DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY...

26
DRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101 Toll Free: 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected] Toll Free: 18001210443 Issue 20|Volume 3|May 2019 Contents Drug Updates Pharma News Press Cutting Questions published by Central Drugs Standard Control Organization (CDSCO)

Transcript of DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY...

Page 1: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

DRUG AND THERAPYBULLETIN

HIMACHALPRADESHSTATEPHARMACYCOUNCIL

DRUGINFORMATIONCENTER

LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Toll Free: 18001210443

Issue 20|Volume 3|May 2019

ContentsDrug Updates

Pharma News

Press Cutting

Questions published by Central Drugs Standard Control Organization (CDSCO)

Page 2: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

1

DRUG AND THERAPY BULLETIN

Content

EDITORIAL

AdvisoryBoard

Dr. Navneet Marwah, Mr. Sanjeev Pandit, Dr. Manoj Kumar, Dr. Ranjit Singh, Prof. CPS Verma,

Dr. Poonam Sandhu, Dr. Rajender Guleria, Mr. Arvind Kumar, Mr. Bihari Lal Gupta, Mr, Hemant Sharma,

Mr. Rakesh Chandel, Mr. Praveen Upadhya, Mr. Kamashwar Chauhan, Mr. Lokesh Kumar, Mr. Vishal Kumar,

Mr. Y.S.Chandel, Mr. Birbal Sharma, Mr. Manoj Kumar, Mr. Yogesh Verma, Mr. Surender Nadda, Dr. Parshuram

Patron

Mr. Gopal Krishan Sharma and Dr. Ran Singh

Editor-in-Chief

Dr. Kamlesh Naik and Dr. M.S. Ashawat

Co-Editors

Dr. Vinay Pandit and Mr. Ankush Sharma

Drug Updates

Eticovo: Second Enbrel Biosimilar..............................................................................................................................................3

Duobrii Lotion for Plaque Psoriasis ..........................................................................................................................................3

Keytruda + Inlyta for advanced RCC ..........................................................................................................................................3

st1 Generic Narcan for Opioid OD .......................................................................................................................................................................4

Balversa for Metastatic Bladder Cancer....................................................................................................................................4

FDA: Avoid Abrupt opioid withdrawl .......................................................................................................................................4

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

stDovato: 1 2 Drug complete HIV regimen................................................................................................................................5

Asceniv: Novel IVIG for PI ..............................................................................................................................................................5

Avaclyr for acute herpetic keratitis ...........................................................................................................................................5

Skyrizi for Plaque Psoriasis ..........................................................................................................................................................3

Praluent to reduce CV Events........................................................................................................................................................3

Page 3: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

2

Content (Continued)

Nagpur: 18-yr-old die after consuming anti-malarial tablets..........................................................................................8

World Malaria Day 2019 observed; Malawi launches world's first malaria vaccine ...........................................8

MOU signed between Ministry of AYUSH and Council of Scientific and Industrial Research ..........................9

PressCutting

What is a “new drug”?...................................................................................................................................................................23

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Pharma News

Doctors find key to eye care in the womb ........................................................................................................................................................7

Stop Johnson & Johnson baby shampoo sale: Child rights body to states ................................................................7

Increased risk of blood clots in lungs and death with higher dose of Xeljanz (tofacitinib) for rheumatoid

arthritis: EMA ....................................................................................................................................................................................9

PCI to establish digital learning platform for Pharmacists ...........................................................................................10

Cimzia for Nr-ax Spa..........................................................................................................................................................................6

stJatenzo: 1 oral Testosterone Product.......................................................................................................................................6

Mayzent for Secondary Progressive MS....................................................................................................................................6

What is an “investigational new drug (IND)”?....................................................................................................................23

What is a “subsequent new drug”?..........................................................................................................................................23

How long a new drug is considered to be a new drug? ..................................................................................................24

What is an “orphan drugs”? .......................................................................................................................................................24

What is “clinical trial”? .................................................................................................................................................................24

What is an “academic clinical trial”? ......................................................................................................................................24

QuestionspublishedbyCentralDrugsStandardControlOrganization(CDSCO)

Duaklir Pressair for COPD..............................................................................................................................................................5

.................................................................................................................................................................10-22

Page 4: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

3

Drug Updates

PraluenttoreduceCVEvents

Prescribing information can be found at:

http://products.sanofi.us/praluent/praluent.pdf.

