Medtech Sector

Govt issues 'Draft National Medical Devices Policy 2022'

        Realising the need to have a holistic policy to accelerate growth and explore the potential of the Medical Devices Sector, the Department of Pharmaceuticals under the Chemicals and Fertilizers ministry has released an Approach Paper for the Draft National Policy for the Medical Devices, 2022, inviting feedback and remarks of the Industry and stakeholders. The Department of Pharmaceuticals has published this approach paper after extensive stakeholder consultations for the Sunrise Sector of Medical Devices, popularly called as MedTech Sector.

          The medical devices sector in India is an essential and integral constituent of the Indian healthcare sector, particularly for the prevention, diagnosis, treatment and management of all medical conditions, diseases, illnesses, and disabilities. The medical device sector has remained largely unregulated till 2017 when CDSCO framed the Medical Device Rules, 2017, for comprehensive regulation of MDs in a phased manner, especially on the quality, safety, and efficacy aspects, under the Drugs and Cosmetic Act, 1940. 

            Currently, nearly 80% of the medical devices sold in the country are imported, particularly high-end ones. Indian players have so far typically focused on low-cost and low-tech products such as consumables and disposables. With the policy, the government aims to reduce import dependence to nearly 30% in the next 10 years as India looks to become one of the top five global manufacturing hubs for medical devices by 2047. The medical devices sector has so far been regulated under provisions of the Drugs and Cosmetics Act of 1940. In February 2020, following revelations about faulty hip implants marketed by Johnson & Johnson, the government had notified changes in the Medical Devices Rules, 2017 to regulate medical devices on the same lines as drugs under the Drugs and Cosmetics Act. It has said the transition to complete regulation and licensing of all medical devices is expected to be complete by October 2023.

            According to the approach paper, by 2047, India is expected to be home to 25 billion dollar medical technology companies and will achieve a 10-12% global market share in the medical devices sector to arrive at a $100- 300 billion industry. Globally, the market is expected to reach $433 billion by 2025, and is currently dominated by the US (40%share), Europe (25%) and Japan (15%). In China, the sector is valued at around $96 billion and has been growing at over20% for several years.

              The sector requires special coordination and communication among Industry and stakeholders because of its diversified nature, continuous innovation and variation.  The department, through various programmatic and schematic interventions such as PLI scheme for promoting domestic manufacturing of medical devices, promotion of medical devices parks intends to encourage the domestic manufacturing of medical devices. Realising that the sector demands high level of coordination between the regulators, which have a specific legal function but are spread over various departments such as DoHFW, Department of Consumer Affairs, Atomic Energy Regulatory Board, National Institute of Biologicals, MoEF&CC, etc, the DoP attempts to resolve many of the issues through institutional arrangements, viz, Standing Forums, Regulatory Round Tables, etc.

           The proposed policy strives to put in place a comprehensive set of measures for ensuring sustained growth and development of the sector and addressing the further challenges of the sector such as regulatory streamlining, skilling of human resources and lack of technology for high end equipment and lack of appropriate infrastructure, through a coherent policy framework. The Draft National Policy aims to facilitate an orderly growth of the sector for the coming years. While addressing the core objectives of accessibility, affordability, safety and quality, the policy focuses on self-sustainability and innovation. This policy envisions that India will have few National Institutes of Medical Devices Education and Research (NIMERs) on the lines of NIPERs by 2047. India will be home to 25 high-end futuristic technologies in MedTech, the policy intends.