiviral
304
Colistin Sulphate……400MIU
Amantadine…………….40gm
(Antibiotics).
drug for flu and
may have drug
interaction and
resistance
problem so
should not be
used in these
combinations.
50. M/s. Jfrin
Pharmaceutical
Laboratories, Hub,
Balochistan.
Jfpidox Oral Powder
Each Kg contains:-
Tylosin Tartrate………100gm
Doxycycline Hcl……...200gm
Phyenylbutazone….……12gm
Bromhexine Hcl…...........5gm
Colistine Sulphate….500 MIU
(Antibacterial/Antibiotic).
Drug which are
“Me too” like
drugs with minor
modifications
which may or
may not be
considered.
51. M/s. Biogen Pharma.
8th Km Rawat Chak Beli
Road, Rawat.
Amcocin Liquid
Each 100ml contains:-
Enrofloxacin………….…10%
Colistin Sulphate…………3%
Amantadine HCI…………4%
(Antibiotic)
Contains
“Amantadine”
which is antiviral
drug for flu and
may have drug
interaction and
resistance
problem so
should not be
used in these
combinations.
52. M/s. Biogen Pharma.
8th Km Rawat Chak Beli
Road, Rawat.
Doxytylodine Powder
Each 1000gm contains:-
Tylosin Tartrate BP…..200gm
Doxycycline HCI BP…100gm
Amantadine HCI……….40gm
Contains
“Amantadine”
which is antiviral
drug for flu and
may have drug
interaction and
resistance problem
so should not be
used in these
combinations.
53. M/s. Biogen Pharma,
Rawat.
Advantage Water Soluble
Powder
Each 1000gm contains:-
Tylosin Tartrate BP..…200gm
Doxycycline HCI BP….40gm
Amantadine HCI……...100gm
Colistin Sulphate…5000 MIU
(Antibiotic/
Antibacterial/Antiviral).
Contains
“Amantadine”
which is antiviral
drug for flu and
may have drug
interaction and
resistance
problem so should
not be used in
these
combinations.
305
54. M/s. Wimits
Pharmaceuticals,
Plot No.129, Sunder
Industrial Estate (P.I.E)
Raiwind Road, Lahore.
Wimtox Injection
Each ml of liquid injection
contains:-
Novaminsulfon………....40mg
Etilefrin B.P …………...0.2mg
Calcium Gluconate B.P.100mg
Magnesium Gluconate
B.P …………………….10mg
Sodium Salicylate B.P …7mg
Nicotinamide B.P …….0.3mg
Caffeine B.P ………..…10mg
Boric Acid B.P ……..…10mg
(Analgesic and Antipyretic)
Finished product specifications
are Manufacturer.
Recommended
55. M/s. Wimits
Pharmaceuticals,
Plot No.129, Sunder
Industrial Estate (P.I.E)
Raiwind Road, Lahore.
Stop Spray
Each 100ml of aerosol
contains:-
Deltamethrin BP……...0.500g
(Insecticide)
Recommended
56. M/s. Wimits
Pharmaceuticals,
Plot No.129, Sunder
Industrial Estate (P.I.E)
Raiwind Road, Lahore.
Defender Spray
Each 30g of aerosol contains:-
Neomycin Sulfate BP...150mg
Clostebol Acetate….....150 mg
(Antiseptic)
Recommended
57. M/s. Wimits
Pharmaceuticals,
Plot No.129, Sunder
Industrial Estate (P.I.E)
Raiwind Road, Lahore.
Methra Spray
Each 100ml of aerosol
contains:-
Permethrin ……………..0.5 g
(Insecticide)
Recommended
58. M/s. D-Maarson
Pharmaceuticals,
Plot # 17, Street # SS-2,
National Industrial Zone
Rawat, Islamabad.
NOVA DM INJECTION
Liquid Injection
Each 100ml contains:-
Novaminsulfon………..…..4g
Etilefrin………………...0.02g
Calcium Gluconate………10g
Magnesium Gluconate…...1.0g
Sodium salicylate……..0.700g
Nicotinamide…………....0.3g
Caffeine……………….…1.0g
Boric acid………………..1.0g
(Analgesic, Antipyretic)
Recommended
306
Decision: Registration Board deferred the case for the recommendations of Expert
Committee on Veterinary Drugs.
Case No.13. Directions from Drug Appellate Board regarding Nitrofurans.
Drugs Appellate Board in its 140th
Sitting held on 20-08-2013 in the appeal of M/s.
Selmore Pharmaceuticals (Pvt.) Ltd., Lahore regarding rejection of their product “URO-
Pessaries” decided as follows:-
i) That the said formulation shall be referred to two veterinary experts, by the
defendants, namely: (i) Vice Chancellor, University of Veterinary and Animal
Sciences, Lahore, and (ii) A veterinary expert from Army, to be named by Brig.
Akbar Waheed, Member, Drugs Appellate Board, for their expert opinion.
ii) The Chairman, Drugs Appellate Board was authorized to take decision on the
aforesaid Appeal in the light of the recommendations of the experts.
iii) That the fate of other drug(s) / brand(s) of the same formulation available in the
market shall also be decided by the Registration Board in the light of the
recommendations of the experts and the provisions of law / rules, under
intimation to the Drugs Appellate Board.
Accordingly, opinion of following experts regarding registration of product has been
obtained, which are as follows:-
S. No. Name of Expert. Recommendations.
1. Prof. Dr. Muhammad Ashraf,
Dean, Faculty of Bio-Sciences,
University of Veterinary &
Animal Sciences, Lahore
URO-Pessaries having combination of
Chlorotetracycline, Furazolidone and
Metronidazole is not recommended for approval in
animals.
2. Ltd. Col. Iftikhar Ahmad Anjum,
for DGRV&F, QMG Branch
RV&F Directorate, GHQ,
Rawalpindi.
In order to proceed further, following steps be
taken up before the product is registered:-
a) A fair trial on animals after cultural sensitivity
test, at least on 50 animals which can be provided
by Military Farms located at Lahore or Okara.
b) Deliberate and authentic recording of readings
and fair evaluation be ensured.
c) Post treatment cultural sensitively in an aseptic
environment.
307
The Drugs Appellate Board in its 142nd
Sitting held on 20-06-2014 keeping in view the
fact that Nitrofurans are recognized by FDA as mutagens / carcinogens, decided to dismiss the
appeal with the directions to the respondent Registration Board to decide the fact of similar
formulations accordingly. As per record, there is only one product “Utacare Pessary” (Reg.
No.035062) is registered in the name of M/s. Nawan Laboratories (Pvt) Ltd., Karachi.
Decision: In compliance to decision of Drugs Appellate Board, Registrstion Board
decided to issue the show cause notice to M/s. Nawan Laboratories (Pvt.) Karachi for
cancellation of registration of Utacare Pessary, (Reg. No.035062). Registration Board
authorized its Chairman for issuance of show cause notice for any other such me too drug.
Case No.14 Registration of imported veterinary drugs - Correction in minutes.
The Drug Registration Board in its 237th
meeting held on 26-02-2013 approved the
registration of following imported veterinary drugs in the name of M/s. Mustafa Brothers,
Faisalabad, manufactured by M/s. Veyx-Pharma B.V, Forellenwegm SJ Raamsdonksveer, The
Netherlands, subject to inspection of manufacturer abroad, verification of storage facilities as per
policy. The firm has deposited the required fee;
S# Name of Drug (s) /Composition. Decontrolled /
Pack Size.
Shelf Life
1. Masti Veyxym ® Suspension for
Intramammary.
Each 10gm contains:-
All-rac-aTocopheryl acetate (Vitamin E
acetate)……120.00mg.
Vitamin A concentrate 100.000 IU.
Chymotrypsin………2400 FIP-U.
Trypsin……………..240 FIP-U.
Papain…………………6-FIP-U.
Tube of 10ml 02 years
2. Veyxyl ® LA 20% Solution.
Each 1ml contains:-
Amoxicillin trihydrate…229.60mg
(equivalent to 200.00mg Amoxicillin).
50ml
100ml
03 years
308
The applicant M/s. Mustafa Brothers, Faisalabad has requested for issuance of
registration letter of the above said drugs. M/s. Mustafa Brothers, Faisalabad was advised to
provide legalized (CoPP) of M/s. Vexy-Pharma B.V., Forellenweg 16, NL-4941 SJ
Raamsdonksveer, issued by Netherlands as the manufacturing site is located in Netherlands duly
endorsed by the Pakistan Embassy/Consulate office in the country of export.
In response, M/s. Mustafa Brothers, Faisalabad have informed that the production of
“Masti Veyxym ® Suspension for Intramammary & Veyxyl ® LA 20% Solution” is performed
in the Netherlands (as contract manufacturer) by M/s. Vexy-Pharma B.V, the Netherlands for
their principal company M/s. Vexy-Pharma GmbH, Germany. However, this production site only
produces bulk (unlabeled bottles / injections) that is shipped subsequently to their site in
Germany M/s. Vexy-Pharma GmbH for finalization the production. At the German site,
the secondary packaging takes place and final batch release is performed. The firm M/s. Vexy-
Pharma GmbH (Germany) is the marketing authorization holder and consequently responsible
for the overall quality, the safety and the efficacy of the products.
The firm has disclosed that the products referred above are being manufactured in bulk at
“M/s. Vexy-Pharma B.V, The Netherlands” then these will be labeled and packed at M/s. Vexy-
Pharma GmbH, Germany. Now it is clear the firm will import these drugs from Germany.
Therefore, it needs amendment in minutes i.e. name of manufacturer is mentioned from
Netherlands in the minutes of 237th
meeting of the Registration Board.
Decision: Registration Board approved correction in minutes of 237th
meeting for
name of manufacturer as M/s. Vexy-Pharma GmbH, Germany for the following products.
S# Name of Drug (s) /Composition. Decontrolled /
Pack Size.
Shelf Life
1. Masti Veyxym ® Suspension for
Intramammary.
Each 10gm contains:-
All-rac-aTocopheryl acetate (Vitamin E
acetate)……120.00mg.
Vitamin A concentrate 100.000 IU.
Chymotrypsin………2400 FIP-U.
Tube of 10ml 02 years
309
Trypsin……………..240 FIP-U.
Papain…………………6-FIP-U.
2. Veyxyl ® LA 20% Solution.
Each 1ml contains:-
Amoxicillin trihydrate…229.60mg
(equivalent to 200.00mg Amoxicillin).
50ml
100ml
03 years
Case No.15 Registration of veterinary drug.
Drug Registration Board in its 236th
meeting held on 20th
November, 2012 approved the
registration of following imported veterinary drugs in the name of M/s. Vet Line International,
Lahore manufactured by M/s. Bela-Pharm GmbH & Co.KG Lohner Strasse 19 49377 Vechta,
Germany, subject to inspection of manufacturer abroad, verification of storage facilities as per
policy. The firm has deposited the required fee.
# No. Name of Drug (s) /Composition. Decontrolled /
Pack Size.
Shelf Life.
1. Neomycinsulfat Powder.
Each gm powder contains:-
Neomycin Sulphate……..1000mg.
100gm.
500gm.
1kg.
5kg.
3 years
2. Belacol 100% Pulver
Each gm powder contains:-
Colistin Sulphate……….1000mg.
100gm.
250gm.
1kg. & 2.5kg
3 years
The storage facility of the importer has also already been verified by the Area FID. The
applicant M/s. Vet Line International, Lahore has requested for issuance of registration letter of
the above said drugs. During processing of case for issuance of registration letter, it was
observed that these products are 100% API and under the Drug Act 1976 the drugs which are
ready to use are registered under the Section 7 of the Act. Then it was deliberated to get opinion
of experts. Accordingly, views of the following experts regarding use of products above in pure
form “100 API” with special reference to efficacy, safety, toxicity and residual effects in food
producing animal has been obtained, which are as follows:-
310
S.# Name of Expert. Opinion
1. Dr. Muhammad Ovais Omer,
Chairman,
Department of Pharmacology &
Toxicology,
University of Veterinary and
Animal Sciences, Lahore.
i) Based on the pharmacological properties,
Neomycinsulfat is a recommended drug for
treatment of enteric infections in calves, pigs and
chickens.
ii) Based on the pharmacological properties,
Colistin Sulphate is a recommended drug for
treatment of Salmonella, E. coli, Campylobacter,
Pullorum, Paratyphoid infections, Colibacillosis
and Diarrhoea by E.coli in different animal
species.
2. Brig. Zahid Hussain Abid,
Director Rem & Vet.,
QMG Branch RV & F Dte,
General Headquarters,
Rawalpindi.
As regards efficacy, safety, toxicity and residual
effects in food producing animal, viz a viz both
the products are concerned, in puts of the experts
from University of Veterinary and Animal
Sciences, Lahore would be more valuable and
pertinent. However, it is suggested that a trial
may be conducted at least on 200 animals for
establishment of all above factors. In this regard
Army Veterinary School can be assigned this
task.
3. Dr. Farzana Chowdhary,
Director,
Department of Pharmacy,
University of Veterinary &
Animal Sciences,
Lahore.
1. Neomycinsulfat – this drug contains 100mg
Neomycin Sulphate in 1gm indicating that it is a
pure API and not a veterinary finished dosage
form. According to the Drugs Act, 1976 APIs do
not require registration and can only be imported
by manufacturers possessing a valid Drug
Manufacturing License (Formulation) and
registration of the finished drug of which it is an
ingredient.
2. Belacol 100% Pulver contains Colistin
Sulphate 1000mg per 1gm (1000mg) powder and
does not contain any adjuvant or excepient
which is indicative of the fact that it is a pure
API and not a finished dosage form for
veterinary use. Only finished dosage forms
require registration under the Drugs Act, 1976,
whereas, APIs can be imported only by those
who hold a valid DML (Formulation) and
registration of finished drug containing that API.
311
Decision: Registration Board deferred the case for the recommendations of Expert
Committee on Veterinary Drugs and list of all such products registered earlier by the
DRAP.
Case No.16. Correction of composition of registered veterinary drug-Neurozoc Injection
Regn. No. 074072.
M/s. Hilton Pharma (Private) Limited, Karachi have requested for correction of
composition of their registered veterinary “Neurozoc Injection (Reg. No.074072)”. They have
informed that they want to apply below composition as “each 1ml contains, pack size of 100ml”
but by typographically mistake it was mentioned in application dossier as “each 100ml contains,
pack size 100ml”. The registration letter received for following composition “each 100ml
contains, pack size 250ml & 500ml”. They have therefore requested for correction of
composition from “each 100ml contains” to “each 1ml contains” and also change in pack size
from 250ml & 500ml to “100ml”:-
Approved composition Revised composition.
Neurozoc Injection.
Each 100ml contains:-
Novaminsulfon …………….. .100mg.
Etilefrin……………………. 0.50mg.
Calcium gluconate …………250mg.
Magnesium gluconate ……… 25mg.
Sodium salicylate ………….17.5mg.
Nicotinamide ………………0.75mg.
Caffeine………………………. 25mg.
Boric acid………………………25mg.
Neurozoc Injection.
Each ml contains:-
Novaminsulfon …………….. .100mg.
Etilefrin……………………. 0.50mg.
Calcium gluconate …………250mg.
Magnesium gluconate ……… 25mg.
Sodium salicylate ………….17.5mg.
Nicotinamide ………………0.75mg.
Caffeine………………………. 25mg.
Boric acid………………………25mg.
M/s. Hilton Pharma (Private) Limited, Karachi have deposited required fee Rs.20000/-
and submitted following supporting documents:-
i) Copy of registration letter.
ii) Copy of old Form-5.
iii) New Stability data.
iv) Copy of new Form-5.
Decision: Registration Board deferred the case for the recommendations of Expert
Committee on Veterinary Drugs.
312
Case No. 17. Cancellation of registration of drugs and stoppage of production.
Drug Registration Board in its 240th
meeting held on 07-11-2013 considered the
inspection report of M/s. Avicenna Laboratories (Pvt) Ltd.,14 Km, Sheikhupura, Faisalabad
Road, Bikhi, District Sheikhupura dated 04-03-2013 conducted by the area FID, wherein the FID
has reported that the firm has registration of following (10) injectable products including
(Penicillin and Steroids) but the Injectable Section is not approved as yet by Licensing Section
and the Registration Section has granted the registration of the same:-
S. No. Reg. No. Name of Drug (s) / composition.
1. 035001 Gentacen 100 Injectable Solution.
Each ml Contains: -
Gentamycin Sulphate (eq to 100mg
Gentamycin base).
2. 035002 Moxicol Injectable Suspension.
Each ml contains: -
Amoxycillin Trihydrate 100mg.
Colistin Sulphate 250,000 IU.
3. 035003 Avimox Injectable Suspension.
Each ml contains: -
Amoxycillin base (as trihydrate) 150mg.
4. 035004 Tylocen-200 Injectable Solution.
Each ml contains: -
Tylosin Sulphate 200mg.
5. 035005 Avoxy LA Injectable Suspension.
Each ml contains: -
Oxytetracycline HCl…200mg.
6. 035006 Dexon-5 Injectable Solution.
Each ml contains: -
Dexamethasone 5mg.
7. 035127 Oxytocen Injectable Solution.
Each ml contains: -
Oxytocin 10 I.U.
8. 043166 Predexon Injectable Suspension.
Each ml contains:-
Dexamethasone ……… 2.5mg.
Prednisolon ………….. 7.5mg.
9. 043167 Lincospec Injectable Solution.
Each ml contains:-
Spectinomycin Sulphate 100mg base.
Lincomycin Hydrochloride 50mg base.
313
10. 043168 Avigen-F20 Injectable Solution.
Each ml contains:-
Gentamycin Sulphate ……. 10mg.
Flumequine ……………… 20mg.
The Drug Registration Board decided that the production of the firm for above mentioned
products should immediately be stopped till the complete investigation of the matter and issue a
show cause notice to the firm for explanation of reasons in their defense. Then place the case
before the Board for further deliberations.
Accordingly, a show cause notice was issued to the firm.
In response to the show cause notice the firm has submitted following documents:-
i) Approval of layout plan.
ii) Copies of registration letters.
iii) Copy of layout plan.
M/s. Avicenna Laboratories (Pvt) Ltd., Sheikhupura was again advised to provide proof
of approval of the Injectable Section and also provide proof of renewal of registration of drugs
above said drugs. The firm have submitted copies of the acknowledgement of last renewal of
registration of above said products and also submitted that on April 15, 2014 the panel
constituted by the Director QA, inspected their Oral Powder, Liquid, Vaccine and Injectable
Sections. The report will be submitted in coming board meeting. The firm have further submitted
that they also want to shift all Penicillin products into toll manufacturing.
DDC (RRR) was also requested to confirm renewal status of the above products. DDC
(RRR) have confirmed the renewal of the drugs.
The Chairman, CLB also resumption of production to the firm only in veterinary oral
powder and veterinary oral liquid sections.
Decision: Registration Board after detailed deliberations canceled the registrations of
following products of M/s. Avicenna Laboratories (Pvt) Ltd., Sheikhupura as the firm do
not have the approved manufacturing facility for these products;
314
S. No. Reg. No. Name of Drug (s) / composition.
1. 035001 Gentacen 100 Injectable Solution.
Each ml Contains: -
Gentamycin Sulphate (eq to 100mg
Gentamycin base).
2. 035002 Moxicol Injectable Suspension.
Each ml contains: -
Amoxycillin Trihydrate 100mg.
Colistin Sulphate 250,000 IU.
3. 035003 Avimox Injectable Suspension.
Each ml contains: -
Amoxycillin base (as trihydrate) 150mg.
4. 035004 Tylocen-200 Injectable Solution.
Each ml contains: -
Tylosin Sulphate 200mg.
5. 035005 Avoxy LA Injectable Suspension.
Each ml contains: -
Oxytetracycline HCl…200mg.
6. 035006 Dexon-5 Injectable Solution.
Each ml contains: -
Dexamethasone 5mg.
7. 035127 Oxytocen Injectable Solution.
Each ml contains: -
Oxytocin 10 I.U.
8. 043166 Predexon Injectable Suspension.
Each ml contains:-
Dexamethasone ……… 2.5mg.
Prednisolon ………….. 7.5mg.
9. 043167 Lincospec Injectable Solution.
Each ml contains:-
Spectinomycin Sulphate 100mg base.
Lincomycin Hydrochloride 50mg base.
10. 043168 Avigen-F20 Injectable Solution.
Each ml contains:-
Gentamycin Sulphate ……. 10mg.
Flumequine ……………… 20mg.
Case No.18. Registration of Magnesium Sulphate 15% in veterinary products.
Drug Registration Board in its 243rd
meeting held on 08-09th
May, 2014 considered and
approved the registration of following drug for import in the name of M/s. BN Pharmaceuticals,
Lahore manufactured by M/s. Laboratories Chaix et Du Marais Lavoisier Head Quarter Paris
France subject to price fixation / calculation:-
315
Name of drug (s)/Composition. Demanded Price
/Pack.
Sulphate De Magnesium Lavoisier (1.5G/10ML) 15%
(I.V) Injectable.
Each ampoule contains: -
Magnesium as Sulphate. 1.5g/10ml (15%).
Rs.450/Per ampoule.
Rs.4500/Per 10 ampoules.
Meanwhile, the firm M/s. BN Pharmaceuticals, Lahore have submitted the references in
support of above mentioned product which is already under process of registration. The firm has
also submitted the list of countries-organizations in which this product is registered / sponsored
at this time along with the report of WHO Drug Information volume-21/2.2007 WHO Geneva.
The Magnesium Sulphate 15% is not approved by any of the reference authorities i.e.
EMA, USFDA, TGA or PDMC, except France.
Decision: Registration Board referred the case to Review Committee for formulation
review.
Registration-II
Case No.19 Registration of drugs deferred by Registration Board.
a. Cases deferred for expert opinions.
i. Lurisa Tablet 40mg and 80mg – M/S Helix Pharma, Karachi.
Registration Board in 242nd
meeting deferred following products for expert opinion. Accordingly
products were referred to expert for views. Comments are as under.
S.
No
Name of drug(s) & Composition Proposed
Pack size
Demanded
Price
1 Lurisa Tablets
Each film coated tablet contains:
Lurasidone HCl………..….40 mg
(Antipsychotic for Treatment of Schizophrenia)
10’s,
20’s,
30’s
As per PRC
2 Lurisa Oral Tablets
Each tablet contains:
Lurasidone HCl…….80 mg
(Antipsychotic for Treatment of Schizophrenia)
10’s,
20’s,
30’s
As per PRC
316
Brig. Saleem Jehangeer
Armed Forces Institute of
Mental Health,
Rawalpindi
Prof. Dr. Rizwan Taj
Psychiatrist,
Pakistan Institute of Medical
Sciences,
Islamabad
Dr. Nadeem Abbas
Fauji Foundation Medical
Centre,
Rawalpindi
Brig for Comdt (Farrukh Hayat
Khan) stated that Maj. Gen
Salim Jehangir, Commandant of
Armed Forces Institute of
Mental Health is not avail due
to official commitments
I have study documents and fee
that this medication should be
available in Pakistan.
It is a new salt which has shown
promising result as compared to
other products in the market it
side effect profile is better also.
I am recommending its
availability in Pakistan
Although Lurasidone salt is not
available / introduced in Pakistan,
In the light of above mentioned
facts & data provided, the drugs
Lurasidone (Lurisa) 40mg &
Lurasidone (Lurisa) 80mg are
recommended for Registration
Board
Decision: Registration Board discussed and agreed to above expert opinions. However, the Board advised firm to provide data for stability studies conducted under zone IV-A conditions as per ICH / WHO guidelines for consideration of Registration Board.
ii. Roflumilast 500mcg Tablet.
Registration Board in its various meetings deferred registration of Roflumilast 500mcg Tablet of
various firms for expert opinion. Accordingly products were referred to expert for views. Comments are
as under.
S.
No
Name of firm(s) Name of drug(s), Composition &
Registration Board Meeting
Proposed
Pack size
Demanded
Price
1. M/s Macter
International
Karachi
Milast Tablet
Each film coated tablet contains:
Roflumilast …………… 500 mcg
(Phosphodiesterase 4 inhibitors)
( M-242 )
Per tab.
Rs.17.36/-
2. M/s Hiranis
Pharma, Karachi
Roflu Tablet
Each film coated tablet contains:
Roflumilast…………..500mcg
10’s
14’s
Rs.270/-
Rs.378/-
317
(Inhibitor of the enzyme PDE-4)
( M-243 )
3. M/s Helix
Pharma, Karachi
Raspro 500mcg Tablet
Each tablet contains:
Roflumilast…………...500 mcg
(Anti-Inflammatory)
( M-243 )
10’s As per PRC
Brig. Dr. Aslam Khan,
Consultant Pulmonologist,
Military Hospital,
Rawalpindi
Dr. Rehana Kauser,
Consultant Pulmonologist,
Pakistan Institute of Mecial
Sciences, Islamabad
Dr. Shazli Manzoor
Quaid-e-Azam International
Hospital, Islamabad
Regarding expert opinion on
efficacy, safety, quality and
cost effectiveness of
Roflumilast in the
management of COPD
Roflumilast is a
Phosphodiesterase-4 Enzyme
Inhibitor. FDA and EMEA has
approved this drug as an
adjunct to bronchodilator
therapy in the maintenance
treatment of severe chronic
obstructive pulmonary disease
(COPD) associated with
chronic bronchitis given for the
purpose of preventing
exacerbations
Roflumilast significantly
improved prebronchodilator
FEV1 and decreased the rate of
moderate to severe
exacerbations in a 52 week,
randomized trial of 3091
patients with COPD .
Compared to placebo,
roflumilast decreased
exacerbations (17 percent [95%,
CI 8-25]).
The use of a once daily oral
Regarding expert opinion on
efficacy, safety, quality and
cost effectiveness of
Roflumilast in the management
of COPD. FDA and EMEA
approved this drug for use in
COPD management in severe
and very severe COPD. This
drug reduce Exacerbations rate
in COPD also included in
GOLD guidelines
However certain studies
reported no much beneficial
role in the COPD patients.
Clinical Studies have also
demonstrated higher
pharmacological activity and
better tolerability of as
compared to earlier PDE-4
inhibitors. In my honest opinion
this drug may be helpful in the
management of COPD in
combination with other drugs
so it should be cost effective
and affordable to the patients.
Regarding expert opinion on
efficacy, safety, quality and cost
effectiveness of Roflumilast. In
this connection I would
recommend that Roflumilast
(PDE4 inhibitor), is an FDA and
EMEA approved drug with
established role in the
management of COPD. This has
been proven to reduce COPD
exacerbations in various clinical
trials and also included in GOLD
guidelines 2014. Clinical Studies
have also demonstrated higher
pharmacological activity and
better tolerability of Roflumilast
as compared to earlier PDE-4
inhibitors. Therefore, Roflumilast
500mcg orally once a day if made
available in Pakistan especially
from Macter platform due to
quality and cost effectiveness
concern; it can held in reducing
suffering due to exacerbations of
COPD.
318
medication in COPD is
enticing; however, the
medication should be used as a
maintenance therapy to prevent
exacerbations rather than to
improve other COPD outcomes
It is a safe drug which is
contraindicated only in
moderate or severe hepatic
impairment (Child-Pugh class B
or C)
In view of the above I
recommend this drug for
registration at an affordable
price.
Decision: Registration Board discussed and agreed to above expert opinions. However,
the Board advised firm to provide data for stability studies conducted under zone IV-A
conditions as per ICH / WHO guidelines for consideration of Registration Board.
iii. Cocard Plus 75/75MG Tablet – M/S Helix Pharma, Karachi.
Registration Board in 237th
meeting approved following product of M/s Helix Pharma,
Karachi subject to reason mentioned in last column. Accordingly provided data was referred to
expert for views. Comments are as under.
S.
No
Name of drug(s) & Composition Proposed
Pack size
Demand
ed Price
Decision
1 Cocard Plus 75/75mg Tablet
Each tablet contains:
Clopidogrel bisulfate eq. to
clopidogrel……….75 mg
Aspirin as enteric coated
pellets………….…75 mg
(Anti coagulant anti platelet)
10’s As per
PRC
Approved subject to
confirmation of
Bilayered tablet
manufacturing facility
319
Dr. Amanullah Khan,
Director, Drug Testing
Laboratory,
Government of Baluchistan,
Quetta
Mr. Abdul Razzaq,
Director, Drug Testing
Laboratory,
Government of Sindh,
Karachi
Mr. Muhammad Jamil Anwar,
Director, Drug Testing
Laboratory,
Government of Punjab,
Lahore
COCARD PLUS 75/81MG
TABLET dissolution profile is
different from the originator
brand (OGREL PLUS 81
TABLET OF M/S BOSCH
PHARMA, Karachi) and
scientifically the dissolution
method applied is incorrect
because they use separate tablet
of Cocard for acid and buffer
stages rather replacing the
buffer medium from acid to
buffer stage, hence on scientific
grounds of dissolution profile
the product COCARD PLUS
75/81MG TABLET is not
recommended.
Tablet COCARD PLUS is a
bilayered film coated
(Antiplatelets) having 02
years shelf life is indicated in
different kind of CV diseases.
The comparative
dissolution profile of
M/s Helix Pharma
Products “ COCARD
PLUS Tablets” with
originator Brand “
OGREL PLUS 81
TABLETS” by M/s
Bosch Pharmaceuticals,
Karachi” was thoroughly
checked & evaluated.
The stability profile
shows that stability
studies was carried out,
and there was no
significant physical and
chemical changes when
product was kept at 40o
C + 2o
C /75% RH +
5%, provided proof of
climatic chamber, also
complies the other tests
performed such as
weight variation, Assay,
disintegration time,
dissolution and other
aspects that meets the
required quality
specifications.
The data provided
also reflects that
manufacturing method /
equipments / instruments
are properly validated
and calibrated.
The last panel
inspection was
COCARD PLUS 75/81MG
TABLET
It is observed that necessary
equipment, particularly Bilayered
Tableting Machine is available for
manufacturing of Cocard Plus 75mg
/81mg Tablet.
The accelerated stability studies for
the product has been carried out
with the concluded results of active
ingredient within the limits and also
shows that no significant physical
and chemical change occurred
during accelerated stability study
carried out for six months.
The Dissolution Profile of the
product Batch TF001 has been
studied in acidic and buffer stage
and observed satisfactory. The
comparative study with the other
brand “Ogrel Plus 81mg Tablets of
M/s Bosch Pharma, Karachi was
also carried out with the acceptable
results.
In the light of above and as per
data / information provide the
drug “Cocard Plus 75mg /81mg
(Clopidogrel 75mg + Aspirin
81mg) Tablet is recommended for
registration.
320
conducted on 28-06-
2013 & for verification
of bilayered tablets
manufacturing facilities
was conducted 06-12-
2013 wherein they stated
that the firm has good
facilities provided for
manufacturing and
quality control and GMP
Compliance was found
good / satisfactory.
The data provided is
sufficient regarding raw
material specification &
finished product
specification &
analytical procedures,
labeling, packing is also
available.
So In the light of
above mentioned facts
& data provided the
drug COCARD PLUS
Tablets is
recommended for
registration.
It is to mention here that following is correct formulation submitted by the firm and same has
been evaluated by experts. However, erroneously wrong formulation has been mentioned in
agenda and minutes of 245th
Registration Board meeting:-
Cocard Plus 75/81mg Tablet
Each tablet contains:
Clopidogrel bisulfate eq. to clopidogrel…….75 mg
Aspirin as enteric coated pellets………….…81 mg
(Anti coagulant anti platelet)
Decision: Registration Board decided to forward comments of Director DTL, Quetta to
the manufacturer for clarification.
321
iv. Dexlansoprazole - M/s OBS Pakistan, Karachi
Registration Board in its 235th
meeting deferred following products of M/s OBS Pakistan,
Karachi for reason mentioned in last column.
Name of Drug & Composition Pack Demanded
MRP
Decision
Kapdex 30mg Capsule
Each capsule contains:-
Dexlansoprazole ………..30mg
(Anti ulcerants)
14’s Rs.840.00 Deferred.
Not me- too
product.
May be referred to
expert committee
for new molecule
Kapdex 60mg Capsule
Each capsule contains:-
Dexlansoprazole ……...60mg
(Anti ulcerants)
14’s Rs.1260.00 Deferred.
Not me- too
product. May be
referred to expert
committee for new
molecule
Registration Board in 245th
meeting discussed same formulation and agreed to expert
opinions and advised the firms to provide data for stability studies conducted under zone IV-A
conditions as per ICH / WHO guidelines for consideration of Registration Board.
M/s OBS Pakistan, Karachi has deposited remaining fee (Rs.50000/-) and requested to consider
their above formulations.
Decision: Keeping in view decision of 245th
meeting of registration board regarding same
formulation, the advised firm to provide data for stability studies conducted under zone
IV-A conditions as per ICH / WHO guidelines for consideration of Registration Board.
b. Cases for registration of Tramadol.
Registration Board in its 236th
meeting held on 20th
November, 2012 had decided
that since Nalbuphine and Tramadol are not controlled drugs as per INCB regulation. So the
Board will not consider these cases in light of controlled drug guidelines. However to avoid
misuse potential, their procurement and manufacturing record shall be strictly maintained and
322
submitted in quadruplicate under Rule 30 (6) of Drugs (Licensing, Registering and Advertising)
Rules, 1976 to the E&M (Evaluation of Monitoring) Department of DRAP.
In light of above decision for registration of Tramadol containing product of
following firm was pending for decision. Firm has deposited the remaining fee @ Rs.12000/- as
per revised schedule for fees. Details are as under:-
S. No. Name of firm Name of Drug(s) Pack MRP Decision
1. M/s Safe
Pharmaceutic
als, Karachi
Magadol Drops
Each ml contains:-
Tramadol HCl ………2.5mg
(Non Narcotic Analgesic)
10ml As per PAC 225th
RB
Deferred for
confirmatio
n of facility
2. -do-
Magadol Capsule
Each capsule contains:-
Tramadol HCl ………50mg
(Non Narcotic Analgesic)
1x10’s As per PAC -do-
Decision: Registration Board deferred the case for evaluation of registration
application as per approved check list.
c. Registration of Agomelatine Tablet 25mg.
Registration Board in its 227th
meetings deferred following products of M/s Nabiqasim
Industries, Karachi and M/s PharmaEvo, Karachi for confirmation of formulation, application on
Form 5D, fee Rs.15, 000.
M/s Nabiqasim Industries, Karachi
Name of Drug & Composition Pack Demanded
MRP
Modton Tablet 25mg
Each film coated tablet contains:-
Agomelatine ……25mg
10’s Rs.1500.00
323
(Antidepressant)
M/s PharmEvo, Karachi.
