NEW DELHI: A parliamentary panel has called for an independent regulator for the medical devices industry to encourage domestic manufacturing and reduce the dependency on costly imports.
The Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General (India), regulates the import, manufacture and distribution of notified medical devices under the provisions of the Drugs and Cosmetics Act, 1940.
The panel headed by BJP MP Prabhat Jha said that it is distressing to note the manner in which the regulatory framework under CDSCO is going to function without a full time Drugs Controller General (India). It also noted that the overall administrative structure to regulate the health sector in the country needs to be restructured.
The medical devices industry in India is at a nascent stage and nearly 75 per cent of the total requirement of medical devices is met by imports. Domestic production, with a few exceptions, is restricted to low end medical devices.
Most medical devices, unlike medicines, are not sold in retail and devices of different sizes are stocked in hospitals keeping in view the requirements of individual patients.
The sale of such devices is, therefore, largely through hospitals. The committee also expressed concern over health-related issues being regulated by the Union Ministry of Chemical and Fertilisers. The panel recommended a fresh approach to understand the need for continued regulation of drugs by the Ministry of Chemical and Fertilisers.