India’s draft medical devices policy

GOVERNANCE/ ECONOMY

• GS-2: Government policies and interventions for development in various sectors and issues arising out of their design and implementation.

India’s draft medical devices policy

Context: The government is proposing a new policy to reduce India’s dependence on import of high-end medical devices.

Do You Know?

• By 2047, India is expected to be home to 25 billion-dollar 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 with 40 per cent market share (Europe has 25% and Japan 15% share).
• In China, the sector is valued at around $96 billion and has been growing at a pace of over 20 per cent for several years.

What is the 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 revelations about faulty hip implants marketed by Johnson & Johnson, exposed the lack of regulatory teeth when it came to medical devices
• 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.
• India suffers from a considerable cost of manufacturing disability vis-à-vis competing economies, which needs to be rectified so as to achieve self-reliance in the sector.

What are the factors that has led to domestic disability in medical devices sector?

• Lack of adequate infrastructure
• Inefficient 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
• Cheap imports available from other countries

What are the key focus areas of the draft policy?

• The key focus areas of the draft policy include 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
  • International collaboration 
  • 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. The NPPA (National Pharmaceutical Pricing Authority) will be empowered for this purpose.
• The Pharmaceuticals Department will also work with industry to implement a Uniform Code for Medical Device Marketing Practices (UCMDMP). 

Conclusion

• The medical devices sector in India is an essential and integral constituent of the Indian healthcare sector, particularly for the prevention, diagnosis, treatment and management of all medical conditions, diseases, illnesses, and disabilities

Connecting the dots:

• Production-linked incentive scheme (PLI scheme) for medical devices industry
• Government Price control on stents