The Indian medical device industry is disarray. Even industry representatives admit so. For instance, Rajiv Nath, the forum coordinator of the Association of Indian Medical Device Industry, goes so far as to state that the sector is “in a state of complete mess”.
That’s because about 99% of medical devices such as ultrasound machines, glucometers, endoscopes and ventilators are not regulated by the government. To remedy this, the Ministry of Health and Family Welfare in October made a revised draft of the Medical Device Rules public for comment. However, though there are over 5,000 kinds of medical devices in the market, the draft rules cover only about 20 devices – stents, orthopedic implants, ocular lenses, condoms, sutures and surgical dressings – that have been notified under the Drugs and Cosmetics Act, 1940.
