Pharmacovigilance (PV) plays a mission-critical role in ensuring drug safety beyond the controlled environment of clinical trials, making it the backbone of Post-Marketing Surveillance (PMS). In a diverse and populous country like India, where medicines are used across varied genetic, socio- economic, and healthcare settings, PMS becomes indispensable for the early detection, assessment, and prevention of adverse drug reactions (ADRs). This review highlights the growing need for robust post-marketing surveillance in India, emphasizing the limitations of pre-approval clinical trials in identifying rare, long-term, and population-specific safety concerns. The article provides an overview of the Pharmacovigilance Programme of India (PvPI), its organizational structure, reporting mechanisms, and its role in strengthening the national drug safety ecosystem. Despite significant progress, pharmacovigilance in India continues to face multiple challenges, including under-reporting of ADRs, lack of awareness among healthcare professionals and patients, inadequate infrastructure, and limited integration of digital health technologies. Furthermore, the review discusses future prospects of PMS in India, focusing on the adoption of electronic reporting systems, artificial intelligence-based signal detection, real-world evidence generation, patient-centric reporting, and stronger regulatory frameworks. To contextualize theoretical concepts, the article concludes with post-marketing safety examples of commonly used drugs, illustrating how pharmacovigilance interventions have contributed to risk identification and safer therapeutic outcomes. Strengthening pharmacovigilance and post-marketing surveillance is essential to enhance patient safety, regulatory decision-making, and public trust in the Indian healthcare system.
Abhishek Tomar*1, Aman Yadav2, Syed Shamsul Huda Nizami3, Ajay4 (Sun,) studied this question.