The sub-committee constituted by the Drugs Consultative Committee (DCC), to formulate rules for licensing of 10 medical devices notified as drugs, has to device a fresh set of regulations, as the categories identified are new to the conservative definitions of drugs, it is learnt. The first meeting of the committee to set the rules under the Drugs and Cosmetics Act is to be held within a month.

The sub-committee, consisting officials from Central Drugs Standard Control Organisation (CDSCO) and various state drug control offices, will have to set standard requirements for manufacturing, testing and qualification of technical staffs both in production and testing process for each notified device, according to official sources. The sub-committee was constituted by the DCC by December 2006.

"Our task is to set up 10 Schedule Ms, one for each devices, as they are entirely different in each aspects. The standards of manufacturing, testing facilities and qualification of the technical staffs also should be defined, expecting the far reaching consequences of the rules," a source from the sub-committee told Pharmabiz.

The committee will consider the issues priority wise, in which the first priority will be for furnishing Schedule M for each devices followed by marking specifications of device standards and qualification of staffs and identifying testing labs for licensing and quality assurance respectively.

The terms like implant, which have complex implications in practical, should also be defined prior to preparing rules. The complexity in preparing the basic rules includes the variety of materials and the types of components used in the notified devices. Different components in certain devices would be manufactured in different places, which make the standardization of manufacturing a big task, according to sources.

The committee will also have to decide whether the new products in the sector should undergo clinical trial to attain product license, and the standards of references to be followed if it is needed. The standards would be established with the support of Bureau of Indian Standards (BIS) and Centre for Plastics technology. The experts in the sub-committee also have plans to visit various hospitals in the country to study the basic critical factors involved in the nature of implanting the devices.

As Pharmabiz reported, the medical devices notified by the government as drugs are freely available in the market in the absence of the rules and guidelines. The Central government came up with a hasty notification identifying 10 medical devices as drugs in October 2005, when the Mumbai High Court sought the needful action from the authority.