Pharmacovigilance in India

Contemporary
Perspectives

Ashwini Kumar
Drugs Controller General of India
 INDIA
World’s largest democracy
Population:

10,00,00,00,00 +
Area: 3,287,263 sq. km.

Age distribution:
<14 yrs=33% 15-64 yrs=60% >65%=7%
Pharmacovigilance in India
Gains so far:
Knowledge about
how not to do it!
 January 13, 2003

IMA ends debate:

Nimesulide is safe
Arun Kumar and Sutirtho Patranobis New Delhi
More than 50 doctors country-wide participated in an
opinion poll organised by the IMA and submitted data
on the use of nimesulide on nearly 5.3 lac patients.
The data clearly showed that the side-effects of the drug
were nothing more than common GI problems …
 January 14, 2003

Nimesulide not safe,

insist doctors
By Kalpana Jain Times News
Network
New Delhi: Doctors have questioned an “opinion poll”
conducted by the Indian Medical Association (IMA) to
declare the controversial fever drug, Nimesuilde, “safe”.
… a leading paediatrician who is the former head of the
pediatrics department at the All India Institute of Medical
Sciences, told The Times of India … that severe side
effects of the drug have been documented and it needs to
be used with caution.
Pharmacovigilance in India

Fresh strategy:
Collaborative Approach
Requisite Resources
Team Mates
Agreed performance benchmarks
Willingness to Learn
Political Will
The rule of “farming”
(preparing / tilling the soil, sowing the seeds, nurturing the seedlings,
providing resources for fostering growth, harvesting the benefits)
 Pharmacovigilance in India
Fresh Tool:
Pharmacovigilance can’t be anyone’s
personal agenda!

EVERYONE’S INVITED!
•Collaborative Protocol
Pharmacovigilance in India
Fresh Team:
•Involving all health-
care professionals
Physicians, Surgeons, Dentists,
Pharmacists, Nurses

Form on the Web

Interactive Reporting
Pharmacovigilance in India
Clear goals &
milestones:
Step 1: Notification culture
•Debriefing, Interaction, Training
Step 2: Data management
•Debriefing, Interaction, Training
Step 3: Data analysis
•Debriefing, Interaction, Training
Advantage India

•Large population >

Potentially large

world scale
ADR database
 Emerging Scenario
(Clinical Research & Industry)
Safe
AE
Reporting Pharmaco-
therapeutics

GCP
Ongoing reviews QC

Regulatory Credible Data

Inspections

Vigilant Ethics Trained

Committees Investigators
National PVig Programme

National
PVig
Center

NE SW
Zonal Zonal

N E W W
Regional Regional Regional Regional
The Road Ahead
Protocol > Validate Protocol > Formal
agreements with centers > Center & Staff
Identification > Prepare & Distribute
Material > Web link > Collate feedback >
Review Progress > Make mid-course
corrections > Close non-performing / non
complying sites > Identify fresh sites >
Eventually broaden the programme base
The Road Ahead
National
Pharmacovigilance Center:
Office of the Drugs Controller General of India
Central Drugs Standard Control Organization,
(Directorate General of Health Services),
Ministry of Health & Family Welfare
Government of India
The Road Ahead
Zonal Center 1: for North and East Regions
All India Institute of Medical Sciences,
New Delhi Coordinator: Dr. S. K. Gupta
Regional Pharmacovigilance Centres
Northern Region
Lady Hardinge Medical College, New Delhi
Coordinator: Dr. Kamlesh Kohli

Eastern Region
NRS Medical College, Kolkata
Coordinator: Dr. S. K. Tripathi
The Road Ahead
Zonal Center 2: for West and South Regions
SGS Medical College, Mumbai
Coordinator: Dr. Nilima Kshirsagar

Regional Pharmacovigilance Centres

Southern Region
Madras Medical College
Coordinator: Dr. Annabelle

Western Region
KEM Medical College, Mumbai
Coordinator: Dr. Urmila Thatte

Central Sub-Region (under Western Region)

Indira Gandhi Medical College, Nagpur
Coordinator: Dr. Meena Shrivastava
 Regulatory Pharmacology

Regulatory decisions
are generally based on “cases”.

Regulators can’t wait for

epidemiological data or evidence.
Acknowledgments:
Indian Council of Medical Research
World Bank
WHO – India Country Office
UMC Uppsala
Professional Colleagues