Mumbai: India plans to set up a regulator to oversee the country’s $4 billion medical device industry, according to a draft policy released this month, the country’s first effort to regulate an industry that covers everything from thermometers to prostheses. The policy document, welcomed by many in the industry despite concerns over a lack of detail, also outlines plans to boost local manufacturing and reduce reliance on imports. While India is the world’s third-largest pharmaceutical market, its share of the medical devices market is way behind.
More than 70% of medical equipment sold in the country is imported, mostly from the US. The draft policy issued by the central Department of Pharmaceuticals proposes an autonomous National Medical Device Authority tasked with promoting the local industry and ensuring adherence to safety standards. It also proposes price controls for devices…