National Medical Devices Policy 2023

Context:

The Union Cabinet, chaired by the Hon’ble Prime Minister approved the National Medical Devices Policy, 2023.

Relevance:

GS II: Government Policies and Interventions

Dimensions of the Article:

1. About National Medical Devices Policy, 2023
2. Salient Features of National Medical Devices Policy, 2023
3. State of the Medical Device Industry in India

About National Medical Devices Policy, 2023

Vision: 

• 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.

Salient Features of National Medical Devices Policy, 2023:

Strategies to Promote Medical Device Sector:

• 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:

• In order to enhance ease of doing research and business and further to balance patient safety with product innovation measures such as creation of a Single Window Clearance System’ for Licensing of Medical Devices coopting all the stakeholder departments / organizations such as AERB, MeitY, DAHD, etc, enhancing the Role of Indian Standards like BIS 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 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 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.

Attracting Investments in the Sector:

• Along with resent 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:

• 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.

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 National Medical Devices Policy, 2023 aims to place the medical devices sector on an accelerated path of growth with a patient-centric approach to meet the evolving healthcare needs of patients.

State of the Medical Device Industry in India

• The medical devices industry is a vital part of the Indian healthcare sector and includes products used for diagnosis, prevention, treatment, and management of medical conditions, illnesses, and disabilities.
• The sector has five broad classifications, including electronics equipment, implants, consumables and disposables, in vitro diagnostics (IVDs) reagents, and surgical instruments.
• The industry remained unregulated until 2017, when the Medical Device Rules were introduced for comprehensive regulation of medical devices under the Drugs and Cosmetic Act, 1940.

Scope of the Sector:

• The Indian medical device market is dominated by multinational companies, with approximately 80% of sales by value generated from imported medical devices.
• The Indian medical devices industry’s contribution has become even more critical as the country supported the global fight against COVID-19 by producing essential medical devices and diagnostic kits such as ventilators, RT-PCR kits, infrared thermometers, personal protective equipment (PPE) kits, and N-95 masks.
• The medical devices industry in India is valued at USD 5.2 billion, contributing about 4-5% to the USD 96.7 billion Indian healthcare industry.
• Although India is one of the top twenty markets for medical devices globally and the fourth largest market in Asia after Japan, China, and South Korea, the medical devices sector in India is small compared to the rest of the manufacturing industry.
• Currently, India imports 80-90% of medical devices in the USD 15 billion market.
• The US, Germany, China, Japan, and Singapore are the top five exporters of high-technology medical equipment to India.

-Source: The Hindu, PIB