On 3-5-2023, the Ministry of Chemicals and Fertilizers notified the National Medical Devices Policy, 2023.
Key Points:
1. Medical devices constitute a multi-disciplinary sector, with the following classification:
● Electronic equipment
● Implants
● Consumables and Disposables
● Surgical instruments
● In-Vitro Diagnostic Reagents
2. Objective: :
● The Policy contributes to the objectives of public health by making available quality products.
● There is a need to facilitate an orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality and innovation.
● The policy is envisaged 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.
3. Vision: to place the Indian medical devices sector on an accelerated growth path with a patient-centric approach to meet the evolving healthcare needs of patients by building an innovative and globally competitive industry in India.
4. The Aim is 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.
5. Mission: is to accelerate growth of the medical devices sector while promoting safety and quality.
6. Strategies to Promote Medical Device Sector:
● Regulatory Streamlining: to balance patient safety with product innovation.
◾ To avoid duplication of efforts and imposition of unnecessary compliance burden, a Single Window System for Licensing of Medical Devices is envisaged in alignment with the National Single Window System.
◾ Indian Standards setting bodies will gradually expand the standards in terms of processes, products, wireless technologies and performances to enhance the level of standardization, quality and enable indigenous industry to gain global competitiveness and achieve the goal of formulation and adoption of Indian Standards for the Medical Devices.
◾ A framework for coherent pricing regulation will be developed, duly aligning the provisions of Drugs (Prices Control) Order (DPCO), 2013 through National Pharmaceutical Pricing Authority (NPPA) to make available quality and effective medical devices to all citizens at affordable prices
● Enabling Infrastructure: it will enhance scale, quality and productivity.
● Facilitating R&D and Innovation: it also includes projects involving academic institutions and industry under the ambit of Department’s proposed ‘National Policy on R&D and Innovation in the Pharma- MedTech Sector in India’.
● Attracting Investments in the Sector: by encouraging private investments, new financial models and engaging, leveraging, and systematically build upon the various initiatives including Start-up mission of the Department for Promotion of Industry and Internal Trade, to encourage startups in the medical devices sector.
● Human Resources Development: The skilling, reskilling and upskilling of professionals and certification will be aligned to the National Skill Qualification Framework and the skilling activities will be integrated with Skill India Portal.
● Branding positioning and Awareness Creation: the policy envisages building global competitiveness and the creation of a dedicated Export Promotion Council for the sector under the Department to deal with various market access issues.
7. Monitoring and Evaluation: to measure the impact, Quantitative Output / Outcome metrics will be developed. Further, economic indicators such as market size, exports and Foreign Direct Investment will be tracked by regular monitoring.
