India’s Regulated Medical Devices to Further Face Price Regulation

The Indian government collaborated with the National Pharmaceutical Pricing Authority (NPPA) to evaluate the pricing of medical devices that are regulated under the Drugs and Cosmetics Act. The most noticeable finding was that these regulated medical devices can vary drastically in terms of selling price.

Catheters were given as an example. Low value sophisticated catheters in India are currently priced at approximately USD $250, but the most expensive catheters are closer to USD $1,800. This trend in highly varied prices is quite common amongst the medical devices controlled by the Drugs and Cosmetics Act. The medical devices that are regulated under the Drugs and Cosmetics Act include orthopedic implants, stents, heart valves and more. Upon reviewing this finding, the Indian government is looking to address the price disparity.

Currently, the NPPA has been summoned to investigate medical device pricing outside of India. With that new information, the Indian government plans to create a new Schedule (i.e. government notice) to regulate medical device prices. India is still exploring the opportunities for comprehensive medical device regulation, so there is a chance that price regulations will not be effective until the overarching medical device Schedule is implemented.