Cabinet approves the Policy for the Medical Device Sector

Introduction:

Policy 2023 intends to support the Medical Device industry’s orderly expansion in order to satisfy the public health goals of access, affordability, quality, and innovation in India. The policy puts forth a plan for the industry’s rapid expansion in order to fulfil a number of objectives. The medical device sector in India is an essential and integral constituent of the Indian healthcare sector. As India supported the domestic and international struggle against the COVID-19 pandemic, the contribution of the Indian medical devices sector has become even more noticeable. The policy for the medical device industry has been approved by the Union Cabinet, and six strategies have been established to maximize the sector’s potential with an implementation action plan.

India’s Medical Device Industry:

In India, the medical device industry is a sunrise sector that is expanding extremely rapidly. Building on these initiatives, a comprehensive policy framework is urgently required to encourage growth in the industry and fulfil its potential. The Indian market for medical devices is expanding and has a great deal of potential to become independent and help realize the dream of universal healthcare. The significant changes being noticed are

Salient Features of the National Medical Devices Policy, 2023

The National Medical Devices Policy, 2023, seeks to promote innovation in the Indian market for medical equipment through regulatory simplification, supportive infrastructure, easing access to research and development, and luring investment. The features of the policy include

Vision: The Medical Devices Sector is expected to become the global leader in the manufacturing and innovation of medical devices by achieving a 10-12% share of the global market over the next 25 years, with a patient-centric approach helping to achieve $11 billion to $50 billion by 2030.

Mission: The policy provides a plan for the sector’s rapid expansion to accomplish the goals of access and universality, affordability, quality, patient-centred care, preventive and promotional health, security, research and innovation, and skilled labour.

Strategies to Promote the Medical Device Industry

The policy aims to increase industrial competitiveness, independence, adaptability, and innovation, while also hastening the sector’s expansion into medical gadgets. To achieve these objectives, a patient-centric strategy is needed with guidance and assistance from the medical device business.

Regulatory Simplification: A Single Window Clearance System for Licensing of Medical Devices will be used, co-opting all stakeholder departments and organizations, expanding the role of Indian Standards, and developing a cogent price policy to improve the convenience of doing research and commerce.

Enabling Infrastructure: The National Industrial Corridor Program and the proposed National Logistics Policy 2021, both of which fall under the authority of Prime Minister Gati Shakti, both envision the establishment and strengthening of large medical device parks, clusters, and facilities equipped with top-notch common infrastructure in close proximity to economic zones with the necessary logistics connectivity.

Facilitating R&D and Innovation

The objective of the policy is to support the Department’s proposed National Policy on R&D and Innovation in the Pharma-MedTech Sector while promoting research and development in India. Additionally, it aspires to create innovation hubs, “plug and play” infrastructures, centers of excellence at academic and research institutions, and assistance for start-ups.

Attracting Investments in the Sector

The policy supports private investments, a series of funding from venture capitalists, as well as Public-Private partnerships (PPP), in addition to current programs and initiatives like Make in India, Ayushman Bharat, Heal-in-India, and Start-up Mission.

Human Resources Development:

The Ministry of Skill Development and Entrepreneurship is responsible for providing resources to develop skilling, reskilling, and upskilling professionals in the medical device sector, as well as supporting multidisciplinary courses and partnerships with foreign academic/industry organizations to keep up with the world market.

Brand positioning and awareness creation:

A market access council for the department’s sector is needed to address market access challenges. Start research and initiatives to learn from the best manufacturing and skilling systems in the world to implement such models in India, creating new forums and networks to bring together stakeholders and create robust networks.

Measures the Indian government has taken to assure the sector’s expansion:

- Manufacturing-Linked Incentives To increase local manufacturing, the government has introduced Production-Linked Incentive Schemes for medical equipment.

- Development of Medical Device Parks To establish a strong manufacturing environment, new medical device parks are being built in Himachal Pradesh, Uttar Pradesh, Madhya Pradesh, and Tamil Nadu.

- Policy Assistance The release of the National Medical Devices Policy and the National R&D Policy, which encourage multidisciplinary cooperation to enhance the development of translational capabilities and the start-up ecosystem, respectively, provide policy support.

Conclusion:

The Cabinet’s approval of the Medical Devices Sector Policy is an important step in fostering the expansion of the Indian medical device sector. It seeks to promote R&D, establish innovation hubs, plug-and-play infrastructures, centres of excellence at academic and research institutions, and start-up support initiatives. The program also seeks to reduce India’s dependency on imports and foster export-focused manufacturing of high-quality, cost-effective products. The PLS Scheme for Medical Devices 2020 and the creation of medical parks are two of the six methods included in the Implementation Action Plan to maximize the sector’s potential. This is the right time for medical device manufacturers to look at the Indian market and expand with the impetus being given to this sector. Contact Morulaa to understand how we can work with you to navigate the medical device market for registration and market entry. For more information on the new medical device regulations, get in touch with Morulaa or send us an email at [email protected].