Name of Drug & Composition Pack Demanded
MRP
Agloda 25mg Tablet
Each tablet contains:-
Agomelatine ……..25mg
(Anti depressant)
10’s
14’s
28’s
Rs.2690/-
Rs.3750/-
Rs.7500/-
Later on scrutiny of registration data reveals that the above formulation is already approved by
the Registration Board in its 236th meeting in favour of M/s Servier Research and Pharmaceuticals
(Pakistan) Ltd, Lahore under the brand name “ Valdoxan 25mg Tablets”
M/s PharmEvo has deposited remaining fee @ Rs.5,000/- and M/s Nabiqasim Industries,
Karachi has also deposited fee @ Rs.15,000/- (dated 10-08-2010) + Rs.52,000/- (dated 24-
01-2013) + Rs.5,000/- (dated 06-05-2013)
Decision: Registration Board deferred the case for evaluation of registration
applications as per approved check list.
d. Kaizen Pharmaceutical (Pvt.) Ltd , Karachi
i. Calcium citrate + Vitamin D.
Registration Board in its 237th
meeting deferred following registration application of M/s
Kaizen Pharmaceuticals (Pvt.) Ltd, Karachi for reason mentioned in last column.
Name of drug(s) & Composition Proposed
Pack size
Demanded
Price
Date of
application,
Diary No. &
Form
Decision
Calvit-D Sachet
Each sachet contains:
Calcium citrate
maleate…………..2500mg
Vitamin D……….400 IU
(Calcium and Vitamin
10’s
20’s
As per PRC 28-01-2013
Dy.No.60
Form-5
Rs.20,000/-
Deferred for
submission of
application on
form-5D with
balance fee
324
supplement/replacement preparation)
Now firm has stated that same formulation is already registered in favour of M/s Maple
Pharmaceuticals, Karachi with the brand name “Calcivit Sachet” Reg. No.076051 in 234th
meeting of Registration Board.
Decision: Registration Board deferred the case for evaluation of registration
application as per approved check list.
ii. Alfacalcidol + Calcium carbonate
Registration Board in its 237th
meeting deferred following registration application of M/s
Kaizen Pharmaceuticals (Pvt.) Ltd, Karachi for reason mentioned in last column.
Name of drug(s) & Composition Proposed
Pack size
Demanded
Price
Date of
application,
Diary No. &
Form
Decision
Alfakal Tablet
Each tablet contains:
Alfacalcidol ………....0.5 mcg
Calcium carbonate….1000 mg
(Calcium and Vitamin Analogue)
10’s
20’s
30’s
As per PRC 28-01 -2013
65
Form-5
Rs.60,000/-
Deferred for
Clarification
regarding dosage
of calcium
Now firm has stated that same formulation is available / marketed by M/s SchazooZaka
(Pvt.) Ltd, Lahore with the brand name “Bone-Care C Tablet” vide Reg. No.062790.
Decision: Registration Board deferred the case for evaluation of registration
application as per approved check list.
e. Sodium Polystyrene– M/s PharmaEvo, Karachi.
Registration Board in its 227th
meeting deferred following product of M/s PharmaEvo,
Karachi for expert opinion.
S.
No
Name of drug(s) & Composition Proposed
Pack size
Demanded
Price
Date of
application,
Diary No. &
Decision
325
Form
1 Klenar Sachet
Each sachet contains:-
Sodium Polystyrene
Sulphonate …………..…15000mg
(Potassium removing resin)
15’s
30’s
Rs.3000.00
Rs.6000.00
02-11-2009
2229
Form-5
Rs.8000/-
Deferred for
expert
opinion
Now M/s PharmEvo have deposited remaining fee @ Rs.42,000/- being new formulation.
Decision: Registration Board deferred the case for evaluation of registration
application as per approved check list. Moreover, the product will be referred to Prof. Dr.
Ghias Butt, PIMS, Islamabad; Syed Ather Hussain, Head of Nephrology, Agha Khan
University Hospital, Karachi and Uzma Bano, FFH, Rawalpindi for expert opinion.
f. Macter International, Karachi
Following products of M/s Macter International, Karachi was deferred by Registration
Board in 214th
meeting for confirmation of atomic absorption spectrophotometer.
Name of Drug & Composition Pack Demanded
MRP
Mactosin Suspension
Each 5ml contains:-
Ossien Mineral Complex (Hydroxy Apatite)
800mg equivalent to
Calcium …………. 130mg
Phosphorous …………… 68.8mg
Residual Mineral Salts ….57.5mg
Collagen …………………87.5mg
Other Proteins …………20mg
Trace elements F1,mg,Zn,Fe,Ni,Cu)
60ml Rs.100.00
Mactosin Tablets
Each tablet contains:-
Ossien Mineral Complex (Hydroxy Apatite)
250mg equivalent to
Calcium ….53.5mg
Phosphorous …….24.8mg
Residual Mineral Salts ….7.5mg
Collagen …………………87.5mg
Other Proteins …………
Per tablet Rs.5.33
326
Trace elements F1,Mg,Zn,Fe,Ni,Cu)
Later on scrutiny of registration data reveals typographic error in above formulation.
Correct formulation as applied by the firm are as under:-
Correct Formulation
Mactosin Tablets
Each tablet contains:-
Ossien Mineral Complex (Hydroxy Apatite) 800mg
equivalent to
Calcium …………. 130mg
Phosphorous …………… 68.8mg
Residual Mineral Salts ….57.5mg
Collagen …………………67.5mg
Other Proteins …………..…20mg
Trace elements F1,mg,Zn,Fe,Ni,Cu)
Mactosin Suspension
Each 5ml contains:-
Ossien Mineral Complex (Hydroxy Apatite) 250mg
equivalent to
Calcium ………….53.5mg
Phosphorous …….24.8mg
Residual Mineral Salts ….7.5mg
Collagen …………………87.5mg
Other Proteins ………… 20mg
Trace elements F1,Mg,Zn,Fe,Ni,Cu)
Federal Inspector of Drug, Karachi in inspection dated 27.09.2012 confirmed atomic
absorption in the Quality Control Laboratory of the firm.
Decision: Registration Board approved correct formulation for registration.
327
g. M/s Bosch Pharmaceuticals, Karachi.
Registration Board in 228th
& 244th
meeting deferred following products of M/s Bosch
Pharmaceuticals, Karachi reason mentioned in last column.
S. No. Name of drug(s) & Composition Proposed
Pack size
Demanded
Price
Decision
1. Calamox Chewable Tablet 200mg
Each chewable tablet contains:-
Amoxycillin as Trihydrate ..200mg
Clavulanic Acid as
Potassium ……….….28.50mg
(Antibiotics)
Not
mentioned
Not
mentioned
Deferred for confirmation of
international availability &
expert opinion
2. Calamox Chewable Tablet 400mg
Each chewable tablet contains:-
Amoxycillin as Trihydrate ..400mg
Clavulanic Acid as
Potassium ………………….57 mg
(Antibiotics)
Not
mentioned
Not
mentioned
-Do-
3. Calamox Dispersible Tablet 375mg
Each Dispersible tablet contains:-
Amoxycillin as Trihydrate ..250mg
Clavulanic Acid as
Potassium ………………...125mg
(Antibiotics)
Not
mentioned
Not
mentioned
-Do-
4. Calamox ES Oral Suspension
Each ml contains:
Amoxycillin as
Trihydrate……….600 mg
Clavulanic acid as potassium salt……
42.9 gm
(ntibiotic / antibacterial for microbial
diseases)
75ml
125ml
200ml
Rs.225.00
Rs.375.00
Rs.600.00
Deferred for confirmation of
me too status
5. Calamox-XR Tablet
Each extended release tablet contains:
Amoxycillin as
trihydrate ……….…...1 gm
Clavulanic acid as
potassium…………… 62.5 mg
(Antibiotic / antibacterial for microbial
diseases)
6’s
14’s
28’s
Rs.180.00
Rs.420.00
Rs.840.00
Deferred for confirmation of
me too status.
328
Now firm has stated as under:-
For products at S. No.1 – 3
Remaining fee @ Rs.35,000/- for each product
Application of Form-5-D
For products at S. No.4 – 5
Remaining fee @ Rs.23,000/- for each product
Application of Form-5-D
Decision: Registration Board advised firm to provide data for stability studies
conducted under zone IV-A conditions as per ICH / WHO guidelines for consideration of
Registration Board.
Case No.20 De-Registration of registered drugs.
M/s Tabros Pharma, Karachi have requested for de-registration of their registered drugs,
as per following details:-
S. No. Name of drug(s) Reg. No. Reason / Justification
1. Tabromide Capsule 2mg
Each capsule contains:-
Loperamide HCl …….2mg
014296 Due to some unavoidable
circumstances and unfeasibility in the
market
2. Evac 100mg Tablets
Each chewable coated tablet
contains:-
Alpha Tocopherol
Acetate J.P ……………100mg
021801 -do-
3. Evac 200mg Tablets
Each chewable coated tablet
contains:-
Alpha Tocopherol
Acetate J.P ……………200mg
021802 -do-
4. Evac 400mg Tablets
Each chewable coated tablet
contains:-
Alpha Tocopherol
021803 -do-
329
Acetate J.P ……………400mg
5. Evac 600mg Tablets
Each chewable coated tablet
contains:-
Alpha Tocopherol
Acetate J.P ……………600mg
021804 -do-
6. Pyrazol 500mg Tablet
Each tablet contains:-
Pyrazolone Magnesium 500mg
014346 -do-
Decision: Registration Board deferred the case for presentation before the Board.
Case No.21 Grant of Registration – Mentioning of two MRPs for a formulation.
Registration Board in its 242nd
meeting approved following registration in favour of M/s
The Searle Company Ltd, Karachi and accordingly registration letter was issued as per following
details.
S. No Reg. No. Name of Drug(s) &
Composition
Packing MRP
1 076280 Peditral-R (Bubble Gum Flavor)
Powder
(Low Osmolar Formulation)
Each sachet contains:-
Pre-cooked Rice Powder…...6g
Sodium Chloride ……….0.35g
Potassium Chloride ……0.30g
Sodium Citrate ………..0.58g
(Manufacturer’s Specifications)
10’s Sachet Rs.100.00
2 076281 Peditral-R (Mango Flavor)
Powder
(Low Osmolar Formulation)
Each sachet contains:-
Pre-cooked Rice Powder…...6g
Sodium Chloride ……….0.35g
Potassium Chloride ……0.30g
Sodium Citrate ………..0.58g
(Manufacturer’s Specifications)
10’s Sachet Rs.100.00
330
3 076282 Peditral-R (Orange Flavor)
Powder
(Low Osmolar Formulation)
Each sachet contains:-
Pre-cooked Rice Powder…...6g
Sodium Chloride ……….0.35g
Potassium Chloride ……0.30g
Sodium Citrate ………..0.58g
(Manufacturer’s Specifications)
10’s Sachet Rs.100.00
Later on firm has stated that basically they have filed for pack size of 10’s in registration
dossier including Costing, pack proposed labeling & design but only in Form-5 pack size 20’s
were also mentioned by mistake. Being brand leader they have demanded the MRP Rs.200/- for
10 sachets. While minutes of meeting 242nd
of RB shows only pack size of 20’s instead of
10’s.Firm has also submitted that Drug Pricing Committee in its 15th
meeting dated 12-04-2011
has already fixed MRP Rs.140/- for pack size of 10’s for same formulation.
Case was referred to Evaluation Cell and they explained that firm has applied for both
packs / prices i.e Rs.200/20’s & Rs.200/10’s in the same dossier.
Decision: Registration Board referred to Cost & Pricing Division, DRAP for their
opinion on the case.
Case No.22 Transfer of registered drugs:
a. Transfer of registration from import to local manufacturing:
M/s The Searle Company Ltd, Karachi have requested for transfer of registration
of following drugs from import to local manufacturing at their own facility i.e M/s The Searle
Company Ltd, F-319, S.I.T.E, Karachi
S. No. Reg. No. Name of drug (s)
1 010172 Tramal – 100 Injection
(Tramadol)
2. 023317 Tramal SR100mg Tablet
(Tramadol)
331
As per SOP, supporting documents were sent for expert opinion to three (03) experts and
now two (02) experts out of three (03) has sent their opinion. Details of comments of experts are
as under:-
Prof. Nadeem Irfan Bukhari,
Faculty of Pharmacy,
University of the Punjab,
Lahore
Director,
Drug Testing
Laboratory,
Government of
Bluchistan,
Quetta
Director,
Drug Testing Laboratory,
Government of Punjab,
Lahore
The report sent for the above
subject shows the results of
ongoing real time stability
studies of Tramal SR Tablets
and Tramal 100mg/2ml
Injection. It is understood that
the case has been filed for the
transfer of registration from
import to local manufacturing
at their local facility. My
opinion / comments are as
follows:-
The data provided on tablet
formulation indicated that the
strength (assay) of tramadol
HCl , dissolution test and the
physical characteristics were
within the limits and
specifications after the real time
one year and accelerated
studies.
The data given on the injection
formulation showed that the
tramadol was stable in this
formulation during real time as
well as in the accelerated
stability study.
The data on real time and
accelerated study reflected
some variations which were
minor and within the acceptable
limits.
After thorough review of
the stability data and
validation of analytical
methods of the products of
Tramal SR Tablets 100mg
and Tramal Injection
100mg/2ml Injection is
recommended.
In this regard the
undersigned scientifically
and logically comments as
under:-
Stability Studies:
The stability studies of
both Tramal 100 Injection
as well as Tramal SR
100mg Tablets have been
carried out against ICH
guidelines.
The results of ongoing real
time stability studies
showing all physical
parameters and assay of
Tramadol HCl is well
within the specified limits.
Also, at accelerated
condition the stability data
is found satisfactory.
The data given on
Tramadol SR Tablets
Awaited
332
The HPLC method developed
for each formulations was
linear, precise and accurate,
through LOQ and LOD was not
provided. Meanwhile the drug
peaks were shown to be
resolved well without
interference. Furthermore, the
drug peaks seem to be
responsive to the changes in
concentrations of the tramadol
HCl in the samples.
Keeping the general reflection,
the data on the stability and
HPLC method of Tramal SR
Tablets 100mg and Tramal
Injection 100mg/2ml Injetion
seem to be appropriate.
specified that the
dissolution test, assay of
Tramadol and physical
characteristics of the
formulation is within the
limits in ongoing stability
studies (real time and
accelerated).
Validation data
The validation studies of
both products have been
evaluated the results are
found satisfactory.
Therefore keeping in view
the present data provided
by the firm for both their
products, the undersigned
is of the opinion to
recommend the
registration of Tramal -100
Injection (Tramadol)
100mg/2ml (Reg.
No.010172 and Tramal SR
100mg Tablets (Tramadol)
(Reg. No.023317) in
favour of the firm.
As per practice in vogue cases for transfer of registration from import to local
manufacturting are considered at same terms and condition including MRP. Cost & Pricing
Divison was also consulted, who confirmed to proceed as per previous practice. Form 5 has
already been evaluated by PEC as per check list approved by Registration Board.
Decision: Registration Board decided as follows:
Cancellation of registrations of Tramal – 100 Injection, Registration No. 010172 and
Tramal SR100mg Tablet, Registration No. 023317 from M/s Serale
Pharmaceuticals, Karcahi.
Grant of registrations of Tramal – 100 Injection, Registration No. 010172 and
Tramal SR100mg Tablet, Registration No. 023317 in name of M/s The Searle
Company Ltd, F-319, S.I.T.E, Karachi for local manufacturing.
333
b. Transfer of registrations from M/s Macter International, Karachi to M/s Ray
Pharma, Karachi.
M/s Ray Pharma, Karachi have requested for transfer of registration of following drugs
from M/s Macter International, Karachi to their name. Registration dossiers were evaluated by
Incharge PEC and DDC (R-II) as per check list approved by the Registration Board and firm has
also rectified shortcomings and following recommendations were framed.
S.
No.
Reg. No. Name of Drug(s) Recommendations
01 000482 Genticyn Ear / Eye
Drops
May be approved subject to confirmation
of renewal status
02 004298 Genticyn HC Ear /
Eye Drops
Referred to Review Committee or may be
discussed in Registration Board due to the
reason that these formulations have not
been found approved in SRA’s (reference
drug agencies)
03 000497 Genticyn Cream
0.1% w/w
May be approved subject to confirmation
of renewal status
04 000483 Genticyn HC Cream Referred to Review Committee or may be
discussed in Registration Board due to the
reason that these formulations have not
been found approved in SRA’s (reference
drug agencies)
05 010186 Genticyn B Cream -do-
06 007701 Multigesic Cream May be approved subject to confirmation
of renewal status
Renewal status of products are as follows:-
S.
No.
Reg. No. Name of Drug(s) Initial date Aplication
receiving
date
Renewal
status
01 000483 Genticyn HC Cream 06-09-2006 Application
received after
expiry date and
grace period
24-02-2012
Registraion
is not valid
02 010186 Genticyn B Cream -do- -do- -do-
334
03 007701 Multigesic Cream -do- -do- -do-
04 000482 Genticyn Ear / Eye Drops 24-08-1978
Trasnfer of
regn date
18-06-2007
07-06-2012 Registraion
is valid
upto
17-06-2017
05 004298 Genticyn HC Ear / Eye
Drops
-do- -do- -do-
0
06
000497 Genticyn Cream 0.1%
w/w
06-09-2006 Application
received after
expiry date
and grace
period
24-02-2012
Registraion
is not valid
Decision: Registration Board decided as follows:
Cancellation of registrations of Genticyn Ear / Eye Drops, Regn No. 010186 from
M/s. Macter International, Karachi.
Grant of registrations of Genticyn Ear / Eye Drops, Regn No. 010186 in name of
M/s. Ray Pharma, Karachi. Chairman, Registration Board will permit issuance of
registration letter after comments of Cost & Price Division.1
Genticyn HC Ear / Eye Drops, Registration No. 004298 referred to review
committee as it’s not found approved in SRA’s (reference drug agencies).
Registrations of Genticyn HC Cream, Genticyn B Cream, Multigesic Cream and
Genticyn Cream 0.1% w/w are not valid.
c. Transfer of registration from M/s Macter Pharmaceutical (Pvt.) Ltd, Karachi to
M/s Macter International (Pvt.) Ltd, Karachi.
M/s Macter International (Pvt.) Ltd, Karachi has requested for transfer of their following
registered drug from previous name i.e M/s Macter Pharmaceutical (Pvt.) Ltd, Karachi to new
name i.e M/s Macter International (Pvt.) Ltd, Karachi.
Sr.
No. Registration No.
Brand
Name(s)
Formulation/Generic
Name
Date of
Registration
Renewal
Status
1.
011206 Relaxin
Tablets 3mg Bromazepam
06-06-1990
Valid up to
05-06-2015
Central Licensing Board in its 238th
meeting held on 19-11-2014 approved Tablet
(Psychotropic) / Narcotic) Section as segregated section.
335
Decision: Registration Board approved registration of Relaxin Tablets 3mg in name of
M/s Macter International (Pvt.) Ltd, Karachi.
Case No.23 Change of Contract Manufacturer – M/s B. Braun Pakistan (Pvt.) Ltd, Karachi
M/s B. Braun Pakistan (Pvt.) Ltd, Karachi was granted approval for transfer of
registration from Import to Local manufacturing by contract manufacturing at M/s Mac & Rains
Pharmaceuticals (Pvt.) Ltd, Lahore. Now firm has requested for change of contract
manufacturing from M/s Mac & Rains Pharmaceuticals (Pvt.) Ltd, Lahore to M/s Frontier
Dextrose Ltd, Hattar as the M/s Mac & Rains were unable to manufacture their medicine due to
hiring of their plant by M/s Searle Pakistan.
Applicant Contract
manufacturer
Reg. No. Name of drug(s) & Composition Date of
application,
Diary No. &
Form
Category
1. M/s B.
Braun
Pakistan
(Pvt.) Ltd,
Karachi
M/s Frontier
Dextrose Ltd,
Haripur
053854 B. Braun-RL Infusion
Each 100ml contains:-
Sodium Chloride …..0.600gm
Sodium Lactate …..…0.32gm
Potassium Chloride…0.040gm
Calcium
Chloride 2H2O …...0.027gm
03-06-2014
537
Form-5
Rs.50,000/-
Import to
local
contract
2. -do- -do- 053855 B. Braun-RLD Infusion
Each 100ml contains:-
Sodium Chloride …..0.600gm
Sodium Lactate …..…0.32gm
Potassium Chloride…0.040gm
Calcium
Chloride 2H2O …...0.027gm
Dextrose Anhydrous for
Parenteral …………5.5gm
03-06-2014
538
Form-5
Rs.50,000/-
Import to
local
contract
3. -do- -do- 053848 B. Braun – Paeds Infusion
Each 100ml contains:-
Sodium Chloride …..0.45gm
Dextrose Anhydrous for
Parenteral use………5.0gm
03-06-2014
543
Form-5
Rs.50,000/-
Import to
local
contract
4. -do- -do- 053849 B. Braun – DS ½ Infusion 03-06-2014 Import to
336
Each 100ml contains:-
Sodium Chloride …..0.45gm
Dextrose Anhydrous for
Parenteral use………5.00gm
536
Form-5
Rs.50,000/-
local
contract
5. -do- -do- 053850 B. Braun – DS Infusion
Each 100ml contains:-
Sodium Chloride …..0.9gm
Dextrose Anhydrous for
Parenteral use………5.00gm
03-06-2014
541
Form-5
Rs.50,000/-
Import to
local
contract
6. -do- -do- 053851 B. Braun – G5 Infusion
Each 100ml contains:-
Dextrose Anhydrous for
Parenteral use………5.00gm
03-06-2014
535
Form-5
Rs.50,000/-
Import to
local
contract
7. -do- -do- 053852 B. Braun – G10 Infusion
Each 100ml contains:-
Dextrose Anhydrous for
Parenteral use………10.00gm
03-06-2014
539
Form-5
Rs.50,000/-
Import to
local
contract
8. -do- -do- 053856 B. Braun - Mannitol Infusion
Each 100ml contains:-
Mannitol ………..17.5gm
Sorbitol for Parenteral
use…………….…2.5gm
03-06-2014
540
Form-5
Rs.50,000/-
Import to
local
contract
9. -do- -do- 053853 B. Braun - NS Infusion
Each 100ml contains:-
Sodium Chloride ……0.90gm
03-06-2014
542
Form-5
Rs.50,000/-
Import to
local
contract
The above case was deferred in 245th meeting of Registration Board for confirmation of TOC
analyzer and particle counter in M/s Frontier Dextrose Ltd, Hattar. Federal Inspector of Drugs, DRAP,
Peshawar has reported that that he has checked physically the installation of TOC analyzer and particle
counter in the said firm’s laboratory on 17-11-2014.
Decision: Registration Board acceded to request of M/s B. Braun Pakistan (Pvt.) Ltd,
Karachi for change of contract manufacturer for above products to M/s Frontier Dextrose
Ltd, Hattar at same terms and conditions. This permission will be valid till 30.06.2015.
337
Case No: 24 Change of contract manufacturer-M/s Excell Health Care Laboratories
(Pvt.) Ltd, Karachi.
Following products of M/s Excell Health Care Laboratories (Pvt.) Ltd, Karachi
were registered for bulk import from M/s ACTAVIS UK Ltd, United Kingdom and local
repacking at M/s Elko Organization, Karachi.
S. No. Name of product(s) Reg. No.
1. Cyclogest Pessaries 200mg
(Progesterone Pessaries)
033181
2. Cyclogest Pessaries 400mg
(Progesterone Pessaries)
033182
Now the firm has requested for change of contract manufacturer for above mentioned
product (bulk import and local repacking) from M/s Elko Organization, Karachi to M/s Apex
Pharmaceuticals (Pvt.) Ltd, D-21-A1, S.I.T.E, Super Highway, Karachi. Firm has deposited fee
@ Rs.10, 0000/- for each product for the purpose.
Registration Board in 241st meeting discussed and decided as under:-
The Board deliberated that reapacking is the part of manufacturing and in this case final
quality control release will be granted by local manufacturer, which will be M/s Apex
Pharmaceuticals (Pvt.) Ltd, D-21-A1, S.I.T.E, Super Highway, Karachi. Thus Board
constituted a panel comprising of Director DTL, Peshawar, Director CDL Karachi and
area FID to inspect the premesis for confirmation of repacking and quality control
facilities of the firm. The Board also advised the panel to confirm that status of imported
products whether in pessaries, blister etc. Registration Board will decide the case in light
of report of the panel.
Accordingly panel inspected the premises of M/s Apex Pharmaceuticals, Karachi
and concluded as under:-
During inspection, it was observed that management has provided adequate facilities for
repacking of above named products and quality control that are being imported from M/s
Actavis, United Kingdom in form of strips and management is intended to repack 15
pessaries in one pack. A room with controlled temperature is also reserved for proper
placement of bulk and repacked products.
Based on the observations made, people met, record reviewed and repacking & QC
facilities provided by the management, panel recommends the transfer of the above name
338
products from M/s Elko Organization, Karachi to M/s Apex Pharmaceuticals (Pvt.) Ltd,
D-21-A1, S.I.T.E, Super Highway, Karachi
Decision: Registration Board acceded to request of M/s Excell Health Care
Laboratories (Pvt.) Ltd, Karachi for change of contract manufacturer for repacking and
quality control release of above products to M/s Apex Pharmaceuticals (Pvt.) Ltd, D-21-A1,
S.I.T.E, Super Highway, Karachi. However the firm will provide legalized COPP at WHO
format for both products and authorized its Chairman for issuance of letter. Permission is
at the same terms and conditions will be valid till 30.06.2015.
Case No.25 Issuance of duplicate registration letter.
M/s Johnson & Johnson, Karachi have requested for issuance of duplicate registration of
their following drugs:-
S. No. Reg. No. Name of Drug(s)
1. 009078 Daktarin Oral Gel
2. 009084 Daktacort Cream
3. 009083 Sibelium Capsule
4. 009082 Vermox Tablet 500mg
Firm has furnished following documents to support their request:-
a) Copy of entry in roznamcha from concerned policy station
b) Fee @ Rs.5000/- for each product for the purpose.
Decision: Registration Board deferred the case for confirmation of renewal status.
Case No.26 Grant of Registration for export purpose - Contract Manufacturing.
Following firm has requested for registration of drug for export purpose only,
on basis of contract manufacturing.
Contract giver Contract
manufacturer
Name of Drug(s) & Composition Date of
application,
Diary No. &
Form
M/s Medisure Labs,
Karachi
M/s Cirin Pharma,
Hattar
Rumaclav Tablet 625mg
Each tablet contains:-
Amoxicillin as Trihydrate ……500mg
Clavulanic Acid as Potassium…125mg
31-12 -2013
Form-5
Rs.50,000/-
339
Decision: Registration Board approved grant of above registration on contract
manufacturing basis for export purpose only. In order to boost export, The Board also
authorized Chairman for grant of registration for export purpose on contract
manufacturing basis excluding controlled drugs and new drug as per contract manufacting
policy.
Case No.27 Grant of Registration for export purpose – Controlled Drug.
M/s Pharmatec Pakistan (Pvt.) Ltd, Karachi has requested for registration of following
drug for export purpose only:-
S.
No.
Date of
application
Diary No.
& Form
Name of drug(s) &
Composition
Information required & reply of firm
30-09-2014
753
Form-5
Rs.20,000/-
Flu-Gone C&F
Tablet
Each tablet contains:-
Paracetamol ...600mg
Pseudoephedrine
HCl…………60mg
Chlorpheniramine
Maleate …….4mg
Application on Form 5 with required fee
as per relevant SRO
NOC for CRF clearance
Copy of approved section from CLB
Copy of last inspection report
An undertaking that applied registration
is exclusively for export purpose and
will not be sold in Pakistan.
If formulation / product is not registered
in Pakistan, then export order from
importing country (Registered in
Pakistan)
Above formulation is registered for local manufacturing as per following details:-
Applied formulations Registered in Pakistan Manufacturer
Flu-Gone C&F Tablet
Each tablet contains:-
Paracetamol …….....600mg
Pseudoephedrine HCl..60mg
Chlorpheniramine Maleate..4mg
Reltus C&F Tab(Reg. No.024908)
Epinol-CF Tab (Reg. No.023982)
M/s Pharmatec
M/s CCL, Lahore
Decision: Registration Board discussed that applied drug contains Pseudoephedrine,
which is a precursor chemical and segregated section is required only for Narcotic Drugs
and Psychotropic substances as per Central Licensing Board decision. Thus applied
formulation registered for export purpose only.
340
Case No.28 Change in flavour – Gastrolyte Rice (Reg.No.070436) –
M/s Sanofi Aventis Pakistan Ltd, Karachi.
M/s Sanofi Aventis Pakistan Ltd, Karachi has informed that their product
Gastrolyte Rice (Reg. No.070436) is registered in Apricot flavor. Now firm has requested for
change of flavor from Apricot to Raspberry.
Firm has submitted for information to support their request.
O6 months accelerated stability data
Undertaking
Specification & Control Method
Copy of Registration letter
Fee @ Rs.5,000/- for the purpose.
Decision: Registration Board approved the request. However, Incharge, PEC will
evaluate the stability data and Chairman, Registration Board will authorize issuance of
permission letter on the basis of these recommendations.
Case No.29 Change of manufacturing site from Contract to own facility.
Following products of M/s Medisure Labs (Pvt.) Ltd, Karachi were initially registered for
import as per following details and then permitted for local contract manufacturing from M/s
Indus Pharma, Karachi which are valid till 30.06.2015. Now M/s Medisure Labs (Pvt.) Ltd,
Karachi has informed that they have developed facility for Liquid Injectables (Ampoules &
Vials) at their own premises 17/24, Korangi Industrial Area Karachi and requested to permit
manufacturing of products at this facility.
S. No. Reg. No. Name of Drug(s) Date of Registration
1. 015566 Rosiden Injection
Each 1ml ampoule contains:-
Piroxicam …………….20mg
23-08-1994
2. 014084 Neurocoline 250mg/2ml Injection
Each 2ml contains:-
Citicoline …………….250mg
01-11-1993
341
Registration dossiers were evaluated by Incharge PEC and DDC (R-II) as per check list
approved by the Registration Board and firm has also rectified shortcomings. It is pertinent to
mention that citicoline is under consideration of Review Committee.
Decision: Registration Board approved request of M/s Medisure Labs (Pvt.) Ltd,
Karachi for manufacturing of Rosiden Injection, Registration No.015566 at its own
premesis. However, request of Neurocoline 250mg/2ml Injection, Registration No.014084
will be considered after recommendation of Review Committee and decision of the Board
on Citicoline.
Case No.30 Correction in Minutes:
a. M/s Amarant Pharma, Karachi
Registration Board in 245th
meeting approved following registration in favour
of M/s Amarant Pharma, Karachi. Registration letter could not be issued due to following
mistake in minutes. Existing and correct formulation are as under:-
Name of Drug(s) & Composition Correct Composition
Amprexa-F Tablet 12/25mg
Each tablet contains:-
Olanzapine ………..……12mg
Fluoxetine HCl …….……25mg
Amprexa-F Capsule 12/25mg
Each capsule contains:-
Olanzapine ……..………12mg
Fluoxetine HCl ………..…25mg
Decision: Registration Board approved the correction as Amprexa-F Capsule 12/25mg
instead of tablets.
Case No.31 Registration of Drugs for export purpose-Not me too Drugs.
Following firms have requested for registration of following drugs for export
purpose only which are not me-too. Details are as under:-
S.
No.
Name of
Company
Name of product(s) Date of application,
Diary No. & Form
Export Order
1. M/s
Genix
Pharma,
Sofos Tablet
Each film coated tablet
contains:-
23-11-2014
769
Rs.20,000/-
Original Export
Order from
Afghanistan
342
Karachi Sofosbuvir MS ....400mg
2. -do- Sofopas Tablet
Each film coated tablet
contains:-
Ledipasvir MS ……90mg
Sofosbuvir MS .......400mg
23-11-2014
770
Rs.20,000/-
Original Export
Order from
Afghanistan
3. M/s
Tabros
Pharma,
Karachi
Vibrenta 400mg Tablet
Each film coated tablet
contains:-
Sofosbuvir MS ....400mg
19-11-2014
767
Rs.20,000/-
Copy of Export
Order from
Afghanistan
4. M/s Getz
Pharma,
Karachi
Azvira 400mg Tablet
Each film coated tablet
contains:-
Sofosbuvir ....400mg
05-12-2014
771
Rs.20,000/-
Not provided
Decision: Mr.A Q Javed Iqbal, Director QA < opined that for export purpose only
those formulations should be registered, which are already registered in Pakistan. For new
formulations (which are not registered in Pakistan), manufacturers should first conduct
stability studies and then registration for export purpose be granted. Prof. Muzammil H
Najmi also endorsed it. Registration Board after deliberation decided that inorder to
facilitate export of quality drugs (non-me too drugs), export registration will be granted
and manufacturer will comply following conditions before export of drug:
Manufacturer will export the product after complying all the conditions as required
under Drug Act, 1976 including No objection certificate from concerned DRAP
office. Moreover, Federal Inspector of drugs will take sample from each
consignemnet for analysis from CDL, Karachi.
Manufacturer will also furnish export documents endorsed from custom authorities
in order to ensure the export of the product.
Registration Board approved above products for registration for export purpose only
with aforementioned conditions. These conditions will also be applicable to products
approved for exports (Sofosbuvir) by Chairman, registration Board
343
Registration-III
Case No.32
Registration Board in its 229th meeting approved the following product of M/s Global
Pharmaceutical, Islamabad.
S.No. Name and Composition of Product Pack size Demanded Price
1. Tamsol-D Tablets
Each film coated tablet contains:-
Tamsulosin Hydrochloride 0.4 mg
(as modified – release tablets)
Dutasteride………………0.5 mg
10’s As Per SRO
Fee
Rs:8,000/=
The Registration Board reconsidered the decision of 229th meeting which is as follows:
“Decision: Registration Board after considering the technical opinion by its members
decided to ask the manufacturer to appear before Registration Board for presentation
of his opinion regarding efficacy of the above drug formulation. The Board further
ordered that till final decision, the registration of above product would remain
suspended under section 7(11) (ad) of Drug Act, 1976.”
Decision: Registration Board discussed the case and decided to issue show cause notice
to M/s Global Pharmaceutical, Islamabad for cancellation of registration.
Case No.33
M/s. Amgomed, Islamabad has requested to transfer of the following drug from being imported for
local manufacturing on contract basis by M/s. Bio-Lab (Pvt) Limited, Islamabad:-
S.No
.
Reg.
No.
Name and Composition of Product Pack size Demanded Price
1 053821 Amgozole Injection
Each vial contains:-
Omeprazole Sodium
≡ Omeprazole……40 mg
(Proton Pump Inhibitor)
Per vial As Per SRO
The dossier has been submitted along with fee amounting Rs.50,000 and has been evaluated with the
collaboration of the Incharge Evaluation Cell as per check list.
