Govt plans new pricing norms for medical device industry

livemint.com:

NEW DELHI : The government is exploring new pricing strategies for the medical device industry and also looking at specific regulations to streamline the licensing, trading, and exporting processes for manufacturers, according to officials familiar with the situation. Medical device licences are currently categorized under the Drugs and Cosmetics Act, and industry associations have long advocated for specific regulations, arguing that the criteria for drug licensing are not suitable for medical devices.

Specific regulations for the medical device industry will streamline the approval process, enabling manufacturers to secure clinical trial approvals and sales licences within a short period. The National Pharmaceutical Pricing Authority (NPPA), which is working on establishing price controls for medical devices in addition to drugs, had in February set up a committee to look into revising the pricing policy of drugs and medical devices.

The committee comprised five core members and later added 12 more representatives from pharma and medical devices associations following requests for broader representation. Also Read: L&T's Naik, Madhusudan Kela bet on this medical devices maker that battles strokes In 2020, the government had regulated 24 types of medical devices, which are considered drugs under the Drugs & Cosmetics Act, 1940, and Drugs and Cosmetics Rules, 1945.

Among these, cardiac stents, drug-eluting stents, condoms and intra-uterine device, are under price control. The NPPA is also exploring international pricing and regulatory strategies for medical devices.