Centre exploring new pricing strategies for medical device industry

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.

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.

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. “We are considering all possibilities and seeking input from industry associations and experts, although decisions are still in the preliminary stages and nothing has been finalized,” said an official aware of the development.

The panel will suggest changes to the pricing framework for both drugs and medical devices, and work on reforms within the NPPA to establish a price moderation framework, encourage reduced imports, and develop pricing strategies for emerging and precision therapies to ensure timely patient access.

It will also supervise the drafting of a new Drugs and Medical Devices (Control) Order, taking into account these objectives.

The government last year approved the National Medical Device Policy, 2023, to help the medical devices sector grow from the present $11 billion to $50 billion by 2030. India is 80% dependent on imported medical devices.

Some of the prominent players in the sector include Medtronic, Trivitron, Novartis, and Abbott.

The Indian manufacturers and pricing when compared to other countries are the lowest. LiveMint