344
Decision: Registration Board approved request of M/s. Amgomed, Islamabad for
contract manufacturing of Amgozole Injection, Registration No. 053821 from M/s. Bio-Lab
(Pvt) Limited, Islamabad. This permission will be valid till 30.06.2015.
Case No. 34.
M/s. Quaper (Pvt) Limited, Sargodha has requested to transfer the manufacturing site from M/s.
Fassgen Pharmaceuticals, Hattar to M/s. Mediate Pharmaceuticals, Karachi on contract basis:-
The dossiers have been submitted along with fee of Rs:50,000/each and have been evaluated with the
collaboration of the Incharge Evaluation Cell as per check list.
Decision: Registration Board approved the request of M/s. Quaper (Pvt) Ltd.,
Sargodha for change in contract manufacturer of above products from M/s.
1. From
Fassgen
Hattar
To
Mediate
Karachi
054069 Cefein 250 Injection IV
Each vial contains:-
Ceftriaxone Sodium
≡ Ceftriaxone……..250 mg
(Cephalosporin)
2. Fassgen
Mediate 054077 Cefein 500 Injection IV
Each vial contains:-
Ceftriaxone Sodium
≡ Ceftriaxone……..500 mg
(Cephalosporin)
3. Fassgen
Mediate 054073 Cefein 250 Injection IV
Each vial contains:-
Ceftriaxone Sodium
≡ Ceftriaxone……..1g
(Cephalosporin)
4. Fassgen
Mediate 054067 Rayxime 400 mg Capsule
Each capsule contains:-
Cefixime Trihydrate
≡ Cefixime…………400 mg
(Cephalosporin)
5. Fassgen
Mediate 054065 Rayxime 100 mg Dry
Suspension
Each 5ml contains:-
Cefixime Trihydrate
≡ Cefixime…………100 mg
(Cephalosporin)
345
Fassgen Pharma to M/s. Mediate Pharma, Karachi. Permission is at already
approved terms and conditions.
Case No.35 Registration Board in 242nd
meeting approved the registration of following drug
of M/s. Olive Laboratories, Rawat.
S.N
o
Existing name with approved
Composition
Correct formulation/Nomenclature
1. 1. Hepatavir 300 mg Tablets
2.Tablets
3. Each film coated Tablet contains:
Tenofovir Disoproxil Fumarate ….30
mg
4. Anti-retroviral / Nucleoside and
Nucleotide Reverse Transcriptase
Inhibitors
1. Hepatavir 300 mg Tablets
2.Tablets
3. Each film coated Tablet contains:
Tenofovir Disoproxil Fumarate…300
mg 4. Anti-retroviral /
Nucleoside and Nucleotide Reverse
Transcriptase Inhibitors
The Evaluation Cell stated that the firm had correctly applied for Tenofovir Disoproxil Fumarate 300
mg film coated tablet but inadvertently incorporated as 30mg in agenda and minutes of 242nd
meeting.
The abovementioned inadvertent typographical error of the strength needs rectification as Tenofovir
Disoproxil Fumarate 300 mg.
Decision: Registration Board approved the correction as Tenofovir Disoproxil
Fumarate 300mg Tablet.
Case No.36
Registration Board in 244th meeting deferred the following registration applications of M/s. Welwink
Pharmaceutical, Gujranwala for manufacturing by M/s. Weather Fold Pharmaceuticals, Hattar on contract
basis in view of required GMP inspection as mentioned below:
M/s Welwink
Pharmaceuticals.
G.T Road,
Industrial Estate,
Gujranwala
Cantt.
Gujranwala
Manufacturing
on Contract basis
by
M/s Weather
Acticef 500 mg Powder for
reconstitution of IM
Injection
Each Vial contains:-
Ceftriaxone Sodium
≡ Ceftriaxone ……500 mg
(Cephalosporin Antibiotic)
(USP Specs)
Form 5
18-07-2012
Dy No 7333
21-05-2013
Rs. 150,000/-
As Per SRO
1‟s
vial
FDA. (Rocephin
(Roche)
SPORCEF(LOWITT
PHARMACEUTICALS
(PVT) LTD)
Advised for further
improvement in
different sections.
(22-03-2014)
Deferred for GMP
inspection of
contract
manufacturer by
panel comprising
of Dr. Muzammal
H. Najmi, Director
QA
& LT and Area
FID. Contract
giver will be
inspected by Area
346
Folds
Pharmaceuticals.
Plot 69/2, Phase-
2, Industrial
Estate, Hattar
FID as last
inspection report is
more than 01 year
old
-do- Acticef 250 mg Powder for
reconstitution of IM
Injection
Each Vial contains:-
Ceftriaxone Sodium
≡ Ceftriaxone…….250 mg
(Cephalosporin Antibiotic)
Form 5
18-07-2012
Dy No 7336
21-05-2013
Rs. 150,000/-
As Per
SRO/1‟s
vial
SPORCEF(LOWITT
PHARMACEUTICALS
(PVT) LTD)
Advised for further
improvement in
different sections. (22-
03-2014)
Deferred for GMP
inspection of
contract
manufacturer by
panel comprising
of Dr. Muzammal
H. Najmi, Director
QA
& LT and Area
FID. Contract
giver will be
inspected by Area
FID as last
inspection report is
more than 01 year
old
-do- Acticef 250mg Powder for
reconstitution of IV
Injection
Each Vial contains:-
Ceftriaxone Sodium
≡ Ceftriaxone ………250
mg
(Cephalosporin Antibiotic)
USP Specs
Form 5
18-07-2012
Dy No 7338
21-05-2013
Rs. 150,000/-
As Per SRO
1‟s
vial
BNF. (Rocephin
(Roche)
SPORCEF(LOWITT
PHARMACEUTICALS
(PVT) LTD)
Advised for further
improvement in
different sections. (22-
03-2014)
Deferred for GMP
inspection of
contract
manufacturer by
panel comprising
of Dr. Muzammal
H. Najmi, Director
QA
& LT and Area
FID. Contract
giver will be
inspected by Area
FID as last
inspection report is
more than 01 year
old
Weather Fold
Pharmaceuticals
Hattar
for
M/s Welwink
Pharmaceuticals,
Gujranwala
Acticef Injection 500mg
(IV)
Each vial contains:
Ceftriaxone sodium
≡ Ceftriaxone …500mg
(Cephalosporin Antibiotic)
USP Specs
Form 5
18-07-12 Dy
No 7341
Rs 8000/-
21-05-13 Dy
No 3283
1,42,000/-
As per SRO/
Pack of 1‟s
Rociphen of Gentech
USA
Rociphen of Roche
Karachi
Inspection of the M/s
Weather Folds
Pharmaceuticals, Hattar
was conducted by the
area FID on 22/03/14
and advised firm for
further improvements in
different sections
Deferred for GMP
inspection of
contract
manufacturer by
panel comprising
of Dr. Muzammal
H. Najmi, Director
QA
& LT and Area
FID. Contract
giver will be
inspected by Area
347
FID as last
inspection report is
more than 01 year
old
-do- Acticef Injection 1gm
(I.M.)
Each vial contains:
Ceftriaxone sodium
≡ Ceftriaxone …….1g
Cephalosporin Antibiotic
USP specs
Form 5
18-07-12 Dy
No 7334
Rs 8000/-
21-05-13 Dy
No 3283
1,42,000/-
As per SRO/
Pack of 1‟s
Rociphen of Gentech
USA
Rociphen of Roche
Karachi
Deferred for GMP
inspection of
contract
manufacturer by
panel comprising
of Dr. Muzammal
H. Najmi, Director
QA
& LT and Area
FID. Contract
giver will be
inspected by Area
FID as last
inspection report is
more than 01 year
old
-do- Acticef Injection 1gm( I.V)
Each vial contains
Ceftriaxone sodium
≡ Ceftriaxone …….1gm
Cephalosporin Antibiotic
USP Specs
Form 5
18-07-12 Dy
No 7339
Rs 8000/-
21-05-13 Dy
No 3283
Rs 1,42,000/-
As per SRO/
Pack of 1‟s
Rociphen of Gentech
USA
Rociphen of Roche
Karachi
Deferred for GMP
inspection of
contract
manufacturer by
panel comprising
of Dr. Muzammal
H. Najmi, Director
QA
& LT and Area
FID. Contract
giver will be
inspected by Area
FID as last
inspection report is
more than 01 year
old
M/s Weather
Folds
Pharmaceuticals.
Plot 69/2, Phase-
2, Industrial
Estate, Hattar
For
M/s Welwink
Pharmaceuticals.
G.T Road,
Maxoxim 200 mg/5ml
Dry powder suspension
Each 5 ml contains:
Cefixime Trihydrate USP
≡ Cefixime ……200 mg
(Cephalosporin antibiotics)
USP Specs
Form 5
18-07-2012
Dy No 7330
Rs. 150,000/-
As per SRO
International: Suprax
for suspension
200mg/5ml (FDA)
Local: Biozil Dry
Suspension 200 mg/5
ml by M/s BioLabs
According to report of
inspection dated 22-10-
2014 of M/s Weather f
old, firm is advised to
rectify shortcomings in
various sections.
Deferred for GMP
inspection of
contract
manufacturer by
panel comprising
of Dr. Muzammal
H. Najmi, Director
QA
& LT and Area
FID. Contract
giver will be
inspected by Area
348
Industrial Estate,
Gujranwala
Cantt.
Gujranwala
According to report of
inspection dated 13-06-
2013 of M/s Welwink,
inspection book was not
available at time of
inspection and firm was
once again directed to
submit their validation
data of areas and
processes before
starting of their
production.
FID as last
inspection report is
more than 01 year
old
-do- Maxoxim 100 mg/5ml
Dry Powder Suspension
Each 5 ml contains:
Cefixime Trihydrate USP
≡ Cefixime ………100 mg
(Cephalosporin antibiotics)
USP Specs
1.Form 5
2.18-07-2012
Dy No 7335
3. 21-05-
2013
Rs. 150,000/-
-do- -do-
-do- Maxoxim 400 mg Capsule
Each capsule contains:
Cefixime trihydrate
≡ Cefixime …….. 400 mg
(Cephalosporin antibiotics)
Finished product
Manufacturing
specifications
1.Form 5
2.18-07-2012
Dy No 7335
3. 21-05-
2013
Rs. 150,000/-
-do- -do-
The panel of Central Licensing Board inspected Weather Fold Pharmaceuticals, on 18-11-2014 and
recommended the Renewal of DML. The Federal Inspector of Drugs Lahore also inspected the M/s.
Welwink Pharmaceutical Gujranwala and stated that the firm possesses the relevant facility of quality
control.
Decision: Registration Board approved the request of M/s. Welwink Pharmaceuticals
for contract manufacturing of above products by M/s. Weather Ford Pharmaceuticals,
Hattar. Permission will be valid till 30.06.2015.
Case No.37
Registration Board in 245th meeting considered the following new molecule of M/s. Global
Pharmaceutical, Islamabad
Dlanz 30mg Capsules
Each capsule contains:-
Dexlansoprazole …. 30 mg
30‘s
As Per
SRO
Registration Board discussed and
agreed to above expert opinions.
However, the Board advised firm to
349
(Proton Pump Inhibitor)
provide data for stability studies
conducted under zone IV-A
conditions as per ICH / WHO
guidelines for consideration of
Registration Board.
Dlanz 60mg Capsules
Each capsule contains:-
Dexlansoprazole …. 60 mg
(Proton Pump Inhibitor)
30‘s
As Per
SRO
-do-
Zaprin SR 15mg Capsules
Each capsule contains:-
Cyclobenzaprine HCl (USP)
≡ Cyclobenzaprine ……15 mg
(Skeletal Muscle Relaxant)
60‘s
As Per
SRO
-do-
Now the firm has submitted the stability report of quality control for period of 12, 9, 6, 3 (months)
and initial QC about Dexlansoprazole. Moreover, Cyclobenzaprine has been already approved in favour
of CCL, Lahore in 242nd
meeting of DRB. The firm has requested to grant of registration of above
mentioned drugs in view of the relevant explanation.
Decision: Registration Board approved the products. However, the Board advised
concerned P E & R Division and Incharge, PEC to evaluate submitted stability studies of
Zone IVA of Dexlansoprazole 30 & 60mg Capsule. Registration Board authorized its
Chairman for subsequent approval for issuance of registration letter.
Registration Board approved Cyclobenzaprine HCl 15mg Capsule, being me too
product.
Case No.38
Registration Board in 245th meeting deferred the following application of M/s. Global
Pharmaceuticals Islamabad for evaluation of dossier with the collaboration of Evaluation Cell as per
check list:-
Anarob Infusion
Each 100 ml contains:-
Metronidazole B.P…500
mg
026985
1x100
ml
M/s. Mac &
Rains
Pharmaceuticals,
M/s. Vision
Pharmaceuticals,
Ofloquin Infusion
Each 100 ml contains:
Ofloxacin HCl
≡ Ofloxacin….. 200 mg
026980
1x100
ml
-do- -do-
Nafcin Injection 026979 100 ml -do- -do-
350
Each 100 ml contains:
Ciprofloxacin Lactate
≡ Ciprofloxacin…..200 mg
The dossiers have been evaluated with the collaboration of Incharge Evaluation Cell as per check list.
Decision: Registration Board approved request of M/s Global Pharmaceuticals,
Islamabad for change of contract manufacturer of above products from the M/s. Mac &
Rains Pharmaceuticals to M/sVision Pharmaceuticals, Islamabad. Permission is at same
terms and conditions.
Case No.39
M/s. Vision Pharmaceutical, Kahuta Road, Islamabad has requested for transfer of registration of
following drugs from M/s. Vision Pharmaceutical, I-10/3, Islamabad. Previously, these products were
contract manufactured by m/s Mac & Rains Pharmaceuticals, Lahore:-
Levovis IV Infusion
Each 100 ml contains:-
Levofloxacin hemihydrate
≡ Levofloxacin……… 500ml
032160 1x100ml M/s. Mac & Rains
Pharmaceuticals,
M/s. Vision
Pharmaceuticals,
Medicip IV infusion
Each 100 ml contains:-
Ciprofloxacin lactate
≡ Ciprofloxacin ......200 mg
030701 1x100ml -do- -do-
M/s. Vision Pharmaceutical, Kahuta Road, Islamabad has developed the relevant manufacturing
facilities and submitted complete dossier along with fee amounting Rs:50000/dossier. The dossiers have
been evaluated with the collaboration of Incharge of the Evaluation Cell as per check list.
Decision: Registration Board decided as follows:
Cancellation of above registrations from M/s. Vision Pharmaceuticals, I-10/3,
Islamabad.
Grant of above registrations in name of M/s. Vision Pharmaceutical, Kahuta Road,
Islamabad. Chairman, Registration Board will permit issuance of registration letter
after comments of Cost & Pricing Division about MRP of the drug.
351
Case No.40
M/s. Metro Pharmaceutical, Islamabad has requested for correction of nomenclature and label claim of
the following drugs as mentioned below:-
Existing /approved formulation Correct formulation/Nomenclature Reg No.
Myzinc Syrup
Each 5ml contains:-
Zinc Sulfate Monohydrate…. 20 mg
(USP Specs)
Myzinc Syrup
Each 5ml contains:-
Zinc Sulphate Monohydrate
≡ Zinc (element)……..…. 20 mg
(USP Specs)
075253
The management has deposited Fee of Rs:5000/- for this purpose. It is pointed out that the strength of the
API is calculated on the basis of content of zinc element.
Decision: Registration Board approved the correction as Zinc Sulphate Monohydrate
equivalent to Zinc (element) 20mg/5ml syrup.
Registration-IV
Case No.41
M/s. Genome Pharmaceutical, Hattar has requested for correction in formulation of following drugs.
Initially these drugs were registered on 2nd August, 2003 and 4th February, 2006 with M/s. Silver Oak
Corporation Hattar. The management was changed and the unit was renamed and registrations of the
products approved for Silver Oak Corporation Hattar were transferred in favour of M/s. Genome
Pharmaceuticals. It is pointed out that at the time of transfer of registration of the products, the brand
name was also changed but the strengths of active pharmaceutical ingredient in the below-mentioned
formulations were inadvertently typed as:
S.N
o
Previous name /
Formulation
Existing name / Incorrect
Formulation Reg No.
1.
Tick-Nil Tablets
Each tablet contains:-
Cetirizine 2HCl…..10 mg
Citgen Tablets
Each tablet contains:-
Cetirizine Dihydrate….10
mg
030815
2.
Solifen Tablets
Each tablet contains:-
Ketoprofen…………100
mg
Proket Tablets
Each tablet contains:-
Ketoprofen………30 mg
042511
352
It is pointed out that it was inadvertently written as Cetirizine Dihydrate 10 mg per tablet while
transferring the registration from M/s. Silver Oak to M/s. Genome. Similarly, the strength of Ketoprofen
was wrongly mentioned as 30mg/tablet. The correct formulation is mentioned below in the right column
of table.
S.N
o
Existing name with
Composition
Correct Formulation/
Nomenclature Reg
No.
1. Citgen Tablet
Each tablet contains:-
Cetirizine
Dihydrate…..…..10mg
Citgen Tablet
Each film coated tablet contains:-
Cetirizine Dihydrochloride… 10
mg
030815
2. Proket Tablet
Each tablet contains:-
Ketoprofen……30mg
Proket Tablet
Each film coated tablet contains:-
Ketoprofen……… 100 mg
042511
Decision: Registration Board approved the correction as Cetirizine Dihydrochloride
10mg film coated tablet and Ketoprofen 100mg film coated tablet of the above mentioned
products.
Case No.42
Registration Board approved the application of M/s. Genome Pharmaceuticals, Hattar for Tablets
containing combination of Domperidone Maleate and Cinnarizine in Drug Registration meeting 214th as
mentioned below:-
1. Approved formulations in
214th meeting
The formulation issued in
the Registration letter)
2. Domenome Tablets
Each tablet contains:-
Domperidone Maleate…19.48 mg
Cinnarizine………20.40mg
Zinom Tablets
Each tablet contains:-
Domperidone
Maleate......19.10 mg
Cinnarizine ...........25mg
(Genome’s Specs)
It is pointed out that Domperidone Maleate and Cinnarizine were inadvertently approved as 19.48 mg
and 20.4mg respectively. Moreover, the certificate of registration also contained typographical error
regarding Domperidone maleate 19.10mg and Cinnarizine 25mg. The firm provided the copy of the
dossier and requested to correct the Minutes of 214th meeting as well as the typographical error of the
respective formulation along with the correction in certificate of registration as mentioned below.
353
Reg No Correct formulation /Nomenclature
053580 Domenome Tablets
Each tablet contains:-
Domperidone Maleate……19.1mg
≡ Domperidone…………..15 mg
Cinnarizine………………..20 mg
(Approved formulations in 214th meeting )
Decision: Registration Board deferred and referred above formulations to Review
Committee.
Case No.43
Registration Board in 243rd
meeting approved the registration of following drug of M/s. Wnsfeild
Pharmaceutical Hattar.
S.N
o
Existing name with Composition Correct formulation/Nomenclature
1. 1. Alfa-Block
2. Capsule
3. Each capsule contains:-
Tamsulosin Hydrochloride SR
pellets……50mg
4. (Selective Alpha-a Adrenergic Blocking
Agents)
1. Alfa-Block Capsule
2. Each capsule contains:-
3.Tamsulosin Hydrochloride SR
pellets 0.2%w/w
≡ Tamsulosin HCl……….0.4mg
4. (USP Specification)
Now the firm has informed that the strength of Tamsulosin HCl pellets is incorrectly mentioned as 50
mg per capsule. Incharge Evaluation Cell stated that above mentioned error had been pointed to the firm
and it was rectified subsequently and prior to the 243-Meeting. But the agenda and minutes of 243rd
meeting could not be amended. The management has requested for the appropriate correction and
issuance of the certificate of registration accordingly.
Decision: Registration Board approved the correction as Tamsulosin Hydrochloride
SR pellets 0.2%w/w equivalent to Tamsulosin Hydrochloride 0.4mg/Capsule.
Case No.44
M/s. Wisdom Pharmaceuticals Industries, Peshawar requested for issuance of registration
letter of Zoramid (Domperidone) Suspension which was approved in 243rd meeting of
Registration Board with the following formulation:-
Zoramid Suspension
354
Each 5ml contains:-
Domperidone Maleate eq. to Domperidone….5mg
The registration letter was not issued due to inappropriate active pharmaceutical ingredient
and the ambiguous label claim. With reference to Motilium Suspension (brand leader Johnson &
Johnson) and BNF 66 it is evident that Suspension contains Domperidone 5mg/5ml instead of
Domperidone maleate equivalent to Domperidone 5mg/5ml.
The management was informed that the inappropriate description of active pharmaceuticals
ingredient and label claim needs verification by the Incharge Pharmaceutical Evaluation Cell
because the dossier was evaluated by the PEC and the management has to apply formally for this
rectification.
Mr. Tahir CEO M/s. Wisdom Pharmaceuticals, Peshawar verbally informed, “The
management corrected the formulation and claim of Zormid Suspension and submitted the same
to the PEC before the commencement of DRB meeting-243rd. The correction was neither
incorporated in agenda nor in the relevant minutes and the ambiguity prevailed the approved
minutes”. Instead of proceeding in the proper way, ironically, Mr. Tahir CEO wrote in the letter
No.WPI/DRAP/40/14 dated 11-11-2014, “but due to unknown reason registration letter of our
product has not been issued till to date it is requested to issue registration letter of our product as
soon as possible. If the registration letter is not issued up to 30-11-2014 the case will be sent to
the Honourable Wafaqi Mohtasib (Ombudsman) of Pakistan Islamabad.,” Moreover, the
management forwarded the copies to Honourable Wafaqi Mohtasib (Ombudsman) of Pakistan,
C.E.O DRAP and Director PE&R without waiting for the response of the department according
to the stipulated period of 30-11-2014.
Resultantly the Incharge Evaluation Cell was asked to verify the in appropriation in
formulation and the proclaimed rectifications of Wisdom Pharmaceuticals. The Evaluation Cell
confirmed from the record that stance of firm is true i.e.Wisdom Pharmaceuticals has corrected
the composition as per reference product but the same could not be reproduced into the agenda
and minutes of 243rd
meeting of DRB.
355
Decision: Registration Board deferred the formulation and referred the case to Review
Committee in conformity of decision of 244th
meeting.
Case No. 45
Registration Board in 227th meeting held on 26
th & 27
th August, 2010 deferred the following
registration application of M/s Cherwel Pharmaceuticals, Hattar for manufacturing on basis of contract till
the finalization of contract policy:-
1. M/s. Cherwel
Pharmaceutical
s, Hattar
Manufacturing
on Contract
basis by
M/s.Wise
Pharma,
Islamabad
Cherzone 250 mg Injection I.V
Each vial contains:-
Ceftriaxone Sodium
≡ Ceftriaxone…….…….250 mg
(Cephalosporin)
Per
vial
As Per
SRO
3-10-2009 Deferred till
the finalization
of contract
policy
2. -do- Cherzone 500 mg Injection I.V
Each vial contains:-
Ceftriaxone Sodium
≡ Ceftriaxone…….…….500 mg
(Cephalosporin)
Per
vial
As Per
SRO
-do- -do-
3. -do- Cherzone 1 g Injection
Each vial contains:-
Ceftriaxone Sodium
≡ Ceftriaxone ………….1 g
(Cephalosporin)
Per
vial
As Per
SRO
-do- -do-
4. -do- Getxime 400 mg Capsules
Each capsule contains:-
Cefixime Trihydrate
≡ Cefixime………….….400 mg
(Cephalosporin)
5’s As Per
SRO
-do- -do-
5. -do- Getxime 100 mg Dry Suspension
Each 5 ml contains:-
Cefixime Trihydrate
≡ Cefixime …..…….….100mg
(Cephalosporin)
30ml As Per
SRO
-do- -do-
6. -do- Getxime200mg Dry Suspension
Each 5 ml contains:-
Cefixime Trihydrate
≡Cefixime …..…….….200 mg
(Cephalosporin)
30ml As Per
SRO
-do- -do-
356
7. -do- Welpime 500mg Injection
Each vial contains:-
Cefepime HCl with L-Aginine
≡ Cefepime (anhydrous)
500mg
(Cephalosporin)
Per
vial
As Per
SRO
-do- -do-
8. -do- Welpime 1gm Injection
Each vial contains:-
Cefepime HCl with L-Aginine
≡ Cefepime (anhydrous) 1 g
(Cephalosporin)
Per
vial
As Per
SRO
-do- -do-
9. -do- Biset 1 g Injection
Each vial contains:-
Cefoperazone Sodium
≡ Cefoperazone.…… 500 mg
Sulbactam Sodium
≡ Sulbactam…………. 500 mg
(Cephalosporin)
Per
vial
As Per
SRO
-do- -do-
10. -do- Biset 2g Injection
Each vial contains:-
Cefoperazone Sodium
≡ Cefoperazone……… 1g
Sulbactam Sodium
≡ Sulbactam…………… 1g
(Cephalosporin)
Per
vial
As Per
SRO
-do- -do-
Now contract manufacturing policy has been finalized and the management of the firm has deposited
the fee of Rs. 50,000/each and requested to change the manufacturer from M/s. Wise Pharmaceuticals
Rawat to M/s. Bloom Pharmaceuticals, Hattar and also to change the brand name of some product. The
Dossiers have been evaluated with the collaboration of Incharge Evaluation Cell as per check list.
Decision: Registration Board registered above products of M/s. Cherwell
Pharmaceuticals, Hattar on contract manufacturing basis from M/s. Bloom
Pharmaceuticals, Hattar. Permission will be valid till 30.06.2015
Case No.46
M/s. Maxi Care International, Lahore has requested for transfer of following drug from import for
local manufacturing on contract basis by M/s. Welwrd Pharmaceuticals Hattar:-
357
S.No
.
Reg.
No.
Name and Composition of Product Pack size Demanded Price
1 059263 PE-40 Lyophilized Injection
Each vial contains:-
Pantoprazole Sodium
≡Pantoprazole……… 40 mg
(Proton Pump Inhibitor)
Per vial Rs.250.00
They have submitted the complete dossier along with fee of Rs. 50,000/- for this purpose. The dossier
has been evaluated by the Incharge Evaluation Cell as per check list.
Decision: Registration Board approved request of Maxi Care International, Lahore for
contract manufacturing of above product from M/s. Welwrd Pharmaceuticals, Hattar.
Permission is at same terms and conditions except that firm will not claim the product as
lyophilized.
Case No.47
M/s. Aries Pharmaceuticals, Peshawar has requested for registration of following drugs for the
export only:-
S.No
.
Name and Composition of Product
1 Xanek Tablets
Each tablet contains:-
Alprazolam……….0.5 mg
(USP Spec)
2 Lexonil Tablets
Each tablet contains:-
Bromazepam…………3 mg
(Aries Specs)
The management of the firm provide the complete dossier, Fee of Rs,20000/- original export order and
requested for registration of drugs for export purpose only. The dossiers have been evaluated accordingly.
Decision: Registration Board approved grant of registration of above mentioned
products for the purpose of export only.
Case No. 48
Registration Board in 243rd
meeting deferred the following application of M/s. Genome
Pharmaceuticals, Hattar for opinion of experts but the panel of experts has not been proposed :-
358
1. M/s. Genome
Pharmaceutical,
Hattar.
Genozal Tablets
Each tablet contains:-
Balsalazide Disodium
Dihydrate………750 mg
(Genome Spec)
(Anti-inflammatory drug)
10’s As Per SRO Deferred for
expert opinion.
2. -do- Rebon-X Tablets
Each film coated tablet contains:-
Strontium citrate………680 mg
(Bone stabilizer)
10’s As Per SRO Deferred due
to Methylene
Chloride.
Inspection
report nil
Form 5/ file
partially
signed.
Now the case is again included in the agenda for constitution of panel of expert for expert opinion.
The dossier has been evaluated and rectified by the Evaluation Cell as per check list.
Decision: Registration Board referred above products to following panel for expert
evaluation:
Genozal Tablets (Balsalazide Disodium Dihydrate………750 mg)
o Brig Dr. Aslam Khan, Member Registration Board.
o Dr. Rauf Niazi, PIMS, Islamabad.
o Dr.Irfan Ahmad, BBH, Rawalpindi
Rebon-X Tablets (Strontium citrate………680 mg)
o Mr. Abdul Latif Sheikh, AKUH.
o Prof Dr. Rafi-uz-Zaman, Member Registration Board.
o Prof. Dr. Zafar Iqbal, University of Peshawar
Case No. 49
M/s. Swat Pharmaceutical, Swat has requested to transfer the manufacturing site from M/s.
Medera Pharmaceuticals (toll manufacturer) to their own manufacturing unit in view of the existence of
the manufacturing facility:
1. Baxib 250mg Tablets
Each film coated tablet contains:-
Ciprofloxacin HCl
≡ Ciprofloxacin……....250 mg
(Quinolone)
030449
2. Baxib 500mg Tablets
Each film coated tablet contains:-
030450
359
Ciprofloxacin HCl
≡ Ciprofloxacin……....500 mg
(Quinolone)
3. Baxib 750 mg Tablets
Each film coated tablet contains:-
Ciprofloxacin HCl
≡ Ciprofloxacin……....750 mg
(Quinolone)
030451
4. Sanlevo 250 mg Tablets
Each film coated tablet contains:-
Levofloxacin Hemihydrate
≡ Levofloxacin…………….250 mg
(Quinolone)
029883
5. Sanlevo 500 mg Tablets
Each film coated tablet contains:-
Levofloxacin Hemihydrate
≡ Levofloxacin…………….500 mg
(Quinolone)
029884
The management of the firm has deposited the fee of Rs. 20,000/each and requested to transfer the
above mentioned drugs to their own manufacturing site M/s. Swat Pharmaceutical, Swat. The Dossiers
have been evaluated with the collaboration of incharge Evaluation Cell as per check list.
Decision: Registration Board approved request of M/s. Swat Pharmaceuticals, Swat for
manufacturing of the above products at its own facility. Permission is at same terms and
conditions.
Case No. 50
M/s. Usawa Pharmaceutical, Rislapur has requested to transfer the manufacturing site from M/s.
Caraway Pharmaceuticals (toll manufacturer) to their own manufacturing unit in view of the existence of
the manufacturing facility:
1. Afixim 400 mg Capsule
Each capsule contains:-
Cefixime Trihydrate
≡ Cefixime……………… 400 mg
060248
2. Durixil Capsule 500 mg
Each capsule contains:-
Cefadroxil Monohydrate
≡ Cefadroxil……………… 500 mg
060249
360
The management of the firm has deposited the fee of Rs. 20,000/each and requested to transfer the
above mentioned drugs to their own manufacturing site M/s. Usawa Pharmaceutical, Rislapurt. The
Dossiers have been evaluated with the collaboration of Incharge Evaluation Cell as per check list.
Decision: Registration Board approved request of M/s. Usawa Pharmaceuticals,
Risalpur for manufacturing of the above products at its own facility.
Permission is at same terms and conditions.
Case No. 51
Registration Board in 228th meeting and 238
th meeting deferred the following drugs of M/s.
Genome Pharmaceuticals, Hattar for the reasons mentioned below:
1. Perilone Tablets
Each tablet contains:-
Paliperidone……….1.5 mg
(Ant-psychotropic)(Genome Spec)
10’s As Per SRO Deferred for expert
opinion being a new
chemical entities.
(M-228
2. Lanso-SR Capsules
Each SR capsule contains:-
Dexlansoprazole enteric coated Pellets
≡ Dexlansoprazole….30 mg
(Proton Pump Inhibitor)
14’s As Per SRO Deferred till
submission of
application on FORM
5-D along with
prerequisite fee
(M-238)
Now the firm has informed that the same formulations and same strength has been registered by the
Registration Board in favour of Pharmatec. The firm deposited the differential fee and dossiers have been
evaluated by the collaboration of Evaluation Cell as per check list.
Decision: Registration Board approved Lanso-SR Capsules. However, the Board
advised concerned P E & R Division and Incharge, PEC to evaluate submitted stability
studies of Zone IVA of Dexlansoprazole 60mg Capsule. Registration Board authorized its
Chairman for subsequent approval for issuance of registration letter.
Registration Board approved Tablets Paliperidone 1.5mg
361
Case No.52
The following anomaly cases drugs of M/s. Wnsfeild Pharmaceuticals, Hattar were deferred in 245th
meeting as mentioned below:-
1. Somac 40 mg Injection
Each vial contains:-
Pantoprazole Sodium
Sesquihydrate
≡ Pantoprazole…..40 mg
(Proton pump inhibitor)
Per
vial
As
per
SR
O
29-
1-13
As per SRO
29-1-13
Registration Board
deferred above products
for scrutinization of
registration application
as per check list.
2. Winomax 500 mg injection
Each vial contains:-
Azithromycin monohydrate
≡ Azithromycin ………..40 mg
(Anti-infective)
Per
vial
As
per
SR
O
29-
1-13
As per SRO
29-1-13
-do-
3. Lantex 30 mg injection
Each vial contains:-
Lansoprazole sodium
≡ Lansoprazole ……..30 mg
(Proton pump inhibitor)
Per
vial
As
per
SR
O
29-
1-13
As per SRO
29-1-13
-do-
4. Kalwin 500 mg Injection
Each vial contains:-
Clarithromycin
≡ Clarithromycin ……..500 mg
(Proton pump inhibitor)
Per
vial
As
per
SR
O
29-
1-13
As per SRO
29-1-13
-do-
The dossiers have been evaluated by with the collaboration of Evaluation Cell as per check list and
the term lyophilized will not be claimed by the manufacturer.
Decision: Registration Board approved the registration of above mentioned products.
362
Case No.53
The following anomaly cases of M/s. Welmark Pharmaceuticals, Hattar were deferred in 237th meeting of
the Drug Registration Board as mentioned below:-
1. M/s. Welmark
Pharmaceuticals,
Hattar
New Section
Carimark 500 mg Injection
Each vial contains:-
Clarithromycin
≡ Clarithromycin …500 mg
(Macrolide)
Per
vial
As
per
SRO
16-08-
11
Deferred for
clarification
weather
Lyophilization
procedure is
mandatory/required
for such
formulation or not.
2. -do- Ezi-mark 500 mg Injection
Each injection contains:-
Azithromycin dihydrate
≡ Azithromycin ….500 mg
(Macrolide)
Per
vial
As
Per
SRO
19-8-
2011
do
Now the firm has removed the word Lyophilized from the formulation and the dossiers have been
evaluated with the collaboration of Evaluation Cell as per check list.
Decision: Registration Board approved the registration of above mentioned products.
Case No.54.
