INTRODUCTION

In April 2023, the Union Cabinet approved the National Medical Devices Policy, 2023 (“Policy”). The medical device industry has been in focus in recent years after the release of the Medical Devices Rules, 2017, aimed at regulating medical devices. This Policy aims to establish India as a global manufacturing hub for medical devices and to reduce its imports. 

MISSIONS OF THE POLICY

The Policy lays down a roadmap for increased growth in the medical device sector by achieving the following missions: 

VISION OF THE POLICY

To cater to evolving patient needs, this Policy intends to accelerate the growth of the Indian medical devices sector with a patient-centric approach by building an innovative and globally competitive industry in India. This growth will be supported by world-class infrastructure in alignment with PM Gati Shakti, fostering an enabling ecosystem, a streamlined regulatory framework, and quality manpower. Moreover, the Policy aims to position India as a global leader in the manufacturing and innovation of medical devices, targeting a 10-12% share in the expanding global market over the next 25 years. India’s share in the global medical device market is 1.5%. Furthermore, the Policy aims to grow the medical device sector from USD 11 Billion to USD 50 Billion by 2030. 

KEY POINTS OF THE POLICY

(a) Regulatory Streamlining

The Policy envisages a single window clearance system for licensing medical devices to reduce complexity and unnecessary compliance burden. Further, standard-setting bodies, including the Bureau of Indian Standards and other sectoral standards development organisations, are expected to gradually expand the standards for medical devices to enhance standardisation and quality. Additionally, a pricing regulation for medical devices in line with the Drug Price Control Order, 2013, is envisaged to be developed to ensure quality and effective medical devices are available to all citizens at affordable prices.

(b) Enabling Infrastructure

Large medical device parks and medium-sized medical device clusters equipped with world-class common infrastructure facilities are being planned in proximity to economic zones. 

(c) Facilitating Research & Development and Innovation

The Policy aims to promote innovation, research, and development. It also recognises the role of technologies like 5G and 6G, IoTs, and AI in medical devices, diagnostic equipment, data analytics, personal devices, and patient care. It also envisages joint research and development projects involving academic institutions and industry under the proposed national policy on research and development and innovation in the pharma-medtech sector in India.

(d) Attracting Investments in the Sector

The Policy envisages additional measures to promote indigenous manufacturing, build competitiveness, and promote an ecosystem for manufacturing. It encourages private investments in the sector by creating an ecosystem for risk-based/risk-adjusted financing through active outreach engagement. Additionally, the Policy also encourages public-private partnerships to complement government initiatives like Make in India, the Ayushman Bharat program, and the start-up mission.

(e) Human Resources Development

The policy envisages a skilled workforce in the medical device sector by leveraging resources in the Ministry of Skill Development and Entrepreneurship for reskilling and upskilling. Further, it aims to support dedicated courses for medical devices in existing institutions to produce skilled manpower for futuristic technologies, manufacturing, and research.

(f) Brand Positioning and Awareness Creation

The Policy envisages building global competitiveness in coordination with the efforts of the Ministry of Commerce and Industry. Additionally, it aims to create a dedicated export promotion council for the sector to address various market access issues.

SIGNIFICANCE OF THE POLICY

The policy is set to have a significant impact on the accelerated growth of the medical devices sector, propelling it from the present USD 11 Billion to USD 50 Billion by 2030 and emerge as a global leader in the manufacturing and innovation of medical devices. It is also expected to reduce India’s import dependence to nearly 30% in the next couple of years and establish India as one of the top five global manufacturing hubs of medical devices. Presently, the United States dominates the global market with a 40% market share, followed by Europe and Japan at 25% and 15%, respectively.

CONCLUSION

The medical device sector holds immense growth potential and achieves public health objectives. A holistic policy like this one is likely to help accelerate the sector’s growth and reach its full potential through its effective implementation. The government has already initiated several schemes and programs for the medical device sector, and this Policy will further advocate for a comprehensive framework to regulate medical devices and provide impetus to the industry in a coordinated manner.