Medical Devices Draft Bill 2019: Niti Ayog holds meeting with affected patients, stakeholders

New Delhi: The Government's think tank- Niti Ayog has stepped up in curing the malaise due to faulty medical devices as it has gone ahead and met the stakeholders including the troubled-stricken patients of faulty hip implants to help build consensus on the proposed regulation of medical device.

A couple of months ago, the Niti Ayog proposed a draft bill, Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019 to bring all medical devices under one regulatory regime. The bill is tailored to provide users with access to safe innovative devices and address the concerns on patient safety and reduce import dependency that is currently pegged at almost Rs 39000 crore, reports IANS.

It is to be noted that presently medical devices and drugs, both are regulated by the Central Drugs Standard Control Organisation(CDSCO) under the Drugs and Cosmetics Act, 1940. However, the draft bill calls for an independent regulator to govern medical devices. This comes in a wake of various lives affected by faulty hip implants manufactured by Johnson and Johnson (JnJ).

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The Government will proposedly set up Medical Devices Administration under the Directorate General of Health Services(DGHS). There will be four separate divisions under the new Medical Devices Administration — health and safety division, conformity assessment division, enforcement division, and the laboratories and medical devices testing division.

According to a recent report in Business Standard, the draft also proposes to do away with the need to have manufacturing licences to register a medical device or get a certificate of compliance. Moreover, the draft proposes to allow victims of faulty implants and medical devices to demand compensation from manufacturers or importing companies.

In this regard, Niti Ayog conducted stakeholders meeting on December 18 to brief and explain the key features of the bill to the civil society groups, medical device lobby groups, former drug controllers, current state drug controllers and patients from the J&J, reports ET.

As per IANS, the medical device industry has responded positively to the bill. Industry bodies expect the proposed medical devices Bill will help India emerge as one of the leaders in this sector. Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AiMeD) described it as a visionary and well thought out the road map.

"We await the copy of presentation and copy of actual draft Bill to give our studied comments, clause wise." he added.