Minutes for 280th Meeting of Registration Board held on 15 ... Minutes for 280th thmeeting of...
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Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 1
Minutes for 280th
Meeting of Registration Board
held on 15th
March, 2018.
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Item No. Detail Page No.
Item No. I Confirmation of Minutes for 279th
meeting 2
Item No. II References sent by Central Licensing Board 3 – 4
Item No. III Pharmaceutical Evaluation & Registration Division
Registration-II Section
Pharmaceutical Evaluation Cell
5 – 53
5-7
8-53
Item No. IV Additional Agenda.
A. Pharmaceutical Evaluation & Registration Division
Registration-I Section
Registration-II Section
Registration-IV Section
Registration-V Section
54 – 58
54-56
57
58-59
60-61
Drug Regulatory Authority of Pakistan
T.F. Complex, Mauve Area, G 9/4
Islamabad.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 2
280th
meeting of Registration Board was held on 15th
March, 2018 in the Committee
Room of Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was chaired by
Dr. Obaidullah, Director, Division of Pharmaceutical Evaluation & Registration, DRAP. The
meeting started with recitation of the verses from Holy Quran. The meeting was attended by the
following:-
1. Dr. Rafeeq Alam Khan,
Meritorious Professor, Chairman, Faculty of Pharmacy,
Univeristy of Karachi.
Member
2. Prof. Dr. Ghulam Sarwar, Dean,
Faculty of Pharmacy, Jinnah Women University, Karachi
Member
3. Dr.Qurban Ali,
Ex-Director General, NVL/ Veterinary Expert
Member
4. Dr. Amanullah Khan
Director, Drugs Testing Laboratory, Quetta
Government of Baluchistan
Member
5. Mr. Abid Hayat,
Director, Drugs Testing Laboratory, Peshawar
Government of Khyber Pakhtunkhwa.
Member
6. Syed Muzaffar Ali Jafri,
Director, Drugs Testing Laboratory, Karachi
Government of Sindh.
Member
7. Mr. Muhammad Aslam
Assistant Draftsman-II, Ministry of Law & Justice
Member
8. Mr. Zahoor Ahmad,
Assistant Controller of Patent, Representative of IPO
Member
9. Dr. Noor-us-Saba
Director, as representative of Division of Biological
Evaluation & Research, DRAP
Member
10. Dr. Hafsa Karam Elahi, Additional Director,
as representative of Division QA<, DRAP
Member
11. Dr.Muhammad Akram,
Assistant Animal Husbandry Commissioner, M/o NFS&R.
Co-Opted
Member
12. Mr. Abdullah, Additional Director (PE&R) Secretary
Mr. Ehsan Awan and Ch. Muhammad Yousaf (PPMA), Mr. Nadeem Alamgir (Pharma
Bureau) and Mr. Kamran Anwar (PCDA) attended the meeting as observers.
Mr. Zaheer-ud-Din M. Babar (Deputy Director R.I/R.IV), Muhammad Amin (Deputy
Director, R.II), Mr. Babar Khan (Deputy Director (R.III) / Incharge-PEC), assisted in presenting
the agenda of PE&R Division.
Item No. I: Confirmation of minutes of 279th
meeting of Registration Board.
279th
meeting of Registration Board was held on 28th
February to 2nd
March, 2018. The
Board was apprised that draft minutes of the meeting are under preparation and will be circulated
for their comments.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 3
Item No. II: References Sent by the Central Licensing Board.
Case No.1: Drug Manufacturing Licenses cancelled by CLB.
Central Licensing Board in its various meetings cancelled Drug Manufacturing Licenses
(DMLs) of following firms as per details mentioned below:-
Sr.
No.
Name of Firms DML No. &
Type
CLB Meeting No.
1. M/s Everest Pharmaceuticals,
124, Industrial Triangle, Kahuta Road,
Islamabad
000535
(Formulation)
258th
held on
08th
March, 2018
2. M/s. Pharmawise Labs (Pvt) Ltd 25-M,
Qauid e Azam Industrial Estate, Lahore
000182
(Formulation)
256th
held on
09-10th
November,2017
3. M/s. Guyton Pharmaceuticals, 25.5 KM,
Raiwand Road, Lahore
000548
(Formulation)
252nd
held on
15th
Macrh, 2017.
4. M/s. Micko Industrial Chemicals Company
(Pvt), Ltd, 28-Km, Ferozepur Road, Lahore
000183
(Formulation)
256th
held on
09-10th
November,2017
5. M/s Vetec Laboratories, 51 Industrial
Triangle, Kahuta Road Islamabad
000320
(Formulation)
255th
held on
16-17th
August, 2017
6. M/s Drug Pharm (Pvt) Ltd, 28-Km, Lahore
Sheikhupura Road, Lahore
000366
(Formulation)
257th
held on
24–25th
January, 2018
The case is submitted for consideration of Registration Board with regard to status of
drugs registered with these firms after cancellation of their DMLs.
Decision: Keeping in view the decision of Central Licensing Board for cancellation of
Drug Manufacturing License the Registration Board deliberated and
cancelled the registration of all drug products registered in the name of
above firms.
Case No.2: Drug Manufacturing License declared invalid by CLB.
Central Licensing Board in its 250th
meetingdeclared Drug Manufacturing License
(DML) of following firm “Invalid” as per details mentioned below:-
S.
No.
Name of Firm DML No. &
Type
CLB Meeting No. Decision
1. M/s Becton Dickenson Pakistan
(Pvt) Ltd, 10-Km Muridkay-
Sheikhupura Road, Muridkay
000673
(Formulation)
250th
held on 27th
October, 2016.
Invalid
The case is submitted for consideration of Registration Board with regard to status of
registration of drugs registered with the firms after their DML is declared Invalid.
Decision: Keeping in view the decision of Central Licensing Board for invalidity of
Drug Manufacturing License, the Registration Board deliberated and
cancelled the registration of all drug products registered in the name of
above firm.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 4
Case No.3: Drug Manufacturing Licenses suspended by CLB.
Central Licensing Board in various meetings considered the cases and declared that DML
of different firms are suspended as per below mentioned detailed:-
S. No. Name of Firm DML No. &
Type
CLB Meeting
No.
Decision
1.
M/s Safe Pharmaceuticals (Pvt)
Ltd., Karachi
000349
(Formulation)
257th
held on
24th
– 25th
January, 2018
Rejection of
renewal.
Manufacturing shall
remain suspended.
2. M/s Kailgon Agro Industries
(Pvt) Ltd., Balochistan
000277
(Formulation)
257th
held on
24th
– 25th
January, 2018
Suspended
3. M/s Gaba Pharmaceutical
Laboratories, Karachi
000168
(Formulation)
257th
held on
24th
– 25th
January, 2018
Suspended
4. M/s Medley Pharmaceuticals,
41-A, P.S.I.E., JhangBahtar
Road, WahCantt, Rawalpindi
000237
(Formulation)
257th
held on
24th
– 25th
January, 2018
Suspended
5. M/s Qintar Pharmaceuticals, 14-
A, P.S.I.E., Lahore Road,
Sargodha
000520
(Formulation)
257th
held on
24th
– 25th
January, 2018
Suspended
6. M/s Tas Pharmaceuticals (Pvt)
Ltd., Plot No. 209, Industrial
Triangle, kahuta road Islamabad
000375
(Formulation)
257th
held on
24th
– 25th
January, 2018
Rejection of
renewal.
Manufacturing shall
remain suspended.
The case is submitted for consideration of Registration Board with regard to status of
registration of drugs registered with the firms after their DML is declared suspended.
Decision: Keeping in view the decision of Central Licensing Board for suspension of
Drug Manufacturing License, the Registration Board deliberated and
suspended the registration of all drug products registered in the name of
above firms at serial no. 2 - 5. The Registration Board deferred the case
regarding firms at serial no. 1 and 6 till final decision by the Central
Licensing Board as their decision on Drug Manufacturing License is pending
before the Central Licensing Board.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 5
Item No. III Pharmaceutical Evaluation & Registration Division
Registration-II Section
Case No. 1: Reply to Show-Cause Notice.
Secretary Central Licensing Board (CLB) has intimated that CLB in its 251st
meeting held on 6th
December 2017 has considered and deliberated the case of M/s Pharmatec
Pakistan (Pvt) Ltd., D-86/A, S.I.T.E, Karachi under DML No. 000024 by way of formulation and
decided to allow grant of renewal section for sterile Liquid ampoule section with the direction
that Registration Board be informed about approval of sterile Liquid ampoule section only. It is
pertinent to mention that few products of M/s OBS Pakistan, Karachi were manufactured by M/s
Pharmatec Pakistan by permission vide letter no. F.3-3/2015-Reg-II (M-249) dated 26th
August,
2015. The permission is valid for 30-06-2020.
The above stated facts of the case were presented in the 275th
meeting of Registration Board.
Wherein, it was decided to “issue a showcause notice to M/s OBS Pakistan, Karachi for their
hormonal products which were being manufactured by M/s Pharmatec Pakistan (Pvt) Ltd.,
Karachi on contract basis.”
Accordingly a show cause was issued to M/s OBS Pakistan (Pvt) Ltd., Karachi vide letter
no. F.3-12/2017-Reg-II (M-275) dated 15.02.2018. Now the firm has submitted a reply which is
summarized as below:
“The reply to the subject notice on behalf of OBS is elucidated here in below:-
1. That a contract manufacturing agreement dated 01.01.2013 was executed inter se
OBS and Pharmatec for manufacturing of the following hormonal drugs:-
S.No Drug(s) Reg.No
1. Deca-Durabolin Injection 25 mg/ml 002442
2. Deca-Durabolin Injection 50 mg/ml 002443
3. Deca-Durabolin Injection 100 mg/ml 002444
4. Sustanon 250 mg/ml 002446
2. That subsequently, vide a letter dated 26.08.2015, the Drug Regulatory Authority of
Pakistan (DRAP) granted extension in respect of the permission for contract
manufacturing till 30.06.2020.
3. That an inspection was carried out by the Federal Inspector of Drugs of the
Pharmactec’s manufacturing site, in which the following observation was given in
Paragraph No. 08 of the inspection Report:
“It was observed by the panel that the firm is manufacturing the hormonal sterile
products (androgens and anabolic steroids) in the area for the sterile Ampoules
for General products. Therefore, the firm was directed to immediately stop the
production of Hormonal products in the aforesaid area and all previous
approvals for hormone production are henceforth, stand cancelled till further
approval by the DRAP Islamabad.”
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 6
4. That the aforementioned paragraph no. 8 was challenged by OBS vide a
Constitutional petition no. 1120 of 2016 before a Division bench of the Honourable
High Court of Sindh. Through order dated 02.03.2016, CP NO. 1120 of 2016 was
disposed of in following terms:
“After arguing the matter in length, counsel says that he has taken instructions
from the petitioner who would rectify the facility in terms of Para 8 of the
Inspection report dated 21.01.2015 and will request for re-inspection afterwards,
so that in case the facility is found in accordance with the Rules of DRAP, then
the respondents should allow the petitioner to manufacture the Hormonal Sterile
Products. The Drugs Inspector present submits that the inspection was conducted
on account of certain breaches found in the premises as detailed in Para 8 of the
above report, manufacturing process was suspended in respect of Hormonal
Sterile Products being manufactured therein, and in case they comply with para 8
of above report by separating the manufacturing facility in respect of Hormonal
Sterile products, then of course permission of manufacturing of the same can be
allowed, after DRAP appoints Inspection Team to ensure that the facility is
rectified in accordance with DRAP regulations. Mr. Pirzada at the request of the
petitioner seeks disposal of this petition as the petitioner is ready to comply with
the instructions in Para 8 of the Inspection report.
…………………………………………….. The Petition along with application stands
disposed of, in above terms.”
5. That the counsel for OBS, vide a letter dated 10.03.2016 intimated to the Secretary,
CLB of DRAP and informed regarding the order passed by the Hon’ble High Court in
C.P. No. D-1120 of 2016.
6. That subsequently, vide a letter dated 13.04.2016, Pharmatec intimated to the
Secretary, CLB of DRAP that:
“Through this letter, we would like to inform you that we are preparing to convert
this existing area into a hormone-manufacturing area. The cleaning, renovation
and other preparation would be completed by third week of May-2016.”
7. That through a letter dated 04.08.2016, sent by Assistant Drug Controller Licensing,
DRAP to Pharmatec, the revised layout plan as intimated by Pharmatec to the
Secretary, CLB, was approved.
8. That subsequently, a dispute ensued between OBS and Pharmatec which culminated
in the institution of Suit No. 2523 of 2016 before Hon’ble High Court of Sindh,
Karachi. During the pendency of the aforementioned legal proceedings, Pharmatec
wrote a letter to Secretary, CLB dated 15.10.2016, wherein it was stated that:-
“We have decided to withdraw our request for the grant of approval of above
mentioned manufacturing areas and request you to kindly approve our sterile
area as per the report of inspection, conducted for the renewal Drug
manufacturing License no. 000024 dated 21.01.2015”.
9. That subsequently, vide a letter bearing reference no. F.2-48/84-Lic (IV) dated
09.08.2017 that the Secretary, Central Licensing Board communicated to the
Pharmatec that they
“decided to allow grant of renewal Section for Sterile Liquid Ampoule Section
with the direction that Drug Registration Board be informed about approval of
Sterile Liquid ampoule section only. Moreover, Federal Inspector of Drugs may
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 7
be directed to verify that no hormonal products are being manufactured in sterile
liquid ampoule section which is only meant for General Products.”
10. That surprisingly, through a letter bearing noF.2-1/2000 Lic(Vol-I) dated 10.08.2017,
sent by the Deputy Director (Licensing) of DRPA to OBS, OBS being the Petitioner in
the aforementioned CP No. D-1120 of 2016, was requested to “make a formal
request for constitution of panel for re-inspection in light of the direction of the
Hon’ble Sindh high Court, Karachi.”
11. That OBS was constrained to impugn/challenge the letter dated 09.08.2017 issued by
the Secretary, Central Licensing Board through a Suit bearing No. 2056 of 2017
before the Hon’ble Court of Sindh at Karachi. Pharmatec along with the Secretary
CLB were impleaded as Defendants in the said suit. Subsequent to the institution of
the suit under reference, an amicable settlement/compromise has been affected
between OBS and Pharmatec. In terms of the said settlement/ compromise,
Pharmatec shall apply to the DRAP and the Drug Licensing Board for obtaining
Campaign Manufacturing permission in respect of OBS’s Hormonal Drugs which
shall be granted by the DRAP in accordance with the law.
12. That through an order dated 07.11.2017; the said suit was decreed in the
aforementioned terms of settlement/compromise. It has been expressly mentioned in
the said order that permission in respect of Campaign Manufacturing of the
Hormonal Drugs shall be granted by the DRAP and the Secretary, CLB in
accordance with Law.
13. It may be noted that Pharmatec will shortly be writing to DRAP and CLB of the
DRAP for seeking permission for the Campaign Manufacturing of OBS Hormonal
Drugs which shall be granted in accordance with law. Furthermore, DRAP being a
party to the aforementioned proceeding before the Hon’ble High Court of Sindh at
Karachi.
PRAYER
In view of the above legal facts and circumstances, it is very humbly prayed that the show cause
notice bearing No. F.3-12/2017-Reg-II (M-275) dated 15.08.2018 addressed to OBS be vacated
and discharged.
Decision: The Board considered and deferred the case till decision of Central Licensing
Board on application of the firm for campaign manufacturing.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 8
Pharmaceutical Evaluation Cell
S.No. Details
Case No. 01 Registration applications for local manufacturing of (Human) drugs
a) New cases
b) Deferred cases
Case No. 02 Registration applications of import (Human) cases
Case No. 03 Registration applications of newly granted DML or New section (Human)
a. New/Additional section(s)
b. Deferred cases
Case No. 04 Deferred cases of previous meetings (Human)
Case No. 05 Deferred cases of previous meetings (Veterinary)
Case No. 06 Verification of stability study data
Case No.1: Registration Applications for Local Manufacturing of (Human) Drugs.
a) New cases 1. Name and address of manufacturer /
Applicant
M/s. Caliph Pharmaceuticals, Plot No. 17, Special
Industrial Zone, Risalpur, Pakistan.
Brand Name +Dosage Form + Strength Moxcin 400mg tablet
Composition Each film coated tablet contains:
Moxifloxacin (as hydrochloride)………400mg
Diary No. Date of R& I & fee Dy. No.1978; 20-02-2017; Rs.20,000/- (20-02-2017)
Pharmacological Group Quinolone
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price 1x5’s; As per SRO
Approval status of product in
Reference Regulatory Authorities
Avelox 400 mg film-coated tablets by M/s Bayer
(MHRA approved)
Me-too status (with strength and
dosage form)
Metoxim 400mg Tablet by M/s Foray Pharmaceutical
GMP status GMP inspection conducted on 07-03-2017 concluded that
firm is working at satisfactory level of GMP compliance.
Remarks of the Evaluator Applicant has claimed USP specifications but applied
formulation is not present in available USP & BP.
Decision: Approved with innovator’s specifications.
2. Name and address of manufacturer /
Applicant
M/s. Caliph Pharmaceuticals, Plot No. 17, Special
Industrial Zone, Risalpur, Pakistan.
Brand Name +Dosage Form + Strength Tizid 2mg tablet
Composition Each film coated tablet contains:
Tizanidine (as hydrochloride)………2mg
Diary No. Date of R& I & fee Dy. No.1977; 20-02-2017; Rs.20,000/- (20-02-2017)
Pharmacological Group Skeletal muscle relaxant
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price 1x10’s; As per SRO
Approval status of product in
Reference Regulatory Authorities
Approved in US-FDA (but discontinued) however it is
written that product was not withdrawn or discontinued
because of safety and efficacy reasons.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 9
Me-too status (with strength and
dosage form)
Muslex Tablet 2 mg of Danas Pharmaceutical
GMP status GMP inspection conducted on 07-03-2017 concluded that
firm is working at satisfactory level of GMP compliance.
Remarks of the Evaluator
Decision: Approved.
