Signal to Safety: Unpacking the Pharmacovigilance Program of India (PVPI)

The Pharmacovigilance Programme of India (PVPI), established in 2010, has become a cornerstone of India’s public health strategy for drug safety. This review critically examines PVPI’s evolution, organizational structure, reporting mechanisms, and signal detection processes. Key achievements include a dramatic increase in Individual Case Safety Reports (ICSRs), the expansion of the AMC network, digital innovations such as the ADR PVPI app, and recognition as a WHO Collaborating Centre. PVPI’s regulatory interventions, such as label changes for carbamazepine-induced Stevens–Johnson Syndrome, demonstrate its impact on patient safety. However, persistent challenges remain: underreporting (especially from the private sector), data quality concerns, limited surveillance of traditional medicines and biologics, funding constraints, and state-level disparities. Comparative analysis with US and EU pharmacovigilance systems highlights the need for mandatory reporting, harmonized data standards, and robust risk management frameworks. Future directions include expanding AMC coverage, mandating ADR reporting in the private sector, integrating pharmacovigilance into all health curricula, leveraging AI-driven analytics, and broadening surveillance to cover traditional medicines, biologics, and counterfeit drugs. Strengthening international collaboration and securing sustainable funding are also essential. As India moves toward universal health coverage, a robust and integrated pharmacovigilance system is vital to ensure that the benefits of medicines consistently outweigh their risks for every citizen.