National Medical Devices Policy, 2023 Approved by the Union Cabinet

To meet the goals of accessibility, affordability, quality, and innovation in public health, it is crucial to facilitate the well-organized expansion of the medical device sector. This requires building a supportive ecosystem for manufacturing, with a strong emphasis on innovation, as well as establishing a robust and streamlined regulatory framework. The policy should also focus on providing support through training and capacity-building programs, along with promoting higher education to cultivate skilled resources aligned with the industry’s requirements. Encouraging domestic investments and local production of medical devices aligns with the government’s “Atmanirbhar Bharat” (self-reliant India) and “Make in India” initiatives.

The envisioned policy aims to provide the necessary support and guidance to strengthen the medical devices industry, transforming it into a competitive, self-reliant, resilient, and innovative sector that not only meets the healthcare needs of India but also contributes to global healthcare requirements.

National Medical Devices Policy

The National Medical Devices Policy aims to address various key objectives. These include:

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  Advocating for universal access to quality medical devices to ensure healthcare services for all
• Enhancing domestic manufacturing capabilities to make devices more affordable and reduce overall healthcare costs
• Emphasizing the importance of quality in domestically manufactured devices to enhance competitiveness
• Improving patient care and outcomes through early diagnosis and accurate treatment
• Promoting preventive and promotive health measures through the widespread use of medical devices
• Ensuring the security of medical devices through local manufacturing capabilities and resilient supply chains
• Fostering research and innovation for technology-driven devices and precision care
• Facilitating the development of skilled manpower aligned with the evolving nature of medical device technologies

What will the Policy Achieve?

According to the Gazette notification, the NDMP has a set of strategies that will cover six broad areas of interventions. These areas have been identified based on the current challenges facing the sector and the opportunities that lie ahead for fulfilling the sector’s potential. These are (2^✔ ✔Trusted Source
National Medical Device Policy, 2023

):

Simplifying the regulatory framework:

Considering the numerous organizations involved in the medical device sector, there is a requirement for further regulatory simplification that balances the safety of patients with product innovation. This would also reduce the burden of compliance and facilitate easier research and business operations. Some proposed measures under the NMDP are:

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  The implementation of a “Single Window Clearance System” for licensing medical devices which would align with the National Single Window System (NSWS) to prevent redundant efforts and unnecessary compliance requirements




• The Bureau of Indian Standards (BIS) and sector-specific standards development organizations, will gradually expand the standards related to processes, products, wireless technologies, and performance. This expansion aims to improve standardization and quality, enabling the domestic industry to become globally competitive. The goal is to formulate and adopt Indian Standards for Medical Devices




• A framework will be developed to regulate pricing in a coordinated manner. This framework will align with the provisions of the Drugs (Prices Control) Order, 2013, through the National Pharmaceutical Pricing Authority (NPPA) to ensure that quality and effective medical devices are available to all citizens at affordable prices




• A guidance framework will be designed to assist researchers, innovators, and entrepreneurs in complying with regulations during the research and development phases of bringing market-ready products. This framework will be implemented from the design phase itself and will also cover testing purposes




• An institutional arrangement is envisioned to align the regulations of the National Medical Commission (NMC) and the industry associations’ code of ethics

Building infrastructure:

The competition in the relevant industry would greatly benefit from the availability of infrastructure that enhances scale, quality, and productivity. The policy outlines the following measures:

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  The establishment and enhancement of large medical device parks and medium-sized medical device clusters will be pursued. These facilities will be equipped with a state-of-the-art common infrastructure, located in proximity to economic zones with appropriate logistics connectivity. This initiative is in line with the National Industrial Corridor Program and the proposed National Logistics Policy 2021 under the PM Gati Shakti framework




• While some testing and certification facilities for medical devices are currently available in government institutions such as the National Institutes of Pharmaceutical Education and Research (NIPERs), Centres under the Department of Biotechnology, and Centres under the Indian Council of Medical Research, the aim is to facilitate the establishment and strengthening of an adequate number of testing laboratories specifically for medical devices. This initiative aims to ensure the quality, safety, and efficacy of medical devices marketed in the country




• Support will be provided for the phased manufacturing of critical components to ensure uninterrupted access and availability of medical devices, thus avoiding disruptions in the supply chain. The objective is to boost domestic manufacturing capabilities in the medical device sector

Developing skilled human resources:

In order to establish a skill development ecosystem that aligns with the Skill India program, the medical device sector requires a consistent supply of skilled workforce throughout the value chain, including scientists, regulators, health experts, managers, technicians, and more. The policy outlines the following initiatives:

• Capitalize on the resources available within the Ministry of Skill Development and Entrepreneurship’s skill ecosystem to develop qualifications for skilling, reskilling, and upskilling professionals in the medical device sector. Certification of candidates/professionals based on these qualifications will be integrated into the National Skill Qualification Framework (NSQF), and all skilling courses will be aligned accordingly




• The policy will provide support for dedicated multidisciplinary courses focused on medical devices within existing institutions. This measure ensures the availability of skilled manpower for futuristic medical technologies, high-end manufacturing, and research. The goal is to produce MedTech human resources that are well-prepared for the sector’s evolving needs




• In consultation with the industry, a National Database will be formulated and regularly updated to identify the various skills required for the latest manufacturing technologies used in the MedTech sector. This database will also encompass the skills necessary for the adoption of specific technologies




• A framework is envisioned to facilitate partnerships between academic institutions in the medical devices sector and foreign academic/industry organizations. These collaborations will focus on developing medical technologies, fostering innovation, and promoting knowledge exchange

Encouraging research and development:

The medical device sector relies heavily on innovation and technology. Next-generation technologies are expected to play a significant role in various aspects of medical devices, including diagnostic equipment, data analytics, personal devices, and patient care. The policy aims to foster innovation and R&D in the sector, including joint R&D projects involving academic institutions and industry, as outlined in the Department’s proposed ‘National Policy on R&D and Innovation in the Pharma-MedTech Sector in India’. This objective will be achieved through the following measures:

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  Encouraging structured interaction between academic institutions and the medical devices industry to create an environment conducive to industry-academia collaboration. This will foster the development of self-reliant technology products




• Coordinating the efforts of the government and industry to establish Centers of Excellence in premier academic and research institutions. These CoEs will contribute to the development of world-class institutions and attract global experts. The expertise available in these institutions will be leveraged to support product development and validate technology




• Exploring the establishment of innovation hubs that bring together a network of academic institutions, start-ups, clinical settings, funding agencies, and other stakeholders. These hubs will create a health technology ecosystem by providing plug-and-play infrastructure. Additionally, they will explore the use of 5G use-case labs




• Seeking convergence of available resources from various institutions such as the Biotechnology Industry Research Assistance Council (BIRAC), Start-up mission, AGNIi, and other enabling mechanisms. This convergence aims to promote innovation and commercialization in India, maximizing the utilization of government-funded inventions

Positioning the brands effectively and creating awareness:

The policy aims to enhance global competitiveness in coordination with the Ministry of Commerce and Industry’s efforts. Additionally, the establishment of a dedicated Export Promotion Council for the sector under the Department will help address market access issues. Recognizing the importance of strengthening stakeholder engagement, where academia, clinical hospitals, industry, funding institutions (such as private equity/venture capital funds and central banking organizations), and the government can converge and collaborate to unlock India’s potential in medical device science and innovation, the policy outlines the following measures:

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  Undertake studies and projects to learn from successful global practices in manufacturing and skilling systems. The objective is to explore the feasibility of adopting such models in India, adapting them to suit the country’s requirements




• Promote awareness regarding medical device safety and standards, while ensuring proactive communication and outreach to the public regarding the value proposition offered by medical devices




• Encourage the establishment of more forums that bring together various stakeholders to facilitate knowledge sharing and the development of robust networks across the sector. These forums will provide a platform for collaboration and collaboration among stakeholders, fostering innovation and growth

Attracting investments in the sector:

In addition to the existing schemes and interventions, the policy proposes the following additional measures to promote indigenous manufacturing, enhance competitiveness, and foster a manufacturing ecosystem:

• Encourage private investments in the sector by establishing an ecosystem that supports risk-based or risk-adjusted financing. This will involve active outreach and engagement activities such as promoting seed capital and funding series from Venture Capitalists. VCs will also be invited to participate in the screening and incubation of start-ups




• Promote new financing models, including blended finance, which combines both public and private funds to support the sector




• Engage, leverage, and build upon various initiatives such as the Start-up mission of the Department for Promotion of Industry and Internal Trade to encourage the growth of start-ups in the medical devices sector




• Utilize initiatives like the Public Procurement (Make in India) Policy and the Ayushman Bharat program to leverage opportunities for domestic manufacturing and promote the production of medical devices within the country

References :

1. The Gazette of India – (https://pharmaceuticals.gov.in/sites/default/files/
   Gazette%20Notification%20%20National%20Medical%20Devices%20Policy%202023.pdf)
2. National Medical Device Policy, 2023 – (https://www.lexology.com/library/detail.aspx?g=75be96cd-af94-4526-9a02-919e53f6507f)

Source: Medindia