The Indian Pharmacopoeia Commission (IPC) has urged all Medical Device Marketing Authorisation Holders (MAHs) in the country to strictly comply with adverse event reporting requirements under the Materiovigilance Programme of India (MvPI).
Reiterating the central role of post-market surveillance in safeguarding patient safety, Dr V Kalaiselvan, secretary-cum-scientific director, IPC said, “Timely and accurate reporting of all medical device adverse events, serious or non-serious, known or unexpected, is essential for protecting patients and strengthening India’s materiovigilance ecosystem. Compliance must be ensured in letter and spirit.”
He emphasised that MAHs must promptly report all medical device adverse events to the National Coordination Centre for MvPI (NCC-MvPI), IPC, preferably through the Adverse Drug Reactions Monitoring System (ADRMS). Proactive and consistent reporting, he noted, enables timely regulatory action and ensures that medical devices marketed and used in the country remain safe, effective, and reliable for both patients and healthcare professionals.
To make reporting seamless and user-friendly, MvPI has established multiple reporting modalities for all stakeholders. A major digital milestone is the launch of ADRMS on August 19, 2024, which is a unified national digital platform for reporting adverse events related to medicines, medical devices, and vaccines. The system allows standardized, real-time data capture and analysis, significantly strengthening India’s pharmacovigilance and materiovigilance framework.
In addition to ADRMS, stakeholders can continue to report adverse events through prescribed Medical Device Adverse Event Reporting Forms (Version 1.2.1), the PvPI/MvPI mobile application, and the toll-free helpline (1800-180-3024).
Despite these simplified mechanisms, IPC has expressed concern over persistent under-reporting by domestic medical device manufacturers. Such gaps, officials warn, limit the completeness of national safety data and may delay the detection of potential risks in the Indian market.
The IPC also drew attention to earlier statutory and policy directives. A letter issued on October 14, 2022 by the secretary, ministry of health and family welfare, underscored that monitoring the safety of medical products is an ethical and professional obligation of all stakeholders. Further, a circular issued by the Drugs Controller General of India (DCGI) on May 15, 2024 reiterated that all medical devices are regulated under the Drugs and Cosmetics Act (D&C Act), 1940 and the Medical Devices Rules (MDR), 2017, mandating license holders to establish robust post-market surveillance systems and report adverse events to MvPI.
Patient safety and the quality of medical devices, including in-vitro diagnostics (IVDs), depend heavily on effective detection, reporting, and analysis of device-related adverse events. Experts caution that inadequate reporting can delay risk identification, adversely affecting patient outcomes and public health.
The MVPI was launched by the ministry of health and family welfare on July 06, 2015 to monitor, record, and analyse adverse events associated with medical devices. Since 2018, IPC, an autonomous institution under the Union Health Ministry, has been serving as the National Coordination Centre (NCC) for MvPI, coordinating nationwide data collection, signal detection, capacity building, and regulatory communication with the Central Drugs Standard Control Organisation (CDSCO). |