Parliamentary Panel Recommends Setting Up Of Separate Legislation, Dept & Regulatory Infrastructure For Medical Devices

New Delhi : The Parliamentary Panel, which looks into the matters related to the ministry of health and family welfare, has emphasized on its recommendations to the Central government to set up a separate legislation, create a new department for the industry under the Ministry and a separate regulatory infrastructure for the medical devices.

The recommendation is in line with the industry’s repeated requests in this direction, especially in the recent days in the wake of the scheduled introduction of the New Drugs, Medical Devices and Cosmetics Bill, 2023 in the current Parliament session.

The Department Related Parliamentary Standing Committee on Health and Family Welfare in its 146th report presented in Lok Sabha on August 4, 2023 said, “…the Committee feels that though both are the medical products but the medical devices are not pharmaceuticals. To bring a world class regulatory framework, give boost to the medical device industry and minimise the dependency on imports, a separate Department and separate legislation is required.”

“Accordingly, the Committee again recommends 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 Department of Medical Devices under ministry of health and family welfare,” said the report by the Committee under the chairmanship of Member of Rajya Sabha Bhubaneswar Kalita.

The report was on the action taken by the government on its recommendations in the 138th report on Medical Devices: Regulations and Control based on the action taken notes submitted by the government in April, 2023.

The Committee welcomed the proposal of the Government to constitute a separate Medical Devices Technical Advisory Board to advise the government on technical matters pertaining to medical devices.

They 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 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.

The Committee added that it is of the considered view that to compete with global standards of medical devices, quality control and quality assurance in conformity with international standards play a major role. Accordingly, it re-iterated that in the suggested Medical Devices Bill, there should be stringent standards and certification processes, particularly for Class C&D products.

The parliamentarians in the 138th report, while welcoming the initiative to bring in the new bill with separate provisions for medical devices, strongly recommended that instead of drafting the combined legislation for Drugs, Medical Devices and Cosmetics, the Ministry should appreciate the medical devices industry and formulate a separate legislation.

The Ministry responded that although the proposed Bill “The Drugs, Medical Devices & Cosmetics Bill, 2022’’ is combined bill for regulation of drugs, cosmetics and medical devices, it is proposed to have separate chapter for regulation of medical devices for import, manufacture, sale, distribution, Central/State medical device testing centres and clinical investigation.

Commenting on the recommendation for a separate regulatory framework the Ministry informed that the Ministry is continuously engaged in strengthening of the Central Drugs Standards Control Organisation (CDSCO) in terms of manpower and infrastructure to strengthen the medical device regulation in the country and the CDSCO has recruited manpower from various engineering fields in order to strengthen and effectively regulate the medical devices sector.

It informed the Committee that presently there are 23 Drugs Inspectors (Medical Devices), 236 Medical Device Officers (MDO) and three ADC (Medical Devices) working in CDSCO. Further, recently the Government has created additional 219 posts at various levels to strengthen CDSCO in medical device regulations.

It was after taking these responses into account, the Committee reiterated its recommendations for a separate regulation, separate department and a dedicated regulatory infrastructure for the medical devices industry.

The Committee made a total of 49 recommendations in the 138th report, out of which nine recommendations were accepted by the Ministry. In 26 recommendations, the Committee did not desire to pursue in view of the Ministry’s replies. However, in 11 recommendations, the Committee did not accept the Ministry’s replies and made further recommendations. In three recommendations, the Committee did not receive final replies from the Ministry.

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