The following registration application of M/s. Navegal Pharmaceuticals, Hattar were considered in 225th
meeting and approved on the ground that the firm develop new separate Psychotropic Section. The
registration letter was not issued.
1. Zocin 25 mg Tablets
Each tablet contains:-
Pentazocine HCl
≡ Pentazocine base….. 25 mg
(Benzomarphan derivative)
10x10’s REs.2.50
per tablet
Approved
2. Fenotal 30mg Tablets
Each tablet contains:-
Phenobarbital………. 30 mg
(Barbiturate)
2x15’s Rs.2.70
per tablet
Approved
3. Buprex 0.2mg Tablets
Each tablet contains:-
Buprenorphine HCl
≡ Buprenorphine base0.2 mg
50’s Rs.0.68
per tablet
Approved
363
(Thebaine derivative)
4. Gytil 3 mg Tablets
Each tablet contains:-
Bromazepam……3 mg
(Benzodiazepine)
3x10’s Rs.3.50
per tablet
Approved
5. Gytil 6mg Tablets
Each tablet contains:-
Bromazepam……6 mg
(Benzodiazepine)
3x10’s Rs.7.50
per tablet
Approved
6. Xafil 0.25mg Tablets
Each tablet contains:-
Alprazolam………0.25 mg
(Benzodiazepine)
3x10’s Rs.4.00
per tablet
Approved
7. Xafil 0.5mg Tablets
Each tablet contains:-
Alprazolam……… 0.5 mg
(Benzodiazepine)
3x10’s Rs.10.00
per tablet
Approved
8. Xafil 1mg Tablets
Each tablet contains:-
Alprazolam………1 mg
(Benzodiazepine)
3x10’s Rs.10.00
per tablet
Approved
9. Xolpi 10mg Tablets
Each tablet contains:-
Zolpidem
Hemitartrate….10mg
(Imidazopyridine)
2x10’s Rs.16.00 Approved
10. Dilamid 1mg Tablets
Each tablet contains:-
Lormetazepam ………1mg
(Short Acting
Benzodiazepine)
100’s Rs.1.70
per tablet
Approved
Now the firm deposited the differential fee of Rs:12000/- each and complete the dossiers. The
dossiers have been evaluated with the collaboration of Evaluation Cell as per check list.
Decision: Registration Board approved the registration of above mentioned products.
364
Registration-V
Case No.55: M/S. CCL Pharmaceuticals (Pvt.) Ltd, Lahore- Export Registrations.
M/s. CCL Pharmaceuticals (Pvt.) Ltd; Lahore has requested for registration of following
products for export purpose only:-
S. No Name of Products
1. Cef-OD Chewable Tablet 100mg
Each chewable tablet contains:-
Cefixime trihydrate equivalent to
Cefixime ……………………….. 100mg
2. Bicarb Capsule 600mg
Each capsule contains:-
Sodium Bicarbonate ………………… 600mg
The above mentioned products are not available locally. However, product at Sr. No. 1 is
FDA approved and product at Sr. 2 is available in Sri-Lanka. The firm has submitted the
following documents:-
a. Fee of Rs. 20000/- for this purpose.
b. Form-5.
c. Under taking stamp paper.
d. Copy of GMP inspection.
e. CRF clearance certificate.
f. Export orders.
Decision: Registration Board approved the products with following conditions:
Manufacturer will export the product after complying all the conditions as required
under Drug Act, 1976 including No objection certificate from concerned DRAP
office. Moreover, Federal Inspector of drugs will take sample from each
consignemnet for analysis from CDL, Karachi.
Manufacturer will also furnish export documents endorsed from custom authorities
in order to ensure the export of the product.
Case No. 56: M/s. Wilshire Labs Lahore - Case deferred for expert opinion
Registration Board in its 237th
deferred the following registration application of M/s.
Wilshire Laboratories, Lahore for expert opinion by Brig.(R).Prof. Dr. Muzammil Hasan Najmi,
member Registration Board and submission of differential fee. Initially the case was deferred for
365
expert opinion and two experts have already been given their opinions as follows. Now
Brig.(R).Prof. Dr. Muzammil Hasan Najmi has also give expert opinion:-
Name of Product Pack Size. MRP
Tripoli 400 mg & 800 mg
Each tablet contains:-
Metaxalone….400 mg & 800 mg
10’s
100’s
500’s
15% less
brand leader
S. No. Name of Expert Opinion
1. Prof. Dr.
Mohammad Hanif
Head Deptt. of
Medicine,
Rawalpindi
Medical College,
Rwp.
The mode of action of this drug has not been clearly identified,
absolute bioavailability is not known. Impact of age, gender,
hepatic and renal disease on the pharmacokinetics, carcinogenic
potential, safety in pregnancy, safety and effectiveness in
children under age of 12 has not determined. Leucopenia and
haemolytic anemia are among the side effects. The drug is not
cost-effective.
“Tripoli tablets cannot be recommended for registration for the
adjunctive treatment of acute, painful, musculo-skeletal
conditions”
2. Dr. Mughees
Sherani, Agha
khan Hospital
Karachi
“I have personal experience of writing this medication as this is
an FDA approved medication and is available in the United State
by the name of “Skelaxin”. Before moving to Pakistan in 2002, I
was practicing in Midland Texas, USA and use to prescribe this
medication”.
“It is used as an adjunctive treatment of acute, painful
musculoskeletal conditions and provides earlier relief.”
“It major side effects include drowsiness. It should be given with
caution in older patients and in patients with chronic disease,
especially in liver and kidney diseases.”
“I think this medication can be approved as this has long track
record without major complications or problems.”
3. Brig.(R).Prof. Dr.
Muzammil Hasan
Najmi
“Metaxalone is a skeletal muscle relaxant used in treatment of
painful muscle spasm/sprains. The exact mechanism of action of
the drug is not known but it produce generalized CNS
depression, which is also responsible for its side effects. It has
significant interactions with other centrally acting drugs like
benzodiazepines and antidepressants. It is considered to be
unsafe in elderly. Safety in pregnancy and location has bot been
determined. The drug is available in USA.
Metaxalone may be registered as a prescription drug to be
marketed with precautions as outlined above”.
366
The firm has also deposited remaining fee of Rs. 35,000/- for this purpose.
Decision: Registration Board discussed and agreed to above expert opinions.
However, the Board advised firm to provide data for stability studies conducted under zone
IV-A conditions as per ICH / WHO guidelines for consideration of Registration Board.
Case No.57 : M/s. Highnoon Labs, Lahore- Case deferred for submission of clinical data
The Registration Board in its 245th
meeting deferred the following product of M/s.
Highnoon Labs; Lahore for submission of safety and efficacy data of the drugs along with
complete clinical trial data of these formulations:-
Sr.No. Product Name with
composition
Pack size Demanded
price
Date of
submission
and fee
Remarks
1. Ebernet 1% Cream
Each gram contains:-
Eberconazole (as
nitrate)….10mg
(anti fungal)
10gm Rs.320.00 21-06-2011
Rs. 8000/-
27-06-2011
Rs. 7000/-
10-7-2013
135000/-
(Total: Rs.
150000/-)
Form-5D
Not available
in FDA,
EMA,
Australia and
Japan.
In compliance to the decision of registration board, M/s. Highnoon Labs; Lahore has
submitted clinical trial data of the above mentioned product.
Decision: Board deferred above products for expert opinion of following experts on
submitted clinical studies data:
Dr.Fareed ur Rehman, FFH, Rawalpindi.
Dr.Afaq, PIMS, Islamabad.
Mr.Abdul Lateef Shaikh, AKUH
367
Case No.58 : Permission for Contract Manufacturing due to renovation.
M/s. Highnoon Laboratories Ltd; Lahore has applied for contract manufacturing of their
following products on toll manufacturing basis through M/s. Titlis Pharma, Lahore. Due to
continuous improvement and capacity enhancement program of their manufacturing plant, they
have planned for renovation/up gradation of their granulation-I area while granulation-II area
will remain operational. Therefore they have applied for contract manufacturing of the products
manufactured in granulation-I to avoid shortage of these products:-
S. No. Name of Drug(s) Reg. No.
1. Cyrocin Tablet 250mg
Ciprofloxacin
011406
2. Cyrocin Tablet 500mg
Ciprofloxacin
011407
3. Hilin Capsule 100mg
Pregabalin
048917
4. Hilin Capsule 150mg
Pregabalin
048834
5. Hilin Capsule 50mg
Pregabalin
048916
6. Hilin Capsule 75mg
Pregabalin
047833
7. Oxaquin Tablet 400mg
Moxifloxacin
043660
8. Aria Tablet 1mg
Ketotfen (Fumarate)
014742
9. Inhibitol Capsule 30mg
Lansoprazole (pellets)
020613
10. Neupentin Capsule 100mg
Gabapentin
035763
11. Neupentin Capsule 300mg
Gabapentin
035764
12. Voxiquin Tablet 250mg
Levofloxacin Hemihydrate
038991
13. Voxiquin Tablet 500mg
Levofloxacin Hemihydrate
038992
14. Senegy-OD Tablet 10mg
Loratidine
017672
They have deposited fee of Rs. 50,000/- for each product and have furnished application
dossiers along with toll agreement.
368
It is submitted that in total there are 83 registered in tablet and capsule sections, however
firm has applied for 14 products only i.e. for products of granulation-I area. Orders are solicited,
whether such cases can be processed as per new toll policy.
Decision: Registration Board deferred the case and advised firm to provide complete
renovation plan with time frame for consideration of the Board. Form-5 will be checked as
per check list approved by Registration Board.
Case No. 59: M/s. Phamrawise Labs (pvt.) Ltd; Lahore - Transfer of registration due to
change of name of the firm without change in manufacturing site.
The name of M/s. Fakma Pharma, Lahore was changed from M/s. Fakma Pharma, Lahore
to M/s. Pharmawise Labs (Pvt.) Ltd; Lahore in 2000 on their request. The firm had requested that
either to change all letters regarding registrations with new name or issue a letter to reflect the
said change in each of the registration letter. However, they had not deposited any fee for this
purpose. The case was presented in Board meeting No. 164th on 30-07-2001 and the Registration
Board had decided as under:-
“The request of the firm was not acceded to and the firm was directed to deposit the
requisite fee of Rs. 8000/- for each product for transfer of registration in the new name”.
It is submitted that as per practice in vogue, in case a company changes their name / title apply
for transfer of registration from previous name to new name with full registration fee. However,
the owner of the firm has the view that there is no provision in law for transfer of registration on
same premises.
The case was also referred to Law Division for comments. Law Division in their reply
referred to the case of change of name of M/s. Breeze Pharma, Islamabad to M/s. ICI, Pakistan
Ltd; due to change in management. The issue was as to whether M/s. ICI Pakistan Ltd; require a
fresh license for manufacturing of drugs on leased premises or license of M/s. Breeze Pharma,
Islamabad would be a valid one for manufacturing of drugs.
In this regard, Law Division was of the opinion that license issued by competent
authority was issued to drug manufacturing facility/plant/premises and inspection was done for
369
drug manufacturing facility, plants, its premises and also of the qualifications of the management
under rule 15, 16 of Drug (Licensing Registering & Advertising) Rules 1976. It would therefore,
be wrong to state that license was issued to the premises and not the management. Law Division
has further referred to Section 196 of the Companies ordinance 1984 which states that business
of a company is run and managed by the Directors of a company. Therefore, lease agreement
between Breeze Pharma, & M/s. ICI amounts to transfer of license which is un-authorized under
the said rules.. It is also been suggested that referring Division (DRAP) shall suitable amend the
rules, so that such like complications due to silent position of rules can be averted in future.
Decision: Registration Board decided to seek opinion of Legal Affairs Division, DRAP in
the matter.
Case No. 60: M/s Servier Research & Pharmaceuticals (Pakistan) (Pvt.) Ltd; Lahore- Case
deferred for confirmation of registration in France
Registration Board in its 245th
meeting deferred the following products of M/s. Servier
Research and Pharmaceuticals (Pakistan) Limited Lahore till confirmation of registration status
of Nartrilam 5 and 10 mg tablets in France:-
S.
No.
Name of Drug(s) with
formulation
Pack
size
Demande
d price
Fee & form
1 Natrilam 10mg Tablets
Each tablet contains:-
Indapamide SR…..1.5mg
AmlodapineBesilate…..10mg
(Antihypertensive diuretic +
Calcium antagonist)
30‘s Rs.72.52/
Tablet
20-6-2012
Rs.8000/-
30-04-13
Rs. 130,000/-
Total Fee Rs. 150,000/-
Form 5-D
2 Natrilam 5 mg Tablets
Each tablet contains:-
Indapamide SR…..1.5mg
Amlodapineas
Besilate…..5mg
(Antihypertensive diuretic +
Calcium antagonist)
30‘s Rs.36.26/
Tablet
05-04-2011 Rs.8000/-
30-04-13
Rs. 130,000/-
Total Fee Rs. 150,000/-
Form 5-D
The management of the firm has provided legalized free certificate of the products in
France and have requested to grant them registration of above mentioned products.
370
Decision: Board decided to defer the product for expert opinion of following experts on
clinical studies data:
Brig(R). Dr. Muzamil H. Najmi, Member Registration Board
Dr. Shahid Nawaz, PIMS, Islamabad.
Brig. Dr. Sohail Aziz, AFIC, Rawalpindi.
Case No. 61: M/s. English Pharma, Lahore- Case Deffred For Expert Opinion
Registration Board in its 243rd
meeting deferred the following product of M/s. English
Pharma, Lahore for expert opinion of Prof. Dr. Ghias Butt; Prof. Mumtaz Ahmad, Benazir
Bhutto hospital and Prof. Muzamil Tahir, Sh Zayed Hospital, Lahore:-
S. No. Name of Drug(s)
1. Ucholin 10mg Tablet
Each tablet contains:-
Bethanechol Chloride equivalent to Bethanechol ……………. 10mg
Two experts have provided their opinion as under:-
Name of expert Comments
Prof. Ghias-ud-Din Butt,
PIMS, Islamabad
Bethanechol chloride is indicated for the treatment of acute
postoperative and postpartum non obstructive (functional) urinary
retention and for neurogesic atony of the urinary bladder with
retention. It works by helping the bladder muscle to squeeze better,
thereby improving your ability to urinate.
Because of the selective action of bethanechol, nicotinic symptoms of
cholinergic stimulation are usually absent or minimal when orally or
subcutaneously administered in therapecutic doses, while muscarinic
effects are prominent.
Special care is required if this drug is given to patients receiving
ganglion blocking compounds because a critical fall in blood pressure
may occur. Usually, severe abdominal symptoms appear before there is
such a fall in the blood pressure. Safety and effectiveness in pediatric
patients have not been established.
Price is a matter of regulator authorities but considering the
effectiveness of Molecule or patients Bethanechol HCl availability
in Pakistan must be assured at affordable price. The maximum
price should not exceed Rs. 30 for 10mg tablet.
Prof. Dr. Mumtaz Ahmad
Benazir Bhutto Shaheed
Hospital, Rawalpindi
This medicine is used to treat certain bladder problems such as the
inability to urinate or empty the bladder completely due to certain
causes (e.g surgery, bladder muscle problems). It works by helping the
371
bladder muscle to squeeze better, thereby improving your ability to
urinate.
Synthetic choline ester with effects similar to those of acetylcholine
(ADh). Acts directly on postsynaptic receptor, and since it is not
hydrolyzed by cholinesterase, its actions are more prolonged than those
of Ach.
Dosage must be individualized, depending on the type and severity of
the condition to be treated. Preferably gives the drug when the stomach
is empty. If taken soon after eating, nausea and vomiting may occur.
Due to non availability of local brand price is at a high and
different prices are charged by patients in different areas. I
therefore recommended the immediate allocation of local
manufacturing of the drug so that the patients can also benefit from it.
There also have been incidents reported for high rates and over
charging of drug due the smuggled version of the drug.
Decision: Registration Board discussed and agreed to above expert opinions.
However, the Board advised firm to provide data for stability studies conducted under zone
IV-A conditions as per ICH / WHO guidelines for consideration of Registration Board.
Case No. 62: Case deferred for confirmation of storage facilities
Registration Board in its 245th
meeting deferred the following product of M/s. Rasco
Pharma, Lahore for further deliberation on storage condition of the Misoprostol API. Chairman,
Registration Board advised members and stakeholders to forward their scientific comments on
storage condition of the Misoprostol API for consideration of Registration Board:-
Name of Drug(s) Form & demanded MRP. Competitor & specification
Aerotec-75 Tablet
(Inner core is enteric coated with outer
core as immediate release)
Each tablet contains:-
Diclofenac Sodium ….. 75mg
Misoprostol …….. 200mcg
NSAID + mucosal protective
1. Form 5
2. Fast Track
3. As per SRO/blister of 2×10
tablets
4. 29.06.2011/Rs.8000
5.21.05.2013/Rs.52000/4237
Arthrotec (Pfizer)
Manufacturers‘s Specs
The firm has now provided assessment report (EMA) of misoprostol API which is reproduced as
under:-
372
Misoprostol, as described in the Ph.Eur., is an only liquid which is very unstable and
difficult to be process into a drug product in liquid form. The stability of misoprostol is
significantly enhanced when it is dispersed in hypromellose. Hence, misoprostol dispersed in
hypromellose is used as an intermediate in the manufacture of misoprostol tablet. The
dispersion consists of a powder that can be stored at 5+3 °C, whereas the actual active
substance is an oily liquid that needs to be stored at -20 °C.
The certificate of analysis of the misoprostol API of the firm shows that the product is
Misoprostol 1% HMPC dispersion (White to off-white powder) and it is to be stored at 2-8 °C.
The panel of inspectors has already been recommended the storage facility of the firm for above
mentioned product. They have requested to grant them registration of above mentioned products.
A panel of inspectors comprising DDG (E & M), Lahore & area FID inspected the firm on
18-06-2014 for verification of manufacturing and storage facilities for misoprostol raw material.
The panel had recommended as under:-
“the management had provided cold cabinet to maintain temperature range from 2 to 8 C° at the
time of inspection. The panel member physically inspected the cabinet and found that the
conditions for storage were maintained. The overall sanitation and hygienic in this area was
satisfactory. SOPs for handling the raw material during sampling and dispensing were
available. The panel was satisfied with storage and production facilities at the time of inspection
to manufacture the Aerotec-75 Tablet”.
Decision: Keeping in view discussion regarding requirement of storage facility for
Misoprostol and inspection report of the firm, the Board approved the product
(Misoprostol with 1% dispersion HPMC) and with change in brand name.
373
RRR Section
Case No. 63: Applications for Re-Registration of drugs
Following firms have applied for registration of drug as they failed to apply for renewal of
registration in time:-
M/s. Ambrosia Pharmaceuticals, Islamabad
S.
No.
Reg.
No.
Name of Drugs with
composition
Date of
Initial Reg.
Renewal
Application
Due Date
Application
Receiving
Date for
Re-Reg.
Documents
Provided
by the firm
1. 035357 Ambrocillin 250mg
Tablets
Each tablets contains:-
Amoxicillin (as
Trihydrate)…….250mg
18-12-2004 17-12-2009 17-10-2012 (i). Form-5
(ii). Initial
Reg. Letter
(iii). CRF
NOC
(iv). Fee
Rs.20,000/-
2. 035358 Ambrocillin 500mg
Tablets
Each tablets contains:-
Amoxicillin (as
Trihydrate)…….500mg
-do- -do- -do- -do-
3. 041411 Micozole N Ointment
Contains:-
Miconazole
Nitrate……………2%
04-10-2005 03-10-2010 -do- -do-
4. 041412 Isozole Vag Cream
Contains:-
Isoconazole
Nitrate…………..1%
-do- -do- -do- -do-
5. 041414 Sexatin N Cream
Each gm cream
contains:-
Bufexamac………50mg
Neomycin
Sulphate……….2500IU
Nystatin……100,000IU
-do- -do- -do- -do-
374
6. 042917 Monorate Ointment
Contains:-
Mometasone
Furoate…….0.1% w/w
-do- -do-
M/s. Woodward Pakistan (Private) LTD., Karachi.
S.
No.
Reg.
No.
Name of Drugs with
composition
Date of
Initial Reg.
Renewal
Application
Due Date
Application
Receiving
Date for
Re-Reg.
Documents
Provided
by the firm
1. 055717 Bactizith 500mg Capsule
Each capsule contains:-
Azithromycin (as
Dihydrate)……..500mg
(USP Specification)
07-04-2009 06-04-2014 24-06-2014 (i). Form-5
(ii). Initial
Reg. Letter
(iii). Fee
Rs.20,000/-
M/s. Macter International Limited, Karachi.
S.
No.
Reg.
No.
Name of Drugs with
composition
Date of
Initial Reg.
Renewal
Application
Due Date
Application
Receiving
Date for
Re-Reg.
Documents
Provided
by the firm
1. 000483 Genticyn HC Cream
Each gm contains:-
Gentamicin Sulphate
Hydrocotisone Acetate
06.9.2006 05.9.2011 24-11-2014 (i). Form-5
(ii). Initial
Reg. Letter
(iii). CRF
NOC
(iv). Fee
Rs.20,000/-
2. 010186 Genticyn B Cream
Each gm contains:-
Gentamicin Sulphate
Betamethasone Valerate
-do- -do- -do- -do-
3. 007701 Multigesic Cream
Each gm contains:-
Diethylamine Salicylate
-do- -do- -do- -do-
4. 000497 Genticyn Cream
Each gm contains:-
Gentamicin Sulphate
-do-
-do- -do- -do-
Decision: Registration Board decided to defer the case till opinion of stake holders in the
matter as decided in Item No. IV(c).
375
Item No. VII Registration of Biological Drugs – Biological Evaluation & Research Division
Case No. 01. Expert Committee for Biological Drugs
The Drug Registration Board in its 241st Meeting decided to strength the expert
committees on biological drugs for the technical evaluation of biological drugs. The earlier
committee was not functional due to resignation of 01 member and absence of another member
due to tour abroad. The proposal of constitutions of new expert committees on biological drugs
was floated with draft notifications for separate expert committees for human and veterinary
biological drugs and were processed as per law with the approval of Federal Government.
However, the Law, Justice and Human Rights Divisions raised certain queries/ legal aspects
regarding composition of committees and role of secretariat officers in the committees, which
needed to be rectified before the notifications are finalized. The notifications were re-visited and
necessary amendments were made in consultation with the Law, Justice and Human Rights
Division. The process of official notification of expert committees is in final stages. However,
due to non functional ECBD, no fresh cases can be placed before the Registration Board.
However, miscellaneous cases of already registered biological drugs are placed before the Board
for its consideration in this meeting.
Decision: Registration Board noted the information.
Case No. 02. Change of manufacturing site for already registered drugs of M/s. R.G.
Pharmaceutica (Pvt), Ltd., Karachi.
M/s R.G. Pharmaceutica (Pvt) Ltd., Karachi has submitted the following
applications for change in manufacturing site of their already registered drugs;
S.# Product &
Registration No.
Existing Manufacturing
site
New Manufacturing Site
1. Ferti-C 5000IU
Chorionic
gonadotrophin for
Injection
(Reg. No070931)
Livzon (Group)
Pharmaceutical Zhohai,
Guangdong, China
Livzon (Group) Pharmaceutical
Factory.
Address: No.38, Chuangye Road
North, Liangang Industrial Zone,
Zhuhai, Guangdong, China.
2. Ferti-C 1000IU
Chorionic
gonadotrophin for
Injection
Livzon (Group)
Pharmaceutical Zhohai,
Guangdong, China
Livzon (Group) Pharmaceutical
Factory.
Address: No.38, Chuangye Road
North, Liangang Industrial Zone,
376
(Reg. No 070930) Zhuhai, Guangdong, China.
3. Ferti-M 150IU
Menotropin for
Injection
(Reg. No 070929)
Livzon (Group)
Pharmaceutical Zhohai,
Guangdong, China
Livzon (Group) Pharmaceutical
Factory.
Address: No.38, Chuangye Road
North, Liangang Industrial Zone,
Zhuhai, Guangdong, China.
4. Ferti-M 75IU
Menotropin for
Injection
(Reg. No 070928)
Livzon (Group)
Pharmaceutical,
Zhohai, Guangdong,
China
Livzon (Group) Pharmaceutical
Factory.
Address: No.38, Chuangye Road
North, Liangang Industrial Zone,
Zhuhai, Guangdong, China.
As per SOP defined by the Drug Registration Board in its 240th
Meeting, the firm has
provided following documents;
1. Application with required fee as per SRO (Rs.100, 000/- per product).
2. Copy of registration letter and last renewal status.
3. NOC for CRF clearance (Not required for Importer)
4. Original legalized CoPP, having address of new manufacturing site.
The source is from China, which falls under category, where the inspection abroad is mandatory.
Decision: Registration Board approved the request of the firm. Inspection of the foreign
manufacturer shall be conducted as per Import Policy. The Board authorized its Chairman
for issuance of letter for change in manufacturing site on the recommendation of inspection
report if it is of recommendation. If inspection report is of not recommendation, then case
will be placed before Registration Board.
Case No. 03. Request for change of importer and manufacturing site for already
registered drugs by m/s. Avior Pharmaceuticals (Pvt) Ltd., Karachi.
M/s. Avior Pharmaceuticals (Pvt) Ltd., Karachi has submitted applications for transfer of
products from M/s Global Pharmaceuticals (Pvt) Ltd. The firm has also informed that the
manufacturing site is also changed by the foreign principal. The details are as under: -
S.# Product &
Registration No.
Existing
Manufacturing site
New Manufacturing Site
1. Tropin 2000iu Inj
Each vial contains: -
Recombinant Human
Erythropoietin
2000iu
M/s Harbin
Pharmaceutical Group
of Bioengineering Co.
Ltd., Harbin China
M/s Harbin Pharmaceutical Group
Bioengineering Co., Ltd., No.99
Zhuhai Road Limin Development
Zone Hulan District, Harbin,
Heilongjiang Province, P.R. of
377
Reg No. 062218 China
2. Tropin 4000iu Inj
Each vial contains: -
Recombinant Human
Erythropoietin
4000iu
Reg No. 62219
M/s Harbin
Pharmaceutical Group
of Bioengineering Co.
Ltd. China
M/s Harbin Pharmaceutical Group
Bioengineering Co., Ltd., No.99
Zhuhai Road Limin Development
Zone Hulan District, Harbin,
Heilongjiang Province, P.R. of
China
Tropin 6000iu Inj
Each vial contains: -
Recombinant Human
Erythropoietin
6000iu
Reg No.066152
M/s Harbin
Pharmaceutical Group
of Bioengineering Co.
Ltd. China
M/s Harbin Pharmaceutical Group
Bioengineering Co., Ltd., No.99
Zhuhai Road Limin Development
Zone Hulan District, Harbin,
Heilongjiang Province, P.R. of
China
4. Auspogen 300ug per
vial
Recombinant Human
G.CSF
Reg No. 062217
M/s Harbin
Pharmaceutical Group
of Bioengineering Co.
Ltd. China
M/s Harbin Pharmaceutical Group
Bioengineering Co., Ltd., No.99
Zhuhai Road Limin Development
Zone Hulan District, Harbin,
Heilongjiang Province, P.R. of
China
5. Refron 3 MIU Inj
Each vial contains
Recombinant Human
Interferon Alpha 2b
3MIU
Reg No. 047665
M/s Harbin
Pharmaceutical Group
of Bioengineering Co.
Ltd. China
M/s Harbin Pharmaceutical Group
Bioengineering Co., Ltd., No.99
Zhuhai Road Limin Development
Zone Hulan District, Harbin,
Heilongjiang Province, P.R. of
China
M/s Avior Pharmaceuticals (Pvt) Ltd, Karachi has provided following documents as per SOP
defined by the Drug Registration Board in its 240th
Meeting;
i) Application on Form 5 A along with fee as defined under SRO (Rs.
100,000 per product).
ii) Copy of registration letters and last renewal status.
iii) NOC for CRF clearance (Not applicable to importers)
iv) Termination letter (Original) of previous importer M/s. Global
Pharmaceuticals (Pvt) Ltd
v) Authority letter/sole agent letter (original) from manufacturer in favour of
M/s Avior Pharmaceuticals (Pvt) Karachi.
vi) No objection letter from Global Pharmaceuticals in favor of M/s. Avior
Pharmaceuticals for transfer of Registration.
vii) Original and legalized CoPP of all above products.
viii) Site Master file.
The source is from China, which falls under category, where the inspection abroad is
mandatory. The case is placed before the Board for its decision.
378
Decision: Registration Board approved the request of the firm. Inspection of the foreign
manufacturer shall be conducted as per Import Policy. The Board authorized its Chairman
for issuance of letter for change in manufacturing site on the recommendation of inspection
report if it is of recommendation. If inspection report is of not recommendation, then case
will be placed before Registration Board.
Case No. 04. Change of manufacturing site for already registered drugs of M/s.
Pharmaevo (Pvt) Ltd, Karachi.
M/s. PharmaEvo (Pvt) Ltd., Karachi has submitted application for change of
manufacturing site of their already registered drugs. The details are as under: -
Product / Registration
No.
Previous Name of
Manufacturing Site
New Name of Manufacturing
site
EPOSINO 4000IU/ML
Each pre-filled syringe
contains: -
Recombinant Human
Erythropoietin…4000IU
(Reg No. 045690)
Sandong Kexing
Bioproducts Co., Ltd.,
China
Shandong Kexing Bioproducts
Co., Ltd. No.2666, Chuangye
Road, Mingshui development
Zone, Zhangqiu, Shandong,
China.
EPOSINO 2000IU/ML
Each pre-filled syringe
contains: -
Recombinant Human
Erythropoietin…2000IU
Erythropoietin
Reg No. (045689)
Sandong Kexing
Bioproducts Co., Ltd.,
China
Shandong Kexing Bioproducts
Co., Ltd. No.2666, Chuangye
Road, Mingshui development
Zone, Zhangqiu, Shandong,
China.
M/s PharmaEvo (Pvt) Ltd, Karachi has provided following documents to support their request as
per SOP decided by the DRB in its 240th
Meeting:-
1. Application with required fee as per SRO (Rs.100, 000/- per product).
2. Copy of registration letter and last renewal status.
3. NOC for CRF clearance.
4. Original legalized CoPP for new manufacturing site.
5. Site Master file
The source is from China, which falls under category, where the inspection abroad is
mandatory. The case is placed before the Board for its decision.
379
Decision: Registration Board approved the request of the firm. Inspection of the foreign
manufacturer shall be conducted as per Import Policy. The Board authorized its Chairman
for issuance of letter for change in manufacturing site on the recommendation of inspection
report if it is of recommendation. If inspection report is of not recommendation, then case
will be placed before Registration Board.
Case No. 05. Change of manufacturing site for already registered drugs by M/s. Roche
Pakistan, Ltd, Karachi.
M/s. Roche Pakistan Ltd., Karachi has submitted application for change of manufacturing
site. The details are as under: -
Product / Registration
No.
Previous Name of
Manufacturing Site
New Name of Manufacturing
site
Avastin 100mg/4ml
injection
Each ml contains:
Bevacizumab 25mg
Reg No. 043004
M/s F. Hoffmann- La
Roche Ltd., Basel,
Switzerland
M/s F. Hoffmann La-Roche Ltd.,
Wurmisweg 4303, Kaiseraugst,
Switzerland.
Avastin 400mg/16ml
injection
Each ml contains:
Bevacizumab 25mg
Reg No. 043005
M/s F. Hoffmann- La
Roche Ltd., Basel,
Switzerland
M/s F. Hoffmann La-Roche Ltd.,
Wurmisweg 4303, Kaiseraugst,
Switzerland.
M/s Roche Pakistan Ltd, Karachi has provided following documents to support their claim:-
1. Application on Form 5-A with required fee as per SRO (Rs.50, 000/- per product).
2. Copy of registration letter and last renewal status.
3. NOC for CRF clearance (Not required for Importer)
4. Original CoPP provided for new manufacturing site, however the CoPP is not
notarized and legalized from Embassy of Pakistan
5. Site Master file
The drugs is used for Matastatic Carcinoma of the Colon are rectum breast cancer and other
types of cancers. The site falls under category of Stringent Regulatory Authorities. It is proposed
that the request of the firm may be approved with condition that change of site letter shall be
issued after submission of legalized CoPP through permission from Chairman Registration
Board.
Decision: Registration Board approved request of the firm. The firm will provide legalized
CoPP of the product and authorized its Chairman for issuance of letter in light of Import
Policy for Finished Drugs.
380
Case No. 06. Request for exemption of printing of registration and MRP on vial M/s.
Popular International (Pvt) Limited, Karachi
M/s Popular International (Pvt) Ltd., Karachi has submitted the following requests for
exemption of printing of Registration Number & MRP on inner vials as exemption for Urdu
Version granted to them vide letter No. F.1-19/95-Reg-I (Pt) dated 11th
July, 2007. The firm has
informed that their principal print lot number, date of manufacturing and date of expiry on each
vial and outer box and finally print registration number on each box before shipment whereas
MRP is printed locally by us on outer box. However due to limited space on the inner vial the
principal cannot print registration and MRP. Further the company has informed that laser
printing may denature the products. The details of their request are as under: -
S.# Product Name Registration
No.
Generic Name
1. KOATE – DVI 007965 Antihemophilic Factor –
VIII(Human)
2. HyperRAB S/D 007972 Rabies Immune Globulin
(Human)
3. HyperHEP B S/D 012835 &
007971
Hepatitis B Immune Globulin
(Human)
4. PLASBUMIN
UMAN
ALBUMIN
007967
059249
Albumin (human)
5. IMMUNORHO 059296
059297
Rho (D) Immune Globulin
(Human)
6. GAMMARAAS 031350 Intravenous Immune Globulin
(Human)
Decision: Registration Board decided to call firm,s representative in its forthcoming
meeting for presentation of their case along with labeling/ printing status/ evidence of
similar products available in the market.
381
Case No. 07 Request for additional pack size by M/s. Snam Pharma, Lahore
M/s Snam Pharma, Lahore has requested to approve additional pack against their
already registered products. The firm has deposited an amount of Rs.5,000/- as prescribed fee for
each product. The detail is as under with justification: -
S.# Product Name Regn
No.
Existing
pack size
Additional
Pack
Justification
1. Biocan R Injection ad
us vet
057167 10x5ml.
5x20ml
(1m1)x20
single dose
The single dose of Biocan R is
necessary as it will be used in
single dog vaccination, and it is
demanded by the market.
2. Ornipet lyof.ad.us.vet 059171 200doses.
500 doses.
1000 doses.
2500 doses.
10x200 doses
10x500 doses
10x1000
doses
10x2500
doses
5000 x 10
doses
Large dose pack size in poultry is
convenient in the large poultry
formers and dose of 5000 bird
packing is demanded by the
market.