3. Name and address of manufacturer /
Applicant
M/s. Caliph Pharmaceuticals, Plot No. 17, Special
Industrial Zone, Risalpur, Pakistan.
Brand Name +Dosage Form + Strength Tizid 4mg tablet
Composition Each film coated tablet contains:
Tizanidine (as hydrochloride)………4mg
Diary No. Date of R& I & fee Dy. No.1976; 20-02-2017; Rs.20,000/- (20-02-2017)
Pharmacological Group Skeletal muscle relaxant
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price 1x10’s; As per SRO
Approval status of product in
Reference Regulatory Authorities
Approved in US-FDA
Me-too status (with strength and
dosage form)
Tandolax 4mg Tablet of High-Q Pharmaceuticals
GMP status GMP inspection conducted on 07-03-2017 concluded that
firm is working at satisfactory level of GMP compliance.
Remarks of the Evaluator
Decision: Approved.
4. Name and address of manufacturer /
Applicant
M/s. Caliph Pharmaceuticals, Plot No. 17, Special
Industrial Zone, Risalpur, Pakistan.
Brand Name +Dosage Form + Strength Tizid 6mg tablet
Composition Each film coated tablet contains:
Tizanidine (as hydrochloride)………6mg
Diary No. Date of R& I & fee Dy. No.1975; 20-02-2017; Rs.20,000/- (20-02-2017)
Pharmacological Group Skeletal muscle relaxant
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price 1x10’s; As per SRO
Approval status of product in
Reference Regulatory Authorities
Could not be confirmed
Me-too status (with strength and
dosage form)
Could not be confirmed
GMP status GMP inspection conducted on 07-03-2017 concluded that
firm is working at satisfactory level of GMP compliance.
Remarks of the Evaluator E Evidence of approval of applied formulation in reference
agencies is required.
E Evidence of Me too of applied formulation is required.
Decision: Deferred for the following reasons:
Evidence of applied formulation/drug for generic / me-too status.
Evidence of approval of applied formulation in reference regulatory authorities/
agencies which were declared approved registration Board in its 275th
meeting.
5. Name and address of manufacturer /
Applicant
M/s. Caliph Pharmaceuticals, Plot No. 17, Special
Industrial Zone, Risalpur, Pakistan.
Brand Name +Dosage Form + Strength CP-Lium 10mg tablet
Composition Each film coated tablet contains:
Domperidone (as maleate)………10mg
Diary No. Date of R& I & fee Dy. No.1974; 20-02-2017; Rs.20,000/- (20-02-2017)
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 10
Pharmacological Group Anti-dopaminergic
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 5x10’s; As per SRO
Approval status of product in
Reference Regulatory Authorities
Approved in MHRA
Me-too status (with strength and
dosage form)
Omeprin Tablets 10 mg of Bio Labs (Pvt) Ltd
GMP status GMP inspection conducted on 07-03-2017 concluded that
firm is working at satisfactory level of GMP compliance.
Remarks of the Evaluator Applicant has claimed Manufacturer’s specifications but
applied formulation is not present in available BP.
Decision: Approved with B.P specifications.
6. Name and address of manufacturer /
Applicant
M/s. Nawan Laboratories (Pvt.) Ltd., 136, Sector 15,
Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Itowan tablet 50mg
Composition Each film coated tablet contains:
Itopride hydrochloride……….…………50mg
Diary No. Date of R& I & fee Dy. No.1077; 13-02-2017; Rs.20,000/- (10-02-2017)
Pharmacological Group Gastroprokinetic
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 10’s; As per DPC
Approval status of product in
Reference Regulatory Authorities
PMDA approved
Me-too status (with strength and
dosage form)
Ganaton 50mg tablet of Abbott
GMP status GMP inspection conducted on 26-09-2017 shows that
firm is operating at satisfactory level of GMP compliance.
Remarks of the Evaluator
Decision: Approved with Innovator’s Specifications.
7. Name and address of manufacturer /
Applicant
M/s. Nawan Laboratories (Pvt.) Ltd., 136, Sector 15,
Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Coxim tablet 30mg
Composition Each film coated tablet contains:
Etoricoxib……….…………30mg
Diary No. Date of R& I & fee Dy. No.1079; 13-02-2017; Rs.20,000/- (10-02-2017)
Pharmacological Group NSAID
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 10’s; As per DPC
Approval status of product in
Reference Regulatory Authorities
MHRA approved
Me-too status (with strength and
dosage form)
Not provided
GMP status GMP inspection conducted on 26-09-2017 shows that
firm is operating at satisfactory level of GMP compliance.
Remarks of the Evaluator Applicant has claimed Manufacturer’s specifications but
applied formulation is not present in available USP & BP.
Decision: Deferred for submission of evidence of applied formulation/drug for generic / me-too
status.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 11
8. Name and address of manufacturer /
Applicant
M/s. Nawan Laboratories (Pvt.) Ltd., 136, Sector 15,
Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Coxim tablet 60mg
Composition Each film coated tablet contains:
Etoricoxib……….…………60mg
Diary No. Date of R& I & fee Dy. No.1076; 13-02-2017; Rs.20,000/- (10-02-2017)
Pharmacological Group NSAID
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 10’s; As per DPC
Approval status of product in
Reference Regulatory Authorities
MHRA approved
Me-too status (with strength and
dosage form)
Oraxib 60mg tablet of M/s Atco Labs.
GMP status GMP inspection conducted on 26-09-2017 shows that
firm is operating at satisfactory level of GMP compliance.
Remarks of the Evaluator ● Applicant has claimed Manufacturer’s
specifications but applied formulation is not
present in available USP & BP.
Decision: Approved with innovator’s specifications.
9. Name and address of manufacturer /
Applicant
M/s. Aspin Pharma (Pvt.) Ltd., Plot # 10 & 25, Sector 20,
Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Benicort-F cream
Composition Each gram contains:
Betamethasone (as valerate)………1mg
Fusidic acid.………………………20mg
Diary No. Date of R& I & fee Dy. No.1474; 15-02-2017; Rs.20,000/- (15-02-2017)
Pharmacological Group Corticosteroids/ Antibacterial
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 5gm; As per DPC
Approval status of product in
Reference Regulatory Authorities
Fucibet cream (MHRA approved)
Me-too status (with strength and
dosage form)
Fucicort Leo cream of M/s Leonine Pharma
GMP status GMP Compliant; dated 18-8-2017
Remarks of the Evaluator ● Applicant has claimed manufacturer’s specifications
and applied formulation is not present in available USP
and BP.
● Firm has proposed following alternate brand names:
➢ Bactovate-F
➢ Betni-F
Decision: Approved with innovator’s specifications.
10. Name and address of manufacturer /
Applicant
M/s. Aspin Pharma (Pvt.) Ltd., Plot # 10 & 25, Sector 20,
Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Benicort-N ointment
Composition Each gram contains:
Betamethasone (as valerate)………1mg
Neomycin sulphate………………..5mg
Diary No. Date of R& I & fee Dy. No.1472; 15-02-2017; Rs.20,000/- (15-02-2017)
Pharmacological Group Corticosteroids/ Antibacterial
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 12
Pack size & Demanded Price 10gm; As per DPC
Approval status of product in
Reference Regulatory Authorities
MHRA approved
Me-too status (with strength and
dosage form)
Betnovate-N ointment of M/s GSK
GMP status GMP Compliant; dated 18-8-2017
Remarks of the Evaluator ● Applicant has claimed manufacturer’s specifications
and applied formulation is not present in available USP
and BP.
● Firm has proposed following alternate brand names:
➢ Bactovate-N
➢ Betni-N
Decision: Approved with innovator’s specifications.
11. Name and address of manufacturer /
Applicant
M/s. Aspin Pharma (Pvt.) Ltd., Plot # 10 & 25, Sector 20,
Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Benicort-N cream
Composition Each gram contains:
Betamethasone (as valerate)………1mg
Neomycin sulphate………………..5mg
Diary No. Date of R& I & fee Dy. No.1473; 15-02-2017; Rs.20,000/- (15-02-2017)
Pharmacological Group Corticosteroids/ Antibacterial
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 10gm; As per DPC
Approval status of product in
Reference Regulatory Authorities
MHRA approved
Me-too status (with strength and
dosage form)
Betnovate-N cream of M/s GSK
GMP status GMP Compliant; dated 18-8-2017
Remarks of the Evaluator ● Applicant has claimed manufacturer’s specifications
and applied formulation is not present in available USP
and BP.
● Firm has proposed following alternate brand names:
➢ Bactovate-N
➢ Betni-N
Decision: Approved with innovator’s specifications.
12. Name and address of manufacturer /
Applicant
M/s. Alza Pharmaceuticals, Al-Shifa Trust Eye Hospital,
Jehlum Road, Rawalpindi.
Brand Name +Dosage Form + Strength Vagicin 2% cream
Composition Each gram contains:
Clindamycin (as phosphate)………20mg
Diary No. Date of R& I & fee Dy. No.895; 22-09-2016; Rs.20,000/- (22-09-2016)
Pharmacological Group Antibacterial
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price 15gram; As per PRC
Approval status of product in
Reference Regulatory Authorities
Cleocin (USFDA approved)
Me-too status (with strength and
dosage form)
Clindanor 2% cream of M/S Nortech pharmaceuticals
GMP status GMP Compliant; dated 07-07-2017
Remarks of the Evaluator
Decision: Approved.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 13
13. Name and address of manufacturer /
Applicant
M/s Epharm Laboratories A-40, Road No.1, S.I.T.E., Super
Highway Industrial Area, North Karachi.
Brand Name +Dosage Form + Strength Ephastine-10mg tablet
Composition Each film coated tablet contains:
Ebastine ………….10mg
Diary No. Date of R& I & fee Dy. No.1284; 14-02-2017; Rs.20,000/- (14-02-2017)
Pharmacological Group Antihistamine
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 1x10’s and 2x10’s; As per SRO
Approval status of product in
Reference Regulatory Authorities
Kestin 10mg film coated tablets (ANSM approved)
Me-too status (with strength and
dosage form)
Histabid 10mg film coated tablets of M/s Platinum
Pharmaceuticals
GMP status Last GMP inspection conducted on 27-04-2017 and the
panel recommended the grant of GMP certificate.
Remarks of the Evaluator ● On clarification regarding submission of
accelerated stability studies data before production
firm submitted the following response:
“Submitted accelerated stability study is for small scale
trial batches however we will provide 06 months
accelerated and real time stability after production starts as
per submitted undertaking to conduct & submit stability
studies along with data as per guidelines/requirements
approved by the Registration Board.”
● Applicant has claimed manufacturer’s
specifications and applied formulation is not
present in available USP and BP.
Decision: Approved with innovator’s specifications.
14. Name and address of manufacturer /
Applicant
M/s Epharm Laboratories A-40, Road No.1, S.I.T.E., Super
Highway Industrial Area, North Karachi.
Brand Name +Dosage Form + Strength Roxin150mg tablet
Composition Each film coated tablet contains:
Roxithromycin ………….150mg
Diary No. Date of R& I & fee Dy. No.1282; 14-02-2017; Rs.20,000/- (14-02-2017)
Pharmacological Group Macrolide antibiotic
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 1x10’s; As per SRO
Approval status of product in
Reference Regulatory Authorities
Roximycin 150mg film coated tablet(TGA approved)
Me-too status (with strength and
dosage form)
Roxibiotic 150mg film coated tablet of M/s Alpine Pharma
GMP status Last GMP inspection conducted on 27-04-2017 and the
panel recommended the grant of GMP certificate.
Remarks of the Evaluator ● On clarification regarding submission of
accelerated stability studies data before production
firm submitted the following response:
“Submitted accelerated stability study is for small scale
trial batches however we will provide 06 months
accelerated and real time stability after production starts as
per submitted undertaking to conduct & submit stability
studies along with data as per guidelines/requirements
approved by the Registration Board.”
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 14
● Applicant has claimed manufacturer’s
specifications and applied formulation is not
present in available USP and BP.
Decision: Approved with innovator’s specifications.
15. Name and address of manufacturer /
Applicant
M/s Epharm Laboratories A-40, Road No.1, S.I.T.E., Super
Highway Industrial Area, North Karachi.
Brand Name +Dosage Form + Strength Des-Loratlax 5mg tablet
Composition Each film coated tablet contains:
Desloratadine ………….5mg
Diary No. Date of R& I & fee Dy. No.1285; 14-02-2017; Rs.20,000/- (14-02-2017)
Pharmacological Group Antihistamine
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 1x10’s and 2x10’s; As per SRO
Approval status of product in
Reference Regulatory Authorities
Clarinex 5mg film coated tablet (USFDA approved)
Me-too status (with strength and
dosage form)
Desdine 5mg film coated tablet of M/s Hygeia
Pharmaceuticals
GMP status Last GMP inspection conducted on 27-04-2017 and the
panel recommended the grant of GMP certificate.
Remarks of the Evaluator ● On clarification regarding submission of
accelerated stability studies data before production
firm submitted the following response:
“Submitted accelerated stability study is for small scale
trial batches however we will provide 06 months
accelerated and real time stability after production starts as
per submitted undertaking to conduct & submit stability
studies along with data as per guidelines/requirements
approved by the Registration Board.”
● Applicant has claimed manufacturer’s
specifications and applied formulation is not
present in available USP and BP.
Decision: Approved with innovator’s specifications.
16. Name and address of manufacturer /
Applicant
M/s Epharm Laboratories A-40, Road No.1, S.I.T.E., Super
Highway Industrial Area, North Karachi.
Brand Name +Dosage Form + Strength Iropharm-F tablet
Composition Each chewable tablet contains:
Elemental iron (as iron (III) hydroxide polymaltose
complex………...….100mg
Folic acid ………….0.35mg
Diary No. Date of R& I & fee Dy. No.1281; 14-02-2017; Rs.20,000/- (14-02-2017)
Pharmacological Group Haematinic
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 1x10’s, 2x10’s and 3x10’s; As per SRO
Approval status of product in
Reference Regulatory Authorities
Could not be confirmed.
Me-too status (with strength and
dosage form)
RBC-F chewable tablet of M/s Genix Pharma
GMP status Last GMP inspection conducted on 27-04-2017 and the
panel recommended the grant of GMP certificate.
Remarks of the Evaluator ● On clarification regarding submission of
accelerated stability studies data before production
firm submitted the following response:
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 15
“Submitted accelerated stability study is for small scale
trial batches however we will provide 06 months
accelerated and real time stability after production starts as
per submitted undertaking to conduct & submit stability
studies along with data as per guidelines/requirements
approved by the Registration Board.”
Decision: Approved.
17. Name and address of manufacturer /
Applicant
M/s Epharm Laboratories A-40, Road No.1, S.I.T.E., Super
Highway Industrial Area, North Karachi.
Brand Name +Dosage Form + Strength Ephacard 5mg tablet
Composition Each tablet contains:
Amlodipine (as besylate) ………….5mg
Diary No. Date of R& I & fee Dy. No.1286; 14-02-2017; Rs.20,000/- (14-02-2017)
Pharmacological Group Calcium antagonist
Type of Form Form-5
Finished product Specifications USP
Pack size & Demanded Price 2x10’s and 3x10’s; As per SRO
Approval status of product in
Reference Regulatory Authorities
Norvasc 5mg tablet (TGA, USFDA approved)
Me-too status (with strength and
dosage form)
Ampress tablets of M/s Barrett Hodgson Pakistan
GMP status Last GMP inspection conducted on 27-04-2017 and the
panel recommended the grant of GMP certificate.
Remarks of the Evaluator ● On clarification regarding submission of
accelerated stability studies data before production
firm submitted the following response:
“Submitted accelerated stability study is for small scale
trial batches however we will provide 06 months
accelerated and real time stability after production starts as
per submitted undertaking to conduct & submit stability
studies along with data as per guidelines/requirements
approved by the Registration Board.”
Decision: Approved.
18. Name and address of manufacturer /
Applicant
M/s Epharm Laboratories A-40, Road No.1, S.I.T.E., Super
Highway Industrial Area, North Karachi.
Brand Name +Dosage Form + Strength Clofen 100mg tablet
Composition Each film coated tablet contains:
Aceclofenac ………….100mg
Diary No. Date of R& I & fee Dy. No.1283; 14-02-2017; Rs.20,000/- (14-02-2017)
Pharmacological Group NSAID
Type of Form Form-5
Finished product Specifications Manufacturer’s specifications
Pack size & Demanded Price 1x10’s, 2x10’s and 3x10’s; As per SRO
Approval status of product in
Reference Regulatory Authorities
Preservex tablets (MHRA approved)
Me-too status (with strength and
dosage form)
Airtal of M/s Highnoon laboratories
GMP status Last GMP inspection conducted on 27-04-2017 and the
panel recommended the grant of GMP certificate.
Remarks of the Evaluator ● On clarification regarding submission of
accelerated stability studies data before production
firm submitted the following response:
“Submitted accelerated stability study is for small scale
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 16
trial batches however we will provide 06 months
accelerated and real time stability after production starts as
per submitted undertaking to conduct & submit stability
studies along with data as per guidelines/requirements
approved by the Registration Board.”
● Applicant has claimed manufacturer’s
specifications and applied formulation is not
present in available USP and BP.
Decision: Approved with innovator’s specifications.
19. Name and address of manufacturer /
Applicant
M/s. Welwrd Pharmaceuticals ,Plot No. 3, Block A,
Phase I-II, Industrial Estate, Hattar,
Brand Name+Dosage Form + Strength W-PentopTablet 40mg
Composition Each enteric coated tablet contains:
Pantoprazole as Sodium Sesquihydrate…..40mg
Diary No. Date of R& I & fee Dy. No. 593, 1-11-2016 , Rs.20,000/- (1-11-2016)
Pharmacological Group PPIs
Type of Form Form-5
Finished product Specification USP
Pack size & Demanded Price 7’s, As per SRO
Approval status of product in
Reference Regulatory Authorities.
Pantoprazole tablets by Rakeda
(MHRA Approved)
Me-too status APTIZOLE by Global Pharma
GMP status 14 June, 2017, GMP compliant.
Remarks of the Evaluator. ● Rs.20,000/- (15-02-2018) for change of formulation
from film coated to enteric coated tablet.
