Evolution Of Drug Safety Surveillance in India: A Review of Government Policies, Reporting systems, And Regulatory Actions on Adverse Drug Reactions

Drug safety surveillance in India has changed considerably over the past five decades, shaped by public health needs, global safety events, and growing regulatory capacity. This review traces the development of pharmacovigilance in the country, from early pilot efforts in the 1980s to the establishment of the National Pharmacovigilance Programme in 2004 and its relaunch as the Pharmacovigilance Programme of India (PvPI) in 2010 under the Indian Pharmacopoeia Commission. It examines key policy milestones, including amendments to the Drugs and Cosmetics Rules, the New Drugs and Clinical Trials Rules, 2019, and the introduction of Materiovigilance and Haemovigilance programmes. The reporting infrastructure is discussed, covering adverse drug reaction monitoring centres, voluntary reporting tools, mobile applications, helplines, and integration with the WHO Uppsala Monitoring Centre. Regulatory actions, such as drug bans, label changes, and safety alerts, are evaluated for their effect on clinical practice. Persistent challenges are highlighted, including underreporting, limited awareness among healthcare professionals, uneven data quality, and resource gaps. The review concludes that stronger training, digital reporting, patient participation, and closer coordination among stakeholders are essential to build a more responsive and reliable drug safety system in India.