India clears new National Medical Devices Policy

The central government has announced a National Medical Devices Policy, 2023, that aspires to strengthen six broad areas to help the medical devices sector grow from the present $11 billion to $50 billion by 2030.

The six broad areas of policy interventions include regulatory streamlining, enabling infrastructure, enabling R&D and innovation, attracting investments, human resource development and brand positioning and awareness creation.

The policy calls for the creation of a ‘Single Window Clearance System for Licensing of Medical Devices’ co-opting all the stakeholder departments/organisations such as AERB (Atomic Energy Regulatory Board), MeitY (Ministry of Electronics and Information Technology), DAHD (Department of Animal Husbandry and Dairying), etc., enhancing the role of Indian Standards like BIS (Bureau of Indian Standards) and designing coherent pricing regulation. It talks of 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. The infrastructure development will happen with the support of the state governments and the industry for better convergence and backward integration.

Facilitating R&D and innovation is another area of focus as the policy envisages to establish centres of excellence in academic and research institutions, innovation hubs, ‘plug and play’ infrastructures and support to start-ups in the medical device sector.

The policy also encourages private investments, a series of funding from venture capitalists, and also public-private partnerships (PPP). It also talks of supporting dedicated multidisciplinary courses for medical devices in existing institutions to ensure the 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. Developing partnerships with foreign academic/industry organisations to develop medical technologies in order to be at an equal pace with the world market is also part of the policy document. It also envisages the creation of a dedicated export promotion council for the sector for brand promotion.

The Association of Indian Manufacturers of Medical Devices (AiMed) called the announcement a long-awaited direction the industry had sought since the initial draft policy of June 2014.

“The policy details will hopefully help traders and importers to start investing in putting up factories and end the 70-80% import dependency and the ever-rising import bill - last year imports shot up by a steep 41% to over ₹63,000 crore”, says Rajiv Nath, forum coordinator, AiMed. “Hopefully, we will see this neglected Sector flourish finally as has the mobile phones & toy Sector recently with policy support,” Nath adds.