On April 26, 2019, the US FDA approved a new

indication for Praluent(R) (alirocumab) subQ

injection to reduce the risk of myocardial

infarction, stroke, and unstable angina requiring

hospitalization in adults with established

cardiovascular (CV) disease. This new indication

was approved based on results of a clinical trial in

which patients treated with Praluent experienced

a significant reduced risk of CV events (ie, heart

attack, stroke, death from coronary heart disease,

or unstable angina requiring hospitalization)

compared with those treated with placebo. In

addition, the FDA approved an expansion to the

hyperlipidemia indication to include patients with

other types of high LDL-C.

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

On April 26, 2019, the US FDA approved Eticovo

(etanercept-ykro) subQ injection indicated to

treat rheumatoid arthritis, polyarticular juvenile

idiopathic arthritis, psoriatic arthritis, ankylosing

spondylitis, and plaque psoriasis. Eticovo, which is

the second biosimilar to Enbrel(R) (etanercept) to

gain FDA approval, was approved based on a

clinical trial in which Eticovo demonstrated

SkyriziforPlaquePsoriasis

On April 23, 2019, the US FDA approved

Skyrizi(TM) (risankizumab-rzaa) subQ injection

indicated to treat moderate-to-severe plaque

psoriasis in adults who are candidates for

systemic therapy or phototherapy. In clinical

trials, a significantly greater proportion of

patients treated with risankizumab-rzaa achieved

a 90% improvement in the Psoriasis Area Severity

comparable safety and efficacy to Enbrel in a

clinical trial.

Prescribinginformationcanbefoundat:

https://www.accessdata.fda.gov/drugsatfda_docs

/label/2019/761066s000lbl.pdf.

Eticovo:SecondEnbrelBiosimilar

DuobriiLotionforPlaquePsoriasis

Prescribing information can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs

/label/2019/209354s000lbl.pdf

On April 25, 2019, the US FDA approved

D u o b r i i ( T M ) ( h a l o b e t a s o l

propionate/tazarotene) topical lotion indicated

to treat plaque psoriasis in adult patients. Duobrii,

the first product with halobetasol propionate and

tazarotene in one formulation, was shown to be

more effective in achieving improvement in

plaque psoriasis than its individual agents and

placebo in clinical trials.

Page 5: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

4

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Keytruda+InlytaforadvancedRCC

On April 22, 2019, the US FDA approved a new

indication for Keytruda(R) (pembrolizumab) IV

injection in combination with Inlyta(R) (axitinib)

oral tablets for the first-line treatment of patients

with advanced renal cell carcinoma (RCC). This is

the first advanced renal cell carcinoma indication

for Keytruda which, in combination with axitinib,

demonstrated significant improvement in overall

survival, progression-free survival, and objective

response rate compared with sunitinib in the

KEYNOTE-426 trial.

Prescribing information can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs

/label/2019/125514Orig1s054lbl.pdf.

Prescribing information can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs

/label/2019/212018s000lbl.pdf.

On April 12, 2019, the US FDA approved

Balversa(TM) (erdafitinib) oral tablets indicated

to treat adult patients with locally advanced or

metastatic urothelial carcinoma that has

susceptible FGFR3 or FGFR2 genetic alterations

and progressed during or following at least 1 line

of prior platinum-containing chemotherapy

including within 12 months of neoadjuvant or

adjuvant platinum-containing chemotherapy.

