Notwithstanding the opposition from many states, the union health ministry wants to amend the Drugs and Cosmetics Act (D&C Act) to provide separate definition of medical devices and has sought an allocation of Rs. 205 crore from the Planning Commission to set up regulatory mechanism for the sector during the next Five Year Plan period.
Besides, the ministry also wants to bring all medical devices under regulation since only 14 medical devices are notified and under regulation at present, sources said. The ministry is examining the amendments to the D & C Act to bring a bill and introduce it in Parliament.
“The Government has already initiated steps to amend the D&C Act to have separate provisions for Medical Devices. The salient features of the proposed bill would be to provide a separate definition of Medical Devices, their risk based classification for regulatory control, Clinical Trials on Medical Devices, Conformity Assessment Procedures, Penal provisions, etc,” sources said.
The ministry has forwarded a proposal to the Planning Commission to strengthen the CDSCO in terms of manpower and infrastructure to take up additional responsibilities in the growing area of medical devices.
As per the proposal, it needed 300 personnel to man the sector. Besides, it will appoint 10 experts in the field of medical devices as the regulation required multi-disciplinary experts like bio-technologist, bio-materialists and electric engineer.
The proposal also suggests setting up of category-wise five national medical devices testing laboratories with each of them would require Rs. 40 crore each. Apart from this Rs. 200 crore, it also sought Rs. 5 crore for international travel for the personnel.
Sources said, though 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 put the bill on the hold.
The consensus still eluded the consultations and a final view could not be taken so far to introduce the bill in Parliament, though the move has been pending for almost four years now. The ministry had circulated the draft among the states, after revising it on the basis of the recommendations by the Parliamentary Standing Committee attached to the Health Ministry since health is under the Concurrent List.
The proposed Authority, under the Bill, will have a classification of devices, notify standards and guidelines from time to time, provide a mechanism for conformity assessment using direct or third party notified bodies and stipulate the procedure and guidelines for testing laboratories. The Bill, framed after many rounds of consultations with the industry under the guidance of the DCGI, has laid down the regulations from an India-specific angle.