Parliamentary committee recommends a separate medical devices Bill

According to sources, DCGI has convened a meeting in Delhi on August 10 to discuss matters related to the draft New Drugs, Medical Devices and Cosmetics Bill, 2023

Amid a tussle between the medical device makers lobby and the Centre, the Parliamentary standing committee on health and family welfare has recommended having a separate legislation for medical devices and also a new department for medical devices under the health ministry.

According to sources, the Drugs Controller General of India (DCGI) has convened a meeting in Delhi on August 10 to discuss matters related to the draft New Drugs, Medical Devices and Cosmetics Bill, 2023.

The panel said in a report tabled in the House on August 4 that “instead of bringing a combined legislation for drugs, medical devices and cosmetics, the ministry should formulate a separate legislation for medical devices and create a new department, namely the Department of Medical Devices”.

It felt that to have a “world-class regulatory framework”, boost the medical device industry, and minimise dependency on imports, a separate department and separate legislation is required. “… the committee feels that though both are medical products but the medical devices are not pharmaceuticals,” the report said.

“The committee has observed that in recent years the indigenous medical industry is growing fast and to match with the pace existing drug inspectors (medical devices) and medical device officers working under the CDSCO would not be able to cater the needs of the industry. Therefore, a separate regulatory infrastructure for medical devices with dedicated work force instead of adjoining with the CDSCO would serve the purpose better,” it said.

Last week, medical device makers, patient interest groups, hospitals among others had written to the Union Health Minister Mansukh Mandaviya seeking a separate Bill for medical devices distinct from drugs, and also recall the draft New Drugs, Medical Devices and Cosmetics Bill, 2023 that is likely to be tabled in the monsoon session.

In a joint plea, the Association of the Indian Medical Devices Industry (AiMeD) has requested the health minister to recall the new draft Bill, stating that the Bill, if passed, would push the sector into a “supply chain crisis” and would “effectively lose its ability to meet domestic demand”.

Sources said the stakeholders met government officials on Wednesday to discuss the matter.

The associations have demanded a separate Medical Devices Act, different from the one meant for regulation of Drugs and also stressed on the need to treat regulatory framework for medical devices as a separate legislative book from drugs. This has been a long-standing demand from the industry.