Pharmacovigilance Programme Pharmacovigilance Programme of Indiaof India

YK GUPTANational Coordinator, Pharmacovigilance Programme of IndiaProf. & Head, Department of Pharmacology AIIMS, New Delhi, India

Pharmacovigilance Programme of India (PVPI)

Pharmacovigilance Programme of India (PVPI) was launched in July 2010.

Goal:

To ensure that the benefits of use of medicine outweighs the risks and thus safeguard the health of the Indian population

Objectives:

• To monitor Adverse Drug Reactions (ADRs) in Indian population

• To create awareness amongst health care professionals about the

importance of ADR reporting in India

• To monitor benefit-risk profile of medicines

• Generate independent, evidence based recommendations on the

safety of medicines

Pharmacovigilance Programme of India (PVPI)

Objectives:

• Support the CDSCO for formulating safety related regulatory

decisions for medicines

• Communicate findings with all key stakeholders

• Create a national centre of excellence at par with global

drug safety monitoring standards

Pharmacovigilance Programme of India (PVPI)

Programme Governance - PvPI

CDSCO ZONAL CENTRES

GOVERNANCE STRUCTURE - PVPI

PHARMAINDUSTRY PHARMA

INDUSTRY

Immunization Programs

Roles & Responsibilities of the Functional UnitsPharmacovigilance Programme of India

40 PvPI AMCs

National Coordinating Center,AIIMS, New Delhi

4 Zonal CDSCO Offices (provide operational and logistical support)

Ghaziabad Mumbai Kolkata Chennai

PvPI Headquarters, CDSCO

Pharmacovigilance Programme of India (PVPI)

PHASE 1

The centres included in the first wave of the Programme - 12

Steering Committee - PvPI

MEMBER SECRETARYAssistant Drug Controller, New Delhi, India

Monitoring and Evaluation – key indicators to measure efficiency

Focused ADR monitoring watchlist

CRITERIA• Restriction/Withdrawal by any other regulatory

agency in the world• Reports in media• Adverse reports published in WHO Newsletters• Diseases of public health importance in relation to

Indian population• Drugs, Vaccines for Epidemics/Pandemics• Signals generated from the spontaneous reports

received under the PvPI

Proposed drugs for focused ADR monitoring

1. Oseltamivir2. Letrozole3. Nimesulide4. Pioglitazone5. Rosiglitazone6. Tegaserod7. PPA 8. Gatifloxacin

Concerns about drug safety in other countries

Absent/ Minimal safety data from India

Proactive & focused ADR

monitoring in dedicated

pharmacovigilancecentres

Regulatory action based on Indian AND global data

Workshop on Operationalizing Pharmacovigilance Programme of

India (PvPI)24th – 25th November 2010

Key Achievements

Vigiflow Training orientation for AMC Coordinators

Vigiflow ‘hands on’ training for all 12 AMCs completed

SOPs deliberated and finalized through collective brainstorming sessions by all AMCs coordinators. Training imparted & training records completed

‘State of art’ videoconferencing facility (AIIMS Telemedicine department) Proof of concept for ‘real time’ distance learning fulfilled and can be utilized for future purposes

“Face to Face” SOP training for Technical Associates will be imparted over next 2 days.

ADR forms received by the AMCs will be entered in Vigiflow over next 3 days – experiential learning

Seamless synergistic pharmacovigilance partnership

Pharmacovigilance

Patient Policy makers(regulators)

Physician and medical associations

Public Press (media)

Pharmaceutical Industry and associations

ACADEMIA

INDUSTRY REGULATOR

Potential for synergy

• 289 medical colleges and 282 dental colleges• More than 837 Pharmacy colleges• More than 657 recognized nursing colleges (B.Sc and

M.Sc)• Over 600 pharmaceutical companies (IDMA

members)• CDSCO, WHO, ICMR, other affiliates• MCI, DCI, PCI, Consumer associations etc.

Thank you