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National Medical Devices Policy, 2023
The union government introduced the National Medical Devices Policy, 2023 to augment the capacity, capabilities and competence of the domestic medical devices manufacturing industry. However, the policy has many lacunae and missing links, which could undermine the aims to foster a strong domestic medical devices manufacturing. There is a need for reform, in line with the existing policy initiatives and to constitute a separate law and regulatory body for the industry. The policy needs to enhance the accessibility by changing the existing procurement system for the public health sector. It further needs to scale up domestic manufacturing capabilities, through production-linked incentives, to ensure affordable medical devices for all citizens.
The infrastructural support provided by the FORE School of Management, New Delhi, in completing this study is greatly acknowledged. The authors express their sincere thanks to the anonymous reviewers for their thoughtful and thorough review of the paper. The authors also acknowledge Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry, New Delhi for the helpful insights on the paper.
Medical devices play an important role in modern healthcare systems, contributing to the diagnosis, treatment, and monitoring of diseases and medical conditions (Kale 2019; James and Jaiswal 2020). Given the large size of India’s population, there is a significant demand for such devices, and yet there exists a substantial demand–supply gap (Peter 2018). With an overall import dependency of 70% to 80%, ensuring the quality, safety, affordability, and accessibility of such devices becomes crucial for the well-being of patients (BioVoice 2023). Recognising the immense growth potential in addressing this gap, both domestic and international medical device manufacturers are actively pursuing opportunities in the Indian market.
To promote the domestic medical device sector, the governments in the past had introduced various initiatives and policies (Mahal and Karan 2009). The medical device sector was identified as a focus area during the “Make in India” campaign in 2014 (Deloitte 2016). However, in the context of inconsistent regulations, red tape in approvals, varying standards of manufacturing, weak research and development (R&D) ecosystem and limited capital, these initiatives have failed to deliver the desired results (Dang and Sharma 2019; Saini et al 2022). Realising the challenges arising out of ever-increasing and unsustainable import bills and affordable medical technology (Mahal et al 2006), the union government approved the National Medical Devices Policy on 2 May 2023.
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