The much-awaited initiative to streamline the medical devices sector with a centralised regulation has been delayed after the state governments failed to send comments on the proposed the Drugs & Cosmetics (amendment) Bill aimed at laying down standards for the sector.

Though the Centre was keen to bring the Bill to the House during the current Monsoon Session and had reiterated its resolve time and again, none of the states has responded to the instruction by the Centre which circulated the draft to the States and the Union Territories some time back. "No final view has been formed as responses from the States were yet to reach," official sources disclosed.

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.

Union minister of state for health and family welfare Dinesh Trivedi had recently announced that the bill would be introduced in the Parliament during the Monsoon Session and the Health Ministry was waiting for the concurrence of the States.

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.

The industry has been calling for a comprehensive regulation as the medical devices were currently governed by the laws stipulated for the drugs whereas both the segments differed drastically by their nature. So primarily, the proposed legislation would be treating the medical devices as separate category instead of clubbing it with the drugs.