Treatment with Balversa, which was granted

accelerated approval and breakthrough therapy

designation by the FDA, resulted in an overall

response rate of 32.2% and duration of response

of 5.4 months in a clinical trial.

BalversaforMetastaticBladderCancerPrescribing information can be found at:

https://www.accessdata.fda.gov/drugsatfda_doc

s/label/2019/761105s000lbl.pdf.

Index (PASI 90) and a static Physician's Global

Assessment (sPGA) score of 0 or 1 at week 16

compared with those treated with ustekinumab

or placebo.

On April 19, 2019, the US FDA granted final

approval for the first generic Narcan(R) (naloxone

hydrochloride) nasal spray indicated for the

emergency treatment of known or suspected

opioid overdose (OD). This new generic will be

marketed by Teva Pharmaceuticals USA. The FDA

st1 GenericNarcanforOpioidOD

On April 9, 2019, the US FDA issued a safety

communication regarding reports of abrupt or

inappropriately rapid discontinuation of opioids

in patients who are physically dependent being

associated with serious withdrawal symptoms,

uncontrolled pain, and suicide. Healthcare

providers and patients should be advised against

FDA:AvoidAbruptopioidwithdrawl

is also taking new steps to support development of

over-the-counter and additional generics of

naloxone to help reduce opioid overdose deaths

and to increase access to emergency treatment

Page 6: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

5

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

On April 8, 2019, the US FDA approved Dovato

(dolutegravir/lamivudine) oral tablets indicated

to treat human immunodeficiency virus type 1

(HIV-1) infection in adults with no antiretroviral

treatment history and with no known

substitutions associated with resistance to

dolutegravir or lamivudine. Dovato, which is the

first two-drug complete regimen for HIV-infected

patients with no antiretroviral treatment history,

was non-inferior to dolutegravir/tenofovir

disoproxil fumarate/emtricitabine with regard to

virologic efficacy in pooled results from 2 clinical

trials.

Prescribing information can be found at:

https://www.gsksource.com/pharma/content/da

m/GlaxoSmithKline/US/en/Prescribing_Informati

on/Dovato/pdf/DOVATO-PI-PIL.PDF.

On April 1, 2019, the US FDA approved

Asceniv(TM) (immune globulin-slra) IV injection

i n d i c a t e d t o t r e a t p r i m a r y h u m o r a l

immunodeficiency (PI) in adult and pediatric

patients 12 to 17 years of age. Asceniv, a novel

intravenous immune globulin (IVIG), was

approved based on a clinical trial in which patients

treated with immune globulin-slra did not

experience any serious bacterial infections

(primary endpoint). Asceniv carries a boxed

warning regarding the risk of thrombosis, renal

dysfunction, and acute renal failure.

Prescribinginformationcanbefoundat:

https://www.fda.gov/downloads/BiologicsBloodV

accines/UCM634958.pdf.

Avaclyrforacuteherpetickeratitis

Prescribing information can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs

/label/2019/0202408s000lbl.pdf.

On April 1, 2019, the US FDA approved

Avaclyr(TM) (acyclovir) ophthalmic ointment

indicated for the treatment of acute herpetic

keratitis (dendritic ulcers) in patients with herpes

simplex (HSV-1 and HSV-2) virus. Avaclyr, which

was granted orphan drug exclusivity, is the first

acyclovir ophthalmic ointment to gain FDA

approval.

stDovato:1 2DrugcompleteHIV

regimen

Asceniv:NovelIVIGforPI

DuaklirPressairforCOPD

On April 1, 2019, the US FDA approved Duaklir(R)

Pressair(R) (aclidinium bromide/formoterol

fumarate) inhalation aerosol powder indicated for

the maintenance treatment of patients with

chronic obstructive pulmonary disease (COPD).

