National Medical Devices Policy

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Context

• The Union Cabinet, approved the National Medical Devices Policy, 2023.

MUST READ- MEDICAL DEVICES SECTOR: https://www.iasgyan.in/rstv/medical-device-industry

Medical Devices Sector in India

• The medical devices sector in India is a sunrise sector which is growing at a fast pace.
• The market size of the medical devices sector in India is estimated to be $11 billion (approximately, ₹ 90,000 Cr) in 2020 and its share in the global medical device market is estimated to be 1.5%.
• The Indian medical devices sector is on a growth track and has an enormous potential to become self-reliant and to contribute towards the goal of universal health care. 

National Medical Devices Policy

• The National Medical Devices Policy, 2023 is expected to facilitate an orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality and innovation.
• The main aim of the policy is to ensure an accelerated growth path with a patient-centric approach and to emerge as the global leader in the manufacturing and innovation of medical devices, by achieving a 10-12 percent share in the expanding global market over the next 25 years.
• The proposed policy is expected to help the medical devices sector grow from the present $11 billion to $50 billion by 2030.

Salient Features of National Medical Devices Policy, 2023:

Vision: 

• Accelerated growth path with a patient-centric approach and to emerge as the global leader in the manufacturing and innovation of medical devices by achieving 10-12% share in the expanding global market over the next 25 years. 
• Policy is expected to help the Medical Devices Sector grow from present $11 Bn to $50 Bn by 2030.

Mission: 

• Policy lays down a roadmap for accelerated growth of the medical devices sector to achieve the following missions viz, Access & Universality, Affordability, Quality, Patient Centred & Quality Care, Preventive & Promotive Health, Security, Research and Innovation and Skilled manpower.

Strategies to Promote Medical Device Sector:

• Medical devices sector will be facilitated and guided through a set of strategies that will be cover six broad areas of policy interventions:

Regulatory Streamlining:

• In order 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,
  • 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, Start-up mission, the policy encourages private investments, series of funding from Venture Capitalists, and also Public-Private Partnership(PPP).

Human Resources Development:

• In order 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 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 in order 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 system so as 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.

https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1919984#:~:text=Policy%20is%20expected%20to%20help,Bn%20in%20next%20five%20years&text=The%20Union%20Cabinet%2C%20chaired%20by,National%20Medical%20Devices%20Policy%2C%202023.