Health Ministry to Form Expert Committee for Monitoring Adverse Effects of Medical Devices

The health ministry is seeking specialists in cardiology, gastroenterology, gynecology, neurology, and radiology to be part of this expert panel.

The Ministry of Health and Family Welfare is set to establish an expert committee dedicated to monitoring adverse effects caused by medical devices, to enhance patient safety.

The committee will be tasked with tracking, recording, and analyzing the root causes of adverse events related to the use of medical devices, including in-vitro diagnostics, and recommending measures to mitigate these risks, as reported by Mint.

The health ministry is seeking specialists in cardiology, gastroenterology, gynecology, neurology, and radiology to be part of this expert panel.

These experts will evaluate reported incidents and suggest appropriate corrective actions.

Medical devices encompass a wide range of equipment, from electronic diagnostic tools and surgical instruments to implants, consumables, disposables, and in-vitro diagnostic reagents.

These devices are crucial for medical diagnosis, patient support, and safety, often functioning as life-saving tools.

Certain devices, such as X-ray machines, are considered more prone to causing adverse effects. Experts believe that monitoring their performance is essential to prevent potential health risks.

Currently, the India Pharmacopoeia Commission (IPC) oversees the Materiovigilance Program of India (MvPI), which handles initial assessments of reported cases.

These cases are then reviewed by a panel of experts from institutions like the National Health Systems Resource Centre (NHSRC), Sree Chitra Tirunal Institute of Medical Sciences and Technology (SCTIMST), and the Central Drugs Standard Control Organization (CDSCO).

Based on these reviews, MvPI provides recommendations to CDSCO for further action and issues safety alerts to Medical Device Adverse Event Monitoring Centres (MDMCs) and Adverse Drug Reactions Monitoring Centres (AMCs) across India.

Concerns Over Pre-Owned Imports

India relies heavily on imported medical devices, with 80% of its devices sourced from abroad.

Of the INR 44,000 Cr spent on medical electronic equipment imports, over 60% comprises pre-owned devices, according to industry estimates.

Experts have raised concerns that adverse events are more commonly associated with these pre-owned devices due to inadequate calibration facilities and insufficient regulatory oversight.

“Lack of proper validation for accuracy and results can lead to incorrect diagnoses or unsafe exposure levels,” said Rajiv Nath from the Association of Indian Manufacturers of Medical Devices (AIMeD).

Despite these challenges, the Indian medtech industry is experiencing significant growth.

According to AIMeD, the domestic medical technology market was valued at approximately $12 billion in 2023-24 and is projected to surpass $50 billion by 2030.

The formation of the expert committee is seen as a critical step in ensuring that this growth is accompanied by robust safety and regulatory measures to protect patients.

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