India’s Draft Medical Devices Policy- UPSC Current Affairs

Why in the News?

The Centre is proposing India’s Draft Medical Devices Policy to reduce India’s dependence on the import of high-end medical devices.

Image Source: Times of India

Probable Question

India’s Draft Medical Devices Policy is proposed to reduce India’s dependence on the import of high-end medical devices. Discuss

Key Points

About India’s Draft Medical Devices Policy

• Funding: It proposes to allow a dedicated fund for encouraging joint research involving existing industry players, reputed academic institutions, and startups. 
• Pricing Regulation: It will also incorporate a framework for a coherent pricing regulation to make available quality and effective medical devices to all citizens at an affordable price.
• Focus Areas:
  • incentivizing 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-carbonizing 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 the share of medical technology companies in research and development to around 50 per cent.
• Balancing Industry and Patient Needs: The NPPA (National Pharmaceutical Pricing Authority) shall be strengthened to provide effective price regulation balancing patient and industry needs.
• Bringing Uniformity: The Pharmaceuticals Department will work with the industry to implement a Uniform Code for Medical Device Marketing Practices (UCMDMP). 
• Public-Private Partnership: Adopting public-private partnerships to reduce the cost of healthcare, drive efficiency, and aid quality improvements in medical devices manufactured in the country.

Need for Medical Devices Policy

• Nearly 80 percent of the medical devices currently sold in India 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 percent to nearly 30 percent in the next 10 years and become one of the top five global manufacturing hubs for medical devices by 2047.
• Moreover, 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.

What are the Challenges faced by Medical device manufacturing in India?

• 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)

Potential of the Medical Devices Sector

• According to the approach paper, by 2047, India is expected to be home to $25 billion in medical technology companies and will achieve a 10-12 per cent global market share in the medical devices sector to arrive at a $100-300 billion industry.
• Globally, the market is expected to reach $433 billion by 2025 and is currently dominated by the US, which has a 40 percent market share, Europe with a 25 percent share, and Japan with a 15 percent share. 

Measures to Promote Medical devices manufacturing

• The Centre launched the production-linked incentive scheme (PLI scheme) last year to encourage domestic manufacturing of high-end medical devices.
• Further, it approved applications of manufacturing commitments worth over Rs 730 crore for the production of devices such as CT scans and MRI machines, dialyzers, anaesthesia unit ventilators, transcatheter aortic heart valves, stents, heart occluders, and others.

Significance

• The policy also aims to increase India’s per capita spending on medical devices. India has one of the lowest per capita spending 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.

News Source: The Indian Express

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