The Central government is considering a proposal to set up a separate committee under the Office of the Drugs Controller General of India (DCGI) to monitor the quality of medical devices used in the country. Prescribing quality specifications for the devices and GMP norms for the manufacturers of these medical devices and diagnostic equipment would also be part of the responsibilities of the committee.

According to highly placed DCGI sources, medical devices regulation will be carried out under guidance from the expert panels set up by DCGI. The department is to take the existing DRDO document on the quality of medical devices as a benchmark to begin with and expand the scope of the document after more discussions. DRDO document is the only document on medical devices in the country.

ICMR is also to be asked to be part of the expert panels to ensure the quality of medical devices. "Once the regulatory system is in place, it can be converted into a totally independent regulatory agency," they opined.

Sources said that the plans for setting up the committee has been based on the recommendations of the Mashelkar Committee set up for introducing quality specifications for medical devices. The Central Drug Standard Control Organization (CDSCO) attached to the office of DCGI had organized a national workshop to gather suggestions from the medical devices manufacturing industry on how to lay down GMP norms for medical devices and inspection of medical devices manufacturing units. The officials are also in the process of understanding the international scenario with respect to the regulation of medical device manufacturing and marketing, it is learnt.

In the beginning, the DCGI is to initiate the preparation of a comprehensive list of all medical devices and diagnostic equipment available in India. It may seek the help of the Bureau of Indian Standards (BIS) to come out with standards and specifications for each of these products also. This is to help the authorities have a clear idea of the current status of Indian medical equipment manufacturing sector.

It is known that there are more than 5,000 medical devices including various kinds of diagnostic kits that are available in international market. Though India's production in this segment is limited to 1000 odd products, almost all devices are available in local market. While there are four categories of medical devices according to the internationally accepted norms, India has no clear distinction in this aspect. Categorization of medical equipment-manufacturing sector is based on the risk factor associated with each product.