National Medical Devices Policy, 2023

The medical devices sector in India holds a crucial position within the nation’s healthcare industry, playing an essential role in combating the COVID-19 pandemic both domestically and globally. Through large-scale production, India provided much-needed medical devices and diagnostic kits like Ventilators, Rapid Antigen Test kits, Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) kits, Infrared (IR) Thermometers, Personal Protective Equipment (PPE) Kits, and N-95 masks, amplifying the sector’s significance.

Being a sunrise sector, the medical devices industry in India is experiencing rapid growth. Valued at approximately $11 billion (₹ 90,000 Cr) in 2020, it occupies a 1.5% share in the global medical device market. With immense potential for self-reliance and contributing to universal health care, the Indian medical devices sector is on a progressive trajectory. The Government of India has already initiated strategic measures, including the implementation of the PLI Scheme for medical devices and the establishment of four Medical Devices Parks in Himachal Pradesh, Madhya Pradesh, Tamil Nadu, and Uttar Pradesh.

To further propel this growth and unleash the sector’s potential, the hour calls for a comprehensive policy framework. Presently, various government departments have undertaken programmatic interventions to support the sector, but a cohesive approach is needed to ensure focused and efficient facilitation. The National Medical Devices Policy, 2023 aims to fulfill this need by promoting an orderly and patient-centric expansion of the medical device industry, emphasizing access, affordability, quality, and innovation.

This policy envisages key strategies such as fostering an enabling ecosystem for manufacturing with a focus on innovation, establishing a robust and streamlined regulatory framework, providing support in training and capacity building programs, and promoting higher education to nurture talent and skilled resources aligned with industry requirements. Encouraging domestic investments and production of medical devices aligns with the Government’s vision of an ‘Atmanirbhar Bharat’ (Self-Reliant India) and ‘Make in India’ programs.

By adhering to these strategies, the medical devices sector is poised to realize its full potential and emerge as a competitive, self-reliant, and innovative industry, catering not only to India’s healthcare needs but also making a global impact. The National Medical Devices Policy, 2023, with its forward-looking approach, aims to transform the industry and fulfill the public health objectives of accessibility, affordability, quality, and innovation.

Salient features of the National Medical Devices Policy, 2023:

Vision: Aiming for accelerated growth with a patient-centric approach, the policy sets its sights on becoming a global leader in medical device manufacturing and innovation, targeting a 10-12% share in the expanding global market within the next 25 years. The ultimate goal is to elevate the Medical Devices Sector’s value from the current $11 billion to $50 billion by 2030.

Mission: The policy outlines a roadmap for the rapid growth of the medical devices sector, with the following mission objectives – Access & Universality, Affordability, Quality, Patient-Centered & Quality Care, Preventive & Promotive Health, Security, Research, Innovation, and Skilled Manpower.

Strategies to Promote the Medical Device Sector:

1. Regulatory Streamlining: Enhancing ease of research and business while maintaining patient safety and fostering product innovation by establishing a Single Window Clearance System for Licensing of Medical Devices, involving all relevant stakeholders such as AERB, MeitY, DAHD, and emphasizing the role of Indian Standards like BIS. A coherent pricing regulation will also be implemented.
2. Enabling Infrastructure: Strengthening large medical device parks and clusters with world-class infrastructure near economic zones, in alignment with the National Industrial Corridor Program and the proposed National Logistics Policy 2021 under PM Gati Shakti. Collaboration with state governments and industry will ensure better convergence and backward integration with the medical device industry.
3. Facilitating R&D and Innovation: Promoting Research & Development in India and complementing the proposed National Policy on R&D and Innovation in the Pharma-MedTech Sector. The policy also envisions establishing Centres of Excellence in academic and research institutions, innovation hubs, plug-and-play infrastructures, and offering support to start-ups.
4. Attracting Investments in the Sector: Encouraging private investments, venture capitalist funding, and fostering Public-Private Partnerships (PPP) through initiatives like Make in India, Ayushman Bharat, and Heal-in-India.
5. Human Resources Development: Ensuring a skilled workforce across the value chain, including scientists, regulators, health experts, managers, and technicians. Skilling, reskilling, and upskilling of professionals in the medical device sector will be supported using resources from the Ministry of Skill Development and Entrepreneurship. Dedicated multidisciplinary courses will be introduced in existing institutions to produce future-ready MedTech human resources and meet the sector’s evolving needs. Partnerships with foreign academic/industry organizations will foster the development of medical technologies.
6. Brand Positioning and Awareness Creation: Creating a dedicated Export Promotion Council under the Department to address market access issues. Studies and projects will explore global manufacturing and skilling best practices to adapt successful models in India, while forums will be promoted to build strong networks and knowledge-sharing across the sector.

The policy aims to bolster the medical devices industry, making it a competitive, self-reliant, resilient, and innovative sector catering not only to India’s healthcare needs but also contributing to the global landscape. With a patient-centric approach, the National Medical Devices Policy, 2023, endeavors to meet the evolving healthcare requirements of patients and propel the medical devices sector towards accelerated growth.