Foundations of Global Pharmacovigilance · Section 1.10
~6 min read · The Drug Safety Coach — Global PV Career Course
Key points
Full text
India has the third-largest pharmaceutical manufacturing base in the world and supplies medicines to more than 200 countries. The Pharmacovigilance Programme of India (PvPI) operates under the Indian Pharmacopoeia Commission, coordinating a network of more than 250 ADR Monitoring Centres in government medical colleges and teaching hospitals nationwide.
India offers multiple reporting pathways — the adrpvpi.net portal, a mobile app, WhatsApp-based reporting in selected states, hospital AMC systems, and physical forms in multiple regional languages. All validated Indian ADR reports are transmitted to VigiBase, meaning signals detected in Indian populations contribute directly to global signal detection. Marketing Authorisation Holders operating in India are required under Schedule Y and the 2024 CDSCO PV Guidelines to designate a responsible person for PV, maintain a PV system, and submit expedited ICSRs within applicable timelines.
The multilingual and multi-channel reporting design isn’t incidental — it directly addresses a well-documented global problem: under-reporting. A large share of adverse events that occur are never formally reported anywhere, and English-only reporting historically compounded that problem in India specifically, since a prescriber or patient more comfortable in a regional language would often simply not report at all rather than navigate an English-only form. WhatsApp-based reporting and regional-language forms are a direct, practical response to that gap — meeting patients and healthcare professionals where they already are, rather than requiring them to adapt to the system.
Quick check
Test yourself before moving on — no pressure, just click an answer.
1. What is the National Coordination Centre for PvPI, and which body does it operate under?
2. Why does PvPI offer WhatsApp-based reporting and regional-language forms specifically?