How Does PvPI Work?

The Pharmacovigilance Programme of India (PvPI) is the Government of India's flagship drug safety monitoring programme. It collects, collates, and analyses drug-related adverse events, sending recommendations to the Central Drugs Standard Control Organisation (CDSCO) for appropriate regulatory actions.

• Adverse Drug Reaction (ADR) Monitoring Centres (AMCs): Over 600 centres across India report ADRs.
• National Coordination Centre (NCC): Located at the Indian Pharmacopoeia Commission (IPC), Ghaziabad.
• VigiFlow® Software: Used for submitting Individual Case Safety Reports (ICSRs) to the NCC.
• Signal Review Panel (SRP): Assesses identified safety signals and recommends actions.

Steps to Fill the ADR Reporting Form

To facilitate understanding, follow these steps:

1. Download the Form: Access the official ADR reporting form from the PvPI website.
2. Fill in Reporter Information: Provide details of the reporter.
3. Enter Patient Information: Include demographic and clinical data.
4. Describe the ADR: Detail onset, severity, and outcome.
5. List Suspected Medications: Provide drug details.
6. Include Concomitant Medications: List concurrent drugs.
7. Provide Medical History: Include relevant health background.
8. Assess Outcome: Indicate resolution status.
9. Submit the Form: Send the completed form to an ADR Monitoring Centre.

PvPI History and Overview

The PvPI was formally launched on July 14, 2010, by the Ministry of Health and Family Welfare, Government of India. Initially coordinated by AIIMS, New Delhi, the National Coordination Centre was shifted to the Indian Pharmacopoeia Commission (IPC), Ghaziabad in 2011.

Mission: Safeguard the health of the Indian population by ensuring the benefits of medicines outweigh the risks.

Vision: Improve patient safety and welfare by monitoring the safety of medicines and reducing risks.

UMC Centre: Role and Responsibilities

The Uppsala Monitoring Centre (UMC) in Sweden is a World Health Organization (WHO) Collaborating Centre for International Drug Monitoring. It provides scientific support to countries, including India, in pharmacovigilance activities.

• Data Analysis: Assessing ADR reports to identify safety signals.
• Database Management: Maintaining VigiBase®, the global ADR database.
• Training and Support: Providing training to national centres on pharmacovigilance practices.
• Research and Development: Conducting research to improve ADR reporting and analysis methodologies.