The Central Government is likely to bring in amendments to Drugs and Cosmetics Rules within three months to arm the Central Drugs Standard Control Organisation (CDSCO) to regulate the entire range of medical devices manufactured or marketed in the country. The Drug Technical Advisory Board (DTAB) is to take up the issue of medical devices in its forthcoming meeting schedule on August 2, 2005. The Drugs Consultative Committee (DCC) has already given its approval for bringing medical devices under the purview of Drugs and Cosmetics Act.

Informing this to Pharmabiz, Ashwini Kumar, Drugs Controller General of India (DCGI) said that the changes were likely to be in place by September end. "We are already working on the list of medical devices that are to be brought under regulatory control. The DTAB approval is to come in the forthcoming meeting," he said.

The amendment would put an end to the confusion prevailing among various state drug regulatory departments with regard to the powers to ensure quality standards of various medical devices.

The question of bringing medical devices under the Drugs and Cosmetics Act has been engaging the attention of the government for sometime. As of now, there is no separate regulation to control the manufacturing and marketing of medical devices in the country. However, under Section 3(b) (iv) of Drugs and Cosmetics Act, the Central Government has scope to regulate medical devices as may be appropriate from time to time. The DTAB meeting would now endorse the view of DCC to enlarge the regulatory overview on medical devices by bringing all "sterile medical devices" under Section 3(b) (iv) of the Act.

What triggered swift action from the government side was the decision of Maharashtra FDA to mandate quality standards for marketing drug-eluting stents, and to ask companies to obtain prior approval from DCGI to market such products in the state.