The Evolution of Pharmacovigilance — Global and Indian Milestones

Pharmacovigilance has evolved through distinct phases: from pure reaction (investigate after catastrophe) to systematic collection (spontaneous reporting), to active surveillance (post-marketing studies, registries), to data science (computational signal detection), and now to predictive intelligence (AI forecasting from multiple data streams).

On the Indian side, the timeline runs from the first formal national effort — an ADR monitoring system under the DCGI in 1986 — through WHO pilot programme participation (1997–2004), the 2010 launch of the Pharmacovigilance Programme of India (PvPI), mandatory ADR reporting for Marketing Authorisation Holders under Schedule Y (2014), integration of vaccine AEFI surveillance (2017), the Digital Personal Data Protection Act (2023), updated CDSCO PV Guidelines (2024), and the ongoing National Digital PV Grid initiative (2025–26).

Three 2025–26 developments stand out as the most consequential regulatory shifts in over a decade: the CIOMS Working Group XIV final report on AI in pharmacovigilance (finalized December 2025), EU Regulation 2025/1466 (fully applicable February 12, 2026, the biggest EU PV overhaul since 2012), and ICH E6(R3) (finalized January 2025, the biggest GCP overhaul since 1996).

What’s striking about this timeline, once you see it laid out, is how each phase was triggered by a specific, nameable event rather than gradual planning: the WHO programme exists because of thalidomide; harmonised electronic reporting exists because paper-based national systems couldn’t scale; and the current wave of AI governance exists because AI-assisted tools moved from pilot projects into daily production workflows faster than regulation could naturally keep pace. India’s trajectory mirrors this same reactive-to-proactive arc, just compressed into a shorter window — from a limited 1986 pilot to a fully networked, multilingual, AI-piloted national system in under 40 years.