Cabinet approves National Medical Devices Policy, 2023

Six strategies planned to tap the potential of the sector, with the implementation action plan

The Union Cabinet, chaired by PM Modi has approved the National Medical Devices Policy, 2023.

The Government of India has already initiated implementation of PLI Scheme for medical devices and support for setting up of 4 Medical devices 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 crore and out of this, so far, an investment of Rs 714 crore has been achieved. Under the PLI scheme, 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, Mammogram, C-Arm, MRI Coils, high end X-ray tubes, etc. Remaining 12 products will be commissioned in near future. Five projects out of total 26 projects have been approved recently, under Category B, for domestic manufacturing of 87 products / product components.

Building upon these measures, a policy framework to accelerate this growth and fulfil the potential of the sector is the need of the hour. While various Departments of the Government have undertaken programmatic interventions to encourage the sector, the current policy aims to put in place a comprehensive set of focus areas for growth of the sector in a coordinated manner. Secondly, in view of the diversity and multi-disciplinary nature of the sector, the regulations, skilling trade promotion of medical device industry are spread over several departments in the government both at the Centre and State levels. There is a need to bring together the range of interventions in a coherent manner that would facilitate focused and efficient support and facilitation for the sector by the respective agencies.

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. This sector is expected to realise its full potential, with the strategies viz, building an enabling ecosystem for manufacturing along with a focus on innovation, creating a robust and streamlined regulatory framework, providing support in training and capacity building programs and promoting higher education to foster talent and skilled resources in line with the industry requirements. Encouraging domestic investments and production of medical devices complements the Government’s ‘Atmanirbhar Bharat’ and ‘Make in India’ programs.

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 per cent 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 billion 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 to balance patient safety with product innovation measures such as creation of a Single Window Clearance System’ for Licensing of Medical Devices coopting all the stakeholder departments / organisations 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, 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 to promote Research & Development in India and complement 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 resent 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 work force 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 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.

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. 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.

Welcoming the National Medical Devices Policy, Pavan Choudary, Chairman MTaI: Though we still have to go through the fine print, we are encouraged by the spotlight turned on R&D. While India has only 1.5 per cent of the global medical device market, it has 8 per cent share of the medtech R&D work force already. This is a fertile and proven area to focus on. In addition to this skilling and upskilling of healthcare workers augers well for patient-care and man power exports. Adjacent to this announcement we have also happily noted that government is planning to open 157 nursing colleges. This is another well chosen space as it is estimated that new technologies like AI which may make the desktop healthcare worker (even many doctors) redundant will not impact the nursing staff so adversely. So, this policy has a note of enduring prudence to it.

The emphasis on creating a systematic brand positioning and awareness creation program is long due and laudable. All in all, from what is available so far in the public domain it seems a policy which harnesses both the domestic and international currents to optimally forge the path ahead.

Bhargav Kotadia, Co-Chair, PHDCCI Medical Device Committee & Managing Director, Sahajanand Medical Technologies: The Medical Devices Committee of PHDCCI welcomes the cabinet approval of the National Medical Device Policy. The policy aims to place the medical devices sector on an accelerated growth path with a patient-centric approach to meet the evolving healthcare needs of patients. This is also a leap forward to fulfil PM Narendra Modi ji’s vision have affordable, accessible and innovative solutions towards healthcare, making India Atmanirbhar and a global medtech hub, achieving the Vision 2047 aimed at Universal Healthcare for All.

Anish Bafna, CEO & MD, Healthium Medtech: The Union Cabinet’s approval of the Medical Devices Policy will fastrack the medtech sector’s progress towards the imminent mission of achieving self-reliance and reducing our dependency on imports. The medtech sector is poised to grow significantly in the next few years with India being the manufacturing hub. The government’s focus on the medtech sector for enabling infrastructure, facilitating R&D, attracting investments like FDI and sectoral upskilling with talent development will encourage and promote domestic manufacturing in India. With the commissioned PLI schemes and medical device parks, the policy will support the ‘Sunrise Sector’ in India to grow rapidly with a patient-centric approach, meet the evolving patient safety standards and ensure last mile delivery of accessible healthcare for all.

