Explained: India’s draft medical devices policy, and why it is needed

What is the News?

The Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers has released “Draft National Policy for the Medical Devices, 2022.

What is the Medical Devices Sector?

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What is the need for National Policy for the Medical Devices?

Firstly, nearly 80% of the medical devices currently sold in the country are imported, particularly high-end devices. This new policy aims to reduce India’s import dependence to nearly 30% in the next 10 years.

Secondly, India’s medical devices sector has so far been regulated as per provisions under the Drugs and Cosmetics Act of 1940 and a specific policy on medical devices has been a long-standing demand from the industry.

Thirdly, the policy aims to increase India’s per capita spending on medical devices. India has one of the lowest per capita spend on medical devices at $3 compared to the global average of per capita consumption $47.

What are the salient features of the policy?

The policy will

– Incentivise core technology projects and exports through tax refunds and rebates.

– Adopt Public-private partnerships to reduce the cost of healthcare and drive efficiency.

– Create a single-window clearance system for licensing medical devices.

– Identify critical suppliers and promote local sourcing.

– Encourage cross-industry collaboration.

– Increase the share of medical technology companies in research and development to around 50%.

– A dedicated fund for encouraging joint research involving existing industry players, reputed academic institutions and startups.

– Incorporate a framework for a coherent pricing regulation to make available quality and effective medical devices to all citizens at affordable prices.

– NPPA (National Pharmaceutical Pricing Authority) shall be strengthened with adequate manpower of suitable expertise to provide effective price regulation, balancing patient and industry needs.

Source: This post is based on the article “Explained: India’s draft medical devices policy, and why it is needed” published in Indian Express on 16th Mar 2022.