The Pharmacovigilance Program of India (PvPI) - Core Functions and Key Metrics

General
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The Pharmacovigilance Program of India (PvPI) is a national initiative to monitor and enhance drug safety by collecting and analyzing adverse drug reaction (ADR) reports. Coordinated by the Indian Pharmacopoeia Commission (IPC) under the Ministry of Health and Family Welfare.

Core Functions:

  • ADR Monitoring - Coordinates in collection of ADR from healthcare professionals, patients, and pharmaceutical companies.
  • Signal Detection - Signals or patterns from ADR data is identified to institute potential safety concerns.
  • Regulatory Action - recommends changes in drug usage, labelling, or withdrawal based on risk assessments.
  • Training and Outreach - Conducts several workshops, publishes newsletters, and promotes awareness about pharmacovigilance.
  • Global Collaboration - PvPI is a part of the WHO program for International Drug Monitoring.

Key Metrics (according to 2025 reports):

  • ADR Monitoring Centers (AMCs) - Over 300 AMCs are operative across India, including medical colleges, hospitals, and research institutions.
  • ADR Reports Submitted - PvPI has collected more than 600,000 Individual Case Safety Reports (ICSRs), with a steady annual increase in reporting volume.
  • Global Contribution - India ranks among the top 15 contributors to the WHO Global ICSR database (Vigibase),.
  • Signal Detection - PvPI has identified and validated over 100 safety signals, leading to regulatory actions.

Have you reported an ADR through Vigibase? What are the difficulties that you face in the process of reporting an ADR?

MBH/AB

3 Likes
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Ive also done research on this topic for Sitagliptin

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Yes, I’ve reported ADRs through the PvPI system. The process is simple enough, but on hectic clinical days, filling in all the detailed fields does feel a bit time-consuming. Sometimes the portal can be a little slow, too, but despite that, submitting a report always feels worth it, knowing it adds to the larger effort of keeping patients safer.

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It is important to keep track of the medicines available in the market. As a result of pharmacovigilance, even some well-established drugs have been withdrawn. Therefore, it is essential not only for healthcare professionals but also for the general public to stay informed about medication safety.