Decision: Approved.
20. Name and address of manufacturer /
Applicant
M/s. Wnsfield Pharmaceuticals ,Plot No. 122, Block
A, Phase V, Industrial Estate, Hattar,
Brand Name+Dosage Form + Strength Terbilet Cream 1 %
Composition Each tube contains
Terbinafine Hydrochloride….1%
Diary No. Date of R& I & fee Dy. No. 574, 26-10-2016 , Rs.20,000/- (24-10-2016)
Pharmacological Group Antifungal
Type of Form Form-5
Finished product Specification JP
Pack size & Demanded Price 5gm, 10gm, As per SRO
Approval status of product in
Reference Regulatory Authorities.
MHRA Approved
Me-too status Terbiderm Cream 1.0% by M/s Atco Laboratories
Limited (Reg#032004)
GMP status Date of inspection: 18-1-18
Purpose of inspection: renewal of DML
Conclusion: Recommended
Remarks of the Evaluator. ● Shelf life after opening: 1 month.
Decision: Approved.
21. Name and address of manufacturer /
Applicant
M/s. Welmark Pharmaceuticals ,Plot No.122, Block B,
Phase V, Industrial Estate, Hattar,
Brand Name+Dosage Form + Strength Muctein Sachet 100mg
Composition Each sachet contains :
Acetylcystein….100mg
Diary No. Date of R& I & fee Dy. No. 1986, 6-12-2016 , Rs.20,000/- (6-12-2016)
Pharmacological Group Expectorant
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 17
Type of Form Form-5
Finished product Specification Manufacturer Specs.
Pack size & Demanded Price 30’s As per SRO
Approval status of product in
Reference Regulatory Authorities.
Switzerland Approved
Me-too status Registration Number: 021175
Brand Name: Fluimucil 100mg/ 1gm Sachet
Manufacturer Name: Zambon Group SPA
Importer Name: Sanital Pharmaceutical
GMP status Date of inspection: 16-09-2017.
Purpose of inspection: Routine GMP
Conclusion: GMP complaint
Remarks of the Evaluator. .
Decision: Approved with innovator’s specifications.
22. Name and address of manufacturer /
Applicant
M/s. Welmark Pharmaceuticals ,Plot No.122, Block B,
Phase V, Industrial Estate, Hattar,
Brand Name+Dosage Form + Strength Markcol Sachet
Composition Each 13.8g sachet contains:
Polyethylene glycol…13.125 mg
Sodium Chloride…350.7 mg
Potassium Chloride…46.6mg
Sodium Bicarbonate…178.5mg
Diary No. Date of R& I & fee Dy. No. 508, 17-11-2016 , Rs.20,000/- (17-11-2016)
Pharmacological Group Laxative
Type of Form Form-5
Finished product Specification USP
Pack size & Demanded Price As per SRO
Approval status of product in
Reference Regulatory Authorities.
MHRA Approved
Me-too status Brand Name: Wivocol Sachet
Registration Number: 080543
Manufacturer Name: Winthrox Pharmaceuticals,
GMP status Date of inspection: 16-09-2017.
Purpose of inspection: Routine GMP
Conclusion: GMP complaint
Remarks of the Evaluator. .
Decision: Approved.
23. Name and address of manufacturer /
Applicant
M/s. Wellborne Pharmachem & Biological, Hattar.
Brand Name+Dosage Form+Strength Dulox 60 mg Capsule
Composition Each Capsule Contains:-
Enteric coated pellets of Duloxetine hydrochloride 17.65%
w/w…... eq. to Duloxetine ….…. 60 mg
Source of pellets: M/s Spansules Formulations, Telangana
state, India.
Diary No. Date of R& I & fee Dy.No. (R&I) 251, 20-7-2016; Rs.20,000/- (20-07-2016)
Rs. 80,000/- (08-02-2018)
Pharmacological Group Antidepressant
Type of Form Form-5
Finished product Specification USP
Pack size & Demanded Price As per policy
Approval status of product in
Reference Regulatory Authorities.
Approved by USFDA
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 18
Me-too status Dulan capsules of M/s Hilton Pharma (Pvt.) Limited
Karachi (Reg.# 055448)
GMP status Last inspection conducted on 27-02-2017“Strictly
following the GMP compliance.”
Remarks of the Evaluator.
Decision: Registration Board referred the case to QA & LT Division to conduct GMP
inspection of Firm on priority. The Board also directed the firm to change the brand name.
24. Name and address of manufacturer /
Applicant
M/s. Wellborne Pharmachem & Biological, Hattar.
Brand Name+Dosage Form+ Strength Dulox 20 mg Capsule
Composition Each Capsule Contains:-
Enteric coated pellets of Duloxetine hydrochloride 17.65%
w/w…... eq. to Duloxetine ….…. 20 mg
Source of pellets: M/s Spansules Formulations, Telangana
state, India.
Diary No. Date of R& I & fee Dy. No. (R&I) 250, 20-7-2016; Rs.20,000/- (20-07-2016)
Rs. 80,000/- (08-02-2018)
Pharmacological Group Antidepressant
Type of Form Form-5
Finished product Specification USP
Pack size & Demanded Price As per policy
Approval status of product in
Reference Regulatory Authorities.
Approved by USFDA
Me-too status Dulan capsules of M/s Hilton Pharma (Pvt.) Limited
Karachi (Reg.# 055446)
GMP status Last inspection conducted on 27-02-2017 “Strictly
following the GMP compliance.”
Remarks of the Evaluator.
Decision: Registration Board referred the case to QA & LT Division to conduct GMP
inspection of Firm on priority. The Board also directed the firm to change the brand name.
25. Name and address of manufacturer /
Applicant
M/s. Wellborne Pharmachem & Biological, Hattar.
Brand Name+Dosage Form+ Strength Dulox 30 mg Capsule
Composition Each Capsule Contains:-
Enteric coated pellets of Duloxetine hydrochloride 17.65%
w/w…... eq. to Duloxetine ….…. 30 mg
Source of pellets: M/s Spansules Formulations, Telangana
state, India.
Diary No. Date of R& I & fee Dy. No. (R&I) 249, 20-7-2016; Rs.20,000/- (20-07-2016)
Rs. 80,000/- (08-02-2018)
Pharmacological Group Antidepressant
Type of Form Form-5
Finished product Specification USP
Pack size & Demanded Price As per policy
Approval status of product in
Reference Regulatory Authorities.
Approved by USFDA
Me-too status Dulan capsules of M/s Hilton Pharma (Pvt.) Limited
Karachi (Reg.# 055447)
GMP status Last inspection conducted on 27-02-2017 “Strictly
following the GMP compliance.”
Remarks of the Evaluator.
Decision: Registration Board referred the case to QA & LT Division to conduct GMP
inspection of Firm on priority. The Board also directed the firm to change the brand name.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 19
S
#
#
.
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 of
the Evaluator
Decision
26. Ray Pharma
(Pvt) Ltd., S-58.
SITE Extension,
Hawksbay Road,
Karachi
SHELET Tablet
Each film coated
tablet contains:
Letrozole….2.5mg
(Non-Steroidal
aromatase inhibitor)
USP Specs
Form 5
Dy No. 1314
22-10-2012
PKR 8,000/-
(22-10-2012)
+
PKR 12,000/-
(22-10-2012)
30’s:
Rs.8500/-
Femara Tablets by
Novartis
(MHRA Approved)
Femara tablets by
Novartis
Last inspection report
dated 8-8-2017
confirms satisfactory
compliance to GMP
Approved.
27. Ray Pharma
(Pvt) Ltd., S-58.
SITE Extension,
Hawksbay Road,
Karachi
IVFer Injection
Each 5ml ampoule
contains:
Iron (as iron
sucrose)….100mg
(Anti anaemics)
BP Specs
Form 5
Dy No. 1313
22-10-2012
PKR 8,000/-
(22-10-2012)
+
PKR 12,000/-
(22-10-2012)
5ml x 5’s:
Rs.1400/-
Venofer Injection by
Vifor
(MHRA Approved)
Venofer injection by
Gastrocare
Last inspection report
dated 8-8-2017
confirms satisfactory
compliance to GMP
Approved
28. CSH
Pharmaceuticals,
North (Pvt) Ltd.,
38-A, Industrial
Estate,
Hayatabad,
Pshawar
PROLIFE 7.5mg
Tablet
Each film coated
tablet contains:
Ivabradine (as
hydrochloride)
….7.5mg
(Anti-anginal)
Form 5
Dy No. 1017
10-12-2012
PKR 20,000/-
(10-12-2012)
1 x 14’s:
Rs. 1150/-
Ivabradine 7.5mg
tablet by Teva UK
(MHRA Approved)
Sivab 7.5mg tablet
by Getz
Last inspection report
28-2-2017: No
observations by the
FID as per data
provided by QA
division
Registration
Board
referred the
case to QA &
LT Division
to conduct
GMP
inspection of
Firm on
priority
29. Al Fazal Pharma
Industries (Pvt)
Ltd., Plot No.
20-22, 16.5 Km,
Sheikhupura
Road Lahore
CECO CAPSULE
200mg
Each capsule
contains:
Celecoxib….200mg
(Cox-II inhibitor)
Form 5
23-5-2014
PKR 20,000/-
(23-05-2014)
(Duplicate)
15g: As per
SRO
Bioxcel 200mg
Genthon
(MHRA
Approved)
Nuzib capsule by
Bosch
Last GMP
inspection report
dated 25-10-2017
concludes “The
Approved
with
innovator’s
specification.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 20
firm need further
improvement
regarding
documentation,
SOP’s, validation
processes of
manufacturing/
QC. However
overall
upgradation
condition of firm
was satisfactory
30. Al Fazal Pharma
Industries (Pvt)
Ltd., Plot No.
20-22, 16.5 Km,
Sheikhupura
Road Lahore
E-THIN cream
Each grm cream
contains:
Eflornithine
hydrochloride……13
.9%
(Antiprotozoal)
Form 5
23-5-2014
PKR 20,000/-
(23-05-2014)
(Duplicate)
15g: As per
SRO
Vaniqa cream by
Skinmedica
(USFDA Approved)
Depilus cream by
Atco
Last GMP inspection
report dated
25-10-2017
concludes “The firm
need further
improvement
regarding
documentation,
SOP’s, validation
processes of
manufacturing/ QC.
However overall
upgradation
condition of firm was
satisfactory
Approved with
innovator’s
specification.
31. Al Fazal Pharma
Industries (Pvt)
Ltd., Plot No.
20-22, 16.5 Km,
Sheikhupura
Road Lahore
LORAMIDE
Capsule 2mg
Each capsule
contains:
Loperamide
hydrochloride….2mg
(Antipropulsive)
USP Specs
Form 5
23-5-2014
PKR 20,000/-
(23-05-2014)
(Duplicate)
30’s: As per
SRO
Diafix 2mg capsule
by Galpharm
(MHRA Approved)
Imodium capsule by
Johnson & Johnson
Last GMP inspection
report dated
25-10-2017
concludes “ The firm
need further
improvement
regarding
documentation,
SOP’s, validation
processes of
manufacturing/ QC.
However overall
upgradation
condition of firm was
satisfactory.
Approved.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 21
32. Al Fazal Pharma
Industries (Pvt)
Ltd., Plot No.
20-22, 16.5 Km,
Sheikhupura
Road Lahore
PROZINE SYRUP
Each 5ml contains:
Promethazine
hydrochloride
…..5mg
(antihistamine)
USP Specs
Form 5
23-5-2014
PKR 20,000/-
(23-05-2014)
(Duplicate)
60ml, 120ml:
As per SRO
Phenergan Elixir by
Sanofi
(MHRA Approved)
Phenergan elixir by
Sanofi
Last GMP inspection
report dated
25-10-2017
concludes “The firm
need further
improvement
regarding
documentation,
SOP’s, validation
processes of
manufacturing/ QC.
However overall
upgradation
condition of firm was
satisfactory
Approved.
33. Al Fazal
Pharma
Industries (Pvt)
Ltd., Plot No.
20-22, 16.5
Km,
Sheikhupura
Road Lahore
TRETIN
CREAM
Each gram
contains:
Tretinoin….0.05%
(Anti acne)
USP Specs
Form 5
23-5-2014
PKR 20,000/-
(23-05-2014)
(Duplicate)
15g: As per
SRO
(USFDA Approved)
0.05% cream
Tretinex cream by
Mass Pharma
Last GMP inspection
report dated
25-10-2017
concludes “ The firm
need further
improvement
regarding
documentation,
SOP’s, validation
processes of
manufacturing/ QC.
However overall
upgradation
condition of firm was
satisfactory
Approved.
34. Barrett Hodgson
Pakistan (Pvt)
Ltd., F/423,
SITE, Karachi
MalEra Sachet
40/240 mg
Each sachet contains:
Artemether….40mg
Lumefantrine….240
mg
(Antimalarial)
Form 5
Dy No. 270
21-3-2011
PKR 8,000/-
(21-3-2011)
8’s: Rs. 450/-
Could not be
confirmed
Could not be
confirmed
Last inspection
report dated 8-8-
2017 confirms
satisfactory
compliance to
GMP
Evidence of
approval in
reference
regulatory
authorities
could not be
confirmed.
Evidence of
me-too could
not be
confirmed.
Evidence of
12,000 fee
Registration
Board rejected
the application
as applied
formulation is
not approved
by any
reference
regulatory
authority and
firm has not
submitted
safety and
efficacy data.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 22
chalan dated
05‐09‐2013
could not be
confirmed.
80/480
sachet is
already
rejected in
258th
meeting of
Registration
Board
Case No. 02: Registration applications of import (Human) cases
35. Name and address of Applicant M/s M&M Pharma, 1
st Floor, opposite gate No. 2, Pepsi
Factory, Guru-mangat Road, Gulberg-II, Lahore Pakistan
Detail of Drug Sale License Address: 1st Floor Javaid Plaza Opposite Gate No. 2, Pepsi
Road Guru-mangat Road, Gulberg-II, Lahore
Validity: 22/07/2018
Status: License to sell drugs as a “Distributor”
Name and address of manufacturer M/s T.P. Drug Laboratories (1969) Co. Ltd., (Rama 2
Branch) 22 Bangkradee 30, Rama II Road Samaedam, Bang
KhunThian, Bangkok 10150, Thailand
Name and address of marketing
authorization holder
Same as above
Name of exporting country Thailand
Type of Form Form 5-A
Diary No. & Date of R& I Dy No. 2065: 9-5-2017
Fee including differential fee PKR 100,000/-: 3-5-2017
Brand Name +Dosage Form +
Strength
DEPTONE Solution for Injection 150mg
Composition Each ml contains:
Medroxyprogesterone acetate…….150mg
Finished Product Specification USP
Pharmacological Group Progestogens
Shelf life 3 Years along with real-time stability data
Demanded Price 7.50 USD
Pack size 1 x 25 ml vials
International availability Depo-Provera 150 mg/ml by Pfizer Limited (MHRA
Approved)
Me-too status Medroxy Depo Injection by Global Pharma
Detail of certificates attached CoPP:
Original, legalized CoPP (Certificate No. 2-2-10-3-16-00297)
issued by Thailand Food and Drug Administration dated 13th
July 2016 is provided by the firm which confirms free sale as
well as GMP status of the manufacturer.
● Firm has also submitted original legalized free sale
certificate valid till 12 July 2018
● Firm has also submitted original, legalized GMP certificate
Remarks of the Evaluator.
Decision: Approved as per Policy for inspection of Manufacturer abroad.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 23
Case No. 03: Registration applications of newly granted DML or New section (Human)
a. New/Additional section(s)
M/s. Akhai Pharmaceuticals Plot #A-248 & A-256 to A-259 H.I.T.E Lasbela, Balochistan, Pakistan
Previously considered molecules: 03
Tablet section( Psychotropic): Products:01, Molecules:01
36. Name and address of manufacturer /
Applicant
M/s. Akhai Pharmaceuticals Plot #A-248 & A-256 to A-
259 H.I.T.E Lasbela, Balochistan, Pakistan
Brand Name +Dosage Form + Strength Alpram 0.5mg tablet
Other suggested names:
Azpram 0.5mg tablet
Bupram 0.5mg tablet
Composition Each tablet contains:
Alprazolam………0.5mg
Diary No. Date of R& I & fee Dy. No.21757; 21-11-2017; Rs.20,000/- (21-11-2017)
Pharmacological Group Anti-depressant/Anxiolytic
Type of Form Form-5
Finished product Specifications USP specifications
Pack size & Demanded Price 10’s; As per SRO
Approval status of product in Reference
Regulatory Authorities
Approved in US-FDA
Me-too status (with strength and dosage
form)
Jibrone 0.5mg tablet of Martin Dow
GMP status GMP inspection conducted on 03-08-2017 concluded that
firm is operating at satisfactory level of GMP
compliance.
Remarks of the Evaluator
Decision: Approved.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 24
b. Deferred Cases
M/s Pharmasol (Pvt) Ltd.
Diluents and water for Injection (Human)
07 Products / 05 Molecules
Decision in 278th
meeting of Registration board held on 29-31st January, 2017 against above mentioned
section was ‘Deferred for confirmation whether manufacturing facility of “Diluents and water for Injection
(Human)” is approved for “Ampoules” or “Vials”.
Evaluation by PEC:
● Firm has responded via letter dated 13/02/2018 that it has facility for filling both ampoule and vials
which is mentioned in panel inspection report.
● Panel inspection report was checked and it was verified that section under consideration has facility to fill
both vials and ampoules.
37. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength PSOL Sterile water for injection 5ml
Diary No. Date of R& I & fee Diary No: 24154, 13-12-2017, Rs: 20,000/-
Composition Each Ampoule Contain
Sterile water for injection (as diluent)
Pharmacological Group Diluent/Solvent for Reconstitution
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 5ml ampoule/ As per SRO
Approval status of product in Reference
Regulatory Authorities.
Water for Injections by M/s Macarthys Laboratories Limited
(MHRA approved )
Me-too status Sterile water for injection 5ml by M/s Getz Pharma (Reg. No.
053041)
GMP status 13-07-2017/ Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator.
