Govt constitutes committee for regulation of medical devices


NEW DELHI: The Union health ministry has constituted a committee which will advise the Central Drugs Standard Control Organisation (CDSCO) regarding strengthening of medical devices regulations in the country and also examine issues relating to their implementation.

Bringing majority of medical devices under regulation is high on the agenda of the ministry in the second tenure of the Modi government with some incidents of adverse reactions and impacts coming to light with the use of medical devices.

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“The aim is to strengthen the regulations to make medical device companies accountable for quality and safety of their products,” a senior official said.

Recently, global pharma giant Johnson and Johnson was directed to pay compensation to the patients who received faulty hip implants made by the firm.

The Union health ministry is already working towards including new provisions to the Drugs and Cosmetics Act to introduce a compensation plan for patients suffering from adverse reactions due to faulty devices or implants.

“With the approval of the Ministry of Health, it has been decided to constitute a Medical Devices Technical Advisory Group (MDTAG) to advise CDSCO on matters related to regulation of medical devices.

The 22-member MDTAG will be headed by the Drugs Controller General of India (DCGI) as the Chairperson and Deputy Drugs Controller of India, Medical Devices Division, CDSCO as the Member Secretary.

“It has been envisaged to examine the issues relating to implementation of Medical Devices Regulations and to suggest CDSCO regarding strengthening of medical devices regulations in the country including Make In India, Ease of doing business etc., and taking up matters with DCC, DTAB and ministry as per requirement,” the terms of reference as mentioned in a recent office order stated.

The meeting will be called by DCGI at least once in four months at CDSCO headquaters.

DTAG members comprises representatives from Department of Science and Technology(DST), National Institute of Biologicals (NIB), Indian Council of Medical Research (ICMR), Atomic Energy Regulatory Board (AERB), Defence Research and Development Organisation (DRDO), Bureau of Indian Standards (BIS); IIT, New Delhi, Department of Electronics and Information Technology (DEITY), National Health Systems Resource Centre (NHSRC) and Association of Diagnostics Manufacturers of India (ADMI) among others.

The committee also has Dr Sandeep Bansal, HOD, Cardiology, VMMC and Safdarjung Hospital, Dr S N Bhattacharya, head, Department of Dermatology, University College of Medical Sciences, New Delhi, Dr Vijay Kumar Jain, associate professor, Department of Orthopaedics, RML Hospital, New Delhi, Dr Arjun Ahuja, head, Seth G S Medical College and KEM Hospital, Mumbai as members. (AGENCIES)