3. Ornibron
lyof.ad.us.vet
057169 10x200 doses
10x500 doses
10x100 doses
10x2500
doses
5000 x 10
doses
Large dose pack size in poultry is
convenient in the large poultry
formers and dose of 5000 bird
packing is demanded by the
market.
4. Orniprim
lyof.ad.us.vet
057170 10x200 doses
10x500 doses
10x100 doses
10x2500
doses
5000 x 10
doses
Large dose pack size in poultry is
convenient in the large poultry
farmers and dose of 5000 bird
packing is demanded by the
market.
5. Ornibur intermediate
lyof.ad.us.vet
059172 500 doses
1000 doses
1000 doses
2000 doses
5000 doses
10x500 doses
10x1000
2500 x 10
doses.
Large dose pack size in poultry is
convenient in the large poultry
farmers and dose of 2500 bird
packing is demanded by the
market.
382
doses
10x2000
doses
10x5000
doses
Decision: Registration Board deferred the request and advised the firm to provide legalized
CoPP of the product for confirmation of availability of applied packs.
Case No. 08 Request for additional pack size by M/s Marush (Pvt) Ltd, Lahore
M/s Marush (Pvt) Ltd, Lahore with the request to approve additional pack against
their already registered products. The firm has deposited an amount of Rs.5,000/- prescribed fee.
The detail is as under with justification: -
S.# Product Name Regn
No.
Existing
pack size
Additional Pack Justification
1. CEVAC
TRANSMUNE
IBD VACCINE
039910 1000 doses. 2000 vial
4000 vial
8000 vial
More recently market trends
and demand of formers have
changed due to initiation of
multiple large sized
commercial farms and
integrated units which,
demands medium and
bigger packs keeping in
view their convenience and
economy in usage.
To demonstrate the benefits
for users regarding
introduction of additional
packs a detailed study as per
DRA’s format.
Decision: Registration Board deferred the request and advised the firm to provide legalized
CoPP of the product for confirmation of availability of applied packs.
383
Case No. 09 Withdrawal of applications for registration of finished drugs by M/s. Sami
Pharmaceuticals, Karachi.
M/s Sami Pharmaceuticals (Pvt) Ltd, Karachi has requested for surrender of
applications for registration of finished drugs to be imported from M/s Xiamen Amoytop Biotech
Co. Ltd, Xiamen, Fujian, P.R. China. These drugs were considered favourable in meeting No. M-
225 dated 15.05.2010 and registration for the same were to be granted after satisfactory
inspection of the manufacturer’s facility abroad which could not be done till to date. However,
the firm was voluntarily withdrawn these long outstanding applications and will have no
objection if registrations for the same are granted either to M/s Xiamen Amoytop Biotech Co.
Ltd and/or to any other party so authorized by them. The details of withdrawn applications are
as under: -
Sl.# Name of company Drug name with
composition
MRP Shelf life Remarks
1. M/s Sami
Pharmaceutical(Pvt)
Ltd, Karachi./M/s
Xiamen Amoytop
Biotech Co., Ltd.,
Xiamen, Fujian,
P.R. China
Relkin 1.5mg Injection
Each vial contains: -
Oprelvekin Recombinant
Human Interleukin-11
(rHulL-11)…..1.5mg
(Immunostimulants)
As per latest
decision
taken by
PAC
24 months Approved
2. M/s Sami
Pharmaceutical(Pvt)
Ltd, Karachi./M/s
Xiamen Amoytop
Biotech Co., Ltd.,
Xiamen, Fujian,
P.R. China
Relkin 3mg Injection
Each vial contains: -
Oprelvekin Recombinant
Human Interleukin-11
(rHulL-11)…..3mg
(immunostimulants)
As per latest
decision
taken by
PAC
24 months Approved
Decision: The request of the firm was acceded to and the Board rejected the above
registration applications.
384
Case No. 10 Grant of registration of solution for injection - M/s. Macter International
Limited, Karachi
M/s. Macter International Limited, Karachi has requested for registration of
solution for injection for local manufacturing. The firm has deposited an amount of Rs. 50,000/-.
The composition detail is as under: -
Name of Company Raw Material Quantity/0.6Ml
M/s Macter International
Limited, Karachi
Sodium Chloride 3mg
Glycine 0.225mg
Polysorbate 80 0.06mg
Water for Injection Qs to 0.6mL
The solvent is required to be co-packed with the product free of cost. The case of manufacturing
of locally manufactured biological product was decided in the 244th
Meeting of the Drug
Registration Board including lyophilized pegylated interferon products of the company which is
under implementation process.
Request of the company for grant of registration of solvent is submitted for the approval of
Registration Board.
Decision: The request of the firm for grant of registration of solvent was approved.
Case No. 11. Change of manufacturing site for already registered drugs by M/s. Hospital
Services & Sales, Karachi and change of brand name.
M/s Hospital Services & Sales, Karachi has submitted the applications for change of
manufacture site and brand name of their already registered vaccine for below mentioned
product;
Sl.No. Reg.
No.
Previous Brand
Name and
composition.
Proposed Brand
Name
Existing
Manufacturing
Site
New proposed
manufacturing
site
1. 053813 EASYFIVE –
Pentavalent
Vaccine
Each dose 0.5ml
contains: -
Diphtheria
Toxoid: 20Lf
(30IU)
Tetanus Toxoid:
EASYFIVE – TT
Pentavalent Vaccine
Each dose 0.5ml
contains: -
Diphtheria Toxoid:
20Lf (30IU)
Tetanus Toxoid:
7.5Lf(40IU in guinea
pig and 60 IU in
M/s. Panacea
Biotech Ltd.,
New Delhi,
India.
M/s. Panacea
Biotech Limited,
Malpur, Baddi,
Distt. Solan
(H.P.) 173 205,
Inda.
385
7.5Lf(40IU in
guinea pig and
60 IU in mice)
Pertussis
Vaccine: 12OU
(4IU)
r-Hepatitis B
surface antigen
(HBsAg):
10mcg
Haemophilus
type b conjugate
vaccine: 10mcg.
mice)
Pertussis Vaccine:
12OU (4IU)
r-Hepatitis B surface
antigen (HBsAg):
10mcg
Haemophilus type b
conjugate vaccine:
10mcg.
M/s Hospital Services & Sales, Karachi has provided following documents to support their
request:-
1. Application on Form 5-A with required fee as per SRO (Rs.100, 000/- per
product).
2. Copy of registration letter and last renewal status.
3. NOC for CRF clearance (Not required for Importer)
4. Original CoPP provided for new manufacturing site.
5. Site Master file
6. The firm has also provided evidence of WHO prequalification of EASYFIVE –
TT vaccine.
Decision: Request of the firm for grant of registration of solvent exclusively to be used with
EASYFIVE – Pentavalent Vaccine, Regn No. 053813 was approved.
Case No. 12. Case of import of interferon from Cuba instead of China by M/s. Macter
International (Pvt) Ltd., Karachi.
The case was discussed in the 244th
Meeting of Drug Registration Board. The decision of the
case was as below:
Decision: Registration Board discussed the matter in detail and advised
investigation officer to further clarify following points:
a) On which documents the firm obtained clearance of Heberon Alfa R-2-
b Registration No.047675 from DRAP, Karachi along with dates of
invoice, airway bill/BL, LC date and other relevant information.
b) After grant of approval of change of source, what is legal status of
renewal application submitted by the firm from previous source?
c) What is the status of recall of stocks, the legal course of
holding/restricting the stocks from sale was followed or otherwise,
after “not to dispose of order” on Form-1 dated 28.10.2013?
386
The decision of the Board was communicated to DDG (E&M) with request to clarify the points
raised by the Drug Registration Board. In response to Directorate of Biological’s letter dated 5th
November, 2014. The Deputy Director General (E&M), DRAP, Karachi has stated that.
a) The documents on which the firm obtained clearance of Heberon Alpha R 2-b,
Registration No. 047675 from DRAP, Karachi are follows: -
i. Attested invoices.
ii. Copy of Airway bill/Bill of lading.
iii. Copy of L.C. dated 23.05.2013 as swift of M/s. Meezan Bank, Karachi
Pakistan.
b) The lyophilized source from Cuba; Product name: Heberon Alpha 3MIU injection
(interferon Alpha 2b3 MIU) Registration No. 022820 vide letter No.F. 3-6/98-Reg-II
(M-137).
2. The liquid source from china product name: Heberon Alpha 3 MIU (Interferon R 2-b
3MIU) Registration No. 047675 vide letter No.F.3-1/2008-Reg-I (M-212).
3. The legal status with justification as I understand is the change of dosage form for
another Registration No.047675 which becomes legal as source was changed only for
Registration No. 047675 of the same product. The first source relates to the Heberon Alpha
3MIU (Interferon R 2-b 3MIU) (Registration No. 022820) but the change of source from Cuba to
China is for Heberon Alpha 3MIU (Inteferon R 2-b 3MIU) (Registration No. 047675) in liquid
form. T he former dosage form was lyophilized. Hence, it is concluded that M/s. Changchun
Heber Biological Technology Co. Ltd., China is the sister concern of M/s. Heber Biotech S.A.
La Havana, Cuba the basic approved site and the product release authority of both the sources
Cuba and China is same. Hence, there is no product Safety, Quality, Efficacy and Economic
value related issued found. As the lot was released by NCLB, Islamabad also the importer (M/s.
Macter International Pvt. Ltd.) applied for the renewal of the said product on form 5-B of the
rule 26 of the Drug renewal for registration on 18.07.2013 and also deposited the required fee
under SRO 1117(I)/2012 which is pending with RRR section, DRAP. Therefore there is no harm
to allow them to market the aforesaid lot in favour of the importer in public interest so required
as protected under rule 27 of the Drugs (Licensing, Registering & Advertising) Rules, 1976
(copies of both the application for registration renewal are enclosed.
As far as the grant of approval of change of source is also valid under rule 26 of
the Drugs renewal for registration dosage form of which is physically different as described
387
above. On the other hand, the legal status of renewal application submitted by the firm from
previous source is also legal as there is no legal embargo if the previous source is rejuvenated by
the applicant that is valid under SRO 145(I)/1976 if pending with the board concerned and
1117(i)/2012.
(i) The status of recall of stocks is laying hold in the cold storage area of the
importer.
(ii) The legal course of holding/restriction of the stocks were followed by the
firm. Through, they are now not bound to sell after the expiration of the
period of the order on Form-I dated 28.10.2013 which is only for the
period of 14 days by the undersigned.
Conclusion:
After having sufficient documents evidences for both the sources of same product, having
different registration for different sources and renewal also pending though applied well in time
under rules, suffice the need of legal protection to import from the either source being the
custodian of two registrations originally and subsequently renewed as per law enacted under
condition of registration under Drug Act 1976.
The intention of the importer depicts that the change of source of one registration from Cuba to
China is positive for the adequate / free availability of life saving drugs in public interest.
Concluding all pros and corns of this investigation the contention and intention of the importer
was found positive professional approach and no evidence was found to contravene the Drugs
Act 1976 and rules prevails thereunder.
Hence the DDG (E&M) has recommended to allow the importer M/s Macter International (Pvt)
LTd, to make this life saving drug available and restriction as imposed after lot release may also
be withdrawn.
Decision: Registration Board discussed that the firm has violated the Drug Act, 1976
and rules framed there under and decided to issue show cause notice to the company, as
why not the consignment be re-exported or legal action be taken as per procedure, after
giving opportunity of personal hearing to the firm in the next meeting.
388
Case No. 13. Import of Insulatard Penfill Syringe from the previous source by M/s Novo
Nordisk Pharma (Pvt ) , Cl i f ton Karachi .
The case of the firm was discussed in 244th
Meeting of Drug Registration Board. The
case details are as below: -
M/s Novo Nardisk has applied for the change of source of their registered product
namely Insulatard Penfill 100iu/ml 5x3ml (Registration No.010341). The decision of the
Registration Board in its 242nd
meeting is as follows: -
S.No. Product &
Regn.No.
API
Manufacture
Site
Existing
secondary
packaged
import site
Proposed
secondary
packaged
import site
1 Insulatard
Penfill ®
100 IU/ml 5x3
ml
(R.No. 010341)
Novo
Nordisk A/S
Novo Alle
DK-2880
Bagsvaerd
Denmark
Novo Nordisk
A/S
Novo Alle
DK-2880
Bagsvaerd
Denmark
Novo Nordisk
Production S.A.S.
5 bis, rue Edmond
Poillot
28000 Chartres
France
Past Decision: The Board approved the new EMA approved site mentioned above for import
of the above mentioned products subject to COPP from new site.
Accordingly the change of source letter was issued to the firm on 7th
April, 2014 clearly
mentioning that the previous source of import stands cancelled. The Assistant Drugs Controller,
Karachi has informed that M/s Novo Nordisk, Karachi has imported Insulatard Penfil 100IU/M
(Reg NO. 010341) from Denmark on 20th
May, 2014 which is the earlier source of import. The
ADC, Karachi was requested to submit complete case along with his recommendations. The
ADC Karachi has stated that he is of the opinion to revoke the orders of sales restrictions as the
safety, quality and economic value of drug in question. The officer has also stated that sale of the
drug may be allowed in the public interest so required.
It is submitted that the source of import was cancelled by the Drug Registration Board vide letter
No. 2-1/2014-DDC (BD)(M-242), dated 7th
April, 2014. Under section 23 subsection 1(a) (vii)
“no person shall himself or by any other person on his behalf export, import or manufacture for
sale or sell any drug which is not registered or is not in accordance with the conditions of
registration”. The firm has violated the Drugs Act, 1976.
The case of the firm was decided as under: -
389
“DECISION: Registration Board approved request of the firm. However the
Board advised firm to provide/submit copy of L/C (original or duly certified) for
establishing the fact that the import order was placed well before the date of
grant of change of manufacture site by DRAP and authorized its Chairman for
permission to issue the letter for sale of drug”.
The firm was asked to provide the documents as per decision of the Drug Registration Board,
however, the company has provided following documents: -
i) Signed distribution Agreement between Novo Nordisk A/S Novo Alle
2880 Bagsveard Denmark and Novo Nordisk Pharma (Pvt) Ltd, 113,
Shahrah-e-Iran, Mian Clifton Karachi by indicating that in place of L/C
the term of payment is 360 days from the date of invoice, which is also
mentioned on custom invoice.
ii) Customs Invoice.
The firm informed that they have not established L/C as per their own system. The case was
submitted to the Chairman Registration Board for decision. The Chairman has desired to place
the case before the Drug Registration Board for decision.
Decision: Registration Board discussed that the firm has violated the Drug Act, 1976
and rules framed there under and decided to issue show cause notice to the company for
not providing the copy of L/C with opportunity of personal hearing, as per procedure of
Drug Registration Board.
Case No. 14. Deferred case of 241st
meeting for Poulvac ® SE Vaccine by M/s. Hi-tech
Pharmaceutical, Lahore.
The following case of M/s. Hi-Tech Pharmaceutical, Lahore was deferred in 241st Meeting of Drug
Registration Board reasons mentioned in the last column below: -
Sl.# Applicant Name and Specs ECBD Committee
Recommendation
Decision
6. M/s Hi-Tech
Pharmaceutical,
Lahore
Manufactured
by:
M/s Pfizer
Animal Health
(Pfizer Inc),
Poulvac ® SE
Vaccine
Each 0.5ml dose
contains: -
Salmonella enteritidis
Phase Type
4….RP…> 1.0/dose at
release.
Recomme
nded
More data is
required
Deferred
for
clarification
from the
application
regarding
use of
formalin
390
2000 Rockford
Road, Charles
City, Iova, USA
Salmoella enteritidis
Phase Type
8…RP….>1.0/dose at
release.
Salmonella enteritidis
Phase Type
13a…RP…> 1.0/dose
at release 37%
Formaldehyde.
Solution…..0.0006ml
White oil….0.1995ml
Arlacel-83…0.1105ml
Tween-
80…0.001105ml
Saline….q.s to 0.3ml
(For Veterinary Use)
concentrati
on and
review by
already
constituted
committee
and
veterinary
expert of
ECBD.
The firm has submitted application to Animal Husbandry Commissioner Dr. Qurban Ali and
submitted clarification to Director Biological Drugs, DRAP, Islamabad. Clarification submitted to
DRAP and comments of Animal Husbandry Commissioner are tabulated below: -
Clarification submitted by the firm to DRAP Comments of Animal Husbandry
Commissioner
For inactivation, formalin is added to the
total volume of the bacterial suspension,
not over 1%
Source of formalin brand used holds 37%
formaldehyde solution, of this 37%
branded formaldehyde stock solution,
maximum upto 1% of formalin is used in
total volume of the bacterial suspension.
Dose of Poulvac SE is 0.3mL/bird and
each dose contains 0.0006mL i.e. 0.2% of
37% formaldehyde solution.
“Formalin is used to produce inactive bacterial
vaccines. For this purpose, 37% formalindehyde
gas is added to water to produce reagent
commonly known as formaline, which is then
used in a very small concentration (as is used in
the subject product “Poulvac SE” at the rate of
1% to the total volume of bacterial suspension).
Therefore, 37% formaldehyde solution or
formalin at the rate of 1% is part of normal
procedure to produce such inactivated vaccines”.
Decision: Registration Board referred the case to Expert Committee on Biological Drugs
(Vet) for its consideration.
391
Case No. 15. Change of manufacturing site for already registered drugs of M/s. Pfizer
Pakistan, Karachi.
M/s Pfizer Pakistan, Karachi had submitted the following application along with
prescribed Fee Rs. 50,000/- for the product as well as CoPP from new manufacturing site. The
details are as under: -
S.# Product &
Registration No.
Existing
Manufacturing site
New Manufacturing
Site
1. Prevenar 13
Suspension for
injection
(Reg # 066110)
Baxter Pharmaceutical
Solutions LLC 927
South City Curry Pike,
Bloomington IN, USA
Pfizer Ireland
Pharmaceuticals
Grange Castle
Business Park,
Clondalkin, Dublin 22
Ireland.
M/s Pfizer Pakistan Ltd, Karachi has provided following documents to support their claim:-
1. Application with required fee as per SRO (Rs.50, 000/- per product) being the
innovative.
2. Copy of registration letter and last renewal status.
3. NOC for CRF clearance.
4. Original legalized CoPP for new manufacturing site.
5. GMP of manufacturing site.
6. Site Master file
Decision: The request of the company was acceded by the Board as per CoPP issued by the
EMA.
Case No. 16
M/s Novo Nordisk, Karachi had requested for registration of Histidine solvent in
Prefilled Syringe for already registered drugs NovoSeven 50KIU (1mg) Powder for solution for
Injection (Reg No. 066157) each vial contains: Eptacog alfa (activated)1mg and NovoSeven
100KIU (2mg) Powder for Solution for Injection (Reg No. 66158) alongwith Hisitidine 2ml each
vial contains Eptacog alfa (Activated) 2mg. The firm has deposited an amount of Rs. 50,000/- for
each product. The composition detail is as under: -
Name of Company Raw Material Quantity/0.6mL
Novo Nordisk, Karachi Powder and solvent 01mg/vial
392
for solution for
injection
(50KIU/vial)
Novo Nordisk, Karachi Powder and solvent
for injection for
injection
02mg/vial
(1000KIU/vial
Decision: Registration Board deferred the case for confirmation of status of solvent in
CoPP.
Case No. 17. Extension in exemption for the biological drugs imported from M/s Ferring
Germany.
Atco Laboratories Limited, Karachi have submitted that they are importing
following Biological drugs from M/s Ferring Pharmaceutical, Germany since 1994 that are in the
process of shifting their manufacturing facility and it would not be possible for them during this
period to incorporate all requirements according to their local labeling rules on the packaging
material. As these products are rare/ already in the market and patient needs them, therefore, M/s
Atco Laboratories Limited, Karachi has requested for extension in exemption in Labeling and
Packing Rules for the Biological Imported Drugs for at least twenty months are more: -
Sl. # Reg.
No.
Name of
Drug(s)
Exemption requested Quantity
1. 016110 Decapeptyl
0.1mg injection
i) Generic Name not in bracket.
ii) Drug registration number to be printed
locally.
iii) MRP to be printed locally.
iv) Urdu instruction to be printed locally.
v) Pharmaceutical specification.
vi)
924 units.
2. 016111 Decapeptyl
3.75mg
injection
-do- 2638 units.
3. 032143 Menogon
Injection
-do- 6106 units.
4. 016153 Glypressin 1mg
Injection
-do- 3438 units.
This case has been discussed in 243 Meeting of Drug Registration Board and deferred for
confirmation of pharmacological group. The firm has provided the pharmacological group as per
following details: -
393
Sl. # Product name Generic Name Pharmacological Group
1. Decapeptyl 0.1mg injection Triptorelin Acetate Eq.
to 95.6UG
Triptorelin/ml
Triptorelin is synthetic form
of Gonaderelin. Triptorelin
causes an increase in the
amount of FSH and LH
release from the Pituitary
gland.
2. Decapeptyl 3.75mg injection Triptorelin Acetate
Corresponding to
3.75mg/Single Dose
Triptorelin is synthetic form
of Gonaderelin. Triptorelin
causes an increase in the
amount of FSH and LH
release from the Pituitary
gland.
3. Menogon Injection Menotrophin 75IU Gonadotrophic Hormone
(used in infertility).
4. Glypressin 1mg Injection 1mg Terlipressin
Acetate Pentahydrate
In 11mg Dry Substance
Terlinpressin is an analog of
vasopressin used for Bleeding
of esophageal varices, spactic
shock and hepato-renal
syndrome.
Decision: Registration Board acceded to the request of the firm for relaxation for the
Urdu version at the time of import for the products referred above subject to local printing
at the licensed premises of M/s. Atco Laboratories Ltd. Karachi for one year. The firm will
comply with all the rest of conditions as per rules for labeling, before importing to
Pakistan.
Case No. 18. Change of manufacturing name for already registered drug of M/s. Allmed
Laboratories, Karachi
M/s Allmed Laboratories, Karachi has submitted the following application for change of
name of manufacturer along with CoPP from new manufacturer as well as fee of Rs. 50,000. The
detail is as under: -
S.# Product &
Registration No.
Existing name of
manufacturer
New Manufacturer
name
1. ATG – Fresenius S
Concentrate for
solution for
infusion.
Each ml contains:-
Rabbit
M/s Fresenius Biotech
GmbH Germany
M/s Neovii Biotech
GmbH, AM Haag 6-7,
82166 Grafelfing
Germany,
394
Immunoglobulin
20mg
(Reg No. 033134)
M/s Allmed Laboratories, Ltd, Karachi has provided following documents to support their
claim:-
1. Application with required fee as per SRO (Rs.50, 000/- per product).
2. Copy of registration letter and last renewal status.
3. NOC for CRF clearance (Not required for Importer)
4. Original legalized CoPP for new manufacturing site.
Decision: The request of the firm was approved as per CoPP provided by the firm.
Case No. 19. Change of name of manufacturing site for already registered drug of M/s.
Wyeth Pakistan Limited, Karachi.
M/s Wyeth Pakistan Limited, Karachi has submitted the following application for change of
name of manufacture site for their already registered product along with copy of CoPP from new
manufacturer as well as fee of Rs. 100,000/-. The detail is as under: -
S.# Product &
Registration No.
Existing name of
manufacturer
New Manufacturer
name
1. Premarin 0.3mg
tablet Conjugated
Estropgens USP
(Desiccated with
Lactose at
4.29%)…0.3mg.
M/s. Wyeth Medica
Ireland
Little Connell New
bridge Country Kildare,
Ireland
Pfizer Ireland
Pharmaceuticals
Little Connell New
Bridge Country
Kildare, Ireland.
1. Application with required fee as per SRO (Rs.100,000/- per product).
2. Copy of registration letter and last renewal status.
3. NOC for CRF clearance.
4. Original legalized CoPP for new name of manufacturer.
5. GMP of manufacturing site.
6. Site Master file
Decision: The request of the company was approved as per CoPP.
Case No. 20. Extension in shelf life of Poliomyelitis Vaccine of M/s. Hospital Services &
Sales, Karachi.
395
M/s. Hospital Services & Sales, Karachi has submitted the following application for
extension in shelf life of already registered drug from 24 months to 36 months: -
Sl.
No.
Name of Drug with Registration No. Existing Shelf Life Demanded Shelf Life
1. Poliomyelitis Vaccines Inactivated,
Suspension for Injection 0.5ml
vial/dose (IM/SC)
24 months (02 years) 36 months (03 years)
The firm has submitted for following documents: -
a. Application on Form 5A with required fee as per relevant SRO (Rs. 5000/-).
b. Copy of registration letter and last renewal status.
c. NOC for CRF clearance (not required in case of importer).
d. Justification for proposed change.
e. Approval of regulatory body of country of origin / Original and legalized
Certificate of Pharmaceutical Product as per WHO format indicating shelf life 36
months.
f. Free sale certificate and GMP certificate
g. Stability studies for product 2-80C.
h. The firm has also provided WHO prequalification evidence indicating the shelf
life from 24month to 36 month at 2-80C.
Usually extension of shelf life case is placed before the Drug Registration Board after
getting the experts opinion from different experts. However considering the polio emergency in
the country and WHO prequalified data of the said drug, the case is placed before the board for a
decision.
Decision: The request of the firm was approved. WHO status shall be checked from
WHO website before issuance of letter to the company. It shall also be mentioned in the
registration letter that incase of any change in WHO status, the company shall immediately
report to the Board and decision of the Board shall stand cancelled.
396
Case No. 21. Local manufacturing of Allergen vaccines by M/s. Pakcure Pharma, Rawat.
The case of manufacturing of Allergen vaccines by M/s. Pakcure Pharma, Rawat was
under consideration of Board. The following products were discussed in different meetings of the
Board.
Applicant Product specifications Registration No. of
similar product
already in the
market as
manufactured by
NIH, Islamabad
Decision
M/s Pakcure
Pharma, Rawat,
Islamabad.
Allergex-MP
Each ml contains:
Beef protein extract…….10mcg
Chicken protein extract. 10mcg
Egg protein
extract……...10mcg
Fish protein
extract……..10mcg
Mutton protein extract..10mcg
Shelf Life: 6 months when
stored at +2 to +8˚C
Allergy vaccine,
immunostimulant
016742 Deferred for
Product specific
inspection by the
panel.
M/s Pakcure
Pharma, Rawat,
Islamabad.
Allergex-Px1
Each ml contains:
Cannabis sativa protein extract
10mcg
Acacia niloticaa protein extract
10mcg
Eucalyptus globulus protein
extract 10mcg
Pininus longfolia protein
extract 10mcg
House dust extract 10mcg
Shelf Life: 6 months when
stored at +2 to +8˚C
Allergy vaccine,
immunostimulant
-do- Deferred for
Product specific
inspection by the
panel.
397
M/s Pakcure
Pharma, Rawat,
Islamabad.
Allergex-Px2
Each ml contains:
Cannabis sativa protein extract
10mcg
Acacia niloticaa protein extract
10mcg
Eucalyptus globulus protein
extract 10mcg
Pininus longfolia protein
extract 10mcg
Mixed grass extract of Lolim
temulentum + Cynodon
dactylon …10mcg
House dust extract ..10mcg
Shelf Life: 6 months when
stored at +2 to +8˚C
Allergy vaccine,
immunostimulant
-do- Deferred Product
specific inspection
by the panel.
M/s Pakcure
Pharma, Rawat,
Islamabad.
Allergex-Px3
Each ml contains:
Cannabis sativa protein extract
10mcg
Acacia niloticaa protein extract
10mcg
Eucalyptus globulus protein
extract 10mcg
Pininus longfolia protein
extract 10mcg
House dust extract ..10mcg
Paper mulberry extract…10mcg
Thrasher extract…10mcg
Raw cotton extract…10mcg
Shelf Life: 6 months when
stored at +2 to +8˚C
Allergy vaccine,
immunostimulant
-do- Deferred for
Product specific
inspection by the
panel.
398
M/s Pakcure
Pharma, Rawat,
Islamabad.
Allergex-Px4
Each ml contains:
Cannabis sativa protein extract
10mcg
Acacia niloticaa protein extract
10mcg
Eucalyptus globulus protein
extract 10mcg
Pininus longfolia protein
extract 10mcg
House dust extract ..10mcg
Paper mulberry extract…10mcg
Thrasher extract…10mcg
Shelf Life: 6 months when
stored at +2 to +8˚C
Allergy vaccine,
immunostimulant
-do- Deferred for
Product specific
inspection by the
panel.
The product specific inspection of the company was conducted and presented before the board in
its 243rd
Meeting wherein the deficiencies of the facility were discussed and the board decided as
under;
Past Decision: - The Board decided to defer the case till removal of deficiencies. Reference
may also be sent to the Licensing Board to ensure compliance as per requirement of Biological
Drugs.
The firm after making improvements, approached again for the inspection. The inspection of the
company was again carried out by the panel. The panel observed that the firm has not made
substantial improvements. However, the panel was also of the opinion that the company may be
allowed trial manufacturing to ensure that all necessary requirements are met by the company.
The trial manufacturing is not for utilization of allergy vaccines for human use.
In the light of inspection report and recommendations of the panel, the case is placed before the
Board for a decision.
Decision: The Board offered personal hearing to Mr. Agha Sadrad ud Din, CEO of the
company. The applicant explained his status of improvements and assured the Board for
its compliance. The Board decided to conduct the inspection of the company by already
approved panel as and when the firm informs for compliance and will be ready for
inspection. The report of panel shall be considered in the next meeting of Board.
399
Case No. 22. Court case of M/s Forward Solution V/S DRAP.
The case of M/s Forward Solution was discussed in 243rd
Meeting of the Drug Registration
Board. The board decided that since the case is sub judice and under the consideration of the
Honorable Court. The firm M/s. Well Pharma, Lahore will be asked to substantiate their claim of
sole agent of the manufacturer in order to satisfy the legal procedure.
The decision of the board was communicated both the companies. M//s Well Pharma, Lahore has
not provided any sole agent agreement.
The firm M/s Forwarded Solution filed a writ petition in the Honourable Islamabad High
Court, Islamabad on 13.09.2014 on the grounds that the Drug Regulatory Authority of Pakistan
is not granting the Registration due to inaction of the functionary of the Drug Regulatory
Authority of Pakistan (CEO, DRAP, Director, Registration and Director Biological Products).
Parawise comments have been prepared and submitted to the Lawyer of DRAP for finalization
and submission to Honourable Court. Meanwhile, Federal Investigation Agency (FIA) has also
directed to appear before them to provide the details of the case, probably on the complain of
aggrieved company for non grant of registrations. The matter is submitted for information of the
Honorable Drug Registration Board and necessary instruction/orders if any.
Decision: The information was noted by the Board.
400
Item No: VIII Quality Control Cases – Quality Assurance & Lab Testing Division
Case No. 01: Deferred Cases
Sr.
No
Name of
Drugs
Firm CDL Report Appellate Testing Detail / Decision
1 Kohsar DS
Tablets
(Artimether &
Lumifantrin)
Tablets
Batch No.001
Mfg. Sep-13
Exp. Aug-15
(F. No. 03-
63/2013)
M/s Kohs
Pharmaceuticals
(Pvt) Ltd
Hyderabad.
Substandard with
regard to :-
Assay for
Artemether:
Found:- 80.256%
Limit: 90% to
110%
Does not comply
Remarks:- The
sample is of
substandard
quality under the
Drugs Act 1976.
Test report No.
852/2013
Firm challenged
the report after 30
days as per record
provided by FID
so the request was
not valid for re
testing by the
Appellate Lab
NIH Islamabad
under Section
22(5) of Drugs Act
1976
The Board was apprised
about the background of
the case as under:-
The Sample of Kohsar DS
Tablets Batch No. 001
manufacture by M/s Kohs
Pharmaceuticals (Pvt) Ltd
Hyderabad, drawn on 10-
10-2013 from
manufacturer’s premises
by FID Hyderabad, was
declared substandard by
Federal Government
Analyst CDL, Karachi
vide Test report No.
852/2013 dated 10-12-
2013. The firm did not
respond FID’s explanation
letter dated 17-12-2013 so
reminder letters dated 06-
01-2014 and 30-01-2014
were issued by the FID.
The firm vide its response
dated 11-02-2014
disagreed and challenged
the CDL report. As per
record provided by the
FID the report was
conveyed to the firm by
the FID vide letter dated
17th
December 2013,
while the firm challenged
the report vide its letter
dated 11th
February 2014.
The FID nominated
following as responsible
persons.
401
i. Owner of the firm, M/s
Kohs Pharmaceuticals
(Pvt) Ltd.,
ii. Quality Control
Incharge of M/s Kohs
Pharmaceuticals (Pvt)
Ltd
iii. Mirza Saleemullah,
Production Manager,
M/s Kohs
Pharmaceuticals (Pvt)
Ltd
The FID has not given
any recommendations
nor made any comments
regarding validity of the
act of challenging the
CDL report by the firm.
However, as per record
provided by the FID, it
appears that firm has
challenged the report
after the 30 days period
prescribed under Section
22(4) of Drugs Act 1976,
therefore, the request was
not valid for retesting by
Appellate Lab.
As per responsibility
fixed by the FID, show
cause notices dated 05-
05-2014 were issued to
the firm and the accused
persons of the firm.
The case was placed
before Drug Registration
Board in its 244th
meeting held on 23-24th
July 2014. The accused
402
of the firm were also
called for personal
hearing in the said
meeting of the Board but
they could not appear
before the Board. The
Board decided to defer
the case and provide a
final opportunity of
personal hearing to the
accused.
The case was again
placed before Drug
Registration Board in its
245th
meeting held on
29-30th
September 2014.
The accused of the firm
were also called for
personal hearing in the
said meeting of the
Board but they could not
appear before the Board.
The Board decided to
defer the case and
provide a final
opportunity of personal
hearing to the accused.
The case was presented
before the registration board
in its 246th
meeting on 11-
12-2014. The Board decided
the case as under in the light
of personal hearing of Mr.
Pardeep Kumar Director of
the firm:-
Decision:-
The Board took the
following decision
i. Cancellation of
Kohsar DS Tablets
Registration No
403
070898.
ii. Panel Inspection for
PSI.
iii. The panel will be
constituted by
Director QA<.
2. Dozabitol
(Paracetamol
Syrup.
Batch No. DB
110
Mfg-Jul -13
Exp. Jun-15
(F.No. 03-
12/2014)-QC
M/s Kohs
Pharmaceuticals
(Pvt) Ltd
Hyderabad
Sub-Standard:-
With regard to
assay for
Paracetamol
Found :-82.2984%
Limit:- 90% to
110%
Does not comply
Remarks:- The
sample is of
substandard
quality under the
Drugs Act 1976.
Test report No.