Decision: Approved.
38. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength PSOL Sterile water for injection 20ml
Diary No. Date of R& I & fee Diary No: 24155 ,13-12-2017 , Rs: 20,000/-
Composition Each Vial Contains:
Sterile water for injection….20ml
Pharmacological Group Diluent/Solvent for Reconstitution
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 1’s vial x 20ml / As per SRO
Approval status of product in Reference
Regulatory Authorities.
Water for Injections BP by M/s Hameln Pharmaceuticals
Limited (MHRA Approved)
Me-too status Sterile water for injection by Mendoza Pharma
(Reg.No.058646) 20ml
GMP status 13-07-2017/Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator.
Decision: Approved.
39. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength NSOL 0.9% W/V Solution for Injection
Diary No. Date of R& I & fee Diary No: 24156 , 13-12-2017 , Rs: 20,000/-
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 25
Composition Each ml contains:
Sodium chloride…9mg
Pharmacological Group Diluent/Solvent for Reconstitution
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 5ml ampoule/ As per SRO
Approval status of product in Reference
Regulatory Authorities.
Sodium Chloride Injection BP 0.9% w/v by M/s Hameln
pharmaceuticals limited (MHRA Approved)
Me-too status Sacro Injection (0.9%w/v) 5ml by M/s Macter (Reg#079756)
GMP status 13-07-2017
Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator.
Decision: Approved.
40. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Bensol(Bacteriostatic Water) for injection
Diary No. Date of R& I & fee Diary No: 24157 , 13-12-2017 , Rs: 20,000/-
Composition Each ml of sterile water contains:
Benzyl alcohol …….9mg
Pharmacological Group Diluent/Solvent for Reconstitution for methyl prednisolone
dry injection
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 1’s ampoule x 7.8ml/ As per SRO
Approval status of product in Reference
Regulatory Authorities.
Bacteriostatic Water for Injection by M/s Pfizer Limited
(MHRA Approved) (1 ml pre-filled syringe)
Me-too status Bacteriostatic water 7.8ml by M/s Upjohn (Reg#031265)
GMP status 13-07-2017/ Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator. ● Applied pack size of 7.8ml ampoule not confirmed from
Reference Regulatory Authorities.
Decision: Approved.
41. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength SBSOL Diluent (Bacteriostatic saline)
Diary No. Date of R& I & fee Diary No: 24158 , 13-12-2017 , Rs: 20,000/-
Composition Each ml contains:
Sodium chloride…9mg
Benzyl alcohol…9mg
Pharmacological Group Diluent
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 1ampoule x 5ml/ As per SRO
Approval status of product in Reference
Regulatory Authorities.
Bacteriostatic sodium chloride solution
Hospira (USA/EU)
Me-too status Bacteriostatic Sodium chloride Injection by M/s Spencer
Pharma (Reg#042113) (pack size not confirmed)
GMP status 13-07-2017
Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator. ● Applied pack size of 5ml ampoule not confirmed from
Reference Regulatory Authorities and me-too database.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 26
● Firm has not specified for which formulation/ product the
diluent will be used
Decision: Deferred for confirmation of drug product for which instant formulation/ product will
be used as diluent.
42. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Diluent For Dotaxol 20mg
Diary No. Date of R& I & fee Diary No: 24159 , 13-12-2017 , Rs: 20,000/-
Composition Each vial contains:
Ethanol 95%.…………..13%(V/V)
Water for Injection………..87%(V/V)
Pharmacological Group Diluent for docetaxel injection
Type of Form Form-5
Finished Product Specification Innovator's specifications
Pack size & Demanded Price 1’sx1.5ml / As per SRO
Approval status of product in Reference
Regulatory Authorities.
Taxotere solvent by Sanofi-Aventis (Canada Approved)
Me-too status Diluent for Meberexel 20mg by M/s CCL Pharmaceuticals
1.5ml (Reg#045609)
GMP status 13-07-2017 / Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator.
Decision: Deferredfor consideration along with applied drug products by the firm.
43. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Diluent For Dotaxol 80mg
Diary No. Date of R& I & fee Diary No: 24160 , 13-12-2017 , Rs: 20,000/-
Composition Each vial contains:
Ethanol 95%.BP…………..13%(V/V)
Water for Injection………..87%(V/V)
Pharmacological Group Diluent for docetaxel injection
Type of Form Form-5
Finished Product Specification Innovator's specifications
Pack size & Demanded Price 1’sx6ml / As per SRO
Approval status of product in Reference
Regulatory Authorities.
Taxotere solvent by Sanofi-Aventis (Canada Approved)
Me-too status Diluent for Meberexel 80mg by M/s CCL Pharmaceuticals
6ml (Reg#045607)
GMP status 13-07-2017/ Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator.
Decision: Deferred for consideration along with applied drug products by the firm.
Liquid Injection (General) (Human)
14 Products / 10 molecules
Decision in 278th
meeting of Registration board held on 29-31st January, 2017 against above mentioned
section was ‘Deferred for confirmation whether manufacturing facility of Liquid Injection (General)
(Human) is approved for “Small Volume Parenteral” or “Large Volume Parenteral”
Evaluation by PEC:
● Firm has responded via letter dated 13/02/2018 that it has 2 vial washing machines (one for large volume
vials and one for small volume vials) and one vial filling machine. The vial filling machine has ability to
fill both large volume vials and small volume vials.
● Firm has submitted broacher and import documents.
● Submitted import documents do not mention the model of machine used for filling.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 27
● According to import documents the ability of filling machine ranges from 2ml to 10ml and 100ml to
250ml.
● Panel inspection report was checked and it could not be verified that section under consideration has
facility to fill vials as both SVP and LVP.
44. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Typhoxcin Injection 200mg/100ml
Diary No. Date of R& I & fee Diary No: 24068, 13-12-2017 , Rs: 20,000/-
Composition Each 100ml vial contains:
Ofloxacin (as hydrochloride)...200mg
Pharmacological Group Quinolone Antibacterial
Type of Form Form-5
Finished Product Specification Innovator’s specifications
Pack size & Demanded Price 1'sx100ml/As per SRO
Approval status of product in Reference
Regulatory Authorities.
Tarivid IV Infusion Solution 2mg/ml by M/s Sanofi, MHRA
approved
Me-too status Tariflox Infusion 200mg/100ml by M/s Bosch (Reg#021506)
GMP status 13-07-2017/ Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator.
Decision: Deferred for Verification of capacity of vial filling machine for both LVP and SVP by
area FID.
45. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Ciproxol Infusion 200mg/100ml
Diary No. Date of R& I & fee Diary No: 24069, 13-12-2017, Rs: 20,000/-
Composition Each 100ml vial contains:
Ciprofloxacin (as lactate)…200mg
Pharmacological Group Quinolone Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 1'sx100ml/As per SRO
Approval status of product in Reference
Regulatory Authorities.
Ciprofloxacin 2 mg/ml solution for infusion by M/s
HikmaFarmacêutica (Portugal), S.A.(MHRA Approved)
Me-too status Qilox 200mg/100ml Infusion by M/s Bosch (Reg#073417)
GMP status 13-07-2017/ Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator.
Decision: Deferred for Verification of capacity of vial filling machine for both LVP and SVP by
area FID.
46. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Ciproxol Infusion 400mg/100ml
Diary No. Date of R& I & fee Diary No: 24070, 13-12-2017, Rs: 20,000/-
Composition Each 100ml vial contains:
Ciprofloxacin (as lactate)…400mg
Pharmacological Group Quinolone Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 1'sx100ml/As per SRO
Approval status of product in Reference
Regulatory Authorities.
Cipro IV 400mg Bayer healthcare Pharmaceuticals Inc. New
Jersey, USA (not confirmed)
Me-too status Novidat DS Injection 400mg/100ml by M/s Sami Phama
(Reg#042270)
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 28
GMP status 13-07-2017/ Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator. ● Approval status of product in Reference Regulatory
Authorities not confirmed.
Decision: Deferred for Verification of capacity of vial filling machine for both LVP and SVP by
area FID.
47. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Levoxol Infusion 500mg/100ml
Diary No. Date of R& I & fee Diary No: 24071, 13-12-2017, Rs: 20,000/-
Composition Each 100ml vial contains:
Levofloxacin (as hemihydrate)…500mg
Pharmacological Group Quinolone Antibacterial
Type of Form Form-5
Finished Product Specification Innovator’s specifications
Pack size & Demanded Price 1'sx100ml/As per SRO
Approval status of product in Reference
Regulatory Authorities.
Evoxil 5 mg/ml solution for infusion by M/s Beacon
Pharmaceuticals, (MHRA approved )
Me-too status Lorex Infusion 500mg/100ml by M/s Regal Pharmaceuticals
(Reg#081996)
GMP status 13-07-2017 / Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator.
Decision: Deferred for Verification of capacity of vial filling machine for both LVP and SVP by
area FID.
48. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Levoxol Infusion 750mg/150ml
Diary No. Date of R& I & fee Diary No: 24072, 13-12-2017 , Rs: 20,000/-
Composition Each 150ml of solution for infusion contains:
Levofloxacin (as hemihydrate)…750mg
Pharmacological Group Quinolone Antibacterial
Type of Form Form-5
Finished Product Specification Innovator’s specifications
Pack size & Demanded Price 1'sx150ml /As per SRO
Approval status of product in Reference
Regulatory Authorities.
Cravit IV by M/s Daiichi Sankyo, Japan (Pack size of 150ml
not confirmed from approved website of PMDA)
Me-too status Leflox 750mg/150ml Infusion By Getz Pharma (Reg.No.
058590),
GMP status 13-07-2017 / Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator. ● Pack size of 150ml and packaging of applied formulation
in vials not confirmed from RRA.
Decision: Deferred for Verification of capacity of vial filling machine for both LVP and SVP by
area FID.
49. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength M-Flox Infusion 400mg/250ml
Diary No. Date of R& I & fee Diary No: 24073, 13-12-2017 , Rs: 20,000/-
Composition Each 250ml contains:
Moxifloxacin (as hydrochloride)…400mg
Pharmacological Group Quinolone Antibacterial
Type of Form Form-5
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 29
Finished Product Specification Innovator’s specifications
Pack size & Demanded Price 1'sx250ml /As per SRO
Approval status of product in Reference
Regulatory Authorities.
Avelox 400 mg/250 ml solution for infusion by M/s Bayer
plc, (MHRA approved)
Me-too status Mofest Infusion 400mg/250ml by M/s Sami (Reg#053227)
GMP status 13-07-2017/ Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator. ● Confirmed as glass vial from MHRA
Decision: Deferred for Verification of capacity of vial filling machine for both LVP and SVP by
area FID.
50. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Linzol Infusion 200mg/100ml
Diary No. Date of R& I & fee Diary No: 24074, 13-12-2017 , Rs: 20,000/-
Composition Each 100ml solution for infusion contains:
Linezolid…200mg
Pharmacological Group Oxazolidone Antibiotic
Type of Form Form-5
Finished Product Specification Innovator’s specifications
Pack size & Demanded Price 1’sx100ml /As per SRO
Approval status of product in Reference
Regulatory Authorities.
ZYVOX linezolid 200mg/100mL injection infusion bag by
M/s Pfizer Australia Pty Ltd, (TGA approved.)
Me-too status Ecasil Infusion 200mg/100ml by M/s Sami (Reg#067516)
GMP status 13-07-2017 / Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator.
Decision: Deferred for Verification of capacity of vial filling machine for both LVP and SVP by
area FID.
51. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Linzol Infusion 600mg/300ml
Diary No. Date of R& I & fee Diary No: 24075, 13-12-2017 , Rs: 20,000/-
Composition Each 300ml solution for infusion contains:
Linezolid…600mg
Pharmacological Group Oxazolidone Antibiotic
Type of Form Form-5
Finished Product Specification Innovator’s specifications
Pack size & Demanded Price 1'sx300ml/As per SRO
Approval status of product in Reference
Regulatory Authorities.
Linezolid 2 mg/ml solution for infusion by M/s Pfizer
Limited , MHRA approved
Me-too status Zolrest Infusion 600mg/300ml by M/s Bosch (Reg#055916)
GMP status 13-07-2017/ Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator.
Decision: Deferred for Verification of capacity of vial filling machine for both LVP and SVP by
area FID.
52. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Linzol Infusion 400mg/200ml
Diary No. Date of R& I & fee Diary No: 24076, 13-12-2017 , Rs: 20,000/-
Composition Each 200ml solution for infusion contains:
Linezolid…400mg
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 30
Pharmacological Group Oxazolidone Antibiotic
Type of Form Form-5
Finished Product Specification Innovator’s specifications
Pack size & Demanded Price 1'sx200ml/As per SRO
Approval status of product in Reference
Regulatory Authorities.
ZYVOX linezolid 400mg/200mL injection infusion bag by
M/s Pfizer Australia Pty Ltd, TGA approved.
Me-too status Linolid Infusion 400mg/200ml by M/s Bio-Labs
(Reg#073088)
GMP status 13-07-2017/ Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator.
Decision: Deferred for Verification of capacity of vial filling machine for both LVP and SVP by
area FID.
53. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Parasol Infusion 1g/100ml
Diary No. Date of R& I & fee Diary No: 24077, 13-12-2017, Rs: 20,000/-
Composition Each 100ml contains:
Paracetamol…1000mg
Pharmacological Group Antipyretic/Analgesic
Type of Form Form-5
Finished Product Specification Innovator’s specifications
Pack size & Demanded Price 1's /As per SRO
Approval status of product in Reference
Regulatory Authorities.
PERFALGAN 10 mg/ml, solution for infusion by M/s
Bristol-Myers Squibb Pharmaceutical Limited, (MHRA
approved )
Me-too status Falgan Infusion 1000mg/100ml by M/s Bosch (Reg#055540)
GMP status 13-07-2017
Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator.
Decision: Deferred for Verification of capacity of vial filling machine for both LVP and SVP by
area FID.
54. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Konacane Infusion 200mg/100ml
Diary No. Date of R& I & fee Diary No: 24078 , 13-12-2017 , Rs: 20,000/-
Composition Each ml contains:
Fluconazole…2mg
Pharmacological Group Anti-Fungal
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 1'sx100ml/As per SRO
Approval status of product in Reference
Regulatory Authorities.
Diflucan 2 mg/ml solution for infusion by M/s Pfizer Limited
(MHRA Approved)
Me-too status Diflucan 2mg/ml IV infusion 50ml by M/s Pfizer (Reg.
No.011830), (pack size not same as of applied formulation.)
GMP status 13-07-2017
Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator. ● Confirmed as glass vial from MHRA
● Pack size of 100ml not confirmed from available me-too
database.
● Firm initially applied for 100ml pack size. When
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 31
communicated with shortcoming, firm replied that they
mistakenly wrote pack size 100ml instead of 50ml. Firm
has submitted revised form-5 and master formulation.
Decision: Deferred for Verification of capacity of vial filling machine for both LVP and SVP by
area FID.
55. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Diazole Injection 500mg/100ml
Diary No. Date of R& I & fee Diary No: 24079 , 13-12-2017 , Rs: 20,000/-
Composition Each 100ml contains:
Metronidazole…500mg
Pharmacological Group Imidazole derivatives/ Antibacterial
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 1'sx100ml/As per SRO
Approval status of product in Reference
Regulatory Authorities.
Metronidazole Braun 5 mg / ml solution for infusion b M/s
B. Braun Melsungen AG (Medical Products Agency, Sweden
Approved)
Me-too status Metrosol I.V Infusion 100ml by M/s Atlantic (Reg.No.
055042)
GMP status 13-07-2017
Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator.
Decision: Deferred for Verification of capacity of vial filling machine for both LVP and SVP by
area FID.
56. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Combifer Infusion 500mg/10ml
Diary No. Date of R& I & fee Diary No: 24080 , 13-12-2017 , Rs: 20,000/-
Composition Each 10ml vial contain:
Iron carboxymaltose complex eq.to Elemental Iron …500mg
Pharmacological Group Haematinic
Type of Form Form-5
Finished Product Specification Innovator’s specifications
Pack size & Demanded Price 1'sx10ml/As per SRO
Approval status of product in Reference
Regulatory Authorities.
Ferinject 50 mg iron/mL solution for injection/infusion. By
M/s Vifor France (MHRA approved)
Me-too status Ferinject 500mg/10ml by M/s RG. Pharmaceuticals
(Reg#072548)
GMP status 13-07-2017 / Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator. ● Confirmed as 2ml, 10 ml and 20ml vial in MHRA, UK.
Decision: Deferred for Verification of capacity of vial filling machine for both LVP and SVP by
area FID.
57. Name and address of manufacturer /
Applicant
M/s Pharmasol (Pvt) Ltd. Plot No. 549, Sundar Industrial
Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Tirosol Injection 12. 5mg/50ml
Diary No. Date of R& I & fee Diary No: 24081, 13-12-2017, Rs: 20,000/-
Composition Each ml contains
Tirofiban (as hydrochloride monohydrate)…0.25mg
Pharmacological Group Antithrombotic agents (Platelet aggregation inhibitors excl.
heparin)
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 32
Type of Form Form-5
Finished Product Specification Innovator’s specifications
Pack size & Demanded Price 1'sx50ml/As per SRO
Approval status of product in Reference
Regulatory Authorities.
AGGRASTAT (250 micrograms/ml) concentrate for solution
for infusion 50ml vial by M/s Correvio (UK) Ltd (MHRA
Approved)
Me-too status Aggrastat Injection 0.25mg/ml 50ml vial by M/s Atco Labs
(Reg#025299),
GMP status 13-07-2017/ Grant of new DML,
Panel recommends grant of new DML.
Remarks of the Evaluator.
Decision: Deferred for Verification of capacity of vial filling machine for both LVP and SVP by
area FID
58. Name and address of manufacturer /
Applicant
M/s Genetics Pharmaceuticals Pvt Ltd. Plot#539-A, Sunder
Industrial Estate, Lahore.
