Evolution and Impact of India's Pharmacovigilance Programme: A Decade of Progress and Challenges

To improve drug safety monitoring nationwide, the Pharmacovigilance Programme of India (PvPI) was established in July 2010. Over the last decade, PvPI has expanded from a small number of coordinating centres to a nationwide network of Adverse Drug Reaction Monitoring Centres (AMCs), introduced new reporting methods, and made significant progress in connecting with international pharmacovigilance systems. This review documents the growth of PvPI, discusses its organisational structure and important operational milestones, evaluates trends in adverse drug reaction (ADR) reporting and signal detection, and assesses the programme's influence on regulatory decision-making and public health. Along with highlighting opportunities brought about by digital reporting, stakeholder participation, and international collaboration, it also examines enduring issues such as underreporting, data quality, geographical discrepancies, and integration of traditional and herbal medicine safety. There are suggestions for boosting India's pharmacovigilance ecosystem, with an emphasis on enhancing consumer reporting, data analytics, connections between academia, industry, and regulators, and ongoing capacity building. International collaborations have improved the stage of development and responsiveness of the domestic system and increased India's involvement in international drug-safety surveillance. Expanding AMC coverage, requiring ADR reporting in the private sector, including pharmacovigilance in all health curricula, utilising AI-driven analytics, and extending surveillance to include conventional medications, biologics, and counterfeit drugs are some of the future directions. Securing sustainable funding and promoting international cooperation are also crucial. A strong and comprehensive pharmacovigilance system is essential as India works towards universal health care to guarantee that the advantages of medications continuously exceed their risks for everyone. In summary, the future of pharmacovigilance will depend on its capacity to maintain its main goal of safeguarding patient health while embracing technological advancements, fostering collaborative networks, and adjusting to scientific findings.