848/2013
Firm challenged
the report after 30
days as per record
provided by FID
so the request was
not valid for re
testing by the
Appellate Lab,
NIH Islamabad
under section
22(5) of Drugs Act
1976
The Board was apprised
about the background of
the case as under:-
The Samples of Dozabitol
Syrup, Batch No. DB110
manufacture by M/s Kohs
Pharmaceuticals (Pvt) Ltd
Hyderabad, drawn on 10-
10-2013 from
manufacturer’s premises
by FID Hyderabad, were
declared substandard by
Federal Government
Analyst CDL Karachi vide
Test report No. 848/2013
dated 27-11-2013. . In
response to FID’s
explanation letter, the firm
disagreed and challenged
the CDL report. As per
record provided by the
FID the report was
conveyed to the firm by
the FID vide letter dated
03rd
December 2013 and
reminder was issued vide
letter dated 30-01-2014
for firm’s response in the
matter. The firm
challenged the report vide
its letter received in
DRAP Karachi office on
13-02-2014. so the request
for retesting was not valid
as the same was received
by FID office after 30
404
days The FID has
nominated following as
responsible persons.
i. Owner of the firm,
M/s Kohs
Pharmaceuticals
(Pvt) Ltd.,
ii. Quality Control
Incharge, M/s Kohs
Pharmaceuticals
(Pvt) Ltd
iii. Mirza Saleemullah,
Production Manager,
M/s Kohs
Pharmaceuticals
(Pvt) Ltd
The FID has not given
any recommendations
nor made any comments
regarding validity of the
act of challenging the
CDL report by the firm.
However, as per record
provided by the FID, it
appears that firm has
challenged the report
after the 30 days period
prescribed under Section
22(4) of Drugs Act 1976,
therefore, the request was
not valid for retesting by
Appellate Lab.
As per responsibility
fixed by the FID, show
case notices dated 05-05-
2014 were issued to the
firm and the accused
persons of the firm.
The case was placed
before Drug Registration
Board in its 244th
405
meeting held on 23-24th
July 2014. The accused
of the firm were also
called for personal
hearing in the said
meeting of the Board but
they could not appear
before the Board. The
Board decided to defer
the case and provide a
final opportunity of
personal hearing to the
accused.
The case was again
placed before Drug
Registration Board in its
245th
meeting held on
29-30th
September 2014.
The accused of the firm
were also called for
personal hearing in the
said meeting of the
Board but they could not
appear before the Board.
The Board decided to
defer the case and
provide a final
opportunity of personal
hearing to the accused.
The case was presented
before the registration board
in its 246th
meeting on 11-
12-2014. The Board decided
the case as under in the light
of personal hearing of Mr.
Pardeep Kumar Director of
the firm:-
Decision:-
The Board took the
following decision
406
i.. Cancellation of
Registration of
Dozabitol
(Paracetamol Syrup
Registration
No.006201.
ii. Panel Inspection
for PSI.
iii. The panel will be
constituted by
Director QA<
3. Dozabitol
(Paracetamol
Syrup.
Batch No. DB
089
Mfg- Jan-13
Exp- Dec-14
(F.No. 03-
31/2013)-QC
M/s Kohs
Pharmaceuticals
(Pvt) Ltd
Hyderabad
Sub-Standard with
regard to:-
Assay for
Paracetamol:-
Found:- 88.62%
Limit:- 95.0% to
105%
Does not comply
with BP 2011
Remarks:- The
sample is of
substandard
quality under the
Drugs Act 1976.
Test report No.
Sub-Standard
With regard to:-
i. Assay for
paracetamol:-
85.52%
Does not comply
with BP 2011.
ii. Description
pink colored syrup
having un
dissolved masses
which do not
disperse even on
shaking
Does not comply
with BP 2011,
which states that
suspension may
show a
sedimentation
which is readily
The Board was apprised
about the background of
the case as under:-
The Sample of Dozabitol
Syrup Batch No. DB089
manufacture by M/s Kohs
Pharmaceuticals (Pvt) Ltd
Hyderabad, drawn on 21-
03-2013 from
manufacturer premises by
FID Hyderabad, was
declared substandard by
Federal Government
Analyst, CDL Karachi
vide Test report No.
535/2013 dated 06-05-
2013. On explanation
letter issued by the FID,
the firm requested
Appellate testing under
section 22(5) of Drugs Act
1976. The Appellate
Laboratories also declared
the sample sub-standard
vide test report No.08-
MNHRS/2013 dated 06th
August 2013. The repot of
Appellate Laboratories
was forwarded to the FID
for sending complete case
407
535/2013 dispersed on
shaking.
Test report No.08-
MNHRS/2013
along with
recommendation and
name of the responsible
persons. The FID in
response has nominated
following as responsible
person with request for
permission for prosecution
and cancellation of
registration.
i. Owner of the firm,
M/s Kohs Pharmaceuticals
(Pvt) Ltd., Hyderabad.
ii. Miss Rakhshanda
Perveen (Quality Control
Manger).
iii. Production Manager
of the firm
As per responsibility fixed
by the FID, show cause
notices dated 07-05-2014
were issued to the firm
and the accused persons
of the firm..
The case was placed
before Drug Registration
Board in its 244th
meeting held on 23-24th
July 2014. The accused
of the firm were also
called for personal
hearing in the said
meeting of the Board but
they could not appear
before the Board. The
Board decided to defer
the case and provide a
final opportunity of
personal hearing to the
accused. They have been
called for personal
hearing again
408
accordingly.
The case was again
placed before Drug
Registration Board in its
245th
meeting held on
29-30th
September 2014.
The accused of the firm
were also called for
personal hearing in the
said meeting of the
Board but they could not
appear before the Board.
The Board decided to
defer the case and
provide a final
opportunity of personal
hearing to the accused.
The case was presented
before the registration board
in its 246th
meeting on 11-
12-2014. The Board decided
the case as under in the light
of personal hearing of Mr.
Pardeep Kumar Director of
the firm:-
Decision:-
The Board took the
following decision
i.. Cancellation of
Registration of
Dozabitol
(Paracetamol Syrup
Registration
No.006201.
ii. Panel Inspection for
PSI.
iii. The panel will be
constituted by
Director QA<.
409
4. Stearox 1ml
Injection
Batch No.
H110112
Mfg:-01-12
Exp:-01-14
(F.No.03-
25/2013 QC)
M/s Gyton
Pharmaceutical
Lahore
Sub-Standard
With regards to:-
i. pH
Determined 5.94
Limit 7.0 to 8.5
Does not comply
with USP 34
ii. Assay for
Dexamethasone
Phosphate 14.59%
Limit 90% to 115%
Does not comply
with USP 34
Not Challenged
Batch No.
H110112,
The Brief about the
background of the case is
as under:-
The samples of Stearox
Injection Batch No.
H110112, Manufactured by
M/s Guyton Pharmaceutical
Lahore drawn by FID
Karachi from Central
Pharmacy of JPMC,
Karachi on 26-02-2013, was
declared Substandard vide
test report No.261/2013
dated 03-04-2013 by
Federal Government
Analyst. The FID has
identified following persons
responsible in the case.
. Mr. Talat Ahmad
Anjum (Q.C In-
charge)
.Muhammad Imran Khalil
(Production In-charge)
As per procedure show
cause notices was issued
to the firm 20th February
2014 and above accused,
offering opportunity of
personal hearing before
the Drug Registration
Board. They have also
been called for personal
hearing accordingly.
The case was placed
before 244th meeting of
Registration Board
which decided the case
as under:-
410
“The accused of the firm
were called for personal
hearing, but they could not
appear before the Board.
The Board decided to defer
the case and a final
opportunity of personal
hearing shall be given in
next meeting of the Board”
Accused as identified by
FID Lahore has also been
called for personal hearing
accordingly. The case was
again placed before 245th
meeting of Refistration
Board which decided the
case as under:-
Decision:- Mr. Muhammad
Salman Ali, Advocate High
Court appeared on behalf of
M/s Guyton Pharmaceutical
Lahore. The Board did not
accept power of Attorney on
behalf of the firm. The
Board decided the case as
under:-
i. The production of the
injection Stearox 1ml
Registration No. 040336
shall be stopped. One more
opportunity of personal
hearing is granted with the
direction that the
Management and Technical
Personnel shall appear
before the Board failing
which the ex-parte decision
411
shall be taken.
ii. The Board further
decided that the firm will
recall all the marketed
batches of sub-standard
drugs from distribution /
sale outlets / institutional
supplies if any and area FID
shall take report from the
firm and submit a
compliance report to
Chairman Registration
Board.
In the light of decision
taken in 245th
meeting of
Registration Board The One
more opportunity of
personal hearing is granted
with the direction that the
Management and Technical
Personnel shall appear
before the Board failing
which the ex-parte decision
shall be taken.
The case was presented
before the registration board
in its 246th
meeting on 11-
12-2014. The Board decided
the case as under in the light
of personal hearing of Mr.
Bilal Khurshid Chief
Executive of the firm:-
Decision:-
The Board took the
following decision:-
i. Area FID Mr.
412
Abdul Rasool
Shiekh to take the
samples of the
batch and submit
the investigation
report of the case
again as the firm
has disowned the
supply of specific
Batch.
ii. The production of
the firm in the
steroidal Injectable
section shall be
stopped along with
suspension of
registration of
Stearox 1ml
Registration No.
040336 which had
already been
suspended in 245th
meeting till
investigation of the
case is finalized.
iii. The firm will be
asked to provide on
stamp paper
regarding their
statement of
disownership of
supply of this
batch.
iv. The case will be
submitted before
the Registration
Board after the
completing the
investigation.
413
Case No. 02 New Cases.
414
Sr.
No
Name of Drugs Firm CDL Report Appellate Testing Detail / Decision
1. Rehumetic 50
Tablets
(Diclofenac
Potassium)
Batch No. RT012
Mfg Date:-03-14
Exp Date:- 03-16
(F.No.03-42/2014-
QC)
M/s Rehmat
Pharma
Lahore.
Sub-Standard with
regard to:-
i. Assay for diclofenac
Potassium:-
Determined
amount/tablet:- 48.44mg
Stated amount/tablet:-
50mg
Percentage:- 96.88%
Fail on Dissolution test
as under:-
ii. Dissolution test:-
Tablet No:- (%)age
1. 17.25
2. 14.37
3. 17.82
4. 13.5
5. 12.94
6. 16.10
No Challenged The background of the
case is as under:-
The FID has submitted
the investigation report.
The FID has fixed the
responsibility and
submitted the name of
Directors, Production
Incharge, Quality
Control Incharge as
under:-
i. Mr. Bashir Ahmed,
Chief Executive,
M/s Rehmat Pharma,
Sheikhupura Road,
Lahore.
ii. Mr. Muzaffar Bashir
Production Incharge
M/sp Rehmat
Pharma, Sheikhupura
Road
Lahore.
iii. Mr. Muhammad
Sarwar, Quality Control
Incharge, M/s Rehmat
Pharma, Sheikhupura
Road,
415
Limits: Not less than
75.0%
Does not comply with
USP 37
Remarks:- The sample
is of substandard
quality under the Drugs
Act 1976.
Test Report No.
LHR.136/2014
Lahore.
The FID has concluded
that the firm has violated
Section 23(1)(a)(v) of
the Drug Act, 1976 and
rules framed there under.
The tablet Rehumetic 50
was declared substandard
by CDL on the basis of
dissolution test. The firm
vide its reply dated 18-
08-2014 to FID did not
challenge the report and
requested to drop the
proceeding against them
in the interest of justice.
The FID has submitted
the copies of recall of the
product from market by
M/s Rehmat pharma,
Lahore.
Keeping in view above
since the firm has not
challenged the report of
CDL therefore the report
dated 21st July, 2014 is
the adducing evidence
under the law.
As per procedure a show
cause notice was issued
to the firm and other
accused, offering
opportunity of personal
hearing before the Drug
Registration Board.
416
The case was presented
before the registration
board in its 246th
meeting
on 11-12-2014. The
Board decided the case
as under in the light of
personal hearing of Mr.
Abid Hussain Awan
Technical Advisor and
Mr. Muhammad Sarwar
QC Incharge of the
firm:-
Decision:-
The Board took the
following decision
i. Warning to the
firm.
ii. Destroy the
recalled quantity
(1,34000) of
Rehumetic 50mg
tablets in
presence of area
FID Lahore. The
area FID will
submit the
report of
destruction to
the Directorate
of QA/LT.
iii. The firm will
submit the
measures taken
to overcome such
incidence in
future.
3. D. Dron
(Dexamethason)
Injection
M/s Epharm
Laboratories,
Adulterated &
Substandard with
Not challenged The Board was apprised
about the background of
417
(IM/IV)
Batch No.
DF.137
Mfg:- 06-13
EXP:- 06-15
&
Karachi. regards to Description:-
Finding of Lab:-
Colorless solution in
clear glass ampoule. Out
of 25 ampoules (referred
portion of sample) one
ampoule contain black
particles and another
ampoule contains white
fibers.
Does not comply with
Description
Remarks:-
The sample is of
“Adulterated &
Substandard” under the
Drugs Act 1976.
Adulterated &
Substandard with
regards to Description:-
Finding of Lab:-
the case as under:-
The samples of D-
Dron Injection Batch
No DF.137 & DF-138
manufactured by M/S
Epharm Laboratories,
Karachi were taken by
FID Hyderabad at
Karachi on 29-01-
2014 from
manufacturer’s
premises. The samples
were declared
Adulterated &
Substandard by
Federal Government
Analyst vide test
reports
No.KQ.60/2014 &
KQ.61/2014 dated 18th
February 2014
respectively.
The FID
communicated the test
reports to the firm
vide his letter No.05-
10/2014-FID-H (K)
255-257 dated 19-02-
2014. The firm in their
reply mentioned about
their right of exercise
the power under
subsection (4) of
Section 22 of Drugs
Act 1976 for retesting
of their samples from
appellate lab
Islamabad. As per
submission of
complete case by the
FID, the firm’s reply
was received in the
office of DRAP
Karachi on 08-04-
418
Batch No.
DF.138
Mfg:- 07-13
EXP:- 07-15
(F.No.03-
10/2014-QC)
Clourless solution in
clear glass ampoule. Out
of 15 ampoules (referred
portion of sample) two
ampoules contain black
particles.
Does not comply with
Description
Remarks:-
The sample is of
“Adulterated &
Substandard” under the
Drugs Act 1976.
2014 which was well
after the expiry of
time allowed under
section 22(4) of the
Drugs Act 1976 and
hence not valid as per
FID’s remarks.
The FID has furnished
the names of the
following persons of
the firm responsible
for committing the
offence under the law.
i. M/S Epharm
Laboratories
Karachi.
ii. Mr. Asad Ilyas
Nainitalwala,
Director,
iii. Mr. Ahmed
Nadeem Qasmi,
QC Manager,
iv Dr. Mohammad
Khokhar
Production
Manager,
Show cause notices
were issued to the firm
and other accused,
offering opportunity
of personal hearing
before the Drug
Registration Board
after the approval of
the competent
authority. They have
been also called for
personal hearing
accordingly.
The case was presented
before the registration
board in its 246th
meeting
419
on 11-12-2014. The
Board decided the case
as under in the light of
personal hearing of Mr.
Asad Ilyas Director of
the firm and Mr. Ahmed
Nadeem Qasmi QC
Manager of the firm.
Decision:-
The Board took the
following decision
i. The Board decided
to suspended the
registration of D-
Dron Injection
Registration
No.058424 (IM/IV)
for a period of three
months.
ii. PSI Inspection by a
panel comprising of
Director DTL
Quetta and area
FID will be
conducted and they
will submit the
report to the
Registration Board
3. i. Loose pink
cloured tablets-
Rumin
(Ibuprofen)
400mg Tablets
M/s Ankaz
Pharmex
(Pvt) Ltd
Karachi
Substandard with regard
to “Assay”
for Ibuprofen:
Determined amount/Tab
=49.512mg
Substandard with
regard to “Assay”
for Ibuprofen (BP)
Stated:-
The Board was apprised
about the background of
the case as under:-
The Federal Inspector
of Drug, Karachi-III
vide his letter dated
420
Batch No. Nil
Mfg Date:- Nil
Exp Date:- Nil
Stated amount/tab
=400mg
Percentage:- 12.378%
Limit: 95% to 105%
Does not comply
Remarks:- The sample
is of substandard
quality under the Drugs
Act 1976.
Test Report No.
RKQ.212/2014.
400mg/Tab
Found:- 313mg/tab.
Percentage:-
78.29%
Limit: 95% to
105%
Does not comply
with BP 2011
Conclusion:-
The sample is of
substandard
quality on the basis
of tests performed.
21-04-2014 informed
that he alongwith Dr.
Shahid Hussain, FID
Karachi and others
raided the premises of
M/s Ankaz Pharmax
(Pvt) Ltd., Karachi on
19-04-2014 at 07.45
AM. The raid was
conducted on the
source information of
FIA Crime Circle
Karachi. Deputy
Director FIA Mr.
Fakeer Muhammad
headed the raid
alongwith his team.
Ten samples of
different products
were taken from the
manufacturers
premises for
test/analysis on the
prescribed Form-3.
The FID vide his
investigation report of
the case intimated that
eight samples of the
drugs taken have been
declared to be
substandard by the
Federal Government
Analyst, CDL
Karachi. In the light of
the same, the FID
issued explanation
letter regarding the
matter of manufacture
and sale of
substandard drugs to
the firm. As per
documents provided
by the FID, the firm
challenged the test
reports and requested
421
to get the samples
retested from the
Appellate Laboratory,
NIH Islamabad. The
Appellate Laboratory
also declared the drug
sample under
reference as
Substandard.
The FID concluded
that the manufacturer
is guilty of
manufacturing
substandard drugs and
de-registered drug in
violation to the
provisions of Drugs
Act 1976 and rules
framed there under.
He has requested for
cancellation DML of
the firm or permission
to lodge the
prosecution against
the firm.
Following persons of
the firm have been
held responsible for
committing the
offence by the FID.
i. Ali Abbass,
Managing Director
of the firm.
ii. Akbar Ali
Production Incharge.
iii. Safdar Alam,
Quality Control
Incharge.
As per procedure
Show cause notices
were issued to the firm
422
and other accused, in
the light of the test
reports of the
Appellate Lab and
report of the FID,
offering them
opportunity of
personal hearing
before the Drug
Registration Board.
They have also been
called for personal
hearing accordingly.
The Federal Inspector
of Drugs, Karachi-III
vide his letter dated
21-04-2014 informed
that he alongwith Dr.
Shahid Hussain, FID
Karachi and others
raided the premises of
M/s Ankaz Pharmax
(Pvt) Ltd., Karachi on
19-04-2014 at 07.45
AM. The raid was
conducted on the
source information of
FIA Crime Circle
Karachi. Deputy
Director FIA Mr.
Fakeer Muhammad
headed the raid
alongwith his team.
The FID vide his
investigation report of
the case intimated that
eight samples of the
drugs taken have been
declared to be
423
substandard by the
Federal Government
Analyst, CDL
Karachi. In the light of
the same, the FID
issued explanation
letter regarding the
matter of manufacture
and sale of
substandard drugs to
the firm. As per
documents provided
by the FID, the firm
challenged the test
reports and requested
to get the samples
retested from the
Appellate Laboratory,
NIH Islamabad. The
Appellate Laboratory
declared the drug
sample under
reference as
Misbranded.
The FID concluded
that the manufacturer
is guilty of
manufacturing
substandard drugs and
de-registered drug in
violation to the
provisions of Drugs
Act 1976 and rules
framed there under.
He has requested for
cancellation DML of
the firm or permission
to lodge the
prosecution against
the firm.
Following persons of
the firm have been
held responsible for
424
-do.
Substandard with regard
committing the
offence by the FID.
i. Ali Abbass,
Managing Director
of the firm.
ii. Akbar Ali
Production Incharge.
iii. Safdar Alam,
Quality Control
Incharge.
As per procedure
Show cause notices
were issued to the firm
and other accused, in
the light of the test
reports of the
Appellate Lab and
report of the FID,
offering them
opportunity of
personal hearing
before the Drug
Registration Board.
They have also been
called for personal
hearing accordingly.
The FID vide his
investigation report of
the above case also
reported that the firm
was found manufacturing
its one of de-registered
product namely syrup
Rumin mentioning the
old manufacturing date
on the label. It has been
425
ii. Loose pink
cloured tablets-
Rumin
(Ibuprofen)
200mg Tablets
Batch No. Nil
Mfg Date:- Nil
Exp Date:- Nil
to :-
Assay for Ibuprofen:
Determined
amount/Tablet
=24.756mg
Stated amount/tablet
=200mg
Percentage:- 12.378%
Limit: 95% to 105%
Does not comply
Remarks:- The sample
is of substandard quality
under the Drugs Act
1976.
Test Report No.
RKQ.213/2014
Substandard with
regard to “Assay”
for Ibuprofen (BP)
Stated:-
200mg/tab
Found:-
153.38mg/tab.
Percentage:-
76.69%
Limit: 90% to
105%
Does not comply
with BP 2011
intimated that Syrup
Rumin was found stored
in bulk in big vessel
placed in liquid
manufacturing areas of
the firm. A huge quantity
of finished goods of
same de-registered syrup
was also seen placed in
finished good wear
house
The FID concluded
that the manufacturer
is guilty of
manufacturing
substandard drugs and
de-registered drug in
violation to the
provisions of Drugs
Act 1976 and rules
framed there under.
He has requested for
cancellation DML of
the firm or permission
to lodge the
prosecution against
the firm.
Following persons of
the firm have been
held responsible for
committing the
offence by the FID.
i. Ali Abbass,
Managing Director
of the firm.
ii. Akbar Ali
426
iii. Tablet
Rumin
(Ibuprofen)
400mg
(Blister packing)
-do-
Substandard with regard
to :-
Assay for Ibuprofen:
Determined
amount/Tablet
=350.71mg
Stated amount/tablet
=400mg
Percentage:- 87.6775%
Limit: 95% to 105%
Does not comply
Remarks:- The sample
is of substandard quality
under the Drugs Act
1976.
Conclusion:-
The sample is of
substandard
quality on the basis
of tests performed.
Test Report
No.09-
MNHSR/2014
Substandard with
regard to “Assay”
for Ibuprofen (BP)
Stated:-
400mg/tab
Found:-
319.24mg/tab.
Percentage:-
79.81%
Production Incharge.
iii. Safdar Alam,
Quality Control
Incharge.
As per record of
Quality Control
Section, registration of
this product was
cancelled by DRB in
its 237th
meeting held
on 26-02-2013, which
was communicated of
the firm vide their
officer letter bearing
No.03-16/2012-QC,
dated 22-03-2013.
As per procedure
Show cause notices
were issued to the firm
and other accused, in
the light of report of
the FID, and record of
QC Section regarding
the de-registration of
the product offering
them opportunity of
personal hearing
before the Drug
Registration Board.
They have also been
called for personal
hearing accordingly
427
Batch No. 1105
Mfg Date:- 1-12
Exp Date:- 12-14
-do-
Test Report No.
RKQ.215/2014
Substandard with regard
to :-
Assay for Ibuprofen:
Determined
amount/Tablet
=30.945mg
Stated amount/tablet
=200mg
Percentage:- 15.4725%
Limit: 95% to 105%
Does not comply
Remarks:- The sample
is of substandard
Limit: 95% to
105%
Does not comply
with BP 2011
Conclusion:-
The sample is of
substandard
quality on the basis
of tests performed.
Test Report
No.08-
MNHSR/2014
Substandard with
regard to “Assay”
for Ibuprofen (BP)
Stated:-
200mg/tab
Found:-
145.60mg/tab.
The Board was apprised
about the background of
the case as under:-
The Federal Inspector
of Drug, Karachi-III
vide his letter dated
21-04-2014 informed
that he alongwith Dr.
Shahid Hussain, FID
Karachi and others
raided the premises of
M/s Ankaz Pharmax
(Pvt) Ltd., Karachi on
19-04-2014 at 07.45
AM. The raid was
conducted on the
source information of
FIA Crime Circle
Karachi. Deputy
Director FIA Mr.
Fakeer Muhammad
headed the raid
alongwith his team.
Ten samples of
different products
were taken from the
manufacturers
premises for
test/analysis on the
prescribed Form-3.
The FID vide his
investigation report of
the case intimated
that eight samples of
the drugs taken have
been declared to be
substandard by the
Federal Government
Analyst, CDL
Karachi. In the light
428
iv. Tablet
Rumin
(Ibuprofen)
200mg
Batch No. 640
(Jar Packing)
Mfg Date:- 2-13
Exp Date:- 01-16
quality under the Drugs
Act 1976.
Test Report No.
RKQ.206/2014
Substandard with regard
to :-
Assay for
Sulphamethoxazole:
Determined
amount/Tablet =101.328
mg
Stated amount/tablet
=800mg
Percentage:- 12.666%
Percentage:-
72.80%
Limit: 95% to
105%
Does not comply
with BP 2011
Conclusion:-
The sample is of
substandard
quality on the basis
of tests performed.
Test Report
No.012-
NHSR/2014
Misbranded with
the following
remarks:-
“Labeling on the
immediate pack is
of the same, the FID
issued explanation
letter regarding the
matter of manufacture
and sale of
substandard drugs to
the firm. As per
documents provided
by the FID, the firm
challenged the test
reports and requested
to get the samples
retested from the
Appellate Laboratory,
NIH Islamabad. The
Appellate Laboratory
declared the drug
sample under
reference as of
standard quality.
As per Section 22
(5) of the Drugs Act
1976 and the report of
conclusive evidence
so in the light of the
same the present case
with regard to drug
under reference may
be filed.
.
Submitted for
Information of the
Board please.
-Do-
429
v.. Biprim (Co-
Trimoxazole) DS
Tablets
Batch No. 305
(Blister packing)
-do-
Does not comply
Remarks:- The sample
is of substandard
quality under the Drugs
Act 1976.
Test Report No.
RKQ.207/2014
not legible. More
over batch
number and
expiry date is
printed with
removable ink and
some strips found
without batch
numbers and
expiry date which
is violation of the
labeling and
packing rules of
Drugs Act 1976.
Conclusion:- The
sample is
misbranded.
Test Report
No.06-
MNHSR/2014
-Do-
The case was presented
before the registration
board in its 246th
meeting
on 11-12-2014. The
Board decided the case
as under in the light of
personal hearing of Mr.
Salim Isharat Husain,
Technical Consultant on
behalf of M.D of the
firm.
Decision:-
The Board in view of
personal hearing of Mr
Saleem Isharat Hussain
on behalf of Managing
Director Ankaz Pharmex
and available
record/facts of the case
decided as under:-
1. The Board decided
to cancel the
registration of the
following products as
per its consideration:-
i. Loose Pink Colored
Tablets- Rumin
(Ibuprofen) 400mg
Tablets. Registration
No. 007545
ii. Loose Pink colored
430
Mfg Date:- 11-13
Exp Date:- 10-16
vi. Rumin
(Iburofen)
Suspension
The sample is of
standard quality with
regard to tests
performed.
Tablets- Rumin
(Ibuprofen) 200mg
Tablets, Reg. No.
007543.
iii. Tab. Rumin 400mg.
(Blister Packing)
Reg. No. 007545
iv. Tab. Rumin 200mg
(Jar Packing) Reg. No.
007543.
v. Tab. Biprim (Co-
Trimoxazole) DS
(Blister Packing)
Reg. No. 008409
vi. Rumin (Ibuprofen)
Suspension, Reg.
No. 008526
2. The Board further
decided to recommend
to the Central
Licensing Board for
cancellation of the
Drug Manufacturing
License of the firm on
the violation of
manufacturing of
already De-registered
product i.e. Rumin
Suspension Reg. No.
008526.
431
Batch No.408
Mfg Date:-03-13
Exp Date:-02-16
vii. Biprim DS
(Co-
Trimoxazole)
Tablets
Batch No. 305
(Jar packing)
Mfg Date:- 11-13
Exp Date:- 10-16
viii. Biprim
(Co-
Trimoxazole)
Tablets
Batch No. 524
(Blister packing)
Test report No.
RKQ.210/2014.
Substandard with regard
to :-
Assay for
Sulphamethoxazole:
Determined
amount/Tablet =101.328
mg
Stated amount/tablet
=800mg
Percentage:- 12.666%
Does not comply
Remarks:- The sample
is of substandard
quality under the Drugs
Act 1976.
Test Report No.
RKQ.209/2014
Substandard with regard
to :-
Assay for
Sulphamethoxazole:
432
Mfg Date:- 01-13
Exp Date:- 12-15
ix. Loose white
cores
claimed/suspecte
d of Tablets-
Rumin
(Ibuprofen)
200mg
Batch No. Nil
Mfg Date:- Nil
Exp Date:- Nil
(F.No.03-
17/2014-QC)
Determined
amount/Tablet =101.328
mg
Stated amount/tablet
=800mg
Percentage:- 12.666%
Does not comply
Remarks:- The sample
is of substandard quality
under the Drugs Act
1976.
Test Report No.
RKQ.208/2014
Substandard with regard
to :-
Assay for Ibuprofen:
Determined
amount/Tablet
=30.945mg
Stated amount/tablet
=200mg
Percentage:- 15.4725%
Limit: 95% to 105%
Does not comply
Remarks:- The sample
433
-Do-
is of substandard
quality under the Drugs
Act 1976.
Test Report No.
RKQ.214/2014
N.A
The Sample has
been declared of
Standard Quality
on the basis of tests
performed.
Test Report
No.013-
MNHSR/2014
The Sample has
been declared of
Standard Quality of
the basis of tests
performed
Test Report No.07-
MNHSR/2014
The Sample has
been declared of
Standard Quality
on the basis of tests
performed by the
Appellate Lab,
NIH, Islamabad.
(Test Report
No.010-
MNHSR/2014)
4. Kemycillin
(Ampicillin)
M/s Alkemy
Pharmaceutica
Substandard with regard
to :-
Sub-Standard
With regard to:-
The Board was apprised
about the background of
434
Syrup
Batch No. A-
1028
Mfg. Oct-13
Exp. Use with in
three years
(F. No. 03-
34/2014)
l Laboratories
Hyderabad.
Assay for Ampicillin
Determined
amount/5ml:-
=103.32mg
Stated amount /5ml
=125mg
Percentage:- 82.66%
Limit: 90% to 120%
Does not comply
Remarks:- The sample
is of substandard
quality under the Drugs
Act 1976.
Test report No.
KQ.230/2014
Assay for
Ampicillin:-
Stated 125mg/5ml
i. First day Found
=101.14mg/5ml
Percentage:-
80.91%
i. On 07th
Day Found
=
78.53mg/5
ml
Percentage:-
62.82%
Limit:- 80-120%
Does not comply
with BP 2011.
Conclusion:-
The sample is of
substandard
quality on the basis
the case as under:-
The Sample of
Kemycillin Syrup Batch
No A-1028,
manufactured by M/s
Alkemy Pharmaceutical
Laboratories P/9, SITE
Hyderabad Sindh was
taken by FID Hyderabad
at Karachi on 24-04-
2014 from
manufacturer’s premises.
It was declared
substandard by Federal
Government Analyst
vide Test report No.
KQ.230/2014 dated 27th
May 2014. In response to
the explanation letter
issued by the FID, the
firm challenged the CDL
report and requested for
Appellate Testing under
Section 22(5) of Drugs
Act, 1976. The Appellate
Laboratory also declared
the sample as
Substandard vide test
report No. 015-
MNHSR/2014 dated 08th
August 2014. The FID in
response to this office
letter dated 29th
August
2014 concluded that the
firm has violated Section
23(1)(a)(v) of Drugs Act
1976. FID has
recommended immediate
action under Section
435
of tests performed.
Test report No.
015-MNHSR/2014
7(11) of the Drugs Act
1976 and has furnished
the names of the
following persons of the
firm responsible for the
offence.
i. M/s Alkemy
Pharmaceutical
Laboratories (Pvt.)
Ltd Hyderabad,
ii. Mr.Fraz Ahmed
Sheikh,
Managing Director,
iii. Mr. Asif Najeeb
Laghari,
QC Manager,
iv. Mr.Abid Ali Khoso
Production
Incharge,
As per responsibility
fixed by the FID,
show case notices
dated 05-05-2014
were issued to the
firm and the accused
persons of the firm.
The case was presented
before the registration
board in its 246th
meeting
on 11-12-2014. The
Board decided the case
as under in the light of
personal hearing of Mr.
Asif Najeeb Laghari QC
Manager of the firm.
436
Decision:-
The Board took the
following decision:
i. Suspended the
registration of
Kemycillin
(Ampicillin)
Syrup, Reg. No.
022520 for a
period of six (06)
months.
ii. Panel Inspection
for PSI.
iii. The panel will be
constituted by
Director
QA<
5. Empoir 500mg
(Ciprofloxacin)
Tablets.
Batch No. 283
Mfg Date- 03-14
Exp Date. 02-17
(F.No. 03-
33/2014)-QC
M/s Alkemy
Pharmaceutica
l Laboratories
Hyderabad.
Sub-Standard:-
With regard to
Dissolution test
Tablet 01= 38.23%
Tablet 02= 48.94%
Tablet 03= 39.30%
Tablet 04= 32.26%
Tablet 05= 39.15%
Tablet 06= 39.15%
Limit:- Not less than
80%
Does not comply with
Substandard with
regard to
Dissolution test
Determined:-
59.9%
57.71% (repeated)
Limit:- Not less
than 80% of the
stated amount
Does not Complies
with USP 32
Conclusion:-
The sample is of
The Board was apprised
about the background of
the case as under:-
The Sample of Empoir
500mg Tablets Batch
283 manufactured by
M/s Alkemy
Pharmaceutical
Laboratories (Pvt.) Ltd,
P/9, SITE Hyderabad
was taken by FID
Hyderabad at Karachi on
24-04-2014 from
manufacturer’s premises.
The Sample was
declared substandard by
Federal Government
Analyst CDL Karachi
vide Test report No.
KQ.228/2014 dated 15th
May 2014. In response to
437
USP 35.
Remarks:- The sample
is of substandard
quality under the Drugs
Act 1976.
Test report No.
KQ.228/2014
substandard
quality on the basis
of tests performed.
Test report No.
014-MNHSR/2014
the explanation letter
issued by the FID, the
firm challenged the CDL
report and requested for
Appellate Testing under
Section 22(5) of Drugs
Act, 1976. The Appellate
Laboratory also declared
the sample as
Substandard vide test
report No. 014-
MNHSR/2014 dated 12th
August 2014. The FID in
response to this office
letter dated 18th
September 2014 has
concluded that the firm
has violated Section
23(1)(a)(v) of Drugs Act
1976. FID has furnished
the names of the
following persons of the
firm responsible for the
offence.
i. M/s
Alkemy Pharmaceutical
Laboratories (Pvt.) Ltd
Hyderabad,
ii. Mr.Fraz
Ahmed Sheikh,
Managing Director,
iii. Mr. Asif
Najeeb Laghari,
QC Manager,
iv. Mr.Abid
Ali Khoso
438
Production Incharge,
.As per responsibility
fixed by the FID,
show case notices
have been issued to
the firm and other
accused persons of the
firm.