Brand Name +Dosage Form + Strength Dobalta 20mg Capsule
Diary No. Date of R& I & fee Each capsule contains:
Duloxetine as hydrochloride (enteric coated pellets
20%)…20mg
Composition Diary No: 416, 17/11/2016, Rs. 20,000/-
Pharmacological Group SSRI
Type of Form Form 5
Finished Product Specification USP
Pack size & Demanded Price 10’s,14’s,20’s,28’s / As per SRO
Approval status of product in Reference
Regulatory Authorities.
Cymbalta (Duloxetine Delayed-Release Capsules) 20mg by
M/s Eli Lilly, (USFDA Approved)
Me-too status D-Lex DR 20 mg Capsule by M/s Ciba Pharmaceuticals,
Karachi. (Reg#081577)
GMP status New DML granted 25/8/16
Previous Remarks of the Evaluator.
● Source of pellets RA Chem Pharma Ltd, India., (Plot#
A-19/C, Road No. 18, Nacharam, Hyderabad – 500076,
Telangana, INDIA)
● GMP certificate of pellet source valid till 23-03-18
● Proof of approval of pellets from Relevant Regulatory
Authority is provided.
Decision in previous meeting 274th Meeting Registration Board held on 21-23
rd
September, 2017.
Deferred for submission of differential fee for imported
pellets.
Evaluation by PEC
● Firm has submitted evidence of submission differential fee for imported pellets of by providing
yellow copy of fee challan of Rs. 80,000/-
(Challan no. 0580838
Ref: TT163570RD8K)
Verified from Statistical Department.
● Furthermore, when firm was asked to furnish latest inspection report conducted within 1 year, the
firm replied:
‘Dobalta 20mg Capsule is submitted in DRAP on 9th November, 2016 and was deferred in 274
th DRB
meeting dated 21-22nd
September, 2017 for verification of challan of pellets and PEC has further raised
a query regarding latest GMP inspection report of our manufacturing facility i.e. Genetics
Pharmaceuticals Pvt Ltd. Located at Plot#539-A, Sunder Industrial Estate, Lahore.
We would like to submit as under;
DRAP has conducted inspection of our new manufacturing facility on 15th June, 2016 and issued us
DML on 25th August, 2016 which is valid for 05 years till 24-08-2021. So far we have not yet started
manufacturing at our plant as we are in process of receiving registrations of products i.e. 10 molecules
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 33
per section. Also we are procuring their raw materials and products are under trial for product
development and stability studies and we will soon start commercial manufacturing.
As we are applying for new registrations, the evaluation cell of DRAP has raised a query regarding
GMP inspection report plus we are unable to get registration letters of our products approved in DRB
meetings.
We assure you that we will have GMP inspection of our manufacturing plant as soon as we will start
manufacturing of products.
Therefore in view of the above we request you to please consider DML till GMP inspection can be
done, so that we can get registration of products to be manufactured at our newly manufactured
facility.’
● However, it was confirmed from R-V section that M/s Genetics Pharmaceuticals Pvt Ltd. Located
at Plot#539-A, Sunder Industrial Estate, Lahore was issued products registration letter in March,
2017.
Decision in previous meeting 277th Meeting of Registration Board held on 27-29
th
December, 2017.
Registration Board referred the case to QA & LT Division
to conduct GMP inspection of Firm on priority.
Evaluation by PEC:
● A letter was forwarded by Area FID, Lahore with letter No.2090/2018-DRAP(L-I) dated 12-2-2018
with subject ‘Inspection of M/s Genetics Pharmaceuticals (Pvt) Ltd. Lahore’. The letter read.
‘Inspection of M/s Genetics Pharmaceuticals (Pvt) Ltd. Lahore was conducted on 05-01-2018
to verify GMP compliance status of the firm for grant of registration of products. The firm has
developed following sections to manufacture drugs by way of formulation:
I.) Tablet Section (General)
II.) Capsule Section (General)
The firm was granted DML on 25-08-2016. The firm has not started manufacturing at their
plant till date. No production activity was being carried out in production area at the time of inspection.
However, the trial batches of Monilor 4mg Tablet and Trampol Tablet were being manufactured in
R&D section of the firm.
The GMP compliance status of the firm could not be verified because the firm was not
operational at the time of production. However, the premise was found well maintained and at a
satisfactory level of sanitation SOPs were also available.’
Decision: Approved.
59. Name and address of Manufacturer /
Applicant
M/s Palpex FD-46-A8, ST-1Sector 38, Korangi Creek
Industrial Park, Karachi.
Brand Name+DosageForm+Strength Palsonate Injection 30mg IV
Composition Each vial contains:-
Artesunate…. 30mg
Diary No. Date of R&I & fee Dy No.22346; 28-11-2017; Rs.20,000/-
Pharmacological Group Antimalarial
Type of Form Form-5
Finished Product Specification International Pharmacopoeia Specifications
Pack Size & Demanded Price As per SRO
Approval status of product in
Reference Regulatory Authorities
WHO recommended formulation
Me-too status Gen-M by Genix Pharma
GMP status New License (Inspection Date: 14th April 2017)
Remarks of Evaluator Applicant was asked to provide justification of submitted
stability studies that how you have performed stability
studies of applied formulation before issuance of DML. The
applicant instead of providing justification has provided
stability studies of applied formulation after issuance of
DML.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 34
Previous Decision Registration Board in its 277th meeting deferred the case for
clarification/justification of following observation:
● How & where the firm has performed stability studies of
applied formulation before issuance of DML?
The firm may submit its response either in writing or may
appear before the Board to clarify its position.
Evaluation by PEC Firm has submitted that we had attached stability study data
by mistake in the registration dossier of trial batches which
were only prepared for training purpose of staff. Sorry for
including in dossier of registration.
We can further explain in person.
Decision: Registration Board deliberated the matter in detail and considering the fact that since
applied formulation is Me-too/Generic for which manufacturer will conduct stability study
before sale of drug product, thus Board Approved the case.
60. Name and address of Manufacturer /
Applicant
M/s Palpex FD-46-A8, ST-1Sector 38, Korangi Creek
Industrial Park, Karachi.
Brand Name+DosageForm+Strength Palsonate Injection 60mg IV
Composition Each vial contains:-
Artesunate…. 60mg
Diary No. Date of R&I & fee Dy No.22347; 28-11-2017; Rs.20,000/-
Pharmacological Group Antimalarial
Type of Form Form-5
Finished Product Specification International Pharmacopoeia Specifications
Pack Size & Demanded Price As per SRO
Approval status of product in
Reference Regulatory Authorities
WHO recommended formulation
Me-too status Gen-M by Genix Pharma
GMP status New License (Inspection Date: 14th April 2017)
Remarks of Evaluator Applicant was asked to provide justification of submitted
stability studies that how you have performed stability
studies of applied formulation before issuance of DML. The
applicant instead of providing justification has provided
stability studies of applied formulation after issuance of
DML.
Previous Decision Registration Board in its 277th meeting deferred the case for
clarification/justification of following observation:
● How & where the firm has performed stability studies of
applied formulation before issuance of DML?
The firm may submit its response either in writing or may
appear before the Board to clarify its position.
Evaluation by PEC Firm has submitted that we had attached stability study data
by mistake in the registration dossier of trial batches which
were only prepared for training purpose of staff. Sorry for
including in dossier of registration.
We can further explain in person.
Decision: Registration Board deliberated the matter in detail and considering the fact that since
applied formulation is Me-too/Generic for which manufacturer will conduct stability study
before sale of drug product, thus Board Approved the case.
61. Name and address of Manufacturer /
Applicant
M/s Palpex FD-46-A8, ST-1Sector 38, Korangi Creek
Industrial Park, Karachi.
Brand Name+Dosage Form+Strength Palsonate Injection 120mg IV
Composition Each vial contains:-
Artesunate…. 120mg
Diary No. Date of R&I & fee Dy No.22348; 28-11-2017; Rs.20,000/-
Pharmacological Group Antimalarial
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 35
Type of Form Form-5
Finished Product Specification International Pharmacopoeia Specifications
Pack Size & Demanded Price As per SRO
Approval status of product in
Reference Regulatory Authorities
WHO recommended formulation
Me-too status Gen-M by Genix Pharma
GMP status New License (Inspection Date: 14th April 2017)
Remarks of Evaluator Applicant was asked to provide justification of submitted
stability studies that how you have performed stability
studies of applied formulation before issuance of DML. The
applicant instead of providing justification has provided
stability studies of applied formulation after issuance of
DML.
Previous Decision Registration Board in its 277th meeting deferred the case for
clarification/justification of following observation:
How & where the firm has performed stability studies of
applied formulation before issuance of DML?
The firm may submit its response either in writing or may
appear before the Board to clarify its position.
Evaluation by PEC Firm has submitted that we had attached stability study data
by mistake in the registration dossier of trial batches which
were only prepared for training purpose of staff. Sorry for
including in dossier of registration.
We can further explain in person.
Decision: Registration Board deliberated the matter in detail and considering the fact that since
applied formulation is Me-too/Generic for which manufacturer will conduct stability study
before sale of drug product, thus Board Approved the case.
62. Name and address of Manufacturer /
Applicant
M/s Palpex FD-46-A8, ST-1Sector 38, Korangi Creek
Industrial Park, Karachi.
Brand Name+Dosage Form+Strength Palzidime Injection 250 mg IV/IM
Composition Each vial contains
Ceftazidime (as pentahydrate)...…250 mg
Diary No. Date of R&I & fee Dy. No.12302; 28-11-2017; Rs.20,000/-
Pharmacological Group cephalosporin, Antibiotics
Type of Form Form-5
Finished Product Specification USP specifications
Pack Size & Demanded Price As per SRO
Approval status of product in
Reference Regulatory Authorities
Fortum 250 mg of GSK Ltd. UK (MHRA,USFDA)
Me-too status Vegazid 250mg Injection of Vega Pharmaceuticals
GMP status New License (Inspection Date: 14th April 2017)
Remarks of evaluator Applicant was asked to provide justification of submitted
stability studies that how you have performed stability
studies of applied formulation before issuance of DML. The
applicant instead of providing justification has provided
stability studies of applied formulation after issuance of
DML.
Previous Decision Registration Board in its 277th meeting deferred the case for
clarification/justification of following observation:
● How & where the firm has performed stability studies of
applied formulation before issuance of DML?
The firm may submit its response either in writing or may
appear before the Board to clarify its position.
Evaluation by PEC Firm has submitted that we had attached stability study data
by mistake in the registration dossier of trial batches which
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 36
were only prepared for training purpose of staff. Sorry for
including in dossier of registration.
We can further explain in person.
Decision: Registration Board deliberated the matter in detail and considering the fact that since
applied formulation is Me-too/Generic for which manufacturer will conduct stability study
before sale of drug product, thus Board Approved the case.
63. Name and address of Manufacturer /
Applicant
M/s Palpex FD-46-A8, ST-1Sector 38, Korangi Creek
Industrial Park, Karachi.
Brand Name+Dosage Form+Strength Palzidime Injection 500 mg IV/IM
Composition Ceftazidime (as pentahydrate)...…500 mg
Diary No. Date of R&I & fee Dy No.22341; 28-11-2017; Rs.20,000/-
Pharmacological Group Cephalosporins, Antibiotics
Type of Form Form-5
Finished Product Specification USP specifications
Pack Size & Demanded Price As per SRO
Approval status of product in
Reference Regulatory Authorities
Fortum 500 mg of GSK Ltd. UK (MHRA)
Me-too status Vegazid 500mg Injection of Vega Pharmaceuticals
GMP status New License (Inspection Date: 14th April 2017)
Remarks of Evaluator Applicant was asked to provide justification of submitted
stability studies that how you have performed stability
studies of applied formulation before issuance of DML. The
applicant instead of providing justification has provided
stability studies of applied formulation after issuance of
DML.
Previous Decision Registration Board in its 277th meeting deferred the case for
clarification/justification of following observation:
● How & where the firm has performed stability studies of
applied formulation before issuance of DML?
The firm may submit its response either in writing or may
appear before the Board to clarify its position.
Evaluation by PEC Firm has submitted that we had attached stability study data
by mistake in the registration dossier of trial batches which
were only prepared for training purpose of staff. Sorry for
including in dossier of registration.
We can further explain in person.
Decision: Registration Board deliberated the matter in detail and considering the fact that since
applied formulation is Me-too/Generic for which manufacturer will conduct stability study
before sale of drug product, thus Board Approved the case.
64. Name and address of Manufacturer /
Applicant
M/s Palpex FD-46-A8, ST-1Sector 38, Korangi Creek
Industrial Park, Karachi.
Brand Name+Dosage Form+Strength Palzidime Injection 1gm IV/IM
Composition Ceftazidime (as pentahydrate)...…1gm
Diary No. Date of R&I & fee Dy No.22342; 28-11-2017; Rs.20,000/-
Pharmacological Group Cephalosporin, Antibiotics
Type of Form Form-5
Finished Product Specification USP specifications
Pack Size & Demanded Price As per SRO
Approval status of product in
Reference Regulatory Authorities
Fortum 1 g of GSK Ltd. UK (MHRA)
Me-too status Vegazid 1g Injection of Vega Pharmaceuticals
GMP status New License (Inspection Date: 14th April 2017)
Remarks of Evaluator Applicant was asked to provide justification of submitted
stability studies that how you have performed stability
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 37
studies of applied formulation before issuance of DML. The
applicant instead of providing justification has provided
stability studies of applied formulation after issuance of
DML.
Previous Decision Registration Board in its 277th meeting deferred the case for
clarification/justification of following observation:
● How & where the firm has performed stability studies of
applied formulation before issuance of DML?
The firm may submit its response either in writing or may
appear before the Board to clarify its position.
Evaluation by PEC Firm has submitted that we had attached stability study data
by mistake in the registration dossier of trial batches which
were only prepared for training purpose of staff. Sorry for
including in dossier of registration.
We can further explain in person.
Decision: Registration Board deliberated the matter in detail and considering the fact that since
applied formulation is Me-too/Generic for which manufacturer will conduct stability study
before sale of drug product, thus Board Approved the case.
65. Name and address of manufacturer /
Applicant
M/s Palpex FD-46-A8, ST-1Sector 38, Korangi Creek
Industrial Park, Karachi.
Brand Name +Dosage Form + Strength Bactopal 2g injection.
Diary No. Date of R& I & fee Dy No. 22344, 25-11-2017, Rs.20,000/-
Composition Each vial contains:-
Cefoperazone as sodium ….1000mg
Sulbactum as sodium… 1000mg
Pharmacological Group Antibiotics ( Cephalosporin)
Type of Form Form-5
Finished Product Specification Manufacturer’s Specs.
Pack size & Demanded Price As per SRO
Approval status of product in Reference
Regulatory Authorities.
Approved in Europe (Poland, Slovakia, Czech Republic)
by EMA
Me-too status SUFZONE by Global Pharmaceuticals.
GMP status New License (Inspection Date: 14th April 2017)
Remarks of the Evaluator. Applied formulation is present in JP
Previous Decision Registration Board in its 277th meeting deferred the case
for clarification/justification of following observation:
● How & where the firm has performed stability
studies of applied formulation before issuance of DML?
The firm may submit its response either in writing or may
appear before the Board to clarify its position.
Evaluation by PEC Firm has submitted that we had attached stability study
data by mistake in the registration dossier of trial batches
which were only prepared for training purpose of staff.
Sorry for including in dossier of registration.
We can further explain in person.
Decision: Registration Board deliberated the matter in detail and considering the fact that since
applied formulation is Me-too/Generic for which manufacturer will conduct stability study before sale
of drug product, thus Board Approved the case.
66. Name and address of manufacturer /
Applicant
M/s Palpex FD-46-A8, ST-1Sector 38, Korangi Creek
Industrial Park, Karachi.
Brand Name+Dosage Form + Strength Bactopal 1g injection
Diary No. Date of R& I & fee Dy No. 3224, 13-04-2017, Rs.20,000/-
Composition Each vial contains:-
Cefoperazone as sodium ….500mg
Sulbactum as sodium… 500mg
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 38
Pharmacological Group Antibiotics ( Cephalosporin)
Type of Form Form-5
Finished Product Specification Manufacturer’s Specs.
Pack size & Demanded Price As per SRO
Approval status of product in
Reference Regulatory Authorities.
Approved in PMDA
Me-too status SUFZONE by Global Pharmaceuticals.
GMP status New License (Inspection Date: 14th April 2017)
Remarks of the Evaluator. Applied formulation is present in JP
Previous Decision Registration Board in its 277th meeting deferred the case
for clarification/justification of following observation:
● How & where the firm has performed stability
studies of applied formulation before issuance of DML?
The firm may submit its response either in writing or may
appear before the Board to clarify its position.
Evaluation by PEC Firm has submitted that we had attached stability study
data by mistake in the registration dossier of trial batches
which were only prepared for training purpose of staff.
Sorry for including in dossier of registration.
We can further explain in person.
Decision: Registration Board deliberated the matter in detail and considering the fact that since
applied formulation is Me-too/Generic for which manufacturer will conduct stability study before sale
of drug product, thus Board Approved the case.
Case No. 04: Deferred cases of previous meetings (Human)
67. Name and address of manufacturer /
Applicant
M/s Medisynth Pharmaceuticals, Plot No. 55, Street No. S-
5, National Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Strength Tirasynth 500mg tablets
Composition Each film coated tablet contains:
Levetiracetam……….500mg
Diary No. Date of R& I & fee Dy.No.1028;(13-02-2017);Rs.20,000/-(13-02-2017)
Pharmacological Group Antiepileptic
Type of Form Form-5
Finished product Specification USP
Pack size & Demanded Price 3x10’s; As fixed by MoH
Approval status of product in Reference
Regulatory Authorities.
Keppra (USFDA approved)
Me-too status Eppra of M/s Global Pharma
GMP status Last GMP inspection conducted on 19-09-2017 and the
report concludes that the firm is operating at fair level of
GMP compliance.
Previous remarks of the Evaluator. Original fee challan for Tirasynth 500mg capsules is
attached instead of Tirasynth 500mg tablets.
Previous decision(s) Deferred in 278th meeting for evidence of fee submitted for
applied formulation
Evaluation by PEC The submission of firm has been verified from original fee
challan (Deposit slip No.0555214) dated 13-02-2017.
