The Central Drugs Standard Control Organisation (CDSCO) is seriously working on a credible system to take care of the approval and post approval surveillance of medical devices in the country. An expert committee has been set up by the CDSCO to look into the matter, it is learnt. The committee is to suggest practical measures that are in tune with the Mashelkar Committee recommendations on quality upgradation of Indian drug regulatory system.
It should be noted that the Mashelkar committee had rejected the proposal for setting up an independent Indian Medical Devices Regulatory Authority and had called for making use of the existing countrywide infrastructure facilities of drugs control administration for the purpose. He had also said that the regulation of medical devices was the job of drug regulatory authorities in several other countries as well.
The Mashelkar Panel had recommended the inclusion of a specific definition for "medical devices" under Section 3 of Drugs and Cosmetics Act. It also called for a separate Medical Devices Division within CDSCO. The mandate of this division was to serve as a regulatory mechanism for certification, quality assurance and post-marketing surveillance of imported as well as locally made medical devices.
Currently, medical devices 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.
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.