The case was presented
before the registration
board in its 246th
meeting
on 11-12-2014. The
Board decided the case
as under in the light of
personal hearing of Mr.
Asif Najeeb Laghari QC
Manager of the firm.
The case was presented
before the registration
board in its 246th
meeting
on 11-12-2014. The
Board decided the case
as under in the light of
personal hearing of Mr.
Asif Najeeb Laghari QC
Manager of the firm.
Decision:-
The Board took the
following decision
i. Suspended the
registration of
Empoir 500mg
(Ciprofloxacin)
Tablets Reg. No.
039367 for a
period of six (06)
months.
ii. Panel Inspection
439
for PSI.
iii. The panel will be
constituted by
Director
QA<
Case No. 03 Substandard Rifacin (Rifampicin Suspension BP 60ml) manufactured by M/s
Pharmawise Labs Pvt Ltd Lahore
Brief Background
The FID Islamabad-II on 03-04-2012 drew samples of Rifacin Suspension Batch No.152
of M/s Pharmawise Labs (Pvt) Lahore, from T.B Center, Asghar Mall Road Rawalpindi for
test/analysis. The samples were declared substandard by the F.G Analyst vide test report
No.T.B.64/2012 dated 01-08-2012. The firm did not challenge the report and case was
accordingly processed and decided by the Registration Board in its 237th
meeting, held on 26-02-
2013 and cancelled the registration of the product under reference. The firm filed an appeal
before Appellate Board against the decision of DRB vide appeal No.04/2013, dated 06-09-2013,
which was dismissed by the Appellate Board in its 140th
sitting.
. .The firm filed a writ petition No.4442-2013, before Honorable Islamabad High Court,
Islamabad against the decision of Appellate Board but the Court upheld the decision of Appellate
Board. The firm filed a C.P.L.A No. 2/2014 before the Honorable Supreme Court of Pakistan
which in its order dated 22-08-2014 the directed to retest the sample in accordance with law.
Accordingly the sample was sent to Appellate Lab (NIH) for retesting which also declared the
sample is of Sub-standard quality.
S.No. CDL Test Report No.
TB.64/2012 & Findings
Appellate Test Report No.016-
MNHSR/2014 & Findings
Remarks
1. i. pH Determined 5.18
ii. Limits:- 4.2 to 4.8 Does not
comply with BP 2011
Assay for Rifampicin
i. Determined amount per ml
i. pH Determined 4.75
ii. Limits:- 4.2 to 4.8 Comply with
BP 2011 .
iii. Volume Determined 60ml
Complies with volume stated on the
label
The sample is of
Substandard quality on the
basis of test
performed by
FGA CDL
440
=15.514mg/ml
ii. Stated amount / ml=
20mg/ml
iii. Percentage:- 77.57%
iv. Limits:- 90% to 110%
Does not comply with BP
2011
Assay for Rifampicin
i. Determined amount per ml
=17.31mg/ml
ii. Stated amount / ml= 20mg/ml
iii. Percentage:- 86.63%
iv. Limits:- 90% to 110%
Does not comply with BP 2011
Karachi and
Appellate Testing
Lab Islamabad.
The case is submitted of the consideration / decision of Registration Board under
intimation to Assistant Registrar motion for Deputy Registrar Judicial in the light of brief
background please.
Decision:-
The Board after through celebration decided as under:-
1. Up held the decision of cancellation of registration of substandard Rifacin
(Rifampicin Suspension BP60ml), Regn. No. 037528 manufactured by M/s
Pharmawise Labs (Pvt) Ltd., Lahore taken in 237th
meeting, Registration
Board.
2. The Board further decided that the case with brief background shall be
intimated to Assistant Registrar motion for Deputy Registrar Judicial in the
light of decision of the Board and substandard test report by the Appellate
Lab NIH Islamabad and Medical Superintended T.B Hospital Asghar Mall
Road Rawalpindi for their further necessary action if any.
3. The firm will recall all its supplied batches to T.B Hospital Asghar Mall Road
Rawalpindi under intimation to area FID-II Islamabad.
Case No. 04 Deaths of persons allegedly due to consumption of cough syrup
manufactured by M/S Ethical Laboratories (Pvt) Ltd and M/S Reko Pharmecal
Laboratories Lahore
The Registration Board in its 245th meeting decided the case as under:-
Decision:- Registration Board decided that Mr. Jamil Anwar Member of the Registration Board, Deputy
Director General (E&M) Lahore & Islamabad will furnish the pending status of these petitions filed by
M/s Ethical laboratories Pvt Ltd and M/s Reko Pharmacal Lahore for consideration of the Board in its
up-coming meeting
441
The pending status of the petitions filed by M/s Reko and Ethical Laboratories pvt Ltd Lahore
have not yet been received from the Honorable member Mr. Jamil Anwar, and DDG (E&M) Lahore and
Islamabad as communicated to them.
Decision: Registration Board again decided that that Mr. Jamil Anwar Member,
Registration Board, Deputy Director General (E&M) Lahore & Islamabad will furnish
the pending status of these petitions filed by M/s Ethical laboratories Pvt Ltd and M/s
Reko Pharmacal Lahore for consideration of the Board in its up-coming meeting
Case No. 05 Damage Samples for Board Portion
Board portion of sealed samples from ADC Quetta and FID Peshawar were received in damage
conditions (File No.13-09/2013-QC)
S.
No.
Product & Batch No. Manufacturer Condition
1. Canrce Tablets
Q18
M/s Merck (Pvt) Ltd
Quetta
Badly damaged, broken carton
and seal.
2. Optifam Tablets
38
M/s Merck (Pvt) Ltd
Quetta
Badly damaged, broken carton
and seal.
3. Naproxen Imported Raw
Material
M/s Merck (Pvt) Ltd
Quetta
Badly damaged, glass broken
bottle and seal.
4. Metformin-Hcl Imported
Raw Material
M/s Merck (Pvt) Ltd
Quetta
Badly damaged, glass broken
bottle and seal.
5. Tablet Klaribact 250mg
Q64
M/s Merck (Pvt) Ltd
Quetta
Badly damaged, broken carton
and seal.
6. Liquid Glucose
014270-Bulk
Rafhan Maiz Pakistan Badly damaged, leaked bottles
and torn memorandum.
7. Liquid Serbetol
00470114
Made in China Badly damaged, leaked bottles
and torn memorandum
. The Board portions of the samples at serial No. 1-5 have been sent by ADC Quetta
whereas the samples at serial No.6-7 have been sent by FID Peshawar. Both officers had been
informed telephonically about the status of these samples.
. The Registration Board in its 238th
meeting allowed the QC Section to get fresh samples
from the inspectors if they are received in damage conditions. In view of above following
proposal is submitted.
i. The FID Peshawar and ADC Quetta may be advised to take special care for
packing and transportation of the Boards portion of samples in future all the
442
DDGs in the field offices may also be advised to instruct FIDs/ADCs to
ensure appropriate packing and sealing of such samples.
ii. FID Peshawar and ADC Quetta may be advised to draw fresh samples, of the same
batches/raw materials, of damaged drugs for test analysis.
Decision:- The Board approved the proposals of QC Section and Directed that all
DDGs, FIDs and ADCs be asked to send the Board Portion intact form and ensure
appropriate packing and sealing of such samples before sending. In future such
approvals will be taken from Director QA/LT on file.
Case No. 06 Manufacture and supply of sub-standard Hepaferon Injection by M/s Pharmedic,
Lahore to Govt of Khyber Pakhtoonkhawa
BRIEF BACK GROUND: The case of M/s Pharmedic Laboratories (Pvt) Ltd was discussed with
reference to the decision taken in also 243rd
& 244th meeting of Registration Board which is reproduced
as under.
Decision taken in 243rd
Meeting of Registration Board
i The Federal Inspector of Drugs Peshawar is advised to get the case completed
covering details of findings, conclusion fixation of responsibilities with his
recommendations.
ii. The Board further decided to get update regarding Suo Moto notice taken by
Hounrable Peshawar High Court Peshawar and fate of case referred to NAB
Khyber Pakhtoon Khawa.
The FID Peshawar has submitted the investigation of the case fixing the responsibility of name of
persons accused & co accused in manufacture and sale of substandard Hepaferon Injection Batch No 80-
87 which are involved directly or indirectly. The FID has also submitted the suo moto judgment a copy of
Honorable High Court Peshawar but did not submitted the report regarding investigation by NAB.
Name of accused persons.
i. Mr. Iftikhar Ahmed Shiekh Director/C.E.O
ii. Mr. Mazhar Hussain Production Incharge.
iii. Mr. Asim Mehmood Quality Control Inchage
Name of Co-accused persons.
Dr. Chuhan Director
Dr. Sharif, Director
443
Dr. Ghulam Subhani Director Hapatitis Program
Mubarik Shah, Store Keeper LRH Hapatitis Program
Dr. Nigar Ahmed, Ms DHQ Mardan.
Mr. Aurengzaib, Store Incharge, DHQ Mardan.
The case was again presented before 244th meeting of the Board in the light of recommendations of
the FID Peshawer as above which decided the instant case as under:-
Decision:- The Board decided to issue show cause notices to accused of M/s Pharmadic
Laboratories (Pvt) Ltd Lahore regarding manufacture and supply of substandard Injection
Hepaferon (3MIU) Interferon Alpha 2a to government of KhyberPakhtoonKhawa.
The The FID Peshawar has submitted the complete investigation of the case fixing the
responsibility of name of persons accused / co-accused in manufacture and sale of substandard Hepaferon
Injection Batch No 80-87and proposed their names for prosecution under Section 23(1)(a)(v)(vii) and 23
(1)(a)(vii), 23(1)(b)(f) which are involved directly or Indirectly in this case some of the co-accused are
employees of Government of Khyber Pakhtoon Khawa.
As directed by Chairman Registration Board the case is again submitted for consideration of the
Registration Board keeping in view of the Public health at large, Suo Moto Notice by Peshawar High
Court, & NAB investigation in instant case please.
Decision:- The Board decided that Federal Inspector of Drugs Peshawar will be asked
to submit the certified copies of decisions of Drug Court Peshawar and Peshawar High
Court, Peshawar in the instant case with in 07 days. Reference will be sent to Law division
to ascertain whether government officials under provincial governments can be issued
show cause notice for violations any provision of Drug Act, 1976 or otherwise.
The Show Cause Notice to the accused of firms will be issued after the receipt of the
letter from the FID and approval from Chairman, Registration Board. However, show
cause to government officials will be served after clarification from Law Division.
444
Case No.07 Supply of substandard /adulterated injection of cil 100ml to DHQ hospital
Hafizabad (25000 vials) and M/s Medisearch Pharma (Pvt) Ltd., 5-km, Raiwind Manga
Road, Lahore which supplied Almajax 250ml Suspension to DHQ Hospital Hafizabad
(35600 bottles).
The Secretary Provincial Quality Control Board (PQCB) Punjab Mr. Tallat Farooq Ahmad
has forwarded two recommendations to DRAP as under:-
i. The Federal Government Cancel the Drug Manufacturing License of M/s
Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind Road Lahore on supply of Sub-
standard / Adulterated injection Ofcil 100ml to DHQ Hospital Hafizabad (25000
vials) and M/s Medisearch Pharma (Pvt) Ltd., 5-KM, Raiwind Manga Road, Lahore
which supplied substandard Almajax 120ml Suspension to DHQ Hospital
Hafizabad (35600 bottles).
ii. The Federal Government Cancel the Registrations of the said drugs of M/s
Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind Road Lahore and M/s Medisearch
Pharma (Pvt) Ltd., 5-KM, Raiwind Manga Road, Lahore.
Brief Background
The Provincial Quality Control Board (PQCB) after scrutiny of the report of Government
analyst i.e report Nos. TRA. 22863 & 22864 dated 21-11-2014 Batch No. JX168 of Almajax
suspension, and statement of the Drug Inspector observed that this is a criminal negligence on
the part of manufacturers and gross loose in GMP compliance. The Punjab Government (PQCB)
observed that there is a dire need to take quick action against the said firms to safeguard the
public health at large and submitted the above mentioned recommendations.
The case is placed before Registration Board for decision on the recommendations of
(PQCB) Punjab by Registration Board regarding cancellation of Registrations of Drugs of these
firms as per law with the proposal that recommendations may also be send to Division of
Licensing for further necessary action at their end so that public health may be saved from risk.
Decision:- The Board decided as under:-
a. To get the complete investigation along with all the reports and case
background from the Secretary Provincial Quality Control Board Health
Department Government of Punjab Lahore through the DDG (E&M)
Lahore.
445
b. The area FID Lahore will be asked to submit the case background in
writing along with all relevant reports for perusal of the Registration
Board for decision.
The Board further decided the case shall be forwarded to Directorate of Licensing for
further necessary action in the light of recommendation of the Provincial Quality Control
Board (PQCB) Punjab.
446
Item No.IX Registration of Medical Devices – Medical Devices Division
Case No.01. Applications for registration of medical devices for import.
Registration Board considered the following applications of medical
devices for import and decided as mentioned against each. Approved applications have already
been recommended by Expert Committee on Medical Devices and are subject to inspection of
manufacturer abroad, verification of storage facilities etc as per policy:-
A) Cannulas:
S.No
.
Name of Importer and
Manufacturer/Exporter.
Name of Medical
Device
Price Pack size Shelf
life
Decision
1. M/s Kaf Surgical &
Disposable Equipments,
GF-116, Panorama Centre,
Plot No.248, Staff Lines,
Fatima Jinnah Road,
Karachi/
Manufactured by
M/s Plasti Lab S.A.R.L,
Roumieh El Metn,
Industrial Area, Main
Road, Khoury Bldg,
P.O.Box 70407, Beruit,
Lebanon.
JRZ Intravenous
Canula without
Wings without
Injection Port
(Pencil Type).
Decontrolled till
policy decision
by the Policy
Board/ Federal
Government.
(14G,
16G, 18G,
20G,
22G, 24G,
26)
50 per box
5
years
Approved.
2. M/s Kaf Surgical &
Disposable Equipments,
GF-116, Panorama Centre,
Plot No.248, Staff Lines,
Fatima Jinnah Road,
Karachi/
Manufactured by
JRZ Intravenous
Canula without
Wings without
Injection Port
(Pen Type)
-do-
(14G,
16G, 18G,
20G,
22G, 24G,
26)
5
years
Approved.
447
M/s Plasti Lab S.A.R.L,
Roumieh El Metn,
Industrial Area, Main
Road, Khoury Bldg,
P.O.Box 70407, Beruit,
Lebanon.
50 per box
3. M/s Lab Link Enterprises,
192-N, Block-II, PECHS,
Karachi.
Manufactured by:
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.
Nipro Safelet
Cath (I.V
Cannula Pen
Type)
Decontrolled till
policy decision
by the Policy
Board/ Federal
Government
(16G,18G,
20G,
22G, 24G)
50 per box
5
years
Approved.
4. M/s Lab Link Enterprises,
192-N, Block-II, PECHS,
Karachi.
Manufactured by:
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.
Nipro Wing Cath
(I.V Cannula with
Injection Port &
Wing)
-do-
(16G,
18G, 20G,
22G, 24G)
50 per box
5
years
Approved.
5. M/s. A. Feroz & Co.,
Medicine Street No.1,
Marriot Road, Karachi
Manufactured by
Star IV. Catheter
with Injection
Port.
-do- (14G,
16G, 18G,
20G, 22G,
24G)
5
years
Approved.
448
M/s. Engineering
Technical Plastic Industries
(Enteplin-Egypt) 10th
of
Ramadan City, Industrial
Zone, A-1 Part 41/3.
Sharqia, Egypt.
100 per
box
B: Infusion Set:
S.No
.
Name of Importer and
Manufacturer/Exporter.
Name of Medical
Device
Price Pack
size
Shelf
life
Decision
1. M/s Lab Link Enterprises,
192-N, Block-II, PECHS,
Karachi.
Manufactured by:
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.
Nipro Infusion
Set
(with needle)
Decontrolled till
policy decision
by the Policy
Board/ Federal
Government
1’s 5
years
Approved.
C: Syringes:
S.No
.
Name of Importer and
Manufacturer/Exporter.
Name of Medical
Device
Price Pack
size
Shelf
life
Decision
1. M/s Lab Link Enterprises,
192-N, Block-II, PECHS,
Karachi.
Manufactured by:
Nipro Disposable
Syringe (with
needle)
Decontrolled till
policy decision
by the Policy
Board/Federal
Government
1ml
3ml
5ml
5
years
Deferred for
clarification
from the
applicant
regarding non-
permanent
449
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.
10ml
20ml
marking of
10ml & 20ml
syringes with
delible ink.
2. M/s Lab Link Enterprises,
192-N, Block-II, PECHS,
Karachi.
Manufactured by:
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.
Nipro Disposable
Syringe
(without needle)
-do- 30ml
50ml
5
years
Deferred for
clarification
from the
applicant
regarding non-
permanent
marking of
30ml & 50ml
syringe with
delible ink.
3. M/s Lab Link Enterprises,
192-N, Block-II, PECHS,
Karachi.
Manufactured by:
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.
Nipro Disposable
Syringe U-100
Insulin with
needle
-do- 1 ml
5
years
Approved.
450
Case No.02. Withdrawal of registration applications of medical devices.
The following importing firms are withdrawing their registration applications of
medical devices as mentioned against each. The firms have also not deposited differential fee as
per revised fee schedule for their products:-
S.No Name of Importer and
Manufacture/Exporter.
Name of Medical
Device (s)
Demanded
price & Pack
size
Shelf
life
Remarks
1. M/s Otsuka Pakistan Ltd.
30-B Sindhi Muslim
Cooperative Housing
Society, Karachi.
Manufactured by
M/s Micro Port Medical
(Shanghai) Co. Ltd.,
China.
Jive Stent (PTCA
Balloon Catheter)
Decontrolled till
policy decision
by the Policy
Board/ Federal
Government.
2
years
Reference
No.27/12/
Stent-Reg.
Dated:
26-12-2011.
2. M/s Otsuka Pakistan Ltd.
30-B Sindhi Muslim
Cooperative Housing
Society, Karachi.
Manufactured by
M/s Micro Port Medical
(Shanghai) Co. Ltd.,
China.
Firebird (Rapamycin
Eluting Stainless Steel
Coronary Stent
System)
Decontrolled till
policy decision
by the Policy
Board/ Federal
Government.
12
month
s
Reference
No.26/12/
Stent-Reg.
Dated:
26-12-2011.
3. M/s Otsuka Pakistan Ltd.
30-B Sindhi Muslim
Cooperative Housing
Society, Karachi.
Manufactured by
M/s Micro Port Medical
(Shanghai) Co. Ltd.,
China.
Firebird-2 (Rapamycin
Cobalt Chromium
Coronary Stent
System)
Decontrolled till
policy decision
by the Policy
Board/ Federal
Government.
09
month
s
Reference
No.30/12/
Stent-Reg.
Dated:
26-12-2011.
4. M/s Otsuka Pakistan Ltd.
30-B Sindhi Muslim
Cooperative Housing
Society, Karachi.
Manufactured by
M/s Micro Port Medical
(Shanghai) Co. Ltd., China.
Mustang Stent
(Stainless Steel
Coronary Stent
System)
Decontrolled till
policy decision
by the Policy
Board/ Federal
Government.
2
years
Reference
No.28/12/
Stent-Reg.
Dated :
26-12-2011.
451
5. M/s. Intek Corporation,
Rawalpindi. /
Manufacturer:
M/s. OrbusNeich
Medical B.V. Drs, W.
Van Royenstraat, AN
Hoevelaken, The
Netherlands.
Shipped From:-
M/s. Asia Cardiovascular
Products Ltd., Kwai
Chung, N.T. Hong Kong.
Blazer CoCr Alloy
Coronary Stent
Delivery System
(Cobalt Chromium
Stent).
(Medical Device).
Decontrolled till policy decision by the Policy
Board/ Federal Government.
24
months
The firm has
informed that
further action
on this
product is no
more
required.
Decision: Registration Board considered the request of the firms for withdrawal of their
applications for registration of above mentioned medical devices and approved
the request.
Case No.03. Cancellatiuon of sole agency agreement.
M/s. A.H Distributors, Kh-1183, Lane No.5, Peshawar Road, Rawalpindi had
applied for registration of Primum Guiding Catheter and Pointer Angiographic Catheter for
import from foreign manufacturer i.e. Pendra Care International B.V Van der Waalspark 22 9351
VC leek the Netherlands. The importing firm was advised to complete the
documents/information including fresh authorization letter and differential fee as per revised fee
schedule but the importing firm has not responded till now. The authorization letter of principal
manufacturer in respect of importer M/s A.H Distributors, Rawalpindi was expired on 31-12-
2011. The manufacturer M/s Pendra Care International B.V Netherlands, has sent a termination
letter in respect of M/s A.H Distributors for the above mentioned products directly to Drug
Regulatory Authority of Pakistan. In the aforementioned letter the manufacturer has confirmed
that they terminated the business relationship with A.H Distributors, Rawalpindi.
Decision: The Board after thorough discussion decided that final reminder should be
issued to the firm for submission of all deficient documents including fresh
authorization letter from the principal manufacturer, attested by the
Embassy of Pakistan in the country of origin and the prescribed differential
452
fee. If the applicant fails to provide the aforesaid documents and prescribed
differential fee within 15 days, the above mentioned applications shall not be
entertained for registration.
Case No.04. Case remanded back by the Appellate Board.
The Registration Board in its 240th
meeting held on 7th
November, 2013 considered and
rejected the following medical device of M/s Mana & Co, Karachi due to the reason mentioned
below against the product:-
S.No. Name of Importer and
Manufacturer/Exporter.
Name of Medical
Device
Demanded
price &
Pack size
Shelf
life
Decision
1. M/s Mana & Co,
204 New Medicine Market, Near
Densohall, Karachi.
Manufactured by
M/s Jiangxi Huali Medical
Instrument Co.Ltd. Yudu
Industrial Zone,Ganzhou, Jiangxi,
China.
Medicare IV
Catheter with
Injection Port.
Decontrolled
(14G, 16G,
18G, 20G,
22G, 24G )
5
years
Rejected due to
incomplete and
unsatisfactory
stability profile.
Rejection letter was issued to the importing firm. The said firm filed an appeal against the
decision of Registration Board before Appellate Board. The Appellate Board in its 142nd
meeting held on 24th
June, 2014 decided as under:-
“The Board in light of the stability data submitted before it and taking a lenient view
decided to remand the case to the Registration Board for decision under the rules.”
Decision: Registration Board decided to ask the importing firm to submit complete
stability profile for the above mentioned device for review.
Case No.05 Miscellaneous Cases.
a. Relaxation in the condition of Drug (Labeling & Packaging) Rules, 1986. (Deferred
in 245th
meeting of Registration Board).
M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi has requested for relaxation in
condition of Drug (Labeling & Packaging) Rules, 1986 i.e. Urdu version, Pak Registration
453
Number and MRP of their already registered imported Prowler Micro Catheters (Registration
No.074692).
The firm has submitted that Prowler family of Micro Catheters being labeled as
per the requirement of Medical Device directives 93/42, GHTF labeling recommendation. As
Prowler Micro Catheters belongs to sterile sensitive class of medical device and it is supplied in
sterile peel open packages after carrying out all recommended package integrity and sterility
validation tests. To ensure the sterility of product till it is received by key user, packaging
qualification testing is performed on all Prowler Micro Catheters which are packaged in a
preformed tray, sealed in packaging pouch and placed in a folding carton. The same sterilized
pack being supplied in all International countries. The firm has deposited the required fee for
above mentioned product.
The firm has further submitted that the demand forecast of Prowler Micro Catheters in
Pakistan is only 1% of the global supply, so it is not viable for their Principal manufacturer to
produce country specific packs for such a small volume. Therefore, the firm requested for the
following approval:-
“That they may be allowed to import Prowler Micro Catheters in international
packs provided that company will perform ink jet printing of Urdu version, Pak
Registration No. and maximum retail price at their locally licensed premises.”
The case was placed before Registration Board in its 245th
meeting and the Board
deferred the case and decided to call the firm M/s Johnson and Johnson Pakistan (Pvt) Ltd,
Karachi for personal hearing alongwith samples of the product in the forthcoming meeting of the
Board. Accordingly letter was issued to the firm for personal hearing alongwith provision of
samples.
Decision: Registration Board deferred the case and decided to call the firm M/s Johnson
and Johnson Pakistan (Pvt) Ltd, Karachi for personal hearing alongwith
samples of the product in the next meeting of the Board.
454
b. Inspection of Manufacturer Abroad M/s Biosensors Interventional Technologies Pte
Ltd., Kampong Ubi, Industrial Estate, Singapore.
The Registration Board in its 238th
meeting held on 5TH
& 6TH
August, 2013
considered and approved the following medical devices of M/s Promed International, Islamabad
subject to inspection of manufacturer abroad, local storage facility etc:-
S.
No
Name of Importer and
Manufacturer/Exporter
Name of Medical Device
(s)
Demanded
Price &
Pack Size
Shelf
Life
1. M/s. Promed International,
Ground Floor, Jamil Mohsin
Mansion, G-6 Markaz,
Islamabad.
Manufacturer:
Biosensors Interventional
Technologies Pte Ltd.,
Kampong Ubi, Industrial
Estate, Singapore.
Power Line TM
PTCA
Catheter
Balloon Dia (mm):
1.5, 2.0, 2.5, 2.75, 3.0,
3.5, 4.0.
Balloon Length (mm):
10,15, 20, 25, 30.
(Many product codes)
Decontrolled
1’s
36
months
2. M/s. Promed International,
Ground Floor, Jamil Mohsin
Mansion, G-6 Markaz,
Islamabad
Legal Manufacturer:
Biosensors Europe SA, Ch-
1110 Morges, Switzerland.
Manufacturing Site:
Biosensors Interventional
Technologies Pte Ltd.,
Kampong Ubi, Industrial
Estate, Singapore.
Bio Matrix TM
Drug
Eluting Coronary Stent
System.
Stent Inner Dia (mm):
2.25, 2.5, 2.75, 3.0, 3.25,
3.50, 4.0.
Stent Length (mm):
8, 11, 14, 18, 23, 24, 28.
(Many product codes)
Decontrolled
1’s
19
months
3. M/s. Promed International,
Ground Floor, Jamil Mohsin
Mansion, G-6 Markaz,
Islamabad
BioMetrix Flex TM
Drug
Eluting Coronary Stent
System
Stent Inner Dia (mm):
Decontrolled
1’s
24
months
455
Legal Manufacturer:
Biosensors Europe SA, Ch-1110
Morges, Switzerland.
Manufacturing Site:
Biosensors Interventional
Technologies Pte Ltd., Kampong
Ubi, Industrial Estate,
Singapore.
2.25, 2.5, 2.75, 3.0, 3.50,
4.0.
Stent Length (mm):
8, 11, 14, 18, 24, 28, 33,
36.
(Many product codes)
4. M/s. Promed International,
Ground Floor, Jamil Mohsin
Mansion, G-6 Markaz,
Islamabad
Legal Manufacturer:
Biosensors International Pte.
Ltd, 21 Kallang Avenue,
Singapore Manufacturing
Site:
Biosensors Interventional
Technologies Pte Ltd.,
Kampong Ubi, Industrial
Estate, Singapore.
Gazelle Coronary Stent
System
Stent Dia (mm):
2.25, 2.5, 2.75, 3.0, 3.25,
3.50, 4.0.
Stent Length (mm):
8, 11, 14, 18, 23, 24, 28.
(Many product codes)
Decontrolled
1’s
24
months
Accordingly the inspection of manufacturer abroad has been carried out by the panel
comprising Mr. Sayyad Hussain Khan, DDC (LA) and Ms. Sara Mehreen, ADC, DRAP,
Islamabad on 1st and 2
nd September, 2014. The panel has not recommended the products for
registration on the basis of following major concerns:-
(i) Firm is importing stents in finish form either from Germany or from China. So
there was no way to verify their manufacturing standard.
(ii) Sterility testing is outsourced and either performed in Malaysia or Germany. So
the panel was not able to check the process of sterilization for the applied
products. However, final release of the products is firm itself.
(iii) As the firm was shifting to their own constructed new premises and few
operations including microbiological testing had already been shifted to the new
premises. So the panel was not able to check their microbiological testing
process as inspection of new premises was not the mandate of the panel.
(iv) One of the applied products namely BioMatrix Flex Drug Eluting Coronary Stent
is not on free sale in the country of origin, which is one of the conditions for
registration of imported drugs in Pakistan.
456
Decision: Regiastration Board discussed the inspection report in detail and keeping in
view nature of the observations being critical rejected the above applications of M/s.
Promed International, Iislamabad manufactured by M/s. Biosensors Interventional
Technologies Pte Ltd., Kampong Ubi, Industrial Estate, Singapore.
457
Item No.X: Local Manufacturing of Biological Drugs.
The following cases for the local manufacturing biological drugs were decided in the
244th
Meeting of the Drug Registration Board. The details of the cases and decisions taken by the
Drug Registration Board in its 242nd
, 243rd
and 244th
Meeting are as below: -
Sl.# Applicant Product Specifications
1. Getz Pharma, Karachi. Eptifib Solution for Infusion 75mg/100ml
2. Getz Pharma, Karachi Eptifib Solution for Injection 20mg/10ml
3. Getz Pharma, Karachi
Enoxa Injection 20mg/0.2ml Injection Each Pre-filled
syringe
4. Getz Pharma, Karachi
Enoxa 40mg/0.4ml Injection
Each Pre-filled syringe
5. Getz Pharma, Karachi
Enoxa 60mg/0.6ml Injection
Each Pre-filled syringe
6. Getz Pharma, Karachi
Enoxa 80mg/0.8ml Injection
Each Pre-filled syringe
7. Getz Pharma, Karachi
Gilia solution for injection
Glatiramer acetate 20mg/ml
8. Getz Pharma, Karachi
Lira Solution for injection
6mg/ml Solution for Injection in Cartridge
9. Getz Pharma, Karachi . Menocon
Lyophilized Powders for Injection 1000 IU
USP
10. Getz Pharma, Karachi
Menocon Lyophilized Powders for Injection 5000 IU
USP
11. Getz Pharma, Karachi Menoget
Menotropins 75IU /2ml vial
12. Getz Pharma, Karachi
Menoget
Menotropins 150IU / 2ml vial
13. Getz Pharma, Karachi Neupeg injection
458
14. Getz Pharma, Karachi Getiferon
Solution for Injection
3 MIU in Vials
15. Getz Pharma, Karachi
Getiferon
Solution for Injection 5MIU in Vials
16. Getz Pharma, Karachi Getiferon
Solution for Injection
3 MIU in Pre-Filled Syringes Each Pre-
Filled
17. Getz Pharma, Karachi Getiferon
Solution for Injection
5 MIU in Pre-Filled Syringes
18. Getz Pharma, Karachi
Uniferon Solution for Injection
3 MIU in Vials
19. Getz Pharma, Karachi
Uniferon Solution for Injection
5 MIU in Vials
20. Getz Pharma, Karachi
Uniferon Solution for Injection
3MIU in Pre-Filled Syringe
21. Getz Pharma, Karachi
Uniferon Solution for Injection
5MIU in Pre-Filled Syringes
22. Getz Pharma Unipeg 80 Solution injection 180mcg/mL
in vial
23. Getz Pharma Unipeg 40 Solution injection 180mcg/0.5
mL in Prefilled Syringe
24. Getz Pharma Unipeg Solution injection 180mcg/mL in
vial
25. Getz Pharma Unipeg Solution injection 180mcg/0.5mL
in Prefilled syringe
Applicant Product Specifications
26. Macter International
Limited, Karachi
Heberon 2a Injection 3MIU/0.3ml.
(Liquid Solution)
27. Macter International
Limited, Karachi
Heberon 2a Injection 5MIU/0.5ml.
(Liquid Solution)
28. Macter International
Limited, Karachi
Heberon 2a Injection 3MIU/ml
(Lyophilized Powder)
29. Macter International
Limited, Karachi
Heberon 2a Injection 5MIU/ml
(Lyophilized Powder)
459
30. Macter International
Limited, Karachi
Peg-In Injection 50mcg /0.5ml
(Lyophilized Powder)
31. Macter International
Limited, Karachi
Peg-In Injection 80mcg /0.5ml
32. Macter International
Limited, Karachi
Peg-In Injection 100mcg /0.5ml
(Lyophilized Powder)
33. Macter International
Limited, Karachi Peg-In Injection 120mcg /0.5ml
(Lyophilized Powder)
34. Macter International
Limited, Karachi Peg-In Injection 150mcg /0.5ml
(Lyophilized Powder)
35. Macter International
Limited, Karachi Neupeg 6mg/ml Injection Each vial
36. Macter International,
Karachi. Prance Injection Recombinant Human Basic Fibroblast
growth factor.
37. Macter International,
Karachi. Macgrastim Injection Pre-filled Syringe
Granulocyte colony stimulating factor.
Applicant Product specifications
38. Hilton Pharma (Pvt)
Ltd., Karachi.
Xiro Injection
Filgrastim 300ug
39. Hilton Pharma (Pvt)
Ltd., Karachi. Lameo Injection 3MIU
Interferon alfa 2a
40. Hilton Pharma (Pvt)
Ltd., Karachi. Lameo Injection 5MIU
Interferon alfa 2a
Applicant Product specifications
41. M/s Nextar Pharma
(Pvt) Ltd., Karachi
Nexfil 150 Injection
42. M/s Nextar Pharma
(Pvt) Ltd., Karachi
Nexfil 300 Injection
Each Prefilled syringe
43. M/s Nextar Pharma
(Pvt) Ltd., Karachi Pegaron Injection
460
44. M/s Nextar Pharma
(Pvt) Ltd., Karachi NP-POETIN 2000 INJECTION
45. M/s Nextar Pharma
(Pvt) Ltd., Karachi NP-POETIN 4000 INJECTION
Decision of 242nd
Meeting of Drug Registration Board. Product Approved, however, cGMP /
COPP is required of the finished Drug manufactured using this particular drug substance in the
country of origin. Biosimilarity data of locally manufactured drug needs to be disclosed by the
local manufacturer. However the minutes of the meeting were quarantine due to observation of
members of Drug Registration Board.
Decision of 243rd
Meeting of Drug Registration Board: - Decision recorded in 242nd
Meeting
upheld. Further, all firms will submit Bio-comparability data followed by regular Pharmaco-
vigilance report.
