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Government to implement revised pricing regulations for medical device sector

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In Short:

The government is looking at new pricing strategies and specific regulations to streamline licensing, trading, and exporting processes for medical devices. This will help in faster approval, clinical trial, and sales licenses for manufacturers. NPPA is revising pricing policy for both drugs and medical devices, exploring international pricing strategies, and developing a new control order. The target is to grow the medical devices sector to $50 billion by 2030.


Government planning new pricing strategies for medical device industry

Government officials are currently exploring new pricing strategies for the medical device industry in **New Delhi**. They are also looking into specific regulations to streamline the licensing, trading, and exporting processes for manufacturers.

Streamlining regulations for the medical device industry

Medical device licenses are currently categorized under the Drugs and Cosmetics Act. Industry associations have been advocating for specific regulations, noting that the criteria for drug licensing are not suitable for medical devices.

The introduction of specific regulations for the medical device industry would streamline the approval process, allowing manufacturers to secure clinical trial approvals and sales licenses more efficiently.

NPPA working on price controls

The National Pharmaceutical Pricing Authority (NPPA) is working on establishing price controls for medical devices. In February, a committee was set up to revise the pricing policy of drugs and medical devices. The committee has been expanded to include representatives from pharma and medical devices associations for broader representation.

Key objectives and initiatives

The committee’s main objectives include suggesting changes to the pricing framework for drugs and medical devices, reforming the NPPA to establish a price moderation framework, reducing imports, and developing pricing strategies for emerging and precision therapies to ensure timely patient access.

The government approved the National Medical Device Policy in 2023 to support the growth of the medical devices sector, aiming to increase the industry size from $11 billion to $50 billion by 2030. Currently, India is heavily dependent on imported medical devices.

Industry insights

Notable players in the medical device sector in India include **Medtronic**, **Trivitron**, **Novartis**, and **Abbott**. Satyaki Banerjee, executive director and group chief operating officer of Trivitron Healthcare, emphasized the importance of government support for the industry’s growth.

According to Banerjee, the Indian medical devices industry is still developing, and the pricing in India is comparatively low when compared to other countries. He stressed the need for the government to take a keen interest in supporting the medical device fraternity.

Summary

The government’s plans to introduce new pricing strategies and regulations for the medical device industry in India aim to foster growth, support local manufacturers, and ensure timely access to medical devices for patients.

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