The Health Ministry has initiated steps to push the long pending bill on medical devices with the consent of the States and hopes to table it in the Parliament during the monsoon session.
The Ministry held a meeting recently with stakeholder associations like FICCI and the Association of Indian Manufacturers of Medical Devices, apart from the senior officials from the Central Drugs Standard Control Organisation (CDSCO) to discuss the issue. In the face of continuing opposition from some States, the meeting decided to follow up the activities to secure the assent of all the States, sources said.
Besides, the Ministry is also reportedly under pressure from Prime Minister’s Office to table the bill in the Parliament at the earliest so that the growing medical devices sector would get a much needed impetus in the form of regulatory mechanism.
“The proposed amendment to the Drugs and Cosmetics Act (D&C Act) will lay down separate provisions for Medical Devices. The salient features of the 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.
Currently, medical devices are treated as drugs. With only 14 notified devices regulated under the D&C Acts, thousands others remain unregulated in the country. The industry, which opposed the moves to increase the number of devices under regulation, wanted separate guidelines and definition for medical devices.
Meanwhile, many States are still opposed to the bill but assent of all the States are required as health is under the concurrent list. 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. The bill has been pending now for over four years.
Hoping that the bill will go to the Parliament during the monsoon session, the ministry had already sought Rs.205 crore from the Planning Commission to set up regulatory mechanism for the sector during the next Five Year Plan period.