National Medical Devices Policy, 2023

Q. Why in News/Context - On April 26, the Union Cabinet approved the National Medical Devices Policy, 2023. (The Hindu May 22, 2023, PIB – April 26,2023).

Q. Aim/purpose-

·  To achieve the public health objectives of access, affordability, quality and innovation. Accelerated growth path with a patient-centric approach.

·     It is expected to help the domestic medical devices sector market grow from $11 billion to $50 billion by 2030 alongside achieving a 10-12% global market share over the next 25 years.

·   The aim is to provide the required support and direction, and help the sector become “competitive, self-reliant, resilient and innovative” to cater not only to domestic but global needs.  

·      To achieve the missions of Access & Universality, Affordability, Quality, Patient Centred & Quality Care, Preventive & Promotive Health, Security, Research and Innovation and Skilled manpower.

Q. What is pricing issue?  

·       Some private hospitals give higher priced products instead of available low-cost options. Because of this, the manufacturer or importer of India is tied up in a system of market operating with artificially inflated MRP labelled on the device. So, pricing regulation is particularly important for addressing a broader challenge in the domestic device manufacturing sector.

Q. Issues in domestic market?   

·     As per the Indian Brand Equity Foundation (IBEF), a huge gap still exists in the current demand and supply of medical devices from U.S., China and Germany; India has an overall 70-80% import dependency on medical devices.

·      India is among the major global manufacturers of equipment such as syringes, needles, surgical blades, surgical gloves, condoms, PPE, masks, hydrocephalus shunts, orthopaedic implants and intra-ocular lenses, it is highly dependent on imports for basic consumables like examination gloves, hot water bottles and home care products like blood pressure instruments, diabetes sugar monitors, and thermometers. China and U.S. combined make up 60% of our import basket.  

·      If the National Medical Devices Policy (2023) and the Parliament Healthcare Committee recommendations are implemented then the trade imbalance can be corrected to be at least 60-70% domestic market share and a more reasonable 30% imports.

Q. What are the Strategies to Promote Medical Device Sector in India:

Medical devices sector will be facilitated and guided through a set of strategies that will be cover six broad areas of policy interventions:

1.   Regulatory Streamlining: In order to enhance ease of doing research and business and further to balance patient safety with product innovation :

·  The policy enhances the role of the Bureau of Indian Standards (BIS) along with designing a coherent pricing regulation.  

·   Besides capping prices, the streamlining endeavour will also create a single window clearance system for licensing of medical devices, combining relevant departments like the Atomic Energy Regulatory Board (AERB), MeitY and the Department of Animal Husbandry and Dairying (DAHD). 

2.   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.

3. 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.

4.  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 also Public-Private Partnership(PPP).

5.  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.

6.   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.

Extra points to note

·        India is the fourth largest Asian medical market after Japan, China and South Korea and is among the top 20 globally.

·        India’s major medical clusters are Gujarat, Karnataka, Maharashtra, Haryana, Andhra Pradesh and Tamil Nadu. Their manufacturing expertise varies from pharmaceuticals, medical electronics, stents and implants to low-end medical consumables.

Way Forward : 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.  It is hoped that the policy will help boost manufacturing, help traders and importers to start investing in factories and end the import dependency forced upon India and the ever-rising import bill which shot up by 41% to over Rs 63,000 crore alongside making quality healthcare accessible and affordable worldwide.