Govt proposes Draft Medical Devices Policy
- Draft Medical Devices Policy to reduce dependence on import of high-end medical devices was recently announced
- Some of the proposals include incentivising the export of medical devices and related technology projects through tax rebates and refunds,
- It also proposes to increase government spending in “high-risk” projects in the medical devices sector, and a single-window clearance system for licensing medical devices.
Draft National Policy for Medical Devices, 2022
- The Policy is proposed by the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilisers
- It has proposed adopting a public-private partnership to reduce the cost of healthcare, drive efficiency, and aid quality improvements in medical devices manufactured in the country.
- It has also proposed enabling a pricing environment with no price control on newly developed innovation in the sector.
- It also proposes to allot a dedicated fund for encouraging joint research involving existing industry players, reputed academic institutions, and startups.
- The policy also 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 of $47, and significantly lower than the per capita consumption of developed nations like the USA at $415 and Germany at $313.
Need for such a policy
- Nearly 80 per cent of the medical devices currently sold in the country are imported, particularly high-end devices.
- 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.
- India’s medical devices sector has so far been regulated as per provisions under the Drugs and Cosmetics Act of 1940
- A specific policy on medical devices has been a long-standing demand from the industry.
key focus areas of the draft policy
- Incentivising core technology projects and exports through tax refunds and rebates,
- Creating a single-window clearance system for licensing medical devices
- Identifying critical suppliers
- De-risking and decarbonising the supply chain
- Promoting local sourcing
- Encouraging cross-industry collaboration
- Creating a central pool of vendors and workers
- Establishing a dedicated mechanism for the local industry’s engagements with international regulatory agencies, and
- Increasing share of medical technology companies in research and development to around 50 percent
Other measures to promote medical devices manufacturing in India
- Production-linked incentive scheme (PLI scheme) to encourage domestic manufacturing of high-end medical devices, and
- Approval of applications of manufacturing commitments worth over Rs 730 crore for production of devices such as CT Scan and MRI machines, dialysers, anesthesia unit ventilators, transcatheter aortic heart valves, stents, heart occluders, and others.
Conclusion
- Such policies are need of the hour as the medical devices sector in India suffers from a considerable cost of manufacturing disability vis-à-vis competing economies, inter alia, on account of lack of adequate infrastructure, domestic supply chain and logistics, high cost of finance, inadequate availability of power, limited design capabilities, low focus on research and development (R&D) and skill development.