Duaklir Pressair, a twice daily long-acting

sudden withdrawal in patients with physical

dependency and to instead discuss an

individualized gradual tapering regimen with the

patients. As a result of this communication, the

FDA is requiring changes to the prescribing

information for these opioids that are used in the

outpatient setting.

Page 7: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

6

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

MayzentforSecondaryProgressiveMSCimziaforNr-axSpa

Prescribinginformationcanbefoundat:

https://ucbusa.com/_up/ucb_usa_com_kopie/doc

uments/Cimzia_PI.pdf.

On March 29, 2019, the US FDA approved a new

indication for Cimzia(R) (certolizumab pegol)

subQ injection for the treatment of adults with

active non-radiographic axial spondyloarthritis

(nr-axSpA) with objective signs of inflammation.

Cimzia, the first drug to gain FDA approval for nr-

axSpA, was approved based on a clinical trial in

which patients treated with certolizumab pegol

showed greater improvement responses on the

Ankylosing Spondylitis Disease Activity Score

compared with placebo.

stJatenzo:1 oralTestosteroneProduct

On March 27, 2019, the US FDA approved

Jatenzo(R) (testosterone undecanoate) oral

capsules indicated for testosterone replacement

therapy in adult male patients with congenital or

acquired primary or hypogonadotropic

hypogonadism. Jatenzo, which is the first

testosterone undecanoate oral formulation to gain

Prescribing information can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs

/label/2019/209884s000lbl.pdf.

On March 26, 2019, the US FDA approved

Mayzent(R) (siponimod) oral tablets indicated to

treat relapsing forms of multiple sclerosis (MS), to

include clinically isolated syndrome, relapsing-

remitting disease, and active secondary

progressive disease, in adults patients. Mayzent,

which is a sphingosine1-phosphate receptor

modulator, showed efficacy in a clinical trial in

which the fraction of patients with confirmed

progression of disability was significantly lower in

the Mayzent group than in the placebo group.

Ref:www.micromedexsolutions.com

muscarinic antagonist (LAMA) and long-acting

beta-agonist (LABA) combination, was approved

based on the ACLIFORM, AUGMENT, AND

AMPLIFY phase III clinical trials.

Prescribing information can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs

/label/2019/210595lbl.pdf.

FDA approval, is not indicated for "age-related

hypogonadism" and carries a boxed warning

regarding blood pressure increases.

Prescribing information can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs

/label/2019/206089s000lbl.pdf.

Page 8: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

7

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

When a child is in the womb, it is attached to the

mother through the placenta, which delivers

oxygen and nutrients to it. The placenta also helps

keep the mother’s blood separate from the baby’s

to protect it against infections. After the delivery, it

is useless. But not anymore. Over the past few

years, the placenta has become a subject of

interest among doctors who are using it for

treatment purposes. One of the unique usages is in

the field of eye surgery. Ophthalmologists said

they are using the amniotic membrane, the

innermost layer of the placenta, as a graft and

dressing to reconstruct the eye.

Doctorsfindkeytoeyecareinthewomb

“It acts like a biological bandage,” said Dr Namrata

Sharma, professor of ophthalmology at R P Eye

Centre at AIIMS. She added that the institute

started using amniotic membrane nearly two

decades ago, but its usage has expanded

extensively in recent years.

Dr A K Grover, chairman, department of

ophthalmology at Sir Ganga Ram Hospital, said

they use amniotic membrane in 10-15 patients

every month. “Initially, we used to obtain the

amniotic membranes from the placenta left

behind by mothers undergoing caesarean section

at the hospital with their permission. But now

there are companies selling the same,” he said. The

amniotic membrane can be stored for long periods

at -80 degrees Celsius and doesn’t get rejected by

the recipient of the graft. Due to these properties,

it is being used by ophthalmologists for a variety of

conditions, including chemical injuries by acids

and alkalis, non-healing defects and infections on

the surface of the eye, Grover added.

