<p>Traditional approaches to adverse event reporting for medical products including drugs, medical devices, in-vitro diagnostics, and vaccines often relied on separate, product-specific reporting mechanisms. These methods typically involved physical documentation, telephonic communication, and email-based submissions as primary channels for incident reporting. Though functional, such processes were fragmented, time-consuming, and heavily dependent on manual data entry, making them prone to reporting inconsistencies and human error. A critical limitation of these legacy systems was the lack of integrated, real-time data tracking. Without a centralized, real-time reporting system, adverse event signal detection faced delays and slackened further necessary action such as potential risk communication, slowing regulatory interventions and increasing patient safety risks. To overcome these challenges, the Adverse Drug Reactions Monitoring System (ADRMS) was launched in August 2024 as a centralized, digital platform for the systematic reporting and monitoring of adverse events associated with medical products. Designed to strengthen India’s post-market surveillance mechanism of medical products, ADRMS enables healthcare professionals, manufacturers, and consumers etc. to capture, validate, and track adverse event data in real time, ensuring faster responses and more informed decision-making process. The platform integrates advanced features such as semi-automated data validation, early quantitative analysis for signal detection, and interoperability with national and international regulatory databases significantly improving data accuracy, transparency, and traceability across the medical products ecosystem. This paper provides a comprehensive overview of ADRMS’s expanded role in medical product safety monitoring, detailing its technical architecture, implementation framework, and strategic relevance to India’s safety surveillance system in the interest of patient safety.</p>