National Medical Devices Policy 2023
The medical devices sector in India is an essential constituent of the Indian healthcare sector, particularly for the prevention, diagnosis, treatment, and management of medical conditions, diseases, illnesses, and disabilities. India’s contribution in this sector is remarkable during the Covid -19 through the large-scale production of PPE kits, N-95 masks, RT-PCR kits, and ventilators.
The medical device is a multi-product sector, with the following broad classifications:
- Electronics Equipment
- Implants
- Consumables and Disposables
- IVD reagents
- Surgical Instruments
On 20th March 2020 Government approved the Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices. Due to a lack of infrastructure, R & D, adequate quality power, and heavy cost of finance, the Indian medical device sector is highly dependent on imports. The Scheme intends to boost domestic manufacturing and attract large investments in the Medical Devices Sector. In line with this, On 26th April 2023, The Union Cabinet, chaired by the Hon’ble Prime Minister Shri Narendra Modi, approved the National Medical Devices Policy, 2023.
The medical devices sector will be facilitated and guided through a set of strategies that will cover six broad areas of policy interventions.
Regulatory Streamlining: To enhance ease of doing research and business and further balance patient safety with product innovation measures such as the creation of a Single Window Clearance System‘ for Licensing of Medical Devices co-opting all the stakeholder departments/organizations such as AERB, MeitY, DAHD, etc, enhancing the Role of Indian Standards like BIS and designing a coherent pricing regulation, will be followed.
Enabling Infrastructure: The establishment and strengthening of large medical device parks, and clusters equipped with world-class common infrastructure facilities in proximity to economic zones with requisite logistics connectivity as envisioned under the National Industrial Corridor Program and the proposed National Logistics Policy 2021 under the ambit of PM Gati Shakti, would be pursued with the State Governments and Industry for better convergence and backward integration with medical device Industry.
Facilitating R&D and Innovation: The policy envisages promoting Research & Development in India and complements the Department’s proposed National Policy on R&D and Innovation in the Pharma- MedTech Sector in India. It also aims at establishing Centres of Excellence in academic and research institutions, innovation hubs, ‘plug and play’ infrastructures and support to start-ups.
Attracting Investments in the Sector: Along with recent schemes and interventions like Make in India, Ayushman Bharat program, Heal-in-India, and Start-up mission, the policy encourages private investments, a series of funding from Venture Capitalists, and also Public-Private Partnerships (PPP).
Human Resources Development: To have a steady supply of skilled workforce across the value chain such as scientists, regulators, health experts, managers, technicians, etc., the policy envisages:
For skilling, reskilling, and upskilling of professionals in the medical device sector, we can leverage the available resources in the Ministry of Skill Development and Entrepreneurship
The policy will support dedicated multidisciplinary courses for medical devices in existing institutions to ensure the availability of skilled manpower for futuristic medical technologies, high-end manufacturing, and research, to produce future-ready MedTech human resources and to meet the evolving needs of the Sector
To develop partnerships with foreign academic/industry organizations to develop medical technologies to be in equal pace with the world
market.
Brand Positioning and Awareness Creation: The policy envisages the creation of a dedicated Export Promotion Council for the sector under the Department which will be an enabler to deal with various market access issues:
Initiate studies and projects for learning from best global practices of manufacturing and skilling systems to explore the feasibility of adapting such successful models in India.
Promote more forums to bring together various stakeholders for sharing knowledge and build strong networks across the sector.
The National Medical Devices Policy, 2023 aims to place the medical devices sector on an accelerated path of growth with a patient-centric approach to meet the evolving healthcare needs of patients. The policy is expected to help the Medical Devices Sector grow from the present $11 Bn to $50 Bn by 2030.
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