Decision: Approved
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 39
68. Name and address of manufacturer /
Applicant
Medisynth Pharmaceuticals, Plot # 55, Street No. S-5,
National Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Strength Synmol Tablet
Composition Each sustained release tablet contains:
Tramadol…….37.5mg
Paracetamol……325 mg
Diary No. Date of R& I & fee Dy. No.3435; 21-12-2016; Rs.20,000/- (19-12-2016)
Pharmacological Group Opiate analogue + Analgesic.
Type of Form Form-5
Finished product Specification USP
Pack size & Demanded Price As per SRO
Approval status of product in Reference
Regulatory Authorities.
Ultra Cet by Janssen pharma (USFDA)
Me-too status Acetra by Amarant
GMP status Last inspection report conducted on 19-09-2017 &
concluded satisfactory GMP compliance status.
Previous remarks of the Evaluator.
Previous decision(s) Deferred in 278th meeting for clarification of applied
dosage form as reference product is not approved as
sustained release tablet.
Evaluation by PEC The composition of immediate release film coated tablet
has been verified from master formulation of applied
product. The correct formulation is as under:
Each Film Coated tablet contains:
Tramadol…….37.5mg
Paracetamol……325 mg
Decision: Approved.
69. Name and address of manufacturer /
Applicant
M/s Medizan laboratories (pvt) Ltd. Plot 313, industrial
triangle Kahuta road, Islamabad
Brand Name +Dosage Form + Strength Tamsulim 0.4 mg Tablets
Composition Each capsule contains:-
TamsulosinHCl…………..0.4mg
Diary No. Date of R& I & fee Dy.No. 984, 10-1-2017, Rs.20,000/=
Pharmacological Group alpha-blocker
Type of Form Form-5
Finished product Specification USP
Pack size & Demanded Price 20’s; As Per SRO
Approval status of product in Reference
Regulatory Authorities.
Flomax of BoehringerIngelheim
Me-too status Alfamax of Platinum Pharmaceuticals
GMP status Last GMP Inspection conducted on 20-11-17 with
conclusive remarks of acceptable level of cGMP.
Previous remarks of the Evaluator.
Previous decision(s) Deferred in 277th meeting for source of pellets, along with
stability studies data, GMP certificate of supplier and
differential fee in case of import of pellets.
Evaluation by PEC Source of pellets (TamsulosinHCl SR pellets 0.2%):
Vision Pharma
The firm has submitted GMP of manufacturer (valid till
21-02-2018), COA of pellets, Stability studies of three
batches.
Decision: Approved.
70. DELETED Due to repetition.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 40
71. Name and address of manufacturer /
Applicant
M/s. Sharex Labs, Sadiqabad
Brand Name +Dosage Form + Strength Cetirex Tablet
Composition Each tablet contains:
Cetirizine Dihydrochloride (B.P) ..…. 10mg
Diary No. Date of R& I & fee Dairy No. 103 dated 08.01.2013 Rs:20,000/-
Pharmacological Group Antihistaminic & Anti Allergic)
Type of Form Form-5
Finished product Specification USP
Pack size & Demanded Price Rs. 42/ 10 Tabs
Approval status of product in Reference
Regulatory Authorities.
Approved by MHRA of UK
Me-too status Serzine of M/s Qintar Pharmaceuticals. (Reg.# 030644)
GMP status
Previous remarks of the Evaluator. Deferred in 258th meeting for following:
Commitment as per 251st meeting of RB is required. Shelf
life is 3 years mentioned by the firm whereas 2 years are
allowed by the Board. Availability is SRA is not provided
Previous decision(s) Deferred in 261th meeting for rectification of
shortcomings
Evaluation by PEC ● Following reference for applied formulation has been
verified:
“Cetec 10 mg film-coated tablets of M/s Bristol
Laboratories Ltd, approved by MHRA of UK”
● USP monograph is available for applied formulation.
● Commitments as per 251st meeting have been
declared as conditions of registration letter by
Registration Board.
Decision: Approved with USP specifications.
72. Name and address of manufacturer /
Applicant
M/s. Sharex Labs, Sadiqabad
Brand Name +Dosage Form + Strength Pedisal Liquid
Composition Each 500ml contains:
Sodium Chloride….1.750g
Sodium citrate….1.450g
Potassium Chloride…..0.750g
Glucose……10g
Diary No. Date of R& I & fee Dy. No: 2695 Dated 11.10.2011, Rs. 8,000/-
29.05.2014, Rs. 12,000/-
Pharmacological Group Electrolyte Replenisher
Type of Form Form-5
Finished product Specification Manufacturer
Pack size & Demanded Price Rs. 80/500ml
Approval status of product in Reference
Regulatory Authorities.
WHO recommended Standard ORS formulation
Me-too status Pedia Fresh Liquid of M/s Fozan Pharmaceuticals
Industries (Pvt.) Ltd. (Reg.# 064266)
GMP status GMP inspection dated 29-03-2017 concluding satisfactory
GMP compliant status
Previous remarks of the Evaluator. Deferred in 261st meeting for the submission of following
i. Inspection report
ii. Commitment as per decision of board
iii. Finished product specification is incomplete.
iv. Fee Rs. 8000/- and 12000/- is Photocopy
v. Approval status in reference country and Pakistan
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 41
Previous decision(s) Deferred in 261th meeting for rectification of
shortcomings
Evaluation by PEC Following reference The applied formulation is WHO
recommended standard ORS formulation and me-too
status has also been verified.
Decision: Registration Board deferred the case for confirmation whether applied formulation is
preservative free or not. Moreover evidence of sterilization facility for applied formulation shall
also be submitted.
73. Name and address of manufacturer /
Applicant
M/s. Sharex Labs, Sadiqabad
Brand Name +Dosage Form + Strength Cynoplex Injection
Composition Each 2ml contains:-
Vitamin B1 BP ….. 10mg
Vitamin B2 BP ….. 2mg
Vitamin B6 BP ….. 5mg
Nicotinamide BP …. 75mg
Dexpanthanol BP ….. 5mg
Diary No. Date of R& I & fee Dy# 3271 (08-3-2011); Rs.8,000/- Form-5 Dy #1087
(29.05.2014) Rs. 12,000/- (14-03-2013)
Pharmacological Group Vitamin
Type of Form Form-5
Finished product Specification --
Pack size & Demanded Price Pack size / 2ml x 25s Rs. 90/-
Approval status of product in Reference
Regulatory Authorities.
--
Me-too status Amroplex injection of M/s Amros, Karachi
(Reg.#042164)
GMP status GMP inspection dated 29-03-2017 concluding satisfactory
GMP compliant status
Previous remarks of the Evaluator. Deferred in 261st meeting for the submission of following
i. Inspection report
ii. Commitment as per decision of board
iii. Finished product specification are incomplete.
iv. Fee Rs. 8000/- and 12000/- is Photocopy
v.Approval status in reference country and Pakistan
Previous decision(s) Deferred in 264th meeting for review of formulation and
evidence of submission of Fee of Rs.12,000/-
Evaluation by PEC ● The applied formulation is approved in Austria with
slight different composition. (MultiVit B-Forte
injection) as under:
“Each 2ml ampoule contains
Vitamin B1 … 11mg
Vitamin B2 … 3.8mg
Vitamin B6 … 5mg
Nicotinamide 110mg
Dexpanthenol … 6 mg
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies as approved by the Registration Board in its 275th
meeting as submitted
reference is of different composition.
74. Name and address of manufacturer /
Applicant
M/s. Sharex Labs, Sadiqabad
Brand Name +Dosage Form + Strength RT-FAST Plus Suspension
Composition Each 5ml suspension (when reconstituted) contains:
Artemether…..15mg
Lumifantrine….90mg
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 42
Diary No. Date of R& I & fee Dy. No: 7853 dated 23-08-10 Rs.8,000/- dated 23-08-10
Rs.12,000/- dated 28-08-13
Pharmacological Group Antimalarial
Type of Form Form-5
Finished product Specification IP
Pack size & Demanded Price Rs. 200/ pack of 60ml
Approval status of product in Reference
Regulatory Authorities.
WHO recommended formulation
Me-too status Artem of Hilton Pharma Karachi
GMP status GMP inspection dated 29-03-2017 concluding satisfactory
GMP compliant status
Previous remarks of the Evaluator.
Previous decision(s) Rejected in 258th meeting as the firm does not possess
oral dry powder section.
Evaluation by PEC Firm has referred to inspection report of DML renewal
dated 11-05-2016 in which it is mentioned that the firm
do possess Sachet/powder/Dry powder suspension
Section.
Also the recommendation from panel also mentions
renewal of License for manufacturing by way of
formulation for following sections which include
Sachet/powder/Dry powder Section.
The case is placed before the Board for review of
previous decision.
Decision: Registration Boar referred the case to Licensing Division for confirmation of approved
manufacturing facility of “Dry powder suspension Section (general)”.
75. Name and address of manufacturer /
Applicant
M/s. Sharex Labs, Sadiqabad
Brand Name +Dosage Form + Strength Pyodex Solution 10%
Composition Each 100ml contains:-
Iodinated povidone 10gm eq to iodine 1gm
Diary No. Date of R& I & fee Dy# 3539 16-03-2011 Rs. 8,000/- Form 5
Dy #1084 29-05-2014
Pharmacological Group Antiseptic
Type of Form Form-5
Finished product Specification USP
Pack size & Demanded Price As per SRO
Approval status of product in Reference
Regulatory Authorities.
MHRA approved Betadine
Me-too status Septinil 10% Antiseptic Solution of M/s Valor
Pharmaceuticals (Reg.# 031107)
GMP status GMP inspection dated 29-03-2017 concluding satisfactory
GMP compliant status
Previous remarks of the Evaluator.
Previous decision(s) Deferred in 264th meeting for confirmation of required
manufacturing facility/section
Evaluation by PEC Firm has referred to inspection report dated 08-05-2008 in
which it is mentioned that the firm do possess Topical
preparation section.
Moreover firm has referred to their two already registered
products:
Curittoothace drops (Reg.# 007871)
Sharexol Solution (Reg.# 025122)
Decision: Approved with change of brand name.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 43
76. Name and address of manufacturer /
Applicant
M/s. Sharex Labs, Sadiqabad
Brand Name +Dosage Form + Strength Pyrofen Plus Tablet
Composition Each tablet contains:-
Codeine Phosphate ……. 20mg
Ibuprofen …………… 200mg
Diary No. Date of R& I & fee Dairy No. 104 dated 08.01.2013 Rs:20,000/-
Pharmacological Group Analgesic
Type of Form Form-5
Finished product Specification Manufacturer
Pack size & Demanded Price Rs. 108/ 36 Tabs
Approval status of product in Reference
Regulatory Authorities.
--
Me-too status Brucodin Tablets of M/s Abbott Labs, Karachi (Reg.#
044415)
GMP status GMP inspection dated 29-03-2017 concluding satisfactory
GMP compliant status
Previous remarks of the Evaluator.
Previous decision(s) Deferred in 261st meeting for the confirmation of approval
status by reference regulatory authorities and
manufacturing section of the firm.
Evaluation by PEC Firm has referred already registered product of M/s Abbot
Labs. Of similar composition.
Moreover the applied combination is available in Sweden
with following strength:
Each tablet contains:-
Codeine Phosphate ……. 30mg
Ibuprofen …………… 200mg
Firm has approved tablet General section.
Decision: Deferred for following:
i. Evidence of approval of required manufacturing facility of “Tablet Section (psychotropic)
ii. Evidence of approval of applied formulation in reference regulatory authorities/agencies as
approved by the Registration Board in its 275th
meeting.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 44
Sr.
No
Name and
address of
manufactur
er /
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
Approval
status in
Reference
regulatory
agencies /
authorities
Me-too status/
GMP status
Previous
Decisions
Evaluation by
PEC
77. M/s
PharmEvo
(Pvt)Ltd,
Plot#A-
29,North
Western
Industrial
Zone, Port
Qasim,
Karachi-
75020
Cinap 1mg Tablet
Film coated Tablet
Each film coated
tablet contains:
Cinitapride….1mg
Antiulcer agent.
(Manufacturers
Specs)
Form5
14-5-2014
Dy.No.738
Routine
Rs.20,000/-
Rs. 500/10’s
Rs.1500/30’s
Rs.2500/50’s
Approved in
Spanish
Agency of
Medicines
and Health
Products
Cinic tablet
of Fynk
Pharma
(Reg #
074446)
GMP
inspection
conducted on
23-02-2018
and the report
concludes
that the firm
was
considered to
be operating
at an
acceptable
level of
compliance
with GMP
standards.
Deferred as
formulation is
under review as
per decision of
250th DRB
meeting(M-262)
Deferred in
277th meeting
for the
following
submission:
Change in
formulation to
uncoated tablet
as per the
reference
product in
Spain.
Fee for change
of formulation
Clarification of
salt form of API
of the product
since the
reference
product contains
Cinitapride as
acid tartarate.
The firm has
submitted
formulation
to uncoated
tablet as per
the reference
product in
Spain.
Fee challan
of
Rs.20,000/-
(Deposit slip
No.0702679)
dated
16-2-2018
for change of
formulation
The firm has
clarified salt
form of API
“Cinitapride
as acid
tartrate”.
Decision: Approved with innovator’s specifications
78. M/s
PharmEvo
(Pvt)Ltd,
Plot#A-
29,North
Western
Industrial
Zone, Port
Qasim,
Karachi-
75020
Cinap Syrup
Each 5ml contains:
Cinitapride….1mg
Antiulcer agnet.
(Manufacturer’s
Specifications)
Form5
14-5-2014
Dy.No.429
Routine 733
Rs.20,000/-
Rs.600/120ml
Approved in
Spanish
Agency of
Medicines
and Health
Products
Gutt oral
solution of
Global
pharma (Reg.
#075278)
GMP
inspection
conducted on
23-02-2018
and the report
concludes
Deferred as
formulation is
under review as
per 250th DRB
meeting(M-262)
Deferred in
277th meeting
for the
following
submission:
Change in
formulation to
oral solution as
per the reference
product in
Spain.
The firm has
submitted
revised
formulation
to oral
solution as
per the
reference
product in
Spain.
Fee challan
of Rs.
20,000/-
(Deposit slip
No.0702680)
dated
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 45
that the firm
was
considered to
be operating
at an
acceptable
level of
compliance
with GMP
standards.
Fee for change
of formulation.
Clarification of
salt form of API
of the product
since the
reference
product contains
Cinitapride as
acid tartarate
16.2.2018 for
change of
formulation
The firm has
clarified salt
form of API
“Cinitapride
as acid
tartrate”.
Decision: Approved with innovator’s specifications
79. M/s GT
Pharma
(Pvt) Ltd,
Lahore
GT-CIP 250mg Dry
Powder Suspension
Each 5ml
reconstituted
suspension
Contains
Ciprofloxacin taste
masked granules
35% eq to
Ciprofloxacin
……..250mg
Quinolones
(Manufacturer’s
Specification)
Source of pellets
M/s Vision
Pharmaceuticals,
Kahuta Road
Islamabad
Form 5
Rs. 20,000/-
vide
Dy. No. 2691
dated 11-12-
2015
Pack size of
1 x 30ml as
per
price fixed by
Government
Ciproxin
250mg/5ml
Granules
and solvent
for oral
suspension
(MHRA
approved)
Quash
suspension
250mg of
Wilshire
Pharma (Reg
# 071192)
Inspection
conducted
on 8-8-2017,
the firm was
granted
GMP
certificate.
Registration Board
deferred in 256th
meeting the
application and
advised to follow
master formulation
of innovator brand
which consist of
granules of
ciprofloxacin base
and a diluent as per
innovator’s
composition.
Registration Board
in 269th
approved the
formulation
and solvent
for oral
suspension as
per reference
product
approved by
USFDA and
MHRA.
Decision: Approved with innovator’s specifications.
80. M/s GT
Pharma
(Pvt) Ltd,
Lahore
GT-CIP 500mg
Dry
Powder Suspension
Each 5ml Contains
Ciprofloxacin taste
masked granules
35% eq to
Ciprofloxacin
…….500mg
Quinolones
(Manufacture
Specification)
Source of pellets–
M/s Vision
Pharmaceuticals,
Kahuta Road,
Islamabad
Quinolones
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide
Dy. No. 2688
dated 11-12-
2015
Pack size of
1 x 60ml as
per
price fixed by
Government
Ciproxin
(USFDA)
Quash
suspension
500mg of
Wilshire
Pharma (Reg
# 071193)
Inspection
conducted
on 8-8-2017,
the firm was
granted
GMP
certificate.
Registration Board
deferred in 256th
meeting the
application and
advised to follow
master formulation
of innovator brand
which consist of
granules of
ciprofloxacin base
and a diluent as per
innovator’s
composition.
Registration
Board in 269th
approved the
formulation
and solvent for
oral
suspension as
per reference
product
approved by
USFDA and
MHRA.
Decision: Approved with innovator’s specifications
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 46
Case No. 05: Deferred Cases of Previous Meetings (Veterinary).
i. Cases of M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd., 21-KM, Ferozpur
Road, Lahore.
The CLB in its 248th
meeting held on 13th
July, 2016 has considered and approved the grant
of two additional sections of firm M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd., Lahore
(Drug Manufacturing License No. 000478-formulation) as under:
● Veterinary Dry powder (General)
● Veterinary Dry powder (General Antibiotic)
Now, the firm has applied for registration of 10 molecules in Veterinary Dry Powder
(General) and 10 molecules in Veterinary Dry powder (General Antibiotic).
Veterinary Dry powder (General)
81. Name and address of manufacturer /
Applicant
M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd., 21-KM,
Ferozpur Road, Lahore.
Brand Name +Dosage Form + Strength FrusaMore Oral Powder
Diary No. Date of R& I & fee 2012, 20-02-2017, 20,000/-, 20-02-2017
Composition Each 100gm contains:-
Frusemide……………….…..…2%
Belladonna Extract…………....0.2%
Pharmacological Group Flusher
Type of Form Form-5
Finished Product Specification In-house
Pack size & Demanded Price 10gm, 30gm,50gm,100gm,500gm,1000gm,5000gm;
Decontrolled
Approval status of product in
Reference Regulatory Authorities.
