Pharmacovigilance in India Contempor ary Perspecti ves Ashwini Kumar Drugs Controller General of India
Nov 23, 2014
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