Arvind Sharma, Partner, Shardul Amarchand Mangaldas & Co: Approval of the National Medical Devices Policy, 2023 by the Union Cabinet is a welcome step towards making India self-sufficient in the medical devices market. This provides an opportunity to boost domestic production of medical devices and reduce the need for imports. Increased domestic production will also result in better local access, affordable prices and a chance to innovate within the medical devices sector of the country. While providing a lucrative picture for the future of the medical devices sector, the policy embodies a framework which promises simultaneous efforts towards 6 core focus areas in the medical devices sector, namely: (i) easing of regulatory procedures; (ii) improvement of infrastructure; (iii) dedicated resources towards R & D and innovation; (iv) promotion of private investment and funding (including venture capital and public private partnership); (v) development of human resources through skilling, re-skilling and up-skilling programmes; and (vi) creation of a dedicated export promotion council for promoting market access to the Indian medical devices sector. This presents us with an extremely positive outlook for the medical devices sector in India and one can hope to see exponential growth in the coming years.

Mudit Dandwate, CEO & Co-Founder, Dozee: The approval of the medical devices policy by the Union Cabinet comes as an excellent step forward in the journey towards making India ‘Atmanirbhar’.  Focused on reducing the country’s dependency on imports, the medical device policy will help the rapidly growing medical device industry flourish over the next 5 years, from its current size of $11 billion to $50 billion. Further, this policy will support India’s already expanding market by encouraging domestic production and fueling exports, helping the nation realize its dream of ‘Make in India, Make for World’. The integration of technology with healthcare requires holistic policies to be in place to enable the digital adoption of new-age innovative solutions such as remote patient monitoring, e-consultations, and telemedicine among others, and this policy helps foster this spirit of cooperation.

GSK Velu, Chairman and MD, Trivitron Healthcare: Great news for India’s medical device industry! The Union Cabinet has approved the National Medical Devices Policy 2023, fulfilling PM Shri Narendra Modi’s vision of making India not just Atmanirbhar Bharat but also a leading international supplier of medical devices. This policy will drive accelerated growth, promote innovation, and create new jobs in the sector. With a patient-centric approach, we will ensure medical devices’ quality, safety, and efficacy while making them affordable and accessible to all. Let’s work towards achieving our goal of making India a global leader in medical device manufacturing, with more than 10-12 per cent share over the next 25 years.

Chandra Ganjoo, Group Chief Executive Officer, Trivitron Healthcare: I am pleased to see the Indian medical device industry making significant strides in recent times. The Indian government’s vision for the National Medical Devices Policy 2023 is a positive step toward establishing India as a world leader in the medical device industry.The policy aims to make the Indian medical device industry self-reliant and meet patients’ evolving healthcare needs. In addition, it aims to encourage domestic manufacturing, reduce imports, and boost exports, resulting in a substantial expansion of the sector.

Vaibhav Tewari,Co-founder & CEO, Portea Medical: Portea welcomes the approval of the National Medical Devices Policy, 2023 by the Union Cabinet. We believe that this policy will provide a comprehensive and coordinated approach to the growth of the medical device sector in India, and help achieve the public health objectives of access, affordability, quality, and innovation. With our focus on delivering quality healthcare services to patients in the comfort of their homes, we are excited about the potential of this policy to drive innovation, enhance regulatory processes, and support the development of a skilled workforce in the medical device sector. Portea remains committed to supporting the government’s efforts towards achieving universal healthcare and a self-reliant India.

Runam Mehta, CEO, Healthcube: We are thrilled to hear about the National Medical Devices Policy, 2023. It is a commendable step towards promoting the medical devices sector in India, intending to capture 10-12 per cent of the expanding global market within the next 25 years. The policy outlines critical strategies such as regulatory simplification, infrastructure development, R&D, innovation facilitation, investment attraction, human resource development, and brand positioning. I believe this will further boost the economy by creating an ecosystem for manufacturing medical devices, promoting innovation, providing support for training and capacity building, and encouraging domestic investments, transforming India into a medical device manufacturing and innovation hub. The policy advances the growth of the medical device sector and realizes public health goals of accessibility, affordability, quality, and innovation. It is a significant step towards achieving the vision of making quality healthcare accessible to all.

Nilesh Aggarwal, CEO, IJCP Group and Founder, MedTalks: The national medical devices policy is a significant development that aims to enhance the healthcare sector in our country. It seeks to ensure the quality and safety of medical devices, drive innovation, and promote domestic production. By introducing robust regulations, we can provide patients with greater assurance in medical devices and enable better outcomes for healthcare providers. It is encouraging to see the government’s commitment to making medical devices more accessible and affordable. I am confident that this policy will greatly benefit our country in achieving this goal.