India Approves National Medical Devices Policy 2023 to Foster Growth and Innovation

India's Union Cabinet has recently given its approval to the National Medical Devices (NMD) Policy, 2023. This policy aims to accelerate the growth of the medical devices sector by focusing on key missions such as accessibility, affordability, quality, patient-centered care, preventive health, research, innovation, and skilled manpower. With a roadmap in place, the policy seeks to streamline regulations, enhance infrastructure, foster R&D and innovation, attract investments, develop skilled resources, and create awareness about the Indian medical devices sector.

Key Features of NMD Policy 2023:

• Regulatory Streamlining:

The policy intends to establish a "Single Window Clearance System" for licensing medical devices, simplifying the process for research, business, and ensuring patient safety. This system will involve various relevant departments and organizations, including the Ministry of Electronics and Information Technology (MeitY) and the Department of Animal Husbandry & Dairying (DAHD).

• Enabling Infrastructure:

To support the growth of the medical devices industry, the policy focuses on establishing large medical device parks with world-class infrastructure facilities near economic zones. This initiative aligns with the National Industrial Corridor Program, the proposed National Logistics Policy 2021, and PM Gati Shakti to improve convergence and integration with the medical device industry. Collaboration with state governments and industry stakeholders will be crucial for this development.

• Facilitating R&D and Innovation:

The policy aims to promote research and development activities in the Indian medical devices sector, complementing the proposed National Policy on R&D and Innovation in the Pharma-MedTech sector. It seeks to establish Centers of Excellence in academic and research institutions, innovation hubs, "plug and play" infrastructures, and support for start-ups. These initiatives will foster innovation and drive advancements in medical device technologies.

• Attracting Investments:

The NMD Policy 2023 encourages private investment and Public-Private Partnerships (PPP) to complement existing schemes such as Make in India, Ayushman Bharat, Heal-in-India, and the Start-up mission. Venture capitalists are also encouraged to provide funding support for the growth of the medical device industry. These measures aim to attract domestic and international investments, strengthening India's position as a global manufacturing hub for medical devices.

• Human Resources Development:

To ensure a skilled workforce in the medical device sector, the policy emphasizes skilling, re-skilling, and up-skilling programs through the Ministry of Skill Development and Entrepreneurship. The policy also advocates for dedicated courses on medical devices in existing institutions to produce skilled manpower for futuristic technologies, manufacturing, and research. By nurturing talent, the policy aims to meet the industry's evolving needs and foster innovation.

• Brand Positioning and Awareness Creation:

The NMD Policy 2023 envisions the creation of a dedicated Export Promotion Council for the medical devices sector. This council will address market access issues and facilitate the promotion of Indian medical devices in international markets. By strengthening the brand positioning and raising awareness about the sector, the policy seeks to boost India's presence as a reliable and competitive player in the global medical devices market.

Significance of the Policy:

• Strengthening the Industry:

The NMD Policy 2023 is expected to provide the necessary support and direction to strengthen the medical devices industry, making it competitive, self-reliant, resilient, and innovative. This will enable the industry to cater to the healthcare needs not only in India but also globally.

• Patient-Centric Approach:

The policy emphasizes a patient-centric approach, aligning with evolving healthcare needs. It aims to enhance accessibility, affordability, and quality of medical devices, ensuring that patients receive the best possible care and treatments.

• Global Leadership and Market Share:

By achieving a 10-12% share in the expanding global market over the next 25 years, India aims to emerge as a global leader in the manufacturing and innovation of medical devices. The policy sets a vision for India to become one of the top five global manufacturing hubs, reducing import dependence and increasing domestic production.

• Economic Growth and Job Creation:

The NMD Policy 2023 is expected to stimulate economic growth and job creation. The growth of the medical devices sector from the current USD 11 billion to USD 50 billion by 2030 will generate significant employment opportunities and contribute to India's overall economic development.

Scenario of the Indian Medical Device Sector:

• Market Position:

India ranks as the fourth largest medical devices market in Asia, trailing Japan, China, and South Korea. With a 1.5% share of the global medical devices market, valued at $11 billion, India has established itself as a significant player. However, the United States dominates the global market with a commanding 40% share, followed by Europe and Japan.

• Government Initiatives:

The Indian government has implemented various initiatives to promote domestic manufacturing of medical devices. Notably, the Production Linked Incentive (PLI) scheme has been introduced to incentivize local production. This scheme works in conjunction with the National Medical Devices Policy 2023, which aims to further propel the industry forward. These initiatives provide crucial support to bolster domestic manufacturing and drive growth in the medical devices sector in India. The government has also supported the establishment of medical devices parks in Himachal Pradesh, Madhya Pradesh, Tamil Nadu, and Uttar Pradesh.

Issues with the Medical Device Sector in India:

• Inconsistent Regulations:

The medical device industry faces challenges due to complex and inconsistent regulatory frameworks. Manufacturers must navigate varying standards and requirements, hindering ease of doing business and compliance.

• Research and Development:

Limited adoption of cutting-edge technologies like artificial intelligence, cloud computing, and robotics in the Indian medical device sector hinders innovation and competitiveness. Expanding research and development efforts is crucial to drive advancements, improve industry competitiveness, and leverage the potential of these transformative technologies.

• Import Dependency:

India heavily relies on imports for medical devices, resulting in a high import bill and increased healthcare costs. Encouraging domestic manufacturing and promoting innovation will help reduce import dependency and improve cost-effectiveness.

• Limited Access to Capital:

Access to funding is a significant challenge for medical device startups in India. The long gestation period and regulatory uncertainties associated with the sector often discourage investors. Addressing this issue will facilitate the growth of startups and innovation in the industry.

Way Forward:

To reduce the dependency on medical device imports, India needs a well-defined action plan. Medical device companies should focus on developing India as a manufacturing hub for domestic and international markets. Collaborations between the 'œMake in India' and Innovate in India initiatives can drive indigenous manufacturing and innovation. Additionally, catering to underpenetrated domestic markets by producing low to medium technology products will strengthen the sector's growth.

Wrapping up:

The National Medical Devices Policy 2023 lays a solid foundation for the growth and development of the medical devices sector in India. By addressing regulatory challenges, enhancing infrastructure, fostering innovation, attracting investments, developing skilled manpower, and promoting brand positioning, the policy aims to position India as a global leader in the manufacturing and innovation of medical devices. With focused efforts and implementation, India's medical device industry is poised to achieve significant growth, economic impact, and improved healthcare outcomes.