GCP Principles

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Pharmacovigilance in India Contemporary
Perspectives
Ashwini Kumar Drugs Controller General of India
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INDIAWorlds largest democracyPopulation
10,00,00,00,00Area 3,287,263 sq. km.Age
distribution lt14 yrs33 15-64 yrs60
gt657

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Pharmacovigilance in India Gains so far
Knowledge about how not to do it!
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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
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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.
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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)
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Pharmacovigilance in India Fresh Tool
Pharmacovigilance cant be anyones personal
agenda!
EVERYONES INVITED!

• Collaborative Protocol

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Pharmacovigilance in India Fresh Team

• Involving all health-care professionals
• Physicians, Surgeons, Dentists, Pharmacists,
  Nurses
• Form on the Web
• Interactive Reporting

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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

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Advantage India

• Large population gt
• Potentially large
• world scale
• ADR database

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Emerging Scenario (Clinical Research Industry)
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National PVig Programme
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The Road Ahead
Protocol gt Validate Protocol gt Formal agreements
with centers gt Center Staff Identification gt
Prepare Distribute Material gt Web link gt
Collate feedback gt Review Progress gt Make
mid-course corrections gt Close non-performing /
non complying sites gt Identify fresh sites gt
Eventually broaden the programme base
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The Road Ahead
National Pharmacovigilance Center Office of the
Drugs Controller General of IndiaCentral Drugs
Standard Control Organization, (Directorate
General of Health Services), Ministry of Health
Family Welfare Government of India
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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
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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
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Regulatory Pharmacology
Regulatory decisions are generally based on
cases. Regulators cant wait for
epidemiological data or evidence.
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Acknowledgments
Indian Council of Medical Research World Bank WHO
India Country Office UMC Uppsala Professional
Colleagues