Scheme for Strengthening the Medical Device Industry

Syllabus: GS2/Government Policy and Intervention; Health

Context

• Recently, the Union Minister Health & Family Welfare launched the Scheme for Strengthening the Medical Device Industry to enhance the manufacturing capabilities, infrastructure, and overall growth of the medical device industry in India.

About the Medical Device Industry in India

• Medical devices are integral to healthcare delivery, from diagnostic machines to surgical instruments to stents and prosthetics.

• India’s medical device market is currently valued at approximately $14 billion and is expected to grow to $30 billion by 2030 which is fueled by rising healthcare demands, increased investment in healthcare infrastructure, and a growing focus on innovation and technology.
• It is expected to enhance the availability and affordability of these devices, thereby improving healthcare outcomes.

Key Concerns and Challenges Ahead of the Medical Device Industry in India

• Regulatory Challenges: The industry has long called for streamlined and clear regulations. The National Medical Devices Policy, 2023, aims to address these issues by creating a more coherent policy framework.
  • However, the implementation and adaptation to these new regulations can be complex and time-consuming for manufacturers.
• Infrastructure and Technology: The lack of advanced infrastructure and technology for high-end medical equipment remains a significant hurdle.
  • While the government has approved the establishment of medical device parks to reduce manufacturing costs and optimise resources, the industry still faces challenges in accessing cutting-edge technology and infrastructure.
• Skilled Workforce: The medical device sector requires a highly skilled workforce, but there is a notable gap in the availability of trained professionals.
• Market Dynamics: India’s medical device market is heavily dependent on imports, with a significant portion of high-end devices being sourced from countries like the U.S., China, and Germany.
  • It not only affects the trade balance but also makes the industry vulnerable to global supply chain disruptions.
• Research and Development (R&D): Investment in R&D is crucial for innovation and competitiveness. However, the Indian medical device industry has historically underinvested in R&D.

Need For Strengthening the Medical Device Industry in India

• Manufacturing Enhancement: The scheme focuses on the production of key components and accessories essential for medical devices.
  • It includes support for setting up new manufacturing units and upgrading existing ones to meet global standards.
• Skill Development: Recognising the need for a skilled workforce, the scheme includes provisions for training and development programs.
  • These aim to equip individuals with the necessary skills to operate advanced medical device manufacturing technologies.
• Support for Clinical Studies: To ensure the safety and efficacy of medical devices, the scheme provides support for clinical trials and studies.
  • It aims to help in the development of innovative and reliable medical devices.
• Infrastructure Development: The scheme promotes the establishment of common infrastructure facilities such as testing centres, research and development hubs, and logistics centres.
  • These facilities are intended to support the entire medical device manufacturing ecosystem.
• Industry Promotion: Various promotional activities are planned under the scheme to boost the visibility and competitiveness of Indian medical devices in the global market.
  • It includes participation in international trade fairs, exhibitions, and other industry events.

Financial Outlay of The Scheme

• The scheme has a total outlay of ₹500 crores under Sub-schemes like Common Facilities for Medical Devices Clusters; Marginal Investment Scheme for Reducing Import Dependence; Capacity Building and Skill Development for Medical Devices; Medical Device Clinical Studies Support Scheme; and Medical Device Promotion Scheme.
• This significant investment underscores the government’s commitment to making India a global hub for medical device manufacturing.

Key Features of the Scheme

• Self-Reliance: The scheme is a significant step towards making India self-reliant in the medical device sector, reducing dependency on imports1.
• Economic Growth: By boosting domestic manufacturing, the scheme aims to contribute to the overall economic growth and create job opportunities.
• Innovation and Quality: Emphasis on innovation and maintaining high-quality standards to compete globally.

Impact of the Scheme and Future Prospects

• It is expected to not only strengthen the domestic manufacturing capabilities but also reduce dependency on imports, thereby making India self-reliant in the medical device sector.
• The scheme is poised to create numerous job opportunities, foster innovation, and ensure the availability of high-quality medical devices at affordable prices. 
• As the demand for medical devices continues to rise, this initiative will play a crucial role in meeting both domestic and international needs.

Conclusion

• The Scheme for Strengthening the Medical Device Industry is a strategic initiative to enhance the domestic manufacturing capabilities, promote innovation, and ensure the availability of high-quality medical devices.
• This scheme not only aims to make India self-reliant but also positions it as a global leader in the medical device sector.

Source: PIB