Policy for the Medical Devices Sector

In News

• The Union Cabinet has approved the policy for the medical devices sector and six strategies have been planned to tap the potential of the sector with the implementation action plan. 

Medical Device Sector in India

• The current market size of the medical devices industry in India is estimated at $11 bn (approximately, ? 90,000 Cr) in 2020 and its share in the global medical device market is estimated to be 1.65%. 
• India is the 4th largest Asian medical devices market after Japan, China, and South Korea, and among the top 20 medical devices markets globally.
• The medical devices industry in India consists of large multinationals as well as small and medium enterprises (SMEs) growing at an unprecedented scale.
• It was recognized as a Sunrise Sector of India under Make in India Campaign of 2014.

Need for the Policy

• Sunrise Sector: The medical devices sector in India is a sunrise sector which is growing at a fast pace. Building upon these measures, a holistic policy framework to accelerate this growth and fulfil the potential of the sector is the need of the hour. 
• Universal Healthcare: The Indian medical devices sector is on a growth track and has an enormous potential to become self-reliant and to contribute towards the goal of universal health care. 
  • The Indian medical devices sector’s contribution has become even more prominent as India supported the domestic and global battle against COVID-19 pandemic through the large scale production of medical devices & diagnostic kits.
• Orderly Growth: The National Medical Devices Policy, 2023 is expected to facilitate an orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality and innovation. 

• While various Departments of the Government have undertaken programmatic interventions to encourage the sector, the current policy aims to put in place a comprehensive set of focus areas for growth of the sector in a coordinated manner.

• Encouraging domestic investments and production of medical devices complements the Government’s ‘Atmanirbhar Bharat’ and ‘Make in India’ programs. 

Salient Features of National Medical Devices Policy, 2023

• Vision: To provide an accelerated growth path with a patient-centric approach and to emerge as the global leader in the manufacturing and innovation of medical devices by achieving 10-12% share in the expanding global market over the next 25 years.  
  • Policy is expected to help the Medical Devices Sector grow from present $11 Bn to $50 Bn by 2030.
• Mission: Policy lays down a roadmap for accelerated growth of the medical devices sector to achieve the following missions viz, Access & Universality, Affordability, Quality, Patient Centred & Quality Care, Preventive & Promotive Health, Security, Research and Innovation and Skilled manpower.
• Strategies to Promote Medical Device Sector: Strategies that will cover six broad areas of policy interventions:

• Regulatory Streamlining: To enhance ease of doing research and business a Single Window Clearance System‘ for Licensing of Medical Devices co opting all the stakeholder departments / organizations, enhancing the Role of Indian Standards and designing a coherent pricing regulation, will be followed.

• Enabling Infrastructure: The establishment and strengthening of large medical device parks, clusters equipped with world class common infrastructure facilities in proximity to economic zones 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 to promote Research & Development in India and complement the Department’s proposed National Policy on R&D and Innovation in the Pharma- MedTech Sector. 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, Start-up mission, the policy encourages private investments, series of funding from Venture Capitalists, and also Public-Private Partnership(PPP).

• Human Resources Development: The policy envisages:

• Leverage the available resources in Ministry of Skill Development and Entrepreneurship for skilling, reskilling and upskilling of professionals in the medical device sector, 
• The policy will support dedicated multidisciplinary courses for medical devices in existing institutions 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.

• Brand Positioning and Awareness Creation: 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 systems 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.

Steps Taken by Government of India to ensure the growth of the sector

• Production Linked Incentives: Government has launched Production Linked Incentive Schemes for medical devices with financial incentives worth $456 mn to boost domestic production.
• Development of Medical Devices Parks: New Medical Devices Parks upcoming in Himachal Pradesh, Uttar Pradesh, Madhya Pradesh, & Tamil Nadu to create a robust ecosystem for medical device manufacturing.
• Policy Support: Release of National Medical Devices Policy to enable strong collaborations for boosting medical devices ecosystem & National R&D Policy to foster interdisciplinary collaborations to develop translational skills & start-up ecosystem.

Source: PIB