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Draft Medical Devices Policy

Context:

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.

Relevance:

GS II- Government Policies and Interventions

Dimensions of the Article:
  1. Key focus areas of the draft policy
  2. Need for such a policy

Key focus areas of the draft policy

Objectives:

  • 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.
  • Enabling a pricing environment with no price control on newly developed innovation in the sector.
Some of the proposals include
  • 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,
  • 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 de-carbonising 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,
  • Increasing share of medical technology companies in research and development to around 50 per cent, among other things.
  • It also proposes to allot a dedicated fund for encouraging joint research involving existing industry players, reputed academic institutions and startups.
  • It will also 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.
  • Pharmaceuticals Department will also work with industry to implement a Uniform Code for Medical Device Marketing Practices (UCMDMP)

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.
  • 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, and become one of the top five global manufacturing hubs for medical devices by 2047.
  • 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 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.

-Source: Indian Express

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October 2022
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