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