The Mashelkar committee is not in favour of the proposal put forth by the Society for Biomedical Technology (SBMT) to set up Indian Medical Devices Regulatory Authority. The committee feels that it is appropriate to make use of the existing countrywide infrastructure facilities of drugs control administration for the purpose. It has also said that the regulation of medical devices is the job of drug regulatory authorities in several other countries as well.

Instead the committee recommended for the inclusion of a specific definition for “medical devices” under Section 3 of Drugs and Cosmetics Act. It has proposed a separate Medical Devices Division in the office of Central Drug Standard Control Organisation (CDSCO) and the setting up of appropriate regulatory mechanism for certification, quality assurance and post-marketing surveillance of imported as well as locally made medical devices.

The SBMT wanted to lay down a mechanism for essential certification of high-risk devices and preferred certification for moderate devices by assessing the safety and efficacy data and also monitoring the post marketing surveillance.

Currently medical devises are considered under the definition of “drug” under Section 3 (b) of D & C Act. No regulatory mechanism exists for certification, quality assurance and post marketing surveillance of imported and locally made medical devices except for the notified devices and diagnostics. Many of these devices are sterilized using various techniques, efficiency of which need to be validated.

Highly placed sources with DCGI informed that CDSCO has already initiated measures to build up capacities to have such a separate division. The recommendation of Mashelkar panel will only speed up and strengthen the initiative, they felt. The committee has observed that the proposed Central Drug Administration (CDA) should aim for adequate enforcement over medical devices in general, by increasing the existing capacity through formation of a separate division. The division should have adequate in-house expertise as well as a networking with external experts and institutions.

The Pharmaceutical Research and Development Committee had also in its report of 1999 recommended the creation of a specific medical devices division within the CDSCO.