Pharmacovigilance in India
Contemporary Perspectives
Ashwini KumarDrugs Controller General of
India
INDIAWorld’s largest democracy
Population:
10,00,00,00,00Area: 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!
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 13, 2003
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 ResourcesTeam Mates
Agreed performance benchmarks
Willingness to LearnPolitical 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:
•Collaborative Protocol
Pharmacovigilance can’t be anyone’s personal agenda!
EVERYONE’S INVITED!
Pharmacovigilance in India
Fresh Team:•Involving all health-care
professionalsPhysicians, Surgeons, Dentists,
Pharmacists, Nurses
Form on the WebInteractive 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)
Vigilant Ethics Vigilant Ethics CommitteesCommittees
Ongoing reviews
AE AE ReportingReporting
GCGCPP
QCQC
Regulatory Regulatory InspectionsInspections
Trained Trained InvestigatorsInvestigators
Credible DataCredible Data
Safe Pharmaco-
therapeutics
National PVig Programme
ERegional
NRegional
WRegional
WRegional
NEZonal
SWZonal
NationalPVig
Center
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 IndiaCentral Drugs Standard Control Organization,(Directorate General of Health Services), Ministry of Health & Family WelfareGovernment of India
The Road Ahead
Zonal Center 1: for North and East RegionsAll India Institute of Medical Sciences, New Delhi Coordinator: Dr. S. K. Gupta
Regional Pharmacovigilance Centres
Northern RegionLady Hardinge Medical College, New DelhiCoordinator: Dr. Kamlesh Kohli
Eastern RegionNRS Medical College, KolkataCoordinator: Dr. S. K. Tripathi
The Road Ahead
Zonal Center 2: for West and South RegionsSGS Medical College, Mumbai Coordinator: Dr. Nilima Kshirsagar
Regional Pharmacovigilance Centres
Southern Region Madras Medical CollegeCoordinator: Dr. Annabelle
Western RegionKEM Medical College, MumbaiCoordinator: Dr. Urmila Thatte
Central Sub-Region (under Western Region)Indira Gandhi Medical College, NagpurCoordinator: 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
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