[Answered] India’s draft medical devices policy will reduce India’s dependence on import of high-end medical devices. Explain how the draft policy will promote medical devices manufacturing in India?

As per the 7th Schedule of the Indian Constitution, drugs fall under the Concurrent List and the definition of medical devices was introduced in 1982, under the definition of drugs under the Drugs and Cosmetics Act, 1940. Thus, as per its authority, the government is proposing a new draft medical devices policy.

What is the need for such a policy?

• Indian health care industry has so far typically focused on low-cost and low-tech products, like consumables and disposables. It means India is dependent upon imports for high tech products.
• A specific policy on medical devices is needed as no quality parameters are present which leads to negligence as in J&J Hips implant case.
• The medical devices sector in India suffers from a considerable cost of manufacturing disability on account of lack of adequate infrastructure, domestic supply chain and logistics issues, high cost of finance, inadequate availability of power, low focus on research and development (R&D) and skill development etc.
• It is desired to encourage domestic manufacturing of high-end medical devices.

Significance for manufacturing sector:

• It will increase export of high-end medical devices by incentivising the export and related technology projects through tax rebates and increasing government spending in “high-risk” projects.
• Important step in positioning India as a hub for manufacturing of medical devices as part of the“Make in India, Make for the World” initiative.
• 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. It will increase India’s per capita spend on medical devices, thus stimulating the development of the local manufacturing ecosystem with private sector investments.
• By incentivising core technology projects and creating a single-window clearance system for licensing medical devices, it will promote local sourcing of medical devices.
• The local industry’s engagements with international regulatory agencies and medical technology companies in research and development will be helpful in Human Resource Development and skilling of various stakeholders for innovative value chain.

Nearly 80% of the medical devices used in the country are imported products, particularly high-end devices and medical equipment. The focus should be on enhancing competency of the Indian medical devices sector through skilling in alignment with the medical and technological advancements.