N/A
Me-too status Not provided by the firm.
GMP status Inspection Report dated 06-07-2016 showed good intention
to improve further.
Remarks of the Evaluator. ● The firm did not submit me-too reference.
● Information regarding dosage of applied product for
different animal species is not clearly mentioned.
● The firm did not mention reference of finished product
specifications whether Pharmacopoeial or non-
pharmacopoeial.
Previous decision Deferred in 272nd
meeting for following reasons:
1. Evidence of me-too reference,
3. Evidence of reference of finished product specifications,
4. Submission of GMP inspection report conducted within a
period of 1 year.
5. Formulation is required to be reviewed.
Evaluation by PEC The submitted me-too reference “Lexi-Fursikon Powder
of Lexicon Pharma (Reg # 041275)” has been verified.
● GMP inspection on 12-12-2017 concluded that at the
time of visit, the different areas of the premises found
clean and maintained. HVAC was also installed in the
sections and functional. No production activity was
observed at the time of visit.
● The firm has corrected enclosures of Form-5.
Decision: Deferred for following;
Clarification of source of Belladonna extract
Rationale of hydroalcoholic extract in veterinary practice.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 47
82. Name and address of manufacturer /
Applicant
M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd., 21-KM,
Ferozpur Road, Lahore.
Brand Name +Dosage Form + Strength Morenovan Water Soluble Powder
Diary No. Date of R& I & fee 2004, 20-02-2017, 20,000/-, 20-02-2017
Composition Each 100g contains:-
Trichlorfon………...……..98gm
Pharmacological Group Ectoparasidal
Type of Form Form-5
Finished Product Specification In-house
Pack size & Demanded Price 100g, 500g, 1Kg, Box of 4 ×250g; Decontrolled
Approval status of product in
Reference Regulatory Authorities.
N/A
Me-too status Tagafon Powder of Star laboratories
GMP status Inspection Report dated 06-07-2016 showed good intention
to improve further.
Remarks of the Evaluator. ● The submitted me-too reference is of different
strengths/compositions.
● Information regarding dosage of applied product for
different animal species is not clearly mentioned.
● The firm did not mention reference of finished product
specifications whether Pharmacopoeial or non-
pharmacopoeial.
Previous decision Deferred in 272nd
meeting for following reasons:
1. Evidence of me-too reference,
2. Clarification of dosage of applied product for different
animal species,
3. Evidence of reference of finished product specifications,
4. Submission of GMP inspection report conducted within a
period of 1 year.
Evaluation by PEC The submitted me-too reference “Trichlor WSP of Alina
Combine Pharma (Reg # 052334)” has been verified.
● GMP inspection on 12-12-2017 concluded that at the
time of visit, the different areas of the premises found
clean and maintained. HVAC was also installed in the
sections and functional. No production activity was
observed at the time of visit.
● The firm has corrected enclosures of Form-5.
Decision: Approved with innovator’s specifications.
83. Name and address of manufacturer /
Applicant
M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd.,21-KM,
Ferozpur Road, Lahore.
Brand Name +Dosage Form + Strength Ampromore-60 Water Soluble Powder
Composition Each 100gm contains:-
Amprolium hydrochloride…………..60gm
Diary No. Date of R& I & fee 3816, 19-04-2017, 20,000/-
Pharmacological Group Anti-coccidial
Type of Form Form-5
Finished Product Specification In-house specifications
Pack size & Demanded Price 100g, 500g, 1000g, Sachet/ Jar; Decontrolled
Approval status of product in
Reference Regulatory Authorities.
N/A
Me-too status Amprolirex powder of Kaaz International;
Amproval of Symoms pharmaceuticals;
Medi AM of Medi Vet;
SB Amprol of SB Pharma
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 48
GMP status Inspection Report dated 06-07-2016 showed good intention
to improve further.
Remarks of the Evaluator. ● The submitted me-too references are of different
strengths.
● Information regarding dosage of applied product for
different animal species is not clearly mentioned.
● The firm did not mention reference of finished product
specifications whether Pharmacopoeial or non-
Pharmacopoeial.
● GMP inspection report is not within the period of 1 year.
Previous decision Deferred in 272nd
meeting for following reasons:
1. Evidence of me-too reference,
2. Clarification of dosage of applied product for different
animal species,
3. Evidence of reference of finished product specifications,
4. Submission of GMP inspection report conducted within a
period of 1 year.
Evaluation by PEC ● GMP inspection on 12-12-2017 concluded that at the
time of visit, the different areas of the premises found
clean and maintained. HVAC was also installed in the
sections and functional. No production activity was
observed at the time of visit.
● The submitted me-too reference “Ampro-60 WSP of
M/s. Decent Pharma (Reg # 079825)” has been verified.
● Target animal species are poultry, turkey and rabbits.
Decision: Approved with innovator’s specifications.
Veterinary Dry powder (General Antibiotic)
84. Name and address of manufacturer /
Applicant
M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd.,
21-KM, Ferozpur Road, Lahore.
Brand Name +Dosage Form + Strength CT More Water Soluble Powder
Diary No. Date of R& I & fee 2007, 20-02-2017, 20,000/-, 20-02-2017
Composition Each 100g contains:-
Chlortetracycline hydrochloride….……………20gm
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification In-house
Pack size & Demanded Price 100g, 500g, 1000gm jar containers of HDPE; Decontrolled
Approval status of product in
Reference Regulatory Authorities.
N/A
Me-too status CTC Mont WSP of Westmont Pharmaceuticals
GMP status Inspection Report dated 06-07-2016 showed good intention
to improve further.
Remarks of the Evaluator. ● The firm has not revised the Form-5 as different active
ingredients were mentioned under enclosure of chemical
name of Form-5.
● Undertaking of Form-5 is not signed.
● The outline of method of manufacture contains active
ingredients other than applied composition.
● Information regarding dosage of applied product for
different animal species is not mentioned.
● The firm did not mention reference of finished product
specifications whether Pharmacopoeial or non-
pharmacopoeial.
● GMP inspection report is not within the period of 1 year.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 49
Previous decision Deferred in 272nd
meeting for following reasons:
1. Revision of Form-5 as different active ingredients were
mentioned under enclosure of chemical name of Form-5.
2. Signature of applicant on Form-5,
3. The outline of method of manufacture contains active
ingredients other than applied composition,
4. Clarification of dosage of applied product for different
animal species,
5. Evidence of reference of finished product specifications,
6. Submission of GMP inspection report conducted within a
period of 1 year.
Evaluation by PEC ● The me-too reference “Chlore-20 Powder of Nawan
Laboratories (Reg # 026416)” for applied formulation
has been verified.
● GMP inspection on 12-12-2017 concluded that at the
time of visit, the different areas of the premises found
clean and maintained. HVAC was also installed in the
sections and functional. No production activity was
observed at the time of visit.
● The firm has corrected enclosures of Form-5.
Decision: Approved with innovator’s specifications.
85. Name and address of manufacturer /
Applicant
M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd.,21-KM,
Ferozpur Road, Lahore.
Brand Name +Dosage Form + Strength Lincomix 4.4 Feed Premix
Diary No. Date of R& I & fee 2008, 20-02-2017, 20,000/-
Composition Each 100gm contains:-
Lincomycin hydrochloride……..……..4.4gm
Pharmacological Group Antibiotic/Antibacterial
Type of Form Form-5
Finished Product Specification In-house specifications
Pack size & Demanded Price 10gm, 30gm,50gm,100gm,500gm,1000gm,5000gm;
Decontrolled
Approval status of product in
Reference Regulatory Authorities.
N/A
Me-too status Licocen 44 of Mustfa Bros;
Lincovet Premix of Medi-Vet (pvt), Ltd;
Linco GP of Jfrin pharmaceuticals
GMP status Inspection Report dated 06-07-2016 showed good intention
to improve further.
Remarks of the Evaluator. ● The submitted me-too references are of different
strengths /compositions.
● Information regarding dosage of applied product for
different animal species is not clearly mentioned.
● The firm did not mention reference of finished product
specifications whether Pharmacopoeial or non-
pharmacopoeial.
● GMP inspection report is not within the period of 1 year.
Previous Decision Deferred in 272nd
meeting for following reasons:
1. Evidence of me-too reference,
2. Clarification of dosage of applied product for different
animal species,
3. Evidence of reference of finished product specifications,
4. Submission of GMP inspection report conducted within a
period of 1 year.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 50
Evaluation ● The firm has submitted me-too reference “Lincos-P
Powder of A & K Pharma (Reg # 049667)” has been
verified.
● GMP inspection on 12-12-2017 concluded that at the
time of visit, the different areas of the premises found
clean and maintained. HVAC was also installed in the
sections and functional. No production activity was
observed at the time of visit.
● The firm has corrected enclosures of Form-5.
Decision: Approved with innovator’s specifications.
86. Name and address of manufacturer /
Applicant
M/s. Moreno Iglisias Research Laboratories (Pvt) Ltd.,21-KM,
Ferozpur Road, Lahore.
Brand Name +Dosage Form + Strength Neomore-72 Water Soluble Powder
Diary No. Date of R& I & fee 2009, 20-02-2017, 20,000/-
Composition Each 100g contains:-
Neomycin Sulphate…………..….72gm
Pharmacological Group Antibacterial
Type of Form Form-5
Finished Product Specification The firm has claimed manufacturer’s specifications.
Pack size & Demanded Price 100g, 500g, 1Kg, Box of 4 ×250g; Decontrolled
Approval status of product in
Reference Regulatory Authorities.
Not provided by the firm.
Me-too status Neomix WSP of Ghazi Brothers
GMP status Inspection Report dated 06-07-2016 showed good intention
to improve further.
Remarks of the Evaluator. ● The name of applied product is different in different
parts of Form-5. The firm did not revise Form-5.
● Form-5 undertaking is not signed.
● The submitted me-too reference could not be found in
available database of DRAP.
● Information regarding dosage of applied product for
different animal species is not clearly mentioned.
● The firm did not mention reference of finished product
specifications whether Pharmacopoeial or non-
pharmacopoeial.
● GMP inspection report is not within the period of 1 year.
Previous decision Deferred in 272nd
meeting for following reasons:
1. Revision of Form-5 as the name of applied product is
different in different parts/enclosures of Form-5,
2. Signature of applicant on Form-5,
3. Evidence of me-too reference,
4. Clarification of dosage of applied product for different
animal species,
5. Evidence of reference of finished product specifications,
6. Submission of GMP inspection report conducted within a
period of 1 year.
Evaluation by PEC ● The firm has submitted signed Form-5.
● The submitted me-too reference “72% Neomycin
Powder of M/s. Mallard Pharma (Reg # 069635)” has
been verified.
● GMP inspection on 12-12-2017 concluded that at the
time of visit, the different areas of the premises found
clean and maintained. HVAC was also installed in the
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 51
sections and functional. No production activity was
observed at the time of visit.
● The firm has corrected enclosures of Form-5.
Decision: Approved with innovator’s specifications.
Case No. 06: Verification of Stability Study Data.
Verification of Authenticity of Stability Data (Dexia 30mg, 60mg capsules-Dexlansoprazole)
M/s Ferozesons Laboratories Ltd, Amangarh, Nowshera Khyber Pakhtunkhwa – 02 Products
Background:
Registration Board in its 277th Meeting decided to constitute the following panel for onsite investigation to
confirm genuineness/ authenticity of stability data and associated documents, import of API, quality,
specification, test analysis, facilities etc. of above 02 Products of M/s Ferozesons Laboratories Ltd,
Amangarh, Nowshera Khyber Pakhtunkhwa.
● Mr. Abid Hayat Director DTL, Peshawar
● Mr. FarhadUllah Assistant Director DRAP Peshawar
● Syed Adnan Ali Shah Assistant Director PE & R, Islamabad
Details of Investigation:
Sr.# Description Observation by panel
1.
Do you have documents confirming the
import of Dexlansoprazole API?
Firm has documents confirming the import of
Dexlansoprazole modified release pellets 22.5%
(Batch No. DEXPDA-0050-006) from M/s. RA Chem
Pharma Limited India along with approval by DRAP
for import.
2.
What was the rationale behind selecting the
particular manufacturer of API?
The firm has informed that they have selected the
manufacturer (i.e M/s RA Chem Pharma Limited
India) on the basis of its GMP compliance and
provision of stability studies of Dexlansoprazole
modified release pellets 22.5%.
3.
Do you have documents confirming the
import of Dexlansoprazole reference
standard and impurity standards?
Firm has documents confirming the import of
Dexlansoprazole reference standard from M/s. RA
Chem Pharma Limited India whereas impurities
standard import from M/s. Chromachemie Laboratory
Pvt. Ltd India.
4. Do you have certificate of Analysis of the
API, reference standards and impurity
standards?
Firm has certificate of analysis of API and reference
standard.
5. Do you have any approval of API or GMP
certificate of API manufacturer issued by
regulatory authority of country of origin?
Firm has provided copy of GMP certificate issued by
Drugs Control Administration (Telangana), India
6. Do you use API manufacturer method of
testing?
The firm has used API manufacturer’s method of
testing for carrying out tests of API.
7. Do you have stability studies reports on
API?
The firm has real time and accelerated stability study
data sheets provided by the API manufacturer.
8. If yes, whether the stability testing has been
performed as per SIM method and
degradation products have been quantified?
The stability studies have been performed as per SIM
method and the degradation products have been
quantified.
9. Do you have method for quantifying the
impurities in the API?
The firm has used the method provided by API
manufacturer for quantification of impurities.
10. Do you have some remaining quantities of
the API, its reference standard and
impurities standards?
The firm don’t have remaining quantities of the API &
reference standard. However, some quantities of
impurity standards were available.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 52
11. Have you used pharmaceutical grade
excipients?
Not applicable.
Since firm has imported pellets which were filled in
the capsules without using any excipients.
12. Do you have documents confirming the
import of the used excipients?
Not applicable.
Since firm has imported pellets which were filled in
the capsules without using any excipients.
13. Do you have test reports and other records
on the excipients used?
Not applicable.
14. Do you have written and authorized
protocols for the development of
Dexlansoprazole capsules?
The firm has written and authorized protocols for the
development of Dexia 30mg and 60mg capsules.
15. Have you performed Drug-excipient
compatibility studies? Not applicable.
16. Whether firm has performed comparative
dissolution studies?
Firm has performed comparative dissolution profile
against Dexilant Capsule of M/s. Takeda.
17.
Do you have product development (R&D)
section
The firm has product development (R&D) section with
requisite manufacturing facilities. However,
development of trial batches of Dexia capsules was
performed in production area as R&D section is
established recently.
18. Do you have necessary equipments
available in product development section
for development of Dexlansoprazole
capsules?
The firm has all the necessary equipment in product
development section. However, development of Dexia
capsule was performed in production area.
19. Are the equipments in product
development section qualified?
The equipments used in the product development
section were qualified.
20. Do you have proper maintenance /
calibration / re-qualification program for
the equipment used in PD section?
The firm has proper maintenance and calibration for
the equipments used in product development.
21. Do you have qualified staff in product
development section with proper
knowledge and training in product
development?
Firm has qualified staff with proper knowledge in
product development.
22. Have you manufactured three stability
batches for the stability studies of
Dexlansoprazole capsules as required?
The firm has manufactured three stability batches for
the stability studies of Dexia 30mg & 60mg capsules.
23. What was the criteria for fixing the batch
size of stability batches?
Firm has informed that criteria approved in 251st
meeting of DRB were followed for fixation of batch
size of the stability batches.
24. Do you have complete record of production
of stability batches?
The firm has complete batch manufacturing record of
all the batches of Dexia 30mg & 60mg capsules.
25. Do you have protocols for stability testing
of stability batches?
Firm has protocols for stability testing of the stability
batches.
26. Do you have developed and validated the
method for testing of stability batches?
The firm has developed and validated the method for
the testing of Dexia 30mg & 60mg capsules.
27. Do you have method transfer studies in
case when the method of testing being used
by your firm is given by any other lab?
The firm has not conducted method transfer studies;
however, they have validated their method.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 53
28. Do you have documents confirming the
qualification of equipments / instruments
being used in the test and analysis of
Dexlansoprazole API and the finished
drug?
Firm has complete record of qualification of
equipment / instruments used in the test and analysis of
API and Dexia 30mg & 60mg capsules.
29. Do your method of analysis stability
indicating? The method of analysis is stability indicating.
30. Do your HPLC software is 21CFR
compliant? The HPLC software of the firm is 21CFR compliant.
31. Can you show Audit Trail reports on
Dexlansoprazole testing?
Firm has demonstrated audit trail reports of testing.
32. Do you have some remaining quantities of
degradation products and stability batches?
The firm has some remaining quantities of stability
batches
33. Do you have commitment batches kept on
stability testing?
The firm has remaining quantities of stability batches.
34. Do you have valid calibration status for the
equipments used in Dexlansoprazole
capsules production in analysis?
The firm has valid calibration status of all equipment
used in production and analysis of Dexia 30mg &
60mg capsules.
35.
Do proper and continuous monitoring and
control are available for stability chamber?
The firm has stability chambers for carrying out
accelerated and real time stability studies provided
with uninterrupted power supply and data loggers,
which are set for recording temperature and humidity.
36. Do related manufacturing area, equipment,
personnel and utilities be rated as GMP
compliant?
Related manufacturing area, equipment, personnel and
utilities are as per GMP compliance.
Conclusion:
On risk-based approach the genuineness / authenticity of stability data submitted by the firm for registration
of Dexia (Dexlansoprazle) 30mg and 60 mg Capsules is verifiable to satisfactory level.
Decision: Registration Board decided to approve registration of “Dexia (Dexlansoprazle) 30mg and
60mg Capsuleby M/s Ferozesons Laboratories Ltd, Amangarh, Nowshera Khyber Pakhtunkhwa.
Manufacturer will place first three production batches of both products on long term stability studies
throughout proposed shelf life and on accelerated studies for six months.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 54
Item No. IV Additional Agenda
Registration-I Section.
