Draft National Policy for Medical Devices, 2022
The government is proposing a new Draft National Policy for Medical Devices, 2022 to reduce India’s dependence on import of high-end medical devices.
- Adopting public-private partnerships to reduce the cost of healthcare, drive efficiency, and aid quality improvements in medical devices manufactured in the country.
- It aims to become one of the top five global manufacturing hubs for medical devices by 2047.
•Incentivising the export of medical devices and related technology projects through tax rebates and refunds
•Increasing government spending in “high-risk” projects in the medical devices sector
•Single-window clearance system for licencing medical devices
•Pricing environment with no price control on newly developed innovation in the sector
•Allot a dedicated fund for encouraging joint research involving existing industry players, reputed academic institutions and start-ups.
•NPPA (National Pharmaceutical Pricing Authority) shall be strengthened with adequate manpower of suitable expertise to provide effective price regulation balancing patient and industry needs.
•Pharmaceuticals Department will also work with industry to implement a Uniform Code for Medical Device Marketing Practices (UCMDMP)
- 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.
- The policy also aims to increase India’s per capita spend on medical devices. India has one of the lowest per capita spend on medical devices.
- With the new policy, the government aims to reduce India’s import dependence from 80 per cent to nearly 30 per cent in the next 10 years.
- Indian players in the space have so far typically focussed on low-cost and low-tech products, like consumables and disposables, leading to a higher value share going to foreign companies.
- The key challenges in manufacturing medical devices in India include lack of adequate infrastructure and logistics, concentrated supply chains and high cost of finance.
- Medical devices sector in India is very small in size as compared to the rest of the manufacturing industry though India is the 4th largest market in Asia.
- The Production Linked Incentive (PLI) scheme for promoting domestic manufacturing of Medical Devices.
- Medical devices has been recognised as a sunrise sector under the ‘Make in India’ campaign in 2014.
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