National Medical Devices Policy 2023, India

The National Medical Devices (NMD) Policy, 2023 was recently approved by the Union Cabinet in April 2023. It defines a roadmap for the enhanced and unhindered growth of the medical devices sector to achieve the following:

• Quality,
• Affordability,
• Patient Centered and Quality Care,
• Preventive and Promotive Health,
• Competent manpower,
• Security,
• Access and Universality, and
• Research and Innovation.

Need for a Policy

The medical devices sector has a huge potential to help achieve the goals of public health by contributing quality products. This made it necessary to have a comprehensive policy in place to boost this sector’s growth and help it achieve its potential. Although the Government launched numerous plans and schemes through different divisions to boost the medical devices sector, the recently approved policy was required for the purpose of laying down a holistic framework that is supported by effective plans to guarantee sustainable growth of the sector seamlessly.

There has been a demand to enable unhindered development of the medical devices sector to achieve the public health goals relating to access, quality, affordability, and innovation. The sector demanded support to discover its full potential by building an empowering ecosystem that allows and focuses on the following while staying in line with the industry requirements:

• Manufacturing,
• Innovating,
• Creation of a strong and efficient managing system,
• Helping with training and capacity building plans,
• Encouraging higher education to promote talent and skilled resources.

Promoting domestic investments and manufacturing medical devices in India complements the ‘Atmanirbhar Bharat’ and ‘Make in India’ initiatives of the Government.

This policy is expected to deliver the support and directions needed to strengthen and empower the medical devices industry into a competitive, self-reliant, resilient, and innovating sector that not only addresses the healthcare requirements of India but of the rest of the world as well.

Structure of the Policy

Vision

The NMD Policy aims to allow the Indian medical devices sector to fulfill the demands of the healthcare market by enabling enhanced growth via a patient-focused method and developing an innovative and world-class healthcare industry in India.

• These efforts shall be supported by the best-in-class setup in accordance with the PM Gati Shakti Policy, supporting ecosystem, streamlined regulatory structure and proficient workforce.
• This shall guarantee access to patient-focused, innovative and affordable healthcare products of top-notch quality for improved results in the healthcare sector.
• The ultimate goal of the policy is to help the Indian medical devices sector grab 10%-12% of the global market share and rise as the global leader in the innovation and production of medical devices in the next 25 years.

Mission

The NMD Policy shall enable the development of the medical devices sector, which shall not only address the demands of the Indian healthcare sector but cater to global needs of the sector as well. The policy defines a strategy for enhanced growth of the medical devices market to achieve the following missions:

• Quality: To guarantee that the quality of the healthcare products manufactured in India shall be of utmost importance. Further, the focus shall be to improve the quality to achieve a position in the global market along with acceptability and competitiveness.
• Affordability: To increase the country’s manufacturing capacity and capability for more advanced technologies; making the medical devices more affordable and, thus, reduce diagnostics-related expenses.
• Patient Centered and Quality Care: To enhance the quality of care provided by enhancing medical results and increasing the convenience for the patients, through early disease-diagnosis and improved treatment-accuracy.
• Preventive and Promotive Health: To increase perception and vigilance amongst the people, allowing them to follow a healthier lifestyle by extensively using more advanced medical devices for early diagnosis and detection or prevention and management of diseases.
• Proficient workforce: To clear the way for a future-ready proficient workforce, which works together with the integrative nature of medical devices.
• Security: Developing adept domestic manufacturing abilities, including building a robust supply chain with optimum levels of external dependency, to assure medical devices security.
• Access and Universality: To strongly support granting universal access to high-quality medical devices to ensure we provide best-in-class healthcare services to people of all ages by complying with various public health strategies.
• Research and Innovation: To develop an infrastructure in sync with the changing times and the demand to boost and encourage innovation in the medical devices sector. This includes nano technology, telecommunication technologies, IoTs and AI, etc.

Key Features of NMD Policy 2023

• Regulatory Streamlining

A ‘Single Window Clearance System’ to license medical devices shall be developed to allow ease of doing research and business, while also ensuring patient safety and innovation for better technologies.

Note: Significant departments and entities such as Ministry of Electronics and Information Technology and Department of Animal Husbandry and Dairying shall be involved in this system’s processes.

• Supporting Infrastructure Development

There are plans to develop medical devices parks that offer world-class infrastructure facilities near foreign-trade zones, commonly referred to as ‘economic zones.’ This step is being taken in accordance with the strategies under the National Industrial Corridor Program and the National Logistics Policy 2021 that has been suggested under the scope of the PM Gati Shakti Policy and together with State Governments and the sector.

• Enabling Innovation and Research & Development

The goal of the NMD Policy is to encourage research and development in the country, which shall complement the National Policy on R&D and Innovation in the Pharma-Medical Technology market. The policy also aims to build Centers of Excellence in academic and research bodies, innovation centers and supporting startups.

• Human Resources Development

The policy shall help build a more skilled and proficient workforce in the medical devices sector by offering to reskill and upskill individuals under the programs offered through the Ministry of Skill Development and Entrepreneurship. It shall also support the current curriculum for medical devices in the current institutions to produce skillful experts for advanced technologies, research and development.

• Attracting Investments

The policy aims to promote private investments and Public-Private Partnerships (PPP) to add more value to the existing plans like Make in India, Ayushman Bharat program, Heal-in-India, and Startup Mission.

Note: This includes investments from venture capitalists to empower the growth of the medical devices sector.

• Brand Positioning & Awareness Creation

The policy foresees the establishment of a dedicated Export Promotion Council for the industry that shall help address and resolve various issues related to accessing the market.

What is the Importance of the NMD Policy 2023?

• The NMD Policy shall provide the much-needed strategies and support to strengthen the medical devices sector and turn it into a more streamlined, self-reliant, competitive industry that can not only fulfill the healthcare demands of India but address healthcare needs around the world as well.
• It shall put India’s healthcare sector on the road for unhindered growth with a patient-focused approach to help address different requirements of the patients.
• It aims to help the Indian healthcare sector grab 10%-12% of the global medical devices market over the next 25 years. Further, it shall reduce India’s reliance on imports to the 30% mark and become one of the most prominent medical devices manufacturing hubs in the world.
• It is expected to help the Indian medical devices market grow from the current USD 11 billion to USD 50 billion by 2030.

Conclusion

There has always been a demand for better healthcare devices and services across the country. As such, the Government’s efforts to enable progress in this sector via the National Medical Devices Policy 2023 would promote extensive development in this market, making India hold a significant share of the global market and emerge as a world class medical devices manufacturer.