India: Medical Device Regulatory Updates

Over the last 10 years, India has been trying to implement a Medical Device Act, without success.

In early June, India’s Department of Pharmaceuticals (DOP) released a draft National Medical Device Policy (2015). The policy would create a National Medical Device Authority (NMDA) under the DOP. The policy lays out plans for the NMDA to strengthen India’s domestic device sector, streamline relevant regulations, issue guidelines, and build medical device parks and centers of excellence.

Furthermore, the NMDA may develop a separate price control system for medical devices in the Essential Commodities Act – as well as a separate medical device pricing division under the National Pharmaceuticals Pricing Authority (NPPA). After a comment period, the DOP plans to release a finalized version of these proposed regulations.

Also, in late May 2015, India announced that certain medical devices – such as pacemakers, orthopedic implants, and stents – would be brought under price control and added to the national list of essential medicines.

India’s device market is valued at more than $4 billion and could be worth more than $10 billion by 2020. Approximately three-quarters of medical devices sold in India are imported.