The Indian Pharmacopoeia Commission (IPC), under the Ministry of Health and Family Welfare, has urged all Medical Device Marketing Authorisation Holders (MAHs) to ensure strict compliance with adverse event reporting under the Materiovigilance Programme of India (MvPI), stressing that timely reporting is critical to patient safety and effective regulatory oversight.
The IPC stated that the safety and quality of medical devices, including in-vitro diagnostics (IVDs), depend on robust monitoring of device-related adverse events. Inadequate detection or delayed reporting can result in late identification of risks, potentially affecting patient outcomes and public health. A strong post-market surveillance system is therefore essential for early risk detection and timely regulatory intervention.
The Materiovigilance Programme of India was launched on July 6, 2015, to monitor, record, and analyse adverse events related to medical devices. Since 2018, the IPC has been functioning as the National Coordination Centre (NCC) for MvPI, coordinating nationwide activities such as adverse event data collection, signal detection, capacity building, and regulatory communication in collaboration with the Central Drugs Standard Control Organisation (CDSCO).
Emphasising that adverse event reporting is not merely a regulatory requirement but a cornerstone of patient safety, the IPC noted that accurate and timely reporting helps identify new and emerging risks, assess the severity and frequency of known risks, and implement corrective actions including design changes, labelling updates, and field safety corrective actions. It also supports continuous product improvement and builds trust among regulators, healthcare professionals, and patients.
To facilitate seamless and user-friendly reporting, MvPI has established multiple reporting channels. A key digital initiative is the Adverse Drug Reactions Monitoring System (ADRMS), launched on 19 August 2024, which serves as a unified national digital platform for reporting adverse events related to medicines, medical devices, and vaccines, enabling real-time and standardised data capture.
In addition to ADRMS, stakeholders can report adverse events using the MvPI Mobile Application, available on the Google Play Store, which allows healthcare professionals, manufacturers, and patients to submit reports conveniently through smartphones. For those preferring telephonic assistance, a dedicated toll-free helpline (1800-180-3024) remains operational, providing guidance and support for adverse event reporting under MvPI. Prescribed adverse event reporting forms also continue to be accepted.
Despite the availability of these simplified reporting mechanisms, the IPC expressed concern over continued under-reporting by domestic medical device manufacturers, which limits the completeness of national safety data and delays detection of potential risks in the Indian market.
The IPC drew attention to previous policy directions, including a D.O. letter dated 14 October 2022 from the Secretary, Ministry of Health and Family Welfare, highlighting that monitoring medical product safety is an ethical and professional responsibility. It also referred to a DCG(I) circular dated 15 May 2024, reiterating that all medical devices are regulated under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017, and mandating license holders to establish robust post-market surveillance systems and report adverse events to MvPI.
In view of these statutory and policy directives, all Marketing Authorisation Holders have been requested to ensure strict compliance by promptly reporting all medical device adverse events which are serious and non-serious, known and unexpected to NCC-MvPI, preferably through the ADRMS platform.
The IPC concluded that proactive and consistent reporting by MAHs is vital for strengthening India’s materiovigilance ecosystem and ensuring that medical devices marketed and used in the country remain safe, effective, and reliable for patients and healthcare professionals. Training support to enhance understanding of adverse event reporting processes is available through MvPI.