Ref:health.economictimes.indiatimes.com

The National Commission for Protection of Child

Rights has written to the chief secretaries of all

states and Union Territories asking them to stop

the sale of Johnson & Johnson baby shampoo in

their respective states and also removing the

product from the stock of the shops in view of the

findings of the sample testing report from the

Rajasthan drug control officer.

Pharma News

Over the past few years, the placenta has

becomeasubjectof interestamongdoctors

who are using it for treatment purposes.

Oneoftheuniqueusagesisinthefieldofeye

surgery.

StopJohnson&Johnsonbabyshampoo

sale:Childrightsbodytostates

Page 9: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

8

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Ref:www.health.economictimes.indiatimes.cm

TOI had reported on April 1 that Johnson &

Johnson’s baby shampoo has come under the

regulatory lens with samples of the product

collected in Rajasthan showing presence of

“harmful ingredients" that may cause cancer.

While seeking an update in the matter from states,

NCPCR in its order recommends that the sale of

the product may be stopped till further notice.

Nagpur:18-yr-olddieafterconsuming

anti-malarialtablets

Ref:www.health.economictimes.indiatimes.cm

According to police, Ruchika Gaikwad, a resident

of Takia Dhantoli, had allegedly took the drastic

step. Ruchika took out her mother’s medicine bag

and consumed around 26 anti-malaria tablets.

Ruchika’s mother is undergoing treatment for

malaria. Some time later she fell unconscious due

to the overdose of the medication. When others in

the family noticed her condition, Ruchika was

rushed to a nearby hospital. Ruchika, however,

breathed her last while undergoing treatment.

The World Malaria Day was observed across the

globe on April 25, 2019 to highlight the need for

continued investment and sustained political

commitment towards malaria prevention and

control.

African country Malawi on April 24, 2019 became

the first to immunise children against Malaria

through the vaccine ‘RTS,S’ (Mosquirix) under the

WHO-coordinated Malaria vaccine pilot

programme.

Malawi is also the first of three countries in Africa

in which the vaccine RTS,S will be made available

to children up to 2 years of age; Ghana and Kenya

will introduce the vaccine later. Malaria remains

one of the world’s leading killers, claiming the life

of one child every two minutes. It took thirty years

for the scientists to develop the RTS,S vaccine that

has demonstrated it can significantly reduce

malaria in children. During the clinical trials, the

vaccine proved to prevent around 4 in 10 malaria

cases, including 3 in 10 cases of life-threatening

severe malaria.

Ref:www.jagranjosh.com

WorldMalariaDay2019observed;

Malawilaunchesworld'sfirstmalaria

vaccine

Page 10: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

9

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

MOUsignedbetweenMinistryof

AYUSHandCouncilofScientificand

IndustrialResearch

Ref:www.pharmatutor.org

A Memorandum of Understanding (MOU) was

signed between the Ministry of AYUSH and

Council of Scientific and Industrial Research

(CSIR), New Delhi. The MoU was signed by Vaidya

Rajesh Kotecha, Secretary, Ministry of AYUSH and

Dr. Shekhar C. Mande, Director General, CSIR and

Secretary, DSIR in the presence of senior officials

from both the organizations. Speaking on the

occasion, Secretary stated in due cognition of the

growing interest of traditional medicines

worldwide, there is a need of multipronged and

innovative approaches for the acceptance of this

science. He said that the combination of

traditional healthcare and modern basic science

has a huge possibility to do innovative and path-

breaking researches which can be used for the

explanation of various basic concepts. DG, CSIR

appreciated the ongoing projects and

programmes between the two organizations. He

stated that enhancing the collaboration through

joint R&D efforts ranging from fundamental

science to validation and thereafter product

development, will significantly help in the growth

of the Indian contributions to this important

sector, not only nationally but internationally as

well.

