India’s health ministry is planning to amend 72-year-old Drugs and Cosmetics Act in order to recognize medical devices as a separate category. There are currently only 14 medical devices regulated by the Drug Controller General of India (DCGI). Amending the Drugs and Cosmetics Act would bring all medical devices under regulation in India.
The revised Medical Devices Bill will provide separate definition of medical devices and has sought Rs 205 crore allocations from the Planning Commission so as to develop a regulatory mechanism for the sector during the next Five Year Plan period.
In addition, the ministry is also considering to bring all medical devices under the ambit of regulation as at present only 14 medical devices are notified and under regulation. Currently, the ministry is examining the rectifications to the D&C Act to bring a bill and introduce it in Parliament.
The Indian health ministry also plans to increase staff and infrastructure at the Central Drugs Standard Control Organization’s (CDSCO) medical device division to support expansion of the government’s regulatory scope.
At the same time, the ministry has forwarded a proposal to the Planning Commission to fortify the manpower and infrastructure of Central Drugs Standard Control Organization (CDSCO) so that it can handle additional responsibilities in the growing area of medical devices.
According to the proposal, the organization requires 300 personnel to man the sector. In addition, the company is also considering to appoint 10 experts in the field of medical devices as the regulation needs multi-disciplinary experts like bio-technologist, bio-materialists and electric engineer.
Indian Drug Controller General VG Somani said the Health Ministry looks forward to amending the present Drugs and Cosmetics Act, which was first enacted in 1940 and has put a proposal for the same before the Planning Commission. ‘’the amendment is aimed to recognise medical device, as a separate category that is presently put in the same segment as drugs, and ensure easier regulation” he added
According to sources, the health ministry had drafted a final version of the amendment to the D&C Act incorporating the concerns of the industry and the inputs from the Department of Science and Technology, the strong opposition by some states and some stakeholders had put the bill on the hold.