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Source: The post is based on the article “Cabinet approves the Policy for the Medical Devices Sector” published in PIB on 26th April 2023
What is the News?
The Union Cabinet approved the National Medical Devices Policy, 2023.
What is the need for a National Medical Devices Policy?
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 $11 billion (approximately, ₹ 90,000 Cr) in 2020 and its share in the global medical device market is estimated to be 1.5%.
The Indian medical devices sector is on a growth track and has an enormous potential to become self-reliant and contribute towards the goal of universal health care.
The Government of India has already initiated the implementation of PLI Scheme for medical devices and support for the setting up of 4 Medical device Parks in the States of Himachal Pradesh, Madhya Pradesh, Tamil Nadu and Uttar Pradesh.
Building upon these measures, a holistic policy framework to accelerate this growth and fulfill the potential of the sector is the need of the hour.
What is the purpose of the National Medical Devices Policy?
Objectives: To accelerate the growth path of the medical devices sector with a patient-centric approach;
– To emerge as the global leader in the manufacturing and innovation of medical devices by achieving a 10-12% share in the expanding global market over the next 25 years;
– To help the Medical Devices Sector grow from the present $11 Bn to $50 Bn by 2030.
Key Features of the policy: 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: Creation of a Single Window Clearance System for Licensing of Medical Devices; coordination between all the stakeholder departments/ organizations such as AERB, MeitY, DAHD, etc., Enhancing the role of Indian Standards like BIS; Designing a coherent pricing regulation.
Enabling Infrastructure: Developing medical device parks and clusters in line with the National Industrial Corridor Program and the proposed National Logistics Policy 2021 under the ambit of PM Gati Shakti.
Facilitating R&D and Innovation: Supporting R&D and innovation through the establishment of 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, Start-up mission, the policy encourages private investments, series of funding from Venture Capitalists and Public-Private Partnership (PPP).
Human Resources Development: Skilling, reskilling, and upskilling of professionals in the medical device sector; Supporting dedicated multidisciplinary courses for medical devices in existing institutions; Developing partnerships with foreign academic/industry organizations.
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.
What is the significance of this policy?
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.
