India’s draft medical devices policy

• IAS NEXT, Lucknow
• 22, Mar 2022

Reference News:-

Recently, the Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers released an Approach Paper for the Draft National Policy for the Medical Devices, 2022.

Highlights of the Draft:

1. Building Competitiveness through fiscal and financial support for stimulating the development of the local manufacturing ecosystem with private sector investments.
2. Incentivise core technology projects and exports through tax refunds and rebates.
3. Adopt Public-private partnerships to reduce the cost of healthcare and drive efficiency.
4. Create a single-window clearance system for licensing medical devices.
5. Identify critical suppliers and promote local sourcing.
6. Encourage cross-industry collaboration.
7. Increase the share of medical technology companies in research and development to around 50%.
8. A dedicated fund for encouraging joint research involving existing industry players, reputed academic institutions and startups.
9. Incorporate a framework for a coherent pricing regulation to make available quality and effective medical devices to all citizens at affordable prices.

This Policy envisions that by 2047:

1. India Will be having few National Institutes of Medical Devices Education and Research (NIMERs) on the lines of National Institute of Pharmaceutical Education & Research (NIPERs).
2. It will be home & originator to 25 high-end futuristic technologies in MedTech (Medical Technology).
3. It will have a MedTech Industry of USD100-300 Bn size with 10-12% of Global Market Share.

Need for and significance of the policy:

• 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.
• 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.

Government initiatives so far:

1. PLI Scheme for promoting domestic manufacturing of Medical Devices.
2. Promotion of Medical Devices Parks.
3. Medical devices has been recognised as a sunrise sector under the ‘Make in India’ campaign in 2014.