The objections of several states to some of the clauses of the medical devices draft bill are holding up the introduction of this key legislation intended to streamline the operations of this critical sector for more than four years now.

Though the Health Ministry has drafted a final version of the amendment to the Drugs and Cosmetics Act (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 other stakeholders have 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 the 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.

“Government has circulated the draft amendments to the said Bill, containing inter-alia, comprehensive legal provisions for regulating the quality of medical devices marketed in the country to the State/Union Territory Governments for their comments. No final view has so far emerged on account of the general opposition to certain other provisions of the said Bill by the State/Union Territory Governments,” according to official sources.

First the States looked lethargic in responding to the queries sent by the Centre about bringing in a centralised regulation. However, when they sent in the comments, most of them chose to object certain provisions in it, sources added.

The Bill, seeking to bring in the amendment to the D&C Act, 1940, was aimed at incorporating comprehensive provisions to regulate the quality, safety and effectiveness of medical devices manufactured and marketed in the country. The main content of the bill was to establish a Medical Devices Regulatory Authority with adequate powers to ensure standards.

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.