Human Imported Cases
Case No. 01: Request of M/s. Webros Pharmaceuticals Plot No.1 Street No. 10 National
Industrial Zone, Rawat, Islamabad for Registration of Detamol Injection
2ml” (Reg. No. 016138).
M/s.Webros Pharmaceuticals Plot No.1 Street No. 10 National Industrial Zone, Rawat,
Islamabad has submitted an application for registration of “Detamol Injection 2ml” (Reg. No.
016138) manufactured by M/s Thai P.D. Chemicals Co. Ltd Thailand from the name of existing
agent M/s. The Healers, Rawalpindi to M/s.Webros Pharmaceuticals Plot No.1 Street No. 10
National Industrial Zone, Rawat. The firm deposited requisite fee of Rs.100,000/- for approval.
Details are as under:
Sr.# Name / detail of
documents
Documents / information provided by firm
1. Product Name /
Composition
Detamol Injection 2ml
As per record:
Each 2ml contains:
Paracetamol…......300mg
Lidocaine HCL….20mg
Benzyl alcohol .....30mg
As per COPP (issued by Thailand authority’s):
Each ml contains.
Paracetamol ..........................150.0mg.
Lignocaine Hydrochloride ....10.0mg
2. Name and address of
Applicant (transferee)
M/s.Webros Pharmaceuticals Plot No.1 Street No. 10 National
Industrial Zone, Rawat.
3. Name of Transferor M/s. The Healers, D/206-2. Satellite Town, Rawalpindi
4. Detail of Drug Sale
License
Flat No. 1-B, First Floor sharif Plaza, IJP Road Near
PindoraChungi Rawalpindi.
5. Name and address of
manufacturer
M/s. Thai P.D. Chemicals Co. Ltd, 2, SoiVibhavadiRangsit 16/41,
VibhavadiRangsit Road, Dindaeng, Dindaeng, Bangkok 10400,
Thailand.
6. Name and address of
product license holder
M/s. Thai P.D. Chemicals Co. Ltd, 2, SoiVibhavadiRangsit 16/41,
VibhavadiRangsit Road, Dindaeng, Dindaeng, Bangkok 10400,
Thailand.
7. Name of exporting country Thailand
8. Diary No. & Date of R& I Dy. No. 709 Dated 25/05/2016
9. Finished Product
Specification
Not provided
10. Shelf life 36 months (as per Form-5A)
a) Copy of valid Drug Sale License.
b) Fresh & original NOC dated 08-02-2018 from existing registration holder as
the already submitted NOC was issued on 15-03-2016.
c) Clarification in respect of difference in composition in provided documents
(i.e. Initial registration letter & COPP).
d) Site master file.
e) Initial Registration letter with renewal status.
Decision: Registration Board deferred the case and advised firm for provision of
evidence of approval of the said formulation in stringent regulatory
authorities (as specified by Registration Board in its 275th
meeting) for
further consideration of Board.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 55
Veterinary Cases
Case No.02: Inspection of Manufacturer Abroad/Issuance of Registration Letter.
The Registration Board in its 275th
meeting approved various products of M/s. Hassan
Brothers, Faisalabad manufactured by M/s. Samyang Anipharm Co. Ltd. Seoul, Korea with
various corrections. In One of the approved product Peperoxin Solution the pack size was
mentioned in Kg inadvertently by the applicant and the same was mentioned in the agenda and
minutes of the Registration Board’s meeting as per following details:-
S.No. Name of Manufacturer/
Importer
Name of drug(s) &
Composition
Decontrolled/
Packs Size
Shelf
Life
1. M/s. Hassan Brothers,
Faisalabad. / manufactured
by M/s. Samyang
Anipharm Co. Ltd. Seoul,
Korea.
Peperoxin Solution
Each Litre contains:-
Pefloxacin………100g
(as Pefloxacinemethanesulfonate
……139.6g)
Excipients (Purified water etc)
………………………Q.S
500gm
1 Kg
2.5 Kg
5 Kg
3 years
The firm subsequently submitted revised Form-5A and deposited fee of Rs.5000/- for
making the correction in pack size as 500ml, 1 Litre, 2.5 Litre & 5 Litre.
Registration Board in its 276th
meeting decided to defer the case for clarification
regarding the demanded pack sizes i.e. 500ml, 1 liter, 2.5 liter and 5 liters as the demanded pack
sizes are not mentioned on the free sale certificate issued by Korean Authority provided by the
firm. The firm has now provided certificate of product registration from Ministry for Agriculture
Food and Rural Affairs of Republic of Korea mentioning pack sizes of 100ml, 500ml, 1 Litre&
20 Litre.
The representative of M/o. Food Security pointed out that there is need to review use of
this molecule in veterinary practices especially with reference to development of resistance in
human.
Decision: Registration Board deferred the case for further clarification from the firm
regarding the submitted certificate of product registration.
The Board further decided to place the molecule “Pefloxacin” before
Working Group on Veterinary Drugs for its review.
Case No.03. Request of M/s. Medi-Vet (Pvt) Ltd., Lahore Sheikhupura Road,
Sheikhupura for additional packs of already Registered Veterinary Drugs.
M/s. Medi-Vet (Pvt) Ltd., Lahore has applied for approval of additional packs of their
registered veterinary drugs as per details mentioned against each:-
S. No. Regn.
No.
Name of Drug(s)/
Composition
Already Granted
Pack Size(s)
Demanded
Additional
Pack(s)
Justification
1. 025396 Albavet Powder
Each Kg contains:-
Albendazole………..200gm
Cobalt Sulphate……7.64gm
100gm
500gm
5gm Due to market
demand.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 56
2. 025398 Albavet Drench Plus Liquid
Each 100ml contains:-
Albendazole…………10gm
Cobalt Sulphate……0.382gm
100ml
500ml
1 Litre Due to market
demand.
M/s. Medi-Vet (Pvt) Ltd., Lahore has deposited the required fee of Rs.5,000 x 2 =
Rs.10,000/- and submitted following supporting documents:-
(i) Copies of registration letters.
(ii) Copies to renewal status.
(iii) Copy of Drug Manufacturing License.
(v) Copy of CRF.
The demanded packs are not given to other firms.
Decision:- Registration Board approved M/s. Medi-Vet (Pvt) Ltd, Lahore request for
grant of additional pack size of “5 gm” and “1 litre” for registered drugs
Albavet Powder (Reg.No.025396) and Albavet Drench Plus Liquid
(Reg.No.025398), respectively, on same terms and conditions.
Case No.04. Request of M/s. Intervac (Pvt) Ltd., Lahore Sheikhupura Road, Sheikhupura
for additional packs of already Registered Veterinary Drugs.
M/s. Intervac (Pvt) Ltd., Lahore Sheikhupura Road, Sheikhupura has applied for approval
of additional packs of their registered veterinary drug as mentioned below:-
S.No. Regn.
No.
Name of
Drug(s)/Composition
Already
Granted Pack
Size(s)
Demanded
Additional
Pack(s)
Justification
1. 069651 Nega-97% Water Soluble
Powder
Each 100gm contains:-
Trichlorphon ……97%.
10gm
20gm
50gm
100gm
250gm
500gm
1Kg
5Kg
25 Kg
50 Kg
The
commercial
clients wide
scale of
business
required the
large packing.
The packs of 25Kg & 50Kg not given to other firms so far. M/s. Intervac (Pvt) Ltd.,
Lahore Sheikhupura Road, Sheikhupura has deposited the required fee of
Rs.5,000x2=Rs.10,000/- and submitted following supporting documents:-
(i) Copy registration letter.
(ii) Copy to renewal status.
(iii) Copy of CRF.
The demanded packs are not given to other firms.
Decision:- Registration Board approved M/s. Intervac (Pvt) Ltd., Lahore Sheikhupura
Road, Sheikhupura request for grant of additional pack sizes of “25 Kg” and
“50 Kg” for registered drug Nega-97% Water Soluble Powder (Reg.No.
069651) on same terms and conditions.
The Board further decided to refer the case to working group on veterinary
drugs for review of already granted small pack sizes of Trichlorphon for
possible misuse.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 57
Registration-II Section
Case No. 05: Rejection of Renewal Application of Drug Manufacturing License No. 000554
(Formulation) of M/s Farmaceutics International, F-1, A-3, S.I.T.E, Karachi.
Secretary, Central Licensing Board vide a letter No. F.2-9/2003-Lic (Vol-I) has informed
that Central Licensing Board in 256th
meeting decided as follows:
“ Proceedings and Decision of Central Licensing Board in 256th
meeting.
Mr. Jamel Hussain Qureshi, Legal Counsel for the firm appeared before the
Board and handed over documents before the Board and contended that if there was any
shortcoming he would submit within 24 hours. He also contended that documents
regarding CRF have been submitted with relevant Division. He further contended that all
formalities are complete and showcause may be withdrawn. The Board after hearing
representative of the firm and perusal of the documents observed that firm has been
manufacturing and selling medicines without approval of qualified approved staff since
more than three years. Moreover, Secretariat of Central Licensing Board accepts
certificate regarding CRF issued from the Division of Budget and Accounts which was
not available at the time of proceedings. The Board, therefore, decided to reject the
application of renewal of the Drug manufacturing License No. 000554 by way of
formulation of M/s Farmacuetics International, F-1, A-3, S.I.T.E., Karachi with
immediate effect under Section 41 of the Drugs Act, 1976 read with Rule 12 of The Drugs
(LR&A) Rules, 1976 for not complying the provisions of Rule 16 and Rule 5 (2A) of
Drugs (LR&A) Rules, 1976”.
He has further informed that the said manufacturing License stands cancelled with
immediate effect under the Drugs Act, 1976 and rules framed thereunder. Manufacturing of
Drugs in the name of said license and at said premises is prohibited and punishable offence under
section 23 and section 27 of Drugs Act, 1976 and rules framed thereunder.
Registration Board deliberated the matter in its 277th
meeting and decided to cancel the
registration of all drug products held by M/s. Farmaceutics International, Karachi, keeping in
view the decision of Central Licensing Board (CLB) taken in its 256th
meeting for cancellation
of their DML.
The firm filed an appeal before Appellate Board in its 148th
meeting and the appellate Board
decided as under:-
“The Board, after hearing arguments and perusing prevailing record and updated
status decided to convert the cancellation into suspension for six (06) months, as
provided by the Central Licensing Board in other similar cases. The firm was
directed to submit documents related to appointment, qualification and experience of
qualified persons to the Licensing Division which shall evaluate and decide the
matter for compliance within thirty (30) days after giving personal hearing to the
appellant and accordingly report to this Board for allowing resumption of the
suspension, compliance of the manufacture and bases on the recommendations of the
Licensing Board”.
Decision: Registration Board deferred the case till Central Licensing Board decides the
matter in light of decision given by the Appellate Board in its 148th
meeting.
Board also directed to solicit opinion from Legal Affairs Division in this
regard.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 58
Registration-IV Section
Case No.6: Approved Products of M/s. Cherwel Pharmaceuticals, Hattar.
Registration Board in its 227th
meeting approved the following products of M/s.
Cherwel Pharmaceuticals, Hattar subject to Panel GMP Inspection, as per following details:-
S.No
.
Name of
Firm
Name of Drugs /label
Claim
Demand
ed Pack
size
Demande
d Price
Date Decision Remarks
1. M/s.
Cherwel
Pharmaceu
ticals,
Hattar
Nimswel 100mg
Tablets
Each tablet contains:-
Nimesulide
.....100mg
(NSAID)
Per
tablet
Rs.6.00 6-10-
2009
Approved
subject to Panel
GMP Inspection.
EMA approved.
Registration Board’s
Decision in 269TH
meeting:
Registration Board
approved the
formulation of
Nimesulide Tablets
100mg with a pack
size of 15 tablets as
per
recommendations of
EMA only for the
following
indications:
Treatment of
acute pain
Primary
Dysmenorrhea
2. -do- Salmocin 400mg
Tablets
Each tablet contains:-
Ofloxacin …..400mg
(Quinolone)
Per
tablet
Rs.20.0
0
-do- -do- USFDA Approved
formulation is film
coated.
3. -do- Flexy 100mg Tablets
Each tablet contains:-
Flurbiprofen
…..100mg
(NSAID)
Per
tablet
Rs.6.20 -do- -do- USFDA approved
formulation is film
coated.
4. -do- Natwel 100mg
Tablets
Each tablet contains:-
Diclofenac
Sodium…100mg
(NSAID)
Per
tablet
Rs.9.80 -do- -do- Standard
formulation
approved by
Reference
Regulatory
Authorities is
Sustained Release
Tablet.
5. -do- Odicam 7.5mg
Tablets
Each tablet contains:-
Meloxicam…..7.5mg
(Oxicam)
Per
tablet
Rs.7.00 -do- -do- USFDA approved
6. -do- Odicam 15mg
Tablets
Each tablet contains:
Meloxicam....15mg
(Oxicam)
Per
tablet
Rs.12.0
0
-do- -do- USFDA approved
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 59
7. -do- Azicap 500mg
Capsules
Each capsule contains:
Azithromycin
………500mg
(Macrolides)
Per
capsule
Rs.41.6
0
-do- -do- Decision of 250th
Meeting:
Applicants shall
either revise their
formulation to
tablet dosage form,
if not registered
previously and if
manufacturing
facility is approved
by CLB (new
registration
application with
complete fee)
8. -do- Klariwel 250mg
Tablets
Each tablet contains:
Clarithromycin
…..250mg
(Macroldie)
Per
tablet
Rs.34.0
0
-do- -do- Standard
formulation is film
coated tablet.
9. -do- Klariwel 500mg
Tablets
Each tablet contains:-
Clarithromycin
……..500mg
(Macroldie)
Per
tablet
Rs.64.0
0
-do- -do- Standard
formulation is film
coated tablet.
The firm has submitted copy of Panel Inspection Report conducted for renewal of DML
dated 27-09-2014 and GMP Inspection Report dated 17-03-2017 (Status: Satisfactory).
The Board was also informed regarding items at S.No.2,3,8 and 9 that the standard
formulations approved by Reference Regulatory Authorities are film coated tablets and the firm
has subsequently submitted revised formulations, accordingly.
Decision: Registration Board decided as under:
i. Approved for the grant of registration for product at S.No. 1 with
“Innovator’s Specifications” in accordance with the decision taken by the
Board in its 269th
meeting.
ii. Approved for the grant of registration for products at S.No.2, 3, 8 and 9 with
film coated tablets and USP Specifications.
iii. Approved for the grant of registration for products at S.No.5 and 6 with
“USP Specifications”.
iv. Deferred the product at S.No. 4 for correction of formulation in accordance
with the standard formulation approved by Reference Regulatory
Authorities along with fresh fee of Rs.20,000/-.
v. Deferred the product at S.No.7 and directed the firm to proceed in
accordance with the decision taken by the Registration Board vide its 250th
meeting for revision of formulation.
vi. The Board further decided that the above mentioned cases shall be processed
in the light of the procedure outlined by the Registration Board vide its 264th
meeting regarding verification of challan/deposit slips which are not
traceable.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 60
Registration-V Section
Case No.7: Products of M/s. Xenon Pharma, Lahore.
Registration Board in its various meetings has considered the following products of
M/s. Xenon Pharma, Lahore as per details mentioned below:-
Sr.
No.
Name of
Firm
Name of Drugs
/label Claim
Date of
Application /
Demanded
Pack size/
Price
Decision of
previous meeting
of Registration
Board
Remarks
1. Xenon
Pharma,
Lahore
Noplat Tablets
75mg
Each film coated
tablet contains:-
Clopidogrel as
Clopidogrel
bisulphate
…….75mg
(Anti-coagulants/
Platelet
aggregation)
30-06-2010
10’s
Rs.125.00
M-238
Deferred till
decision of DRAP
on show cause
notice/ stop
production to the
firm dated 23rd
April, 2013 and
provision of Latest
GMP Inspection
Report.
Panel inspection for renewal
of DML conducted on
16.02.2017.
Firm has submitted letter
N0.F.16-1/2013 (Reg-V)
dated 07-03-2013 as
evidence of paid fee.
Rs.20,000/-
2. Xenon
Pharma,
Lahore
Zepred Syrup
Each 5ml
contains:
Prednisolone…5
mg
60ml
Rs.4.50 per
5ml
M-226
Approved subject to
separate section
UK MHRA approved.
Section verified from Panel
inspection for renewal of
DML conducted on
16.02.2017.
Photocopy of DRAP’s
receiving of Rs.8,000/-
dated 16-01-2006 and fresh
fee of Rs. 12000/- have been
submitted.
Furthermore, the firm has
also submitted clarification
regarding the formulation
i.e.
Each 5ml contains:
Prednisolone as sodium
phosphate…5mg.
Request for change of brand
name to Preloid.
Decision: Registration Board approved above mentioned products.
Minutes for 280th meeting of Registration Board (15
th March, 2018), DRAP 61
Case No.8: Products of M/s. Sharex Laboratories, Sadiqabad.
Registration Board in its various meetings has considered the following products of
Sharex Laboratories, Sadiqabad as per details mentioned below:-
S.
No.
Name of Firm Name of Drugs /
label Claim
Demanded
Pack size /
Price
Decision of previous
meeting of
Registration Board
Remarks
1. Sharex
Laboratories,
Sadiqabad
R.T-Fast Injection
Each vial contains:-
ArtemetherInt.P….
80mg
(Anti malarial)
5x75
Rs.75.00/
Amp
M-236
Approved
Photocopy challan of
Rs.12000/-along with
drap’s receiving
Panel Inspection
Report dated
29-3-2017
Status: Satisfactory
2. -do- N-Cid Tablet
Each tablet
contains:
Flurbiprofen
…100mg
(Anti Inflammatory)
30’s
Rs.186.00
M-238
Approved. The Board
advised to provide
Coating specification
Firm has now
submitted evidence
of film coating
specification.
Photocopy challan of
Rs.12000/-along with
DRAP’s receiving.
Decision: Registration Board approved above mentioned products. Reference will be
sent to Budget & Accounts Division, DRAP for verification of challan of
Rs.12,000/- and the Board also authorized the Chairman, Registration Board
for issuance of registration letter.
Meeting ended with a vote of thanks to and from the chair.
End of Document
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