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DRUG AND THERAPYBULLETIN
HIMACHALPRADESHSTATEPHARMACYCOUNCIL
DRUGINFORMATIONCENTER
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101
Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: hpspcdic@gmail.com/dic@hpspc.in
Toll Free: 18001210443
Issue 20|Volume 3|May 2019
ContentsDrug Updates
Pharma News
Press Cutting
Questions published by Central Drugs Standard Control Organization (CDSCO)
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: hpspcdic@gmail.com/dic@hpspc.in
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
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: hpspcdic@gmail.com/dic@hpspc.in
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
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: hpspcdic@gmail.com/dic@hpspc.in
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.
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: hpspcdic@gmail.com/dic@hpspc.in
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
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: hpspcdic@gmail.com/dic@hpspc.in
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.
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: hpspcdic@gmail.com/dic@hpspc.in
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.
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: hpspcdic@gmail.com/dic@hpspc.in
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
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: hpspcdic@gmail.com/dic@hpspc.in
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
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: hpspcdic@gmail.com/dic@hpspc.in
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
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: hpspcdic@gmail.com/dic@hpspc.in
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
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: hpspcdic@gmail.com/dic@hpspc.in
Ref:AmarUjala;01-05-2019
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: hpspcdic@gmail.com/dic@hpspc.in
Ref:DainikJagran(RashtriyaSanskaran);30-04-2019
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: hpspcdic@gmail.com/dic@hpspc.in
Ref:DainikJagran(RashtriyaSanskaran):29-04-2019
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: hpspcdic@gmail.com/dic@hpspc.in
Ref:DivyaHimachal;26-04-2019
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: hpspcdic@gmail.com/dic@hpspc.in
Ref:DainikJagran(RashtriyaSanskaran);20-04-2019
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: hpspcdic@gmail.com/dic@hpspc.in
Ref:DainikJagran(RashtriyaSanskaran);19-04-2019
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: hpspcdic@gmail.com/dic@hpspc.in
Ref:DainikJagran(RashtriyaSanskaran);19-04-2019
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: hpspcdic@gmail.com/dic@hpspc.in
Ref:DainikJagan(RashtriyaSanskaran);15-04-2019
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: hpspcdic@gmail.com/dic@hpspc.in
Ref:DainikJagran(RashtriyaSanskaran);13-04-2019
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: hpspcdic@gmail.com/dic@hpspc.in
Ref:DainikJagran(RashtriyaSanskaran);10-04-2019
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: hpspcdic@gmail.com/dic@hpspc.in
Ref:DainikJagran(RashtriyaSanskaran);20-03-19Ref:DainikJagran
(RashtriyaSanskaran);09-04-19
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: hpspcdic@gmail.com/dic@hpspc.in
Ref:AmarUjala;02-04-2019
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: hpspcdic@gmail.com/dic@hpspc.in
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.
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: hpspcdic@gmail.com/dic@hpspc.in
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
TollFree18001210443
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HIMACHALPRADESHSTATE PHARMACYCOUNCIL
DRUGINFORMATIONCENTER
LaureateInstituteofPharmacy,Kathog,Distt.Kangra,HP-177101
TollFree:18001210443|Phone:09218428042/9459220253
E-mail:hpspcdic@gmail.com/dic@hpspc.in
TollFree:18001210443|Phone:9218428042/9459220253
Foranyclarifications,anyonecandirectlycalltotheDICofficeorsendtheirquerybypost
orE-mailtothebelowaddress.
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