Union Cabinet approves National Medical Devices Policy

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

The current state of the medical device 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, Rs 90,000 Cr) in 2020 and its share in the global medical device market is estimated to be 1.5%.
• What is the National Devices Policy, 2023?
• The National Medical Devices Policy, of 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.
• Salient Features of National Medical Devices Policy, 2023:
• Vision: Accelerated growth path with a patient-centric approach and 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.  The Policy is expected to help the Medical Devices Sector grow from the present $11 Bn to $50 Bn by 2030.
• Mission: The 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:

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: 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 coopting 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 Partnership (PPP).
• Human Resources Development: The scheme aims to have a steady supply of skilled workforce across the value chain such as scientists, regulators, health experts, managers, technicians, etc.
• 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.

Significance of the policy

• Strengthening the industry: The policy is expected to provide the required support and directions to strengthen the medical devices industry into a competitive, self-reliant, resilient and innovative industry that caters to the healthcare needs of not only India but also of the world.
• Patient-centric approach: 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.

Government schemes & interventions

• The Government of India has already initiated the implementation of the PLI Scheme for medical devices and support for the setting up of 4 Medical device Parks in the States of Himachal Pradesh, Madhya Pradesh, Tamil Nadu and Uttar Pradesh.
  • Under the PLI scheme for Medical Devices, till now, a total of 26 projects have been approved, with a committed investment of Rs.1206 Cr and out of this, so far, an investment of Rs.714 Cr has been achieved.
  • Under the PLI scheme, a total of 14 projects producing 37 products have been commissioned and domestic manufacturing of high-end medical devices has started which include Linear Accelerator, MRI Scan, CT-Scan, Mammograms, C-Arm, MRI Coils, high-end X-ray tubes, etc. The remaining 12 products will be commissioned in the near future.
  • Five projects out of a total of 26 projects have been approved recently, under Category B, for domestic manufacturing of 87 products/product components.