Ref:www.pharmatutor.org

EMA is advising healthcare professionals and

patients not to exceed the recommended dose of

Xeljanz (tofacitinib) when treating rheumatoid

arthritis. The advice follows early results from an

ongoing study (study A3921133) in patients with

rheumatoid arthritis which showed an increased

risk of blood clots in the lungs and death when the

normal dose of 5 mg twice daily was doubled. In

the EU, 5 mg twice daily is the authorised dose for

rheumatoid arthritis and psoriatic arthritis. The

higher dose of 10 mg twice daily is approved for

the initial treatment of patients with ulcerative

colitis.

Healthcare professionals are being informed in

writing of the preliminary results of the study and

the current treatment recommendations. Xeljanz

is authorised to treat adults with moderate to

severe rheumatoid arthritis (a disease that causes

inflammation of the joints) and psoriatic arthritis

(red, scaly patches on the skin with inflammation

of the joints). In these indications, Xeljanz is used

together with methotrexate after treatment with

one or more medicines known as disease-

modifying anti-rheumatic drugs (DMARDs) has

not worked well enough or has led to troublesome

side effects. In patients with rheumatoid arthritis,

Xeljanz can also be used alone in patients who

cannot take or are intolerant to methotrexate.

Increasedriskofbloodclotsinlungs

anddeathwithhigherdoseofXeljanz

(tofacitinib)forrheumatoidarthritis:

EMA

Page 11: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

10

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Ref:www.pharmatutor.org

Pharmacy council of India (PCI) announced for

digital learning platform for pharmacists and it

will be helpful for pharmacists to gain knowledge

as per PCI members. As per PCI, continuous

learning of pharmacists will be supported through

their digital platform. Dr. B. Suresh said, “Today

Pharmacy profession is a growing profession. It is

growing in every area whether it is healthcare

delivery or manufacture of medicine or excess to

medicine, pharmacists play an important role.

Pharmaceutical industry growing exponentially

but challenge is profession is becoming

knowledge based than skill base. So when you go

to industry, they look at you that what knowledge

you are carrying with you to get require position in

industry. So, pharmacists focus should be on to

accessing and gaining knowledge. Dr. B. Suresh

announced that, “PCI is going digital and

processes are started. Lot of teaching content will

available in free of cost at PCI portal. If somebody

had given good lecture in Mumbai and you are not

able to attend it, just don’t worry. Same will appear

on PCI portal for everyone access. We are trying to

realize things what we called as anytime,

anywhere learning whether there are working

pharmacists or teachers or students, there

continuous learning will be supported through

PCI’s digital platform.”Ref:DainikJagran(RashtriyaSanskaran);

02-05-2019

PCItoestablishdigitallearning

platformforPharmacists Press Cutting

Page 12: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

11

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Ref:AmarUjala;01-05-2019

Page 13: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

12

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Ref:DainikJagran(RashtriyaSanskaran);30-04-2019

Page 14: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

13

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Ref:DainikJagran(RashtriyaSanskaran):29-04-2019

Page 15: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

14

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Ref:DivyaHimachal;26-04-2019

Page 16: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

15

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Ref:DainikJagran(RashtriyaSanskaran);20-04-2019

Page 17: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

16

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Ref:DainikJagran(RashtriyaSanskaran);19-04-2019

Page 18: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

17

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Ref:DainikJagran(RashtriyaSanskaran);19-04-2019

Page 19: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

18

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Ref:DainikJagan(RashtriyaSanskaran);15-04-2019

Page 20: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

19

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Ref:DainikJagran(RashtriyaSanskaran);13-04-2019

Page 21: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

20

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Ref:DainikJagran(RashtriyaSanskaran);10-04-2019

Page 22: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

21

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Ref:DainikJagran(RashtriyaSanskaran);20-03-19Ref:DainikJagran

(RashtriyaSanskaran);09-04-19

Page 23: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

22

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Ref:AmarUjala;02-04-2019

Page 24: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

23

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

QuestionspublishedbyCentralDrugsStandardControlOrganization(CDSCO)

Whatisa“newdrug”?

