National Medical Devices Policy Approved By Union Cabinet

National Medical Devices Policy

The Indian Government has taken steps for National Medical Devices Policy to implement the PLI Scheme for medical devices and establish 4 Medical Devices Parks in Himachal Pradesh, Madhya Pradesh, Tamil Nadu and Uttar Pradesh. At present, 26 projects worth Rs 1206 crore have been approved under the scheme, with an investment of Rs 714 crore realized.

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National Medical Devices Policy: Key Highlights

• 14 projects producing 37 products have been commissioned to date and high-end medical devices like Linear Accelerator, MRI Scan, Mammogram, CT-Scan, C-Arm, high-end X-ray tubes, MRI Coils, etc., are being manufactured domestically with the remaining 12 products to follow soon.
• Recently, 5 projects have been approved under Category B, for domestic manufacturing of 87 products/product components under National Medical Devices Policy.
• To further boost growth in the sector and realize its potential, a comprehensive policy framework is urgently required.
• Despite various Government departments taking initiative to encourage the medical device sector, there is currently a lack of a coordinated approach.
• Therefore, the regulations, skilling, and trade promotion of medical device industry must be integrated in a coherent manner to enable focused and efficient support from the authorities.

National Medical Devices Policy: Aim

• The National Medical Devices Policy 2023 aims to build on these measures to facilitate the orderly growth of the medical device sector.
• This sector is expected to grow from $11 billion to $50 billion by 2030.
• The policy focuses on creating an enabling ecosystem for manufacturing and innovation, streamlining regulations, promoting training and capacity building programs, and fostering talent and skilled resources in line with the industry requirements.
• Domestic investments and production of medical devices will also be encouraged to complement the Government’s ‘Atmanirbhar Bharat’ and ‘Make in India’ programs.
• The policy covers six broad areas of policy interventions—regulatory streamlining, enabling infrastructure, facilitating R&D and innovation, attracting investments, human resources development, and brand positioning and awareness creation.
• The policy aims to enhance ease of doing research and business, create world-class common infrastructure facilities, promote R&D and innovation, attract private investments, develop skilled workforces, and create a dedicated Export Promotion Council for the sector.

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Important aspects of the National Medical Devices Policy for 2023:

Vision:

In the next 25 years, we will achieve a 10–12% market share in the expanding worldwide market while pursuing an accelerated growth path with a patient-centric mindset. We will do this by being the world leader in the manufacture and innovation of medical devices. By 2030, the medical device industry is anticipated to rise from its current $11 billion in revenue to $50 billion.

Mission:

The policy outlines a plan for the sector’s quick development in order to fulfil the following objectives: access and universality, affordability, quality, patient-centered care, preventive and promotion of health, security, research and innovation, and skilled labour.

Promotional tactics for the medical equipment industry:

A set of plans covering six major areas of governmental interventions will help and direct the medical device industry.

Regulatory simplification:

In order to improve the ease of conducting research and business and further to balance patient safety with product innovation, measures such as the development of a “Single Window Clearance System” for Licencing of Medical Devices, coopting all the stakeholder departments/organizations such as AERB, MeitY, DAHD, etc., enhancing the role of Indian Standards such as BIS and designing a coherent pricing regulation, will be followed.

Enabling infrastructure:

The National Industrial Corridor Programme and the proposed National Logistics Policy 2021, both of which fall under the purview of Prime Minister Gati Shakti, both envision the establishment and strengthening of large medical device parks, clusters, and facilities equipped with top-notch common infrastructure in close proximity to economic zones with the necessary logistics connectivity.

Fostering innovation and research:

The goal of the policy is to support the Department’s proposed National Policy on R&D and Innovation in the Pharma-MedTech Sector in India while promoting research and development in India. Additionally, it intends to create innovation centres, ‘plug and play’ infrastructures, centres of excellence at academic and research institutions, and support for start-ups.

Boosting investment in the sector:

In addition to current initiatives and programmes like Make in India, Ayushman Bharat, Heal-in-India, and the Start-up Mission, the policy promotes private investments, rounds of funding from venture capitalists, and public-private partnerships (PPP).

Human resources development:

• The policy aims to provide a consistent supply of competent workers across the value chain, including scientists, regulators, health experts, managers, technicians, etc.
• The Ministry of Skill Development and Entrepreneurship’s resources can be used to skill up, reskill, and upskill professionals in the medical device industry.
• In order to ensure the availability of skilled labour for cutting-edge manufacturing and research as well as futuristic medical technologies, the policy will support specialised multidisciplinary courses for medical devices in existing institutions.
• This will create future-ready MedTech human resources and meet the sector’s changing needs to establish collaborations with international academic and business institutions in the development of medical technology in order to keep up with the global market.

Brand positioning and raising consumer awareness:

The policy calls for the establishment of an Export Promotion Council specifically for the sector inside the Department, which will make it possible to address a variety of market access issues:

• Start studies and projects to learn from the best manufacturing and skilling systems around the world in order to determine whether it is feasible to implement such successful models in India.
• Encourage the creation of more forums that will bring together various stakeholders to exchange expertise and create robust networks across the industry.
• The policy is anticipated to give the medical device industry the assistance and guidance needed to grow into a competitive, self-sufficient, resilient, and innovative sector that meets the healthcare requirements of not just India but also of the rest of the world.

Overall, the National Medical Devices Policy, 2023 is expected to strengthen the medical device industry into a competitive, self-reliant, resilient, and innovative industry that caters to global healthcare needs while meeting the evolving healthcare needs of patients in India.

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