Final Decision of the Drug Registration Board in its 244th
Meeting: -
“ a) Biosimiliarity is the principal requirement for the registration of biological
drugs, as it is part of requirements of DRAP Act, 2012 mainly focusing on
patient safety and also to promote biological production and availability of
biological products.
b) All those manufacturing units which have been approved by Central
Licensing Board for manufacturing of biological drugs and also had
qualified product specific inspection by panel of Registration Board, are
allowed registrations of applied biological drugs for local manufacturing on
case to case basis. Item for which product specific inspection is required,
then it will be conducted by already constituted panel of Registration Board.
c) Local manufacturer will provide legalized documents from concerned
regulatory body confirming the status of licensed manufacturer of
concentrate/bulk source in its country of origin. Moreover manufacturer
will provide legalized documents for confirmation that finished product is
also available in market from the same biological material. Case will be
processed for issuance of registration letter after fulfillment of above
mentioned requirements, with following conditions:
i. Registration is exclusively for trial manufacturing of the drug and
manufacturer shall not be allowed in any way to sale/utilize these
trial manufactured drugs. Manufacturer will perform biosimilarity
studies as per WHO guidelines confirming the biosimilarity of
applied product to original innovator product.
ii) Manufacturer will submit actual result of conducted biosimilarity
studies to the Biological Division for its scientific evaluation
through Expert Committee on Biological Drugs (ECBD).
Moreover manufacturer will also provide sufficient quantity of
these trial manufactured drugs to Biological Division for testing by
461
National Control Laboratory for Biological (NCLLB) as per WHO
guidelines.
iii) Recommendation of ECBD and report of NCLB will be submitted
to Registration Board for permission of commercial manufacturing
of the product or otherwise.
d) This decision supersedes all the already taken decisions so far in the
earlier meetings of Registration Board on the subject cases”.
The decision of the Board was communicated to the concerned companies. In response to
which the companies have submitted documents. The documents of M/s Nextar, Karachi were
complete and inspections of the company already conducted supported the trial manufacturing of
biological products. Accordingly trial production of 04 products out of 05 products (for one
product COPP was missing) was allowed to the company. Product specific inspection of the
company has not been conducted. The Board may decide the requirement of product specific
inspection of the company.
The documents of M/s Getz Pharma, Karachi required further support (COPP not provided) of
their case and under process while M/s Hilton has not responded yet. Two products of M/s
Macter Pharma, Karachi i.e., Prance and Macgrastim are to be imported in the form of
labelled finished vial and repacked locally which may be dealt as per procedures of import policy
for finished drugs. For rest of the products the documents submitted by the company are under
review.
The case of local manufacturing of biological drugs was also under examination of
Honourable Ombudsman on the complaint of M/s Macter International, Karachi. The
findings/recommendations of the Honourable Wafaqi Mohtasib are as below: -
The record of DRAP showed that more than 300 drugs of similar formulation
were freely available in the market. Moreover, DRAP had already
registered/approval more than 500 vaccines. The complainant’s case was
approved in 243rd
board meeting with certain conditions which the complainant’s
fulfilled. He was never informed as to why without assigning any reason new
conditions were imposed. It was surprising to note that although the decision of
243rd
meeting had become final and the minutes were displayed on DRAP Website
yet again the earlier decision was revised in 244th
Board meeting and fresh
stringent requirements were proposed. The record also indicates that the drugs
registration board did not work in a systematic and organized manner. The
complainant’s case was examined and scrutinized by an expert committee and
cleared by the drug registration board which included technical experts and
eminent health professionals. It was noteworthy that the conditions prevalent at
the time of submission of application by the complainant were met and
subsequently additional conditions were applied retrospectively which was an
unfair practice. New conditions could only have been applied to fresh application.
After finalization of the decision of the 243rd
Drug Registration Board Meeting,
imposition of a new condition by DRAP tantamount to mal-administration in
462
terms of Article 2(2) of the President’s Order No.1 of 1983. It is therefore,
recommended that: -
1) The complainant’s product be registered in line with the decision of
243rd
board meeting and already done in the case of more than 300
registered biological products which are already being manufactured
in accordance with previous requirements.
2) There should be no discrimination and the complainant be allowed a
time frame as had been granted to other manufacturers of registered
biological products to bring their products in conformity with the new
requirements.
Compliance should be reported within 30 days of the receipt of a copy of these
findings or the reasons for not doing so be submitted in terms of Article 11(2) of
the President’s Order No 1 of 1983. Under provision of Article 11(2A) of P.O. 1
of 1983 read with section 13 of Federal Ombudsmen Institutional Reforms Act,
2013 and Article 32 of P.O. 1 of 1983 under which any person, aggrieved by a
decision or an order by the Wafaqi Mohtasib may also, within thirty days: -
(a) File a review petition before the Wafaqi Mohtasib; or
(b) Make a representation to the President.
Discussion:
On the direction of the Honorable Ombudsman, the case was taken up by the Drug
Registration Board on priority.
The matter related to local manufacturing of biological drugs was discussed on 10th
December, 2014 in the meeting. The Board discussed / examined in detail its earlier decisions
taken in 243rd
and 244th
Registration Board meeting regarding registration of biological drugs.
The Board observed that there is no difference in both decisions and in later meeting (244th
), the
Board only devised implementation process for decision taken in 243rd
meeting. The members of
the Board also examined the decision of Honorable Ombudsman and the whole matter of local
manufacturing of biological drugs was re-examined with holistic approach, keeping in view
ensuring the public health and safety, efficacy, quality of locally manufactured biological drugs.
It was also agreed by the Board that these local manufacturers (M/s. Macter International
Karachi, M/s. Getz Pharma Karachi, M/s. Nextar Pharma, Karachi and M/s. Hilton Pharma,
Karachi) will be provided an opportunity for appraising their views with the Registration Board
on next day.
Following representatives of four manufacturers attended the meeting for presentation of
their case.
463
i. Mr. Abdur Jabbar Saya (M/s. Nextar, Karachi)
ii. Syed Asghar Abbass Alve (M/s. Nextar, Karachi)
iii. Mr. Saleem Riaz (M/s. Hilton Pharma, Lahore)
iv. Dr. Salman Ahmad (M/s. Macter Pharma, Karachi)
v. Mr. Farooq Mustafa (M/s. Macter Pharma, Karachi)
vi. Mr. Zeeshan Ahmad (M/s. Getz Pharma, Karachi)
vii. Mr. Ayub Malik (M/s. Getz Pharma, Karachi)
viii. Mr.Shamim Ahmad, PPMA representative for the meeting
The firms unanimously presented / argued that Registration Board previously did not implement/
demand CoPP/ Free sale certificate from local manufacturer of biological drugs. But now only
GMP certificate of the foreign manufacturer can be provided which should be accepted by the
Drug Registration Board. Moreover, the condition of providing bio-similarity data should not be
imposed as per previous practice of the Registration Board for already registered locally
manufactured drugs as this condition will result in further delay which can be very damaging to
new biopharmaceutical units. Condition of clinical studies should not be imposed. The
manufacturer shall ensure the quality, safety and efficacy of locally manufactured biological
drugs by them.
Representatives of the firms, PPMA and Pharma Bureau re-iterated that already
registered biological drugs may be re-assessed in light of safety, efficacy and quality parameters.
Decision: After all detailed discussion and directions of the Ombudsman, Registration
Board decided as follows:
1. As the Registration Board in 244th
meeting has already approved registration of
biological drugs for four manufacturers (M/s. Macter International Karachi, M/s.
Getz Pharma Karachi, M/s. Nextar Pharma, Karachi and M/s. Hilton Pharma,
Karachi) for local manufacturing. In order to issue registration letter, the Board
advised these manufacturers to provide following document as discussed and agreed
during the deliberations with manufacturers:
a. The firms shall provide legalized GMP certificate of biological drug
manufacturer abroad (who will provide concentrate / ready to fill bulk of
biological drug to Pakistani manufacturers for further processing) as an
evidence that the manufacturer is an authorized manufacturer of that
particular biological drug in its country of origin.
464
b. The firm shall provide studies conducted by manufacturer abroad (dully
verified with statement for correctness / genuineness of data) regarding
structural similarity of subject biological drug product (concentrate/ ready to
fill bulk for further processing) with reference biological product
(innovator).
c. The local manufacturer shall be authorized to manufacture the finished
biological product and then perform bio-comparability studies including
identity testing to parent molecule, purity testing, in vitro biological activity,
potency and toxicity with support of iso-electro focusing data, gel
electrophoresis, Western-Blot and other analytical techniques) and stability
studies of finished biological product. Data provided by the local
manufacturer shall be evaluated by the Expert Committee on Biological
Drugs. Recommendation of the committee shall be considered by the
Registration Board for issuance of registration letter.
d. The firms shall conduct parallel bio-similarity studies as per WHO
guidelines immediately after grant of registration and shall submit complete
studies with in two (2) years in any case. Manufacturer will provide progress
report to this effect to Directorate of Biological Drugs on quarterly basis.
e. Regular monitoring through pharmacovigilance reporting system shall be
observed through proper pharmacovigilance cell of the manufacturer and
report will be forwarded to the National Pharmacovigilance Centre, Division
of Pharmacy Services and Biological Division of DRAP. In case of any severe
adverse event, immediate mandatory reporting procedure shall be followed.
f. If any of the conditions is not fulfilled or public health risk reported at any
stage, the drug registration shall stand cancelled with immediate effect.
g. All the provisions as contained in the Drugs Act, 1976 and rules made there
under including provisions of Lot Release certification from National
Control Laboratory for Biologicals shall be strictly adhered to.
2. Already registered biological drugs shall be reviewed in the same manner.
3. New applications for registration of biological drugs shall be considered after
compliance of above point.
465
Item No.XI: Applications for transfer of registrations
Various firms (column II) have applied for transfer of registrations. Registration Board
on 10.12.2014 advised P E & R Division to bring such applications for its consideration. Various
applications were considered as per following details:
S. No. Name of
applicant(s)
Name of
existing
manufacturer
Date of
application,
Diary No . &
Form
Registration
No.
Name of product with
composition
I II III IV V VI
1. M/s
GlaxoSmithKlin
e Pakistan Ltd,
Kara
M/s Akhai
Pharmaceutical
s, Karachi
20-06-2014
Dy.No.594
Form-5
Rs.40000/-
017889 Traxon 1gm IM/IV
Injection
Each vial contains:-
Ceftriaxone Sodium
…………..1gm
2. -do- -do- 20-06-2014
Dy.No.595
Form-5
Rs.40000/-
017890 Traxon 500mg IM/IV
Injection
Each vial contains:-
Ceftriaxone Sodium
…………..500mg
3. -do- -do- 20-06-2014
Dy.No.596
Form-5
Rs.40000/-
017891 Traxon 250mg IM/IV
Injection
Each vial contains:-
Ceftriaxone Sodium
…………..250mg
4. M/s Martin Dow
Ltd, Karachi
M/s Martin
Dow
Pharmaceutical
s (Pakistan)
Ltd, 45-KM,
Multan Road,
Lahore
10-02-2014
Dy.No.113
Form-5
Rs.20,000/-
027216 Biprofin Tablets
Each tablet contains:-
Flurbiprofen
…………..50mg
5. -do- -do- 10-02-2014
Dy.No.112
Form-5
Rs.20,000/-
027216 Biprofin Tablets
Each tablet contains:-
Flurbiprofen
…………..100mg
6. -do- -do- 10-02-2014
Dy.No.111
Form-5
Rs.20,000/-
049189 Fexinol-D Tablet
Each tablet contains:-
Pseudoephedrine HCl
…….120mg
466
Fexofenadine HCl
………. 60mg
7. -do- -do- 10-02-2014
Dy.No.110
Form-5
Rs.20,000/-
018485 Covatine Coated Tablet
Each tablet contains:-
Captodiamine HCl
……….50mg
8. -do- -do- 14-04-2014
Dy.No.341
Form-5
Rs.20000/-
042810 Fexinol Tablets 30mg
Each tablet contains:-
Fexofenadine HCl
……30mg
9. -do- -do- 14-04-2014
Dy.No.342
Form-5
Rs.20000/-
024311 Fexinol capsule
Each capsule contains:-
Fexofenadine HCl
……80mg
10. -do- -do- 14-04-2014
Dy.No.340
Form-5
Rs.20000/-
024312 Fexinol Tablets 120mg
Each tablet contains:-
Fexofenadine HCl
……120mg
11. -do- -do- 14-04-2014
Dy.No.343
Form-5
Rs.20000/-
024313 Fexinol Tablets 180mg
Each tablet contains:-
Fexofenadine HCl
……180mg
12. M/s Novartis
Pharma
(Pakistan) Ltd,
(DML
No.000193),
West Wharf
Road, Karachi
M/s Novartis
Pharma
(Pakistan) Ltd,
(DML
No.000010),
Jamshoro.
24-06-2014
Dy.No.636
Form-5
Rs.20,000/-
18-09-2014
Dy.No.800
Rs.80,000/-
022204 Lozal 20mg Capsule
Each capsule contains:-
Omeprazole
…………..20mg
13. M/s Elko
Organization
(Pvt.) Ltd,
Karachi
M/s Macquin’s
International,
Karachi
12-11-2013
Dy.No.1003
Form-5
Rs.20,000/-
048507 Aqua Teas Eye Drops
Each ml contains:-
Dextran………1mg
HPMC……….3mg
Glycerin……...2mg
(Manufacturer’s
467
Specification)
14. -do- -do- 12-11-2013
Dy.No.1003
Form-5
Rs.20,000/-
044457 MetaDex Eye / Ear
Drop
Each ml contains:-
Ciprofloxacin…..3mg
Dexamethasone..1mg
(Manufacturer’s
Specification)
15. -do- -do- 12-11-2013
Dy.No.1003
Form-5
Rs.20,000/-
044449 Blepharite Eye Drop
Each ml contains:-
Sulfacetamide…0.10g
Prednisolone
Acetate.…..2mg
Phenyephrine
HCl……..1.2mg
(Manufacturer’s
Specification)
16. M/s
GlaxoSmithKlin
e Pakistan Ltd,
F-268, S.I.T.E,
(DML
No.000233)
Karachi
M/s AGP (Pvt.)
Ltd, Karachi
26-06-2013
Dy.No.1084
Form-5
Rs.20,000/-
015027 Atarax Syrup
Each 5ml contains:-
Hydroxyzine
Dihydrochloride..10mg
17. -do- -do- 26-06-2013
Dy.No.1084
Form-5
Rs.20,000/-
007591 Atarax Tablet 10mg
Each tablet contains:-
Hydroxyzine
Dihydrochloride..10mg
18. -do- -do- 26-06-2013
Dy.No.1084
Form-5
Rs.20,000/-
002287 Navidoxine Tablet
Each tablet contains:-
Meclozine
Dihydrochloride..25mg
Pyridoxine
Hydrochloride..50mg
19. -do- -do- 26-06-2013
Dy.No.1084
Form-5
Rs.20,000/-
034675 Xyzal Tablet
Each film coated tablet
contains:-
Levocetirizine
468
Dihydrochloride………
…….5mg
20. -do- -do- 26-06-2013
Dy.No.1084
Form-5
Rs.20,000/-
016937 Zyrtec Syrup
Each ml contains:-
Cetirizine 2HCl
………….1mg
21. -do- -do- 26-06-2013
Dy.No.1084
Form-5
Rs.20,000/-
011020 Zyrtec Tablet 10mg
Each tablet contains:-
Cetirizine 2HCl
………….1mg
22. M/s Bosch
Pharmaceuticals
(Pvt.) Ltd,
(DML
No.000707),
Karachi (Plant-
II)
M/s Bosch
Pharmaceutical
s (Pvt.) Ltd,
(DML
No.000350),
Karachi (Plant-
I)
12-03-2014
Dy.No.190
Form-5
Rs.20,000/-
037306 Ambac Injection 0.75gm
Each vial contains:
Ampicillin sodium USP
eq. to
Ampicillin…….500 mg
Sulbactam Sodium USP
eq. to
Sulbactam……250 mg
23. -do- -do- 12-03-2014
Dy.No.188
Form-5
Rs.20,000/-
037629 Ambac Injection 1.5gm
Each vial contains:
Ampicillin sodium USP
1.06gm eq. to
Ampicillin………1gm
Sulbactam Sodium USP
0.545gm eq. to
Sulbactam……500 mg
24. -do- -do- 12-03-2014
Dy.No.189
Form-5
Rs.20,000/-
042424 Bactamox Plus 0.75gm
Injection
Each vial contains:
Amoxicillin Sodium (as
Amoxicillin Sodium
Anhydrous)B.P …0.50
gm
Sulbactam Sodium USP
….0.25gm
(USP Specification)
25. -do- -do- 12-03-2014
Dy.No.187
Form-5
042425 Bactamox Plus 1.5gm
Injection
Each vial contains:
469
Rs.20,000/- Amoxicillin Sodium (as
Amoxicillin Sodium
Anhydrous)B.P …1.0
gm
Sulbactam Sodium USP
….0.5gm
(USP Specification)
26. -do- -do- 12-03-2014
Dy.No.186
Form-5
Rs.20,000/-
042426 Bactamox Plus 3gm
Injection
Each vial contains:
Amoxicillin Sodium (as
Amoxicillin Sodium
Anhydrous) B.P …2.0
gm
Sulbactam Sodium USP
….1.0gm
(USP Specification)
27. -do- -do- 12-03-2014
Dy.No.185
Form-5
Rs.20,000/-
015906 Boschoclox Injection
250mg
Each vial contains:
Cloxacillin Sodium USP
eq. to 250mg
Cloxacillin Base
28. M/s
GlaxoSmithKlin
e Pakistan Ltd,
Korangi Plant
Karachi
M/s
GlaxoSmithKli
ne Pakistan
Ltd,
West Wharf,
Karachi
14-06-2012
Dy.No.315
Form-5
Rs.8,000/-
29-04-2013
Rs.12000/-
0001859 Kenacomb Cream
Each gram contains:-
Triamcinolone
Acetonide USP …1mg
Nystatin USP
………….100,000 units
Gramidicin USP
………...0.25mg
29. -do- -do- 14-06-2012
Dy.No.314
Form-5
Rs.8,000/-
29-04-2013
Rs.12000/-
005026 Kenacomb Ointment
Each gram contains:-
Triamcinolone
Acetonide USP ….1mg
Nystatin USP
………….100,000 units
Gramidicin USP
……………...0.25mg
470
Neomycin Sulphate eq.
to 2.5mg base
30. -do- -do- 14-06-2012
Dy.No.316
Form-5
Rs.8,000/-
29-04-2013
Rs.12000/-
009452 Kenalog Orabase
Ointment
Each gram contains:-
Triamcinolone
Acetonide USP ….1mg
31. M/s Hilton
Pharma, Karachi
M/s Brookes
Pharma,
Karachi
11-07-2013
Dy.No.692
Form-5
Rs.20,000/-
021661 Zinum 250mg Injection
Each vial contains:-
Ceftazidim Sodium
……….250mg
32. -do- -do- 11-07-2013
Dy.No.693
Form-5
Rs.20,000/-
021662 Zinum 500mg Injection
Each vial contains:-
Ceftazidim Sodium
……….500mg
33. -do- -do- 11-07-2013
Dy.No.697
Form-5
Rs.20,000/-
021663 Zinum 1gm Injection
Each vial contains:-
Ceftazidim Sodium
……….1gm
34. -do- -do- 11-07-2013
Dy.No.696
Form-5
Rs.20,000/-
021664 Axone 250mg Injection
Each vial contains:-
Ceftriaxone Sodium
…….250mg
35. -do- -do- 11-07-2013
Dy.No.699
Form-5
Rs.20,000/-
021665 Axone 500mg Injection
Each vial contains:-
Ceftriaxone Sodium
…….500mg
36. -do- -do- 11-07-2013
Dy.No.695
Form-5
Rs.20,000/-
021666 Axone 1gm Injection
Each vial contains:-
Ceftriaxone Sodium
…….1gm
37. M/s Indus
Pharma, Karachi
M/s Nimrall
Laboratories,
Islamabad
05.11.2014
Dy.No.394
Form-5
054553 Rudra 5mg Tablet
Each tablet contains:-
Rosuvastatin (as
471
Rs.20,000/- Calcium) …….5mg
38. -do- -do- 05.11.2014
Dy.No.395
Form-5
Rs.20,000/-
054554 Rudra 10mg Tablet
Each tablet contains:-
Rosuvastatin (as
Calcium) …….10mg
39. M/s Sante (Pvt.)
Ltd, Karachi
M/s Elko
Organization
(Pvt.) Ltd,
Karachi
18-09-2014
Dy.No.657
Form-5
Rs.20,000/-
070516 Dequsan Throat / Mouth
Spray Solution
Each 100ml contains:-
Dequalinium Chloride
BP………15mg
Benzalkonium Chloride
BP………..35mg
40. M/s Pfizer
Pakistan Ltd,
DML
No.000025
(Formulation) at
B-2, SITE,
Karachi
M/s wyeth
Pakistan Ltd.,
Karachi
contract
manufactured
by M/s Spencer
& Co
(Pakistan) Ltd,
Karachi.
06-02-2014
Dy.No.68
Form-5
Rs.20,000/-
000083 Ativan 1mg Tablets
(Lorazepam)
41. -do- -do- 06-02-2014
Dy.No.68
Form-5
Rs.20,000/-
000084 Ativan 2mg Tablets
(Lorazepam)
42. M/s Ambrosia
Pharmaceuticals
, Rawat
M/s Spencer &
Co, Karachi
29-10-2014
Dy.No.634
Form-5
Rs.20,000/-
006348 Calcipan-T 50 mg
Tablet
Each tablet contains:-
Calcium
Pantothenate……..50
mg
43. -do- -do- 29-10-2014
Dy.No.635
Form-5
Rs.20,000/-
067454 Infacol 40 mg Drops
Each ml contains:-
Simethicone
…………40 mg
44. -do- -do- 29-10-2014
Dy.No.633
Form-5
008801 Infacol Suspension
Each 5 ml contains:-
Dicyclomine HCl
……….5 mg
472
Rs.20,000/- Simethicone ………
…50 mg
45. M/s Glitz
Pharma,
Islamabad
M/s Caraway
Pharmaceutical
, Rwat
784; 09.12.2014
Rs.50000/-
Form 5
066362 G-Cal 5 mg Injection
Each ampoule contains:-
Cholecalciferol eq. to
Cholecalciferol
……………. 5 mg
46. M/s Focus &
Rulz, Islamabad
M/s Highnoon
Labs, Lahore
970; 10.12.2014
Rs.20000/-
Form 5
027104 Helezol 20 mg Capsule
Each delayed-release
capsule contains:-
Omeprazole enteric
coated pellets 8.5%
≡ Omeprazole……. 20
mg
47. -do- -do- 976; 10.12.2014
Rs.20000/-
Form 5
051054 Helezol 40 mg Capsule
Each delayed-release
capsule contains:-
Omeprazole enteric
coated pellets 8.5%
≡ Omeprazole……. 40
mg
48. -do- -do- 971; 10.12.2014
Rs.20000/-
Form 5
025098 Angiocard 2.5mg
Capsule
Each sustained-release
capsule contains:-
Nitroglycerin SR Pellets
≡ Nitorglycerin……..2.5
mg
49. -do- -do- 969; 10.12.2014
Rs.20000/-
Form 5
025099 Angiocard SR 6.5 mg
Capsule
Each sustained-release
capsule contains:-
Nitroglycerin SR Pellets
≡ Nitorglycerin……..6.5
mg
50. -do- -do- 974; 10.12.2014
Rs.20000/-
Form 5
024929 Artonec 50 mg Capsule
Each delayed-release
capsule contains:-
Diclofenac Sodium
enteric coated pellets
≡ Diclofenac Sodium
…... 50 mg
473
51. -do- -do- 972; 10.12.2014
Rs.20000/-
Form 5
024930 Artonec SR-100 Capsule
Each sustained-release
capsule contains:-
Diclofenac Sodium
sustained release coated
pallets
≡ Diclofenac Sodium
….100 mg
52. -do- -do- 973; 10.12.2014
Rs.20000/-
Form 5
027105 Neopres 5 mg Tablet
Each tablet contains:-
Amlodipine Besylate eq.
to
Amlodipine……….5mg
53. -do- -do- 968; 10.12.2014
Rs.20000/-
Form 5
027106 Neopres 10 mg Tablet
Each tablet contains:-
Amlodipine Besylate eq.
to Amlodipine…10 mg
54. -do- -do- 975; 10.12.2014
Rs.20000/-
Form 5
051057 Delergic 5 mg Tablet
Each film coated tablet
contains:-
Desloratidine……..5 mg
55. M/s. Synchro
Pharmaceutical
s Lahore
M/s. Obsons
Pharmaceutic
als, Lahore
05-06-2013
926
Form-5
059991 Obdin Tablet 5mg
Each tablet contains:-
Desloratadine…. 5mg 56. -do- -do-
05-06-2013
5549
Form-5
025404 Azrocin Suspension
Each 5ml contains:-
Azithromycin
dihydrate eq. to
Azithromycin.. 200mg 57. -do- -do- 05-06-2013
5548
Form-5
054157 Obflox Tablet
Each tablet contains:-
Levofloxacin
Hemihydrate
equivalent to
Levoflocaxin
…………. 500mg 58. -do- -do- 05-06-2013
5547
Form-5
030488 Obflox Tablet
Each tablet contains:-
Levofloxacin
Hemihydrate
equivalent to
Levoflocaxin
474
…………. 250mg 59. -do- -do- 05-06-2013
5554
Form-5
054166 Obpra Capsule 40mg
Each capsule
contains:-
Enteric coated pellets
of Esomeprazole
magnesium trihydrate
eq. to Esomeprazole
…………… 40mg 60. -do- -do- 05-06-2013
5552
Form-5
029834 Vincam Capsule 20mg
Each capsule
contains:-
Piroxicam…… 20mg 61. -do- -do- 05-06-2013
5551
Form-5
025406 Rubinol Tablet
Each tablet contains:-
Flurbiprofen.. 100mg 62. -do- -do- 05-06-2013
5553
Form-5
025403 Azrocin Capsule
Each capsule
contains:-
Azithromycin
dihydrate….. 250mg 63. -do- -do- 05-06-2013
5550
Form-5
054153 LevortizinTablet
Each tablet contains:-
Leocetirizine
dihydrate 5mg 64. -do- -do- 05-06-2013
5555
Form-5
054165 Obpra Capsule
Each capsule
contains:-
Esomeprazole
magnesium trihydrate
enteric coated pellets
equivalent to
Esomeprazole
…………. 20mg 65. M/s. Searle IV
Solutions
(Pvt.) Ltd;
Lahore
M/s. the
Searle
Company,
Karachi
22-04-2014
780
Form-5
018632 Metronzine Injection
Each 100 ml
contains:-
Metronidazole
……….. 500 mg
66. -do- -do- 22-04-2014
783
Form-5
044077 Vaptor 20 mg Tablets
Each tablet contains:-
Rosuvastatin (as
Calsium) 20 mg
475
67. -do- -do- 22-04-2014
790
Form-5
047384 Searl-α 0.5 mcg
Tablets
Each tablet contains:-
Alfacalcidol
……………0.5 mcg
68. -do- -do- 22-04-2014
778
Form-5
047391 Rhulef 20 mg Tablets
Each film coated
tablet contains:-
Leflunomide
…………. 20 mg
69. -do- -do- 22-04-2014
782
Form-5
014408 Gravinate Injection
Each ml contains:-
Dimenhydrinate
………… 50 mg
70. -do- -do- 22-04-2014
779
Form-5
047383 Searl- α 1 mcg Tablet
Each tablet contains:-
Alfacalcidol
……………….. 1 mcg
71. -do- -do- 22-04-2014
797
Form-5
067114 Peditral Liquid
Each 5 ml contains:-
Sodium Chloride
…...... 17.50 mg
Potassium Chloride
…… 7.50 mg
Trisodium Citrate
Dihydrate .. 14.5 mg
Dextrose… 100.00 mg
(Flavour: Orange)
72. -do- -do- 22-04-2014
781
Form-5
067113 Peditral Liquid
Each 5 ml contains:-
Sodium Chloride ......
17.50 mg
Potassium Chloride
…… 7.50 mg
Trisodium Citrate
Dihydrate .... 14.5 mg
Dextrose… 100.00 mg
(Flavour: Regular)
73. -do- -do- 22-04-2014 047390 Rhulef 10 mg Tablets
476
787
Form-5
Each film tablet
contains:-
Leflunomide…. 10 mg
74. -do- -do- 22-04-2014
789
Form-5
047382 Searl- α 0.25 mcg
Tablet
Each tablet contains:-
Alfacalcidol….0.25
mcg
75. -do- -do- 22-04-2014
791
Form-5
058022 Co-Olesta Tablet
Each tablet contains:-
Olmesartan…... 20 mg
Hydrochlorothiazide
….. 12.5 mg
76. -do- -do- 22-04-2014
792
Form-5
044075 Vaptor Tablets
Each tablet contains:-
Rosuvastatine (as
Calcium) 5 mg
77. -do- -do- 22-04-2014
793
Form-5
050736 Olesta 20 mg Tablet
Each tablet contains:-
Olmesartan
Medoxomil … 20 mg
78. -do- -do- 22-04-2014
794
Form-5
050737 Olesta 40 mg Tablet
Each tablet contains:-
Olmesartan
Medoxomil … 40 mg
79. -do- -do- 22-04-2014
795
Form-5
067116 Peditral Liquid
Each 5 ml contains:-
Sodium Chloride ……
17.50 mg
Potassium Chloride
….. 7.50 mg
Trisodium Citrate
Dihydrate .. 14.5 mg
Dextrose… 100.00 mg
(Flavour: Banana)
80. -do- -do- 22-04-2014
796
Form-5
067115 Peditral Liquid
Each 5 ml contains:-
Sodium Chloride ……
477
17.50 mg
Potassium Chloride
….. 7.50 mg
Trisodium Citrate
Dihydrate….. 14.5 mg
Dextrose...100.00 mg
(Flavour: Bubble gum)
81. -do- -do- 22-04-2014
798
Form-5
058023 Co-Olesta Tablet
Each tablet contains:-
Olmesartan ... 40 mg
Hydrochlorothiazide
….. 12.5 mg
82. -do- -do- 22-04-2014
783
Form-5
044048 Simbex Tablets
Each tablet contains:-
Simvastatin …. 10 mg
Ezetimibe …… 10 mg
83. -do- -do- 22-04-2014
783
Form-5
044076 Vaptor Tablet
Each tablet contains:-
Rosuvastatin (as
Calcium) 10 mg
84. -do- -do- 22-04-2014
786
Form-5
044049 Simbex Tablets
Each tablet contains:-
Simvastatin.. 20 mg
Ezetimibe …… 10 mg
85. -do- -do- 22-04-2014
788
Form-5
047389 Rhulef 100 mg Tablets
Each tablet contains:-
Leflunomide
…………… 100 mg
86. -do- -do- 22-04-2014
876
Form-5
060631
Requested for
change of
name
Levomac Infusion
Each 100 ml
contains:-
Levofloxacin.. 500 mg
87. -do- -do- 22-04-2014
781
Form-5
060632
Requested for
change of
name
Moxirains Infusion
Each 250 ml
contains:-
Moxifloxacin as HCl
…… 400 mg
(Mac & Rains Specs)
88. M/s. The M/s. The 23-10-2013 018627 Sermol Suspension
478
Searle
Company
Limited 32-
Km Multan
Road, Lahore
(DML #
000647)
Searle
Company
Limited F-
319, S.I.T.E,
Karachi
(DML #
000016)
487
Form-5
Each 5ml contains:-
Paracetamol…..120mg
89. -do-
-do- 23-10-2013
486
Form-5
018628 Sermol Forte
Suspension
Each 5ml contains:-
Paracetamol
………….. 250mg
90. -do- -do-
23-10-2013
488
Form-5
018629 Sermol Tablet
Each tablet contains:-
Paracetamol ………..
500mg
91. M/s. Allmed
(Pvt.) Ltd;
Lahore at same
premises
M/s. Ever
Green
Pharmaceutic
als (Pvt.) Ltd;
Plot No. 509
Sundar
Industrial
Estate, Lahore
21-02-2013
469
Form-5
052455 Hemfil Syrup
Each 5ml contains:-
Iron Polymaltose
complex eq. to
Elemental Iron
…………….. 50mg
92. -do- -do- -do- 052434 Hemifim-F Tablet
Each tablet contains:-
Iron hydroxide
Polymaltose complex
…. 100mg
Folic Acid … 0.35mg
93. -do- -do- -do- 059964 Uriflow Capsule
Each capsule
contains:-
Tamsulosin
Hydrochloride
…………….. 0.4mg
94. -do- -do- -do- 052462 Protx 20mg Capsuel
Each capsule
contains:-
Esomeprazole
……………… 20mg
479
95. -do- -do- -do- 052460 Protx 40mg Capsuel
Each capsule
contains:-
Esomeprazole
……………… 40mg
96. -do- -do- -do- 052422 Everlom-400 Tablet
Each tablet contains:-
Lomefloxacin as HCl
….. 400mg
97. -do- -do- -do- 063136 Ichunil D Syrup
Each 10ml contains:-
Pseudeophedrine
(HCl) . 13.3mg
Phlocodine ... 3.33mg
Paracetamol … 200mg
98. -do- -do- -do- 063135 Ichunil D Syrup
Each 10ml contains:-
Pseudeophedrine
(HCl) . 13.3mg
Phlocodine . 3.33mg
Paracetamol… 200mg
Diphenhydramine
…….. 3.33mg
99. -do- -do- -do- 052424 Okcin-200 Tablet
Each tablet contains:-
Ofloxacin …. 200mg
100. -do- -do- -do- 052440 Meamin Capsule
Each capsule
contains:-
Mecobalamin..500mcg
101. -do- -do- -do- 067918 Everlose Syrup
Each 5ml contains:-
Lactulose …. 3.35mg
102. -do- -do- -do- 067898 Methemin Injection
Each ml contains:-
Mecobalamin..
500mcg
103. -do- -do- -do- 052444 Itrdym Capsule
480
Each capsule
contains:-
Itraconazole ... 100mg
104. -do- -do- -do- 052461 Sopra-Praz Capsule
Each capsule
contains:-
Lansoprazole… 30mg
Decision: Registration Board decided as follows:
Cancellation of above registrations from name of manufactyrer (column II) except
item at S.No.45 as it is case for change of contract manufacturer.
Grant of above registrations in name of manufactyrer (column III). Chairman,
Registration Board will permit issuance of registration letter after evaluation /
completion of Form 5A as per check list approved by Registration Board, renewal
status and comments of Cost & Pricing Division about MRP of the drug.
Meeting ended with a vote of thanks to and from the chair.
______________________________________________________________________________
End of the Document