A new drug means a drug, including active pharmaceutical ingredient or phytopharmaceutical drug,

which has not been used in the country to any significant extent, has not been approved as safe and

efficacious by Central Licencing Authority (CLA) i.e. DCG (I) with respect to its claims.

A modified or sustained release form of a drug or novel drug delivery system of any drug approved by the

Central Licencing Authority;

A drug approved by the CLA for certain claims and proposed to be marketed with modified or new claims

including indication, route of administration, dosage and dosage form;

or

or

or

A vaccine, r-DNA derived product, living modified organism, monoclonal antibody, stem cell derived

product, gene therapeutic product or xenografts, intended to be used as drug;

or

A fixed dose combination of two or more drugs, approved by CLA separately for certain claims and

proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved

combination is proposed to be changed with certain claims including indication, route of administration,

dosage and dosage form;

Whatisan“investigationalnewdrug(IND)”?

An “investigational new drug (IND)” means a new chemical or biological entity or substance that has not

been approved for marketing as a drug in any country.

Whatisa“subsequentnewdrug”?

A subsequent new drug means a drug approved by the Central Licencing Authority for certain claims and

proposed to be marketed with modified or new claims including indication, route of administration,

dosage and dosage form. A subsequent new drug also includes a new drug already approved in the

country.

Page 25: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

24

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Howlonganewdrugisconsideredtobeanewdrug?

A new drug which is a modified or sustained release form of a drug or Novel Drug Delivery System (NDDS)

of any drug approved by the Central Licencing Authority; or a vaccine, recombinant Deoxyribonucleic

Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, stem cell derived product,

gene therapeutic product or xenografts, intended to be used as drug shall continue to be a new drug

forever. However, new drugs covered other than above categories shall be considered as a new drug for a

period of 4 years of their approval by the CLA.

Whatisan“orphandrugs”?

An “orphan drug” means a drug intended to treat a condition which affects not more than 5 lakh persons in

India.

Whatis“clinicaltrial”?

A “clinical trial” in relation to a new drug or investigational new drug means any systematic study of such

new drug or investigational new drug in human subjects to generate data for discovering or verifying its

clinical and pharmacological effects including its adverse effects with the objective of determining the

safety, efficacy or tolerance of such new drug or investigational new drug.

Whatisan“academicclinicaltrial”?

An “academic clinical trial” means a clinical trial of a drug already approved for a certain claim and

initiated by any investigator, academic or research institution for a new indication or new route of

administration or new dose or new dosage form, where the results of such a trial are intended to be used

only for academic or research purposes and not for seeking approval of the Central Licencing Authority or

regulatory authority of any country for marketing or commercial purpose.

Ref:www.nhp.gov.in

Page 26: DRUG AND THERAPY BULLETIN - hpspc.inhpspc.in/pdf/drug_therapy_20_may_2019.pdfDRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE

TollFree18001210443

ScanthisQuickResponse(QR)

codetoknowmore

YoumaydownloadanyQRcodescannerfrom

PlayStore/iTunes

HIMACHALPRADESHSTATE PHARMACYCOUNCIL

DRUGINFORMATIONCENTER

LaureateInstituteofPharmacy,Kathog,Distt.Kangra,HP-177101

TollFree:18001210443|Phone:09218428042/9459220253

E-mail:[email protected]/[email protected]

TollFree:18001210443|Phone:9218428042/9459220253

Foranyclarifications,anyonecandirectlycalltotheDICofficeorsendtheirquerybypost

orE-mailtothebelowaddress.

Note:Ifanyonewanttopublishhis/herarticleinthemonthlybulletinofDrug InformationCenterregardingPharmaupdates, theycansend theirarticleswith their full address and professional status on the following

threferencebefore25 ofeverymonth.

© 2

019 P

harm

a P

uls

e | in

fo@

pharm

apuls

e.in

| 9

482797901