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|
National
Pharmacovigilance Advisory Committee
|
| No.
Z.14012/1/2001-DC |
| Government
of India |
| Ministry
of Health and Family Welfare |
| Department
of Health |
| Nirman
Bhavan, New Delhi |
| Dated
the 22nd July,2004 |
ORDER
With
a number of new drugs being regularly approved for
marketing in India, there is a need for a vibrant
pharmacovigilance system in the country to protect
the population from the potential harm that may be
caused by some of these new drugs. Besides, with
the patent regime coming in force from 2005, it is
widely believed that India would become a centre
for new drug trials. India being a vast country
with multi ethnic population, it is necessary to
have a viable Adverse Drug Reaction(ADR) Data
capturing system. The Indian Central Drugs
Regulatory Authority, therefore, proposes to set
up a pharmacovigilance programme in the country.
The specific aims of the proposed
pharmacovigilance programme are to:-
1.
contribute to the regulatory assessment of
benefit, harm, effectiveness and risk of
medicines, encouraging their safe, rational and
more effective(including cost effective) use,
2.
improve patient care and safety in relation
to use of medicines and all medical and
paramedical interventions,
3.
improve public health and safety in
relation to use of medicines,
4.
promote understanding, education and
clinical training in pharmacovigilance and its
effective communication to the public
The
programme envisages setting up of 24 Peripheral
centers for recording Adverse Events (AE), 6
Regional Centres to collate and scrutinize the
data received from the Peripheral Centres and 2
Zonal Centres for causality analysis of the
reported AE’s and to provide training, general
support and coordinate the functioning of the
Regional Centres. The National Pharmacovigilance
Advisory Committee (NPAC) will oversee the
performance of various Zonal, Regional and
Peripheral Pharmacovigilance centres as well as
recommend possible regulatory measures based on
data received from various centres. NPAC will also
oversee data collection and assessment,
interpretation of data as well as publication of
ADR monitoring data. The Committee will also
periodically evaluate their protocol compliance
levels to ensure that the data is received is
homogenous and can be scientifically pooled for
informed regulatory decisions. Wherever necessary
, NPAC will also seek the opinion of experts in
various specializations.
As
a first step in setting up a countrywide National
Pharmacovigilance programme as envisaged under the
World Bank Assisted Capacity Building Project on
Food Safety and Quality Control of Drugs, it has
been decided with the approval of the competent
authority to set up a National Pharmacovigilance
Advisory Committee (NPAC) under the chairmanship
of Director General of Health Services. The
Committee will consists of following members in
addition to the Chairperson :-
|
1.
CHAIRMAN
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Director
General of Health Services
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2.
Member Secretary
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DCG(I)
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3.
ICMR
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D.G.,
ICMR, New Delhi
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4.
Ministry of Health and Family Welfare
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Director
I/c of Drugs Division
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5.
AIIMS, New Delhi, Zonal Centre Coordinator
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Dr.
S.K. Gupta, Head of the Department,
Pharmacology, AIIMS, New Delhi
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6.
SGC Medical College, Mumbai, Zonal Centre
Coordinator
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Dr.
Nilima Kshirsagar, SGS, Medical College, (Mumbai)
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7.
Member, Pharmacology
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Dr.
Ranjit Roy Chaudhary, NII, New Delhi
Dr.
C. Adithan, Prof. Pharmacology, JIPMER,
Pondicherry.
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8.
Member, Forensic Medicine
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Dr.
T.D. Dogra, AIIMS, New Delhi
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9.
Member,
General Medicine
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Dr.
Anoop Mishra(AIIMS, New Delhi)
Dr.
A.K. Agarwal (RML, New Delhi)
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10.Member,
Clinical Pharmacology
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Dr.
S.D. Seth, Chair-in Clinical Pharmacology
(ICMR, New Delhi)
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11.
Member , Pharmacy
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Mr.
Brijesh Regal, Former WHO Consultant
(New Delhi)
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12.
Member , Toxicology
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Dr.
Y.K. Gupta, Director, (ITRC, Lucknow)
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13.
Member, Epidemiology
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Dr.
M.D. Gupte (ICMR Institute of Epidemiology,
Chennai)
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14.
Member , Pathology
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Dr.
Kusum Verma Member Secretary, (AIIMS
Ethics Committee, New Delhi)
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15.
Member , Drug Information
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Dr.
Pramil Tiwari (NIPER, Mohali)
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16.
Member , Phytotherapy
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Dr.
Urmila Thatte.Head of the Department,
Pharmacology, B.L.Nair, Medical College
Hospital , Mumbai
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Consequent
to formation of NPAC, the National
Pharmacovigilance Centre will operate at CDSCO
(H.Q.).
The
formation of the NPAC has been approved by the
Minister of Health and Family Welfare vide orders
dated 12th March, 2004
(Nita
Kejriwal)
Under
Secretary
To
| PS
to HFM/MOS(HFW) |
| PPS
to Secretary(Health) / Secretary(FW/Secretary(AYUSH) |
| PPS
to DGHS |
| JS(RT)/DCG(I) |
| All
members of NPAC |
| All
State/UT Health Secretaries |
| All
State / UT Drug Controllers. |
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