National Medical Commission directs colleges to form panels to track adverse events from devices

NEW DELHI: The National Medical Commission (NMC) has directed all deans and principals of medical colleges across the country to constitute committees for monitoring, assessing and preventing adverse events related to medical devices.

In a public notice, the NMC stated that each medical institution must register such a committee with the Indian Pharmacopoeia Commission (IPC). The notice underlined that medical devices have become an indispensable component of modern healthcare, playing a crucial role in the diagnosis, treatment, and management of diseases.

Citing incidents wherein medical devices have caused harm to patients, the commission emphasised the need for a robust system to monitor such events and implement corrective measures to prevent their recurrence. In response to this, the Ministry of Health and Family Welfare had launched the Materiovigilance Programme of India (MvPI) in 2015 at the IPC, with the objective of monitoring adverse events and risks associated with medical devices used across the country.

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Medical Devices Rules, 2017

The national initiative aims to systematically collect, analyse, and respond to such events, ensuring better patient safety and promoting quality healthcare delivery, the NMC said. Coordinated by the IPC, the programme operates through a growing network of Medical Device Adverse Events Monitoring Centres (MDMCs) established in hospitals and medical colleges.

The Medical Devices Rules, 2017 regulate the import, manufacture, sale, and distribution of medical devices in India, including post-market surveillance. The MvPI seeks to ensure the safety of medical devices throughout their lifecycle by promoting systematic reporting and analysis of adverse events. The data generated is shared with the Central Drugs Standard Control Organisation (CDSCO) to support regulatory action and improvements in clinical practice, the notice said.

Highlighting the benefits of becoming an MDMC, the NMC said medical colleges are well-positioned to serve as centres for materiovigilance due to their diverse patient base and access to advanced medical technologies.

"Becoming an MDMC offers several strategic advantages, including academic recognition, professional development, infrastructure enhancement, policy influence, and enhanced patient safety," the commission noted. The NMC also directed that the name of the committee's Coordinator/Convenor and its members be published on the institution's official website.

The Medical Superintendent shall ordinarily serve as Chairperson of the committee. Medical colleges have also been reminded to update the details of their Pharmacovigilance Committee on their respective websites and complete the registration process by July 31.