Pharmacovigilance Programme of India

GENESIS

Pharmacovigilance Programme of India is Government of India's flagship drug safety monitoring programme, which collects, collates and analyses drug-related adverse events and send recommendations to CDSCO for taking appropriate regulatory actions.

Adverse Drug Reaction (ADR) is one of the leading causes of morbidity and mortality worldwide. The consequences of ADRs burden the healthcare system with increased cost of therapy and prolongation of hospitalization. In developing countries, the cost of management of adverse reactions in the general population is very high and under-recognized. It is, therefore, imperative to evaluate the safety of medicines through Pharmacovigilance system.

The Ministry of Health and Family Welfare, Government of India recasted PvPI on 15th April, 2011 and shifted the National Coordination Centre from All India Institute of Medical Sciences (AIIMS), New Delhi to IPC, Ghaziabad and is continuing.

PvPI: An Overview

Mission

To safeguard the health of Indian population by ensuring that the benefits of use of medicine outweigh the risks associated with its use.

Vision

To improve patient safety and welfare of Indian population by monitoring safety of medicines, thereby reducing the risk associated with their use.

Aims and Objectives

• Create a Nation-wide system for patient-safety by ensuring drug-safety
• Identify and analyse new signals from the reported cases
• Analyse the benefit-risk ratio of marketed medications
• Generate evidence-based information on safety of medicines
• Support regulatory agencies in the decision-making process on use of medications
• Communicate safety information on use of medicines to various stakeholders for preventing/minimizing the risk
• Collaborate with other National Centres for exchange of information and data management
• Provide training and technical support to other National Pharmacovigilance Centres across the globe
• To organise and sensitize the stakeholders for celebration of National Pharmacovigilance Week from 17th September- 23rd September every year
• Promote rational use of medicines
• Emerge as a National Centre of Excellence for Pharmacovigilance activities

Core committees at NCC-PvPI

Following committees are constituted at NCC-PvPI to ensure smooth and effective functioning of the programme:

Steering Committee

It is the chief administrative and monitoring body of NCC-PvPI, which guides and supervises the functioning of programme.

Working Group

All technical issues related to the establishment and implementation of the programme, including providing technical inputs, are handled by the Working Group, which reports to the CDSCO for regulatory interventions.

Quality Review Panel

Quality Review Panel is responsible for quality, causality assessment and completeness of ICSRs. The panel also makes recommendations to the PvPI Working Group after data analysis and devises formats and guidance documents for follow-up action.

Signal Review Panel

The Signal Review Panel (SRP) of PvPI comprises scientists and clinical experts affiliated to government and non-government academic institutions and hospitals. As and when required experts from the pharmaceutical industries are also invited for taking expert inputs, to collate and analyse information from ICSRs. This panel assesses the results of identified computerized Signals from ICSRs to validate and confirm. It looks into biostatistical methods for analysis and creates standardized post-analytical reports that help in understanding the information derived from ADRs. It also decides upon actionable indicators.

Core Training Panel

The Core Training Panel (CTP) of PvPI guides in the identification of training needs, organizing National and International training programmes, designing training modules and helps to conduct the training for healthcare professionals and other stakeholders throughout the year. It also identifies trainers for zone-wise training centres. The CTP interacts with National and International agencies for participation and implementation of training programmes in Pharmacovigilance. The Core Training Panel is assisted by the internal training team of PvPI.