Cabinet Approves A New Six Strategy Policy For Medical Devices Sector
On Wednesday, the Union Cabinet, chaired by Prime Minister Narendra Modi, approved the National Medical Devices Policy, 2023. According to the Union Health Ministry, the policy aims for an accelerated growth path 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.
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 USD 11 billion (approximately, Rs 90,000 Cr) in 2020 and its share in the global medical device market is estimated to be 1.5 per cent.
"The policy is expected to help the Medical Devices Sector grow from the present USD 11 Billion to USD 50 Billion by 2030. The policy is also expected to facilitate orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality and innovation," the Union Health Ministry said in a statement.
The framework of the policy will focus on six broad strategies which will facilitate and guide the medical devices sector of India, which subsumes 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.
The Six Strategies
Streamlining Regulatory System: To enhance the ease of doing research and business, the policy has introduced a 'Single Window Clearance System' for licensing of medical devices coopting all the stakeholder departments and organisations such as AERB, MeitY, DAHD, etc. This will enhance the Role of Indian Standards like BIS and design a coherent pricing regulation, which 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 Partnerships (PPP).
Human Resources Development: In order to have a steady supply of skilled workforce 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 the Ministry of Skill Development and Entrepreneurship.
The policy will support dedicated multidisciplinary courses for medical devices in existing institutions to ensure the 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 and 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 Union Ministry said in a statement.
