The National Medical Device Policy was presented with an outlook paper by the Department of Pharmaceuticals (DoP), stating a conscript for the stakeholder’s evaluation to position India as the real “Diagnostic Capital of the World”. This newly acquired policy will stand valid for the next 10 years during which a range of developments is seen in making like setting up of institutions like NIPER in the medical devices sector. The outcome of this policy is likely to be the base of the next revision of the policy post 10 years. 

The stated policy is estimated to bring together the various policies which the Government of India (GoI) has on offer on the scaffolding, like the focus on quality control checks and safety of the devices, supervisory streamlining, creation of support groups to develop competitiveness through capital and financial support, development of the infrastructure provided, facilitation of R&D and innovation, human resource development, and brand positioning. 

The policy aims to incorporate a framework for a systematic pricing regulation, and the National Pharmaceutical Pricing Authority shall be strengthened with adequate human resources of suitable expertise to provide effective price regulation balancing the patient and industry needs and incorporating innovation and life cycle costs as factors pricing regulation of medical devices. The Department also proposes the implementation of a Uniform Code for Medical Devices Marketing Practices (UCMDMP). Setting up medical devices parks with common infrastructure facilities will also be a part of the policy recommendation. It also proposes to develop additional NABL accredited laboratories for medical device testing, amongst other infrastructure development supports. 

The new policy proposes to allot a dedicated fund for encouraging joint research with industry players, academic institutions, small and medium enterprises, and startups for research and development activities targeted at leveraging state-of-the-art technology for the domestic manufacturing of medical equipment and to support coalition comprising industry, academics, startups and SMEs, to undertake joint R&D projects with pre-defined agreements around intellectual property related issues. The policy also proposes to promote industry-academia coherence and innovation hubs, Centres of Excellence in premier academic and research institutions, purposeful investment in a few priority institutes to build CoEs focusing on medical technology innovation and R&D, among topics of other research. 

For Human Resources development, the policy intents to set up National Institutes of MedTech (Medical Devices Education and Research [NIMERs], on lines of NIPERs, as institutes of National Importance), formulating a National Registry for priority which corresponds to skills required in the production of specific technologies and will maintain a databank having details related to the latest technology and the skill required to do the production, and financing of such skills through hands-on training, internships/training in specialized industry locations as par with Junior Research Fellow stipends made available by UGC granted universities. 

It also envisages promoting awareness on medical devices safety standards and ensuring proactive communication and outreach on the value proposition, promoting various national and international events and roadshows, and promoting Made in India for the World movement. 

The performance metrics is expected to reach an outcome with a target of $50 billion market size by FY 2025, increasing global market share, reducing disease burden, and increasing disability-adjusted life years in India comparable to developed economies such as the US and UK by 2030. 

It is proposed that by 2047, India will be one amongst the top five global manufacturing hubs in terms of value and technology for Medical Devices, and will be home to 25 MedTech Billion Dollar companies and home and originator to 25 high-end futuristic technologies in MedTech. India will achieve 10-12 percent of the global market share of the medical devices sector to reach a $100-300 billion industry and will have 50 medical devices clusters across the country for faster clinical testing of medical devices to boost product development and innovation, according to the approach paper worked on by the Department of Pharmaceuticals (DoP).