Strengthening Post-Marketing Surveillance in India : A Study on Adverse Drug Reaction (ADR) Reporting

Post-marketing surveillance plays a pivotal role in ensuring the safety and efficacy of medicines after their approval for clinical use. In India, adverse drug reaction (ADR) reporting remains a major challenge due to underreporting, lack of awareness, inadequate training, and limited integration of pharmacovigilance into healthcare practice. This study highlights the current status of ADR monitoring in India, the functioning of the Pharmacovigilance Programme of India (PvPI), and the barriers faced by healthcare professionals in spontaneous reporting. It emphasizes the importance of strengthening reporting systems, improving regulatory frameworks, and encouraging active participation of physicians, pharmacists, nurses, and patients in ADR reporting. Enhancing digital reporting platforms, integrating pharmacovigilance into medical curricula, and conducting awareness campaigns are key strategies to improve ADR documentation. Strengthening post-marketing surveillance will not only improve drug safety but also build public trust in the healthcare system and contribute to evidence-based therapeutic action.