The Indian Government has initiated the National Medical Devices Policy to implement the Production Linked Incentive (PLI) Scheme for medical devices and establish four Medical Devices Parks in Himachal Pradesh, Madhya Pradesh, Tamil Nadu, and Uttar Pradesh.
Under the scheme, 26 projects have been approved with an investment of Rs 714 crore realised, out of the total of Rs 1206 crore.
About National Medical Devices Policy
- Currently, 14 projects have been completed, producing 37 different medical devices.
- These include advanced equipment like Linear Accelerators, MRI Scans, Mammograms, CT Scans, C-Arms, high-end X-ray tubes, and MRI Coils.
- The remaining 12 products are expected to be manufactured domestically soon.
- Under the National Medical Devices Policy, 5 more projects have been approved under Category B for the domestic manufacturing of 87 products or product components.
- In order to fully tap into the potential of the medical device industry and promote its growth, there is a need for a comprehensive policy framework.
- Although the Indian government has taken several initiatives to encourage the sector, there is currently a lack of a coordinated approach.
- As a result, it is essential to integrate regulations, skilling, and trade promotion of the medical device industry in a coherent manner. This will enable focused and efficient support from the authorities.
Aim
- The National Medical Devices Policy 2023 has been introduced to continue the progress made towards the growth of the medical device sector.
- The goal is to expand this sector from $11 billion to $50 billion by the year 2030.
- The policy concentrates on developing a favourable environment for manufacturing and innovation, simplifying regulations, encouraging training and skill-building programs, and cultivating expertise and skilled resources in accordance with the industry’s demands.
- The National Medical Devices Policy 2023 has six areas of focus to encourage the growth of the medical device sector in India.
- These include making regulations more efficient, creating better infrastructure, promoting research and development and innovation, attracting investments, developing skilled workers, and increasing awareness of the industry.
- The policy aims to encourage domestic investment and production of medical devices to align with the Indian government’s ‘Atmanirbhar Bharat’ and ‘Make in India’ initiatives.
- The goal is to make it easier to conduct business, develop better infrastructure, promote research and innovation, attract more investment, and develop a dedicated Export Promotion Council for the medical device industry.
- The National Medical Devices Policy aims to make it easier to conduct research and business in the medical device sector while maintaining a balance between patient safety and product innovation.
- To achieve this, the policy proposes the development of a “Single Window Clearance System” for licensing medical devices, with all relevant stakeholder departments and organisations, such as AERB, MeitY, DAHD, etc., working together.
- The policy also seeks to enhance the role of Indian standards, such as BIS, and create a coherent pricing regulation system.
- Vision: The government’s goal is to become the leader in manufacturing and innovation of medical devices with a patient-centric approach. They aim to achieve a 10-12% market share in the global market over the next 25 years and pursue rapid growth. By 2030, the medical device industry is projected to grow from $11 billion to $50 billion in revenue.
- Mission: The National Medical Devices Policy 2023 sets out a plan to expedite the growth of the sector to achieve the following goals: ensure access and universality, improve affordability, enhance quality, promote patient-centred care, prioritise preventive healthcare, strengthen research and innovation, ensure safety and security, and develop skilled labour.
- The National Industrial Corridor Programme and the proposed National Logistics Policy 2021, which are under the jurisdiction of Pradhan Mantri Gati Shakti National Master Plan, aim to set up and improve large medical device parks, clusters, and facilities with advanced common infrastructure near economic zones with adequate logistics connectivity.
- The policy aims to support the proposed National Policy on R&D and Innovation in the Pharma-MedTech Sector in India, while also promoting research and development within the country. It seeks to establish innovation centres, “plug and play” infrastructures, centres of excellence at academic and research institutions, and provide support for start-ups.
- The policy not only supports existing initiatives such as Make in India, Ayushman Bharat, Heal-in-India, and the Start-up Mission but also promotes private investments, venture capitalist funding, and public-private partnerships (PPP).
- The National Medical Devices Policy aims to ensure that there is a steady supply of skilled professionals across the entire medical device industry value chain, including health experts, scientists, technicians, regulators, managers, and more.
- The policy also aims to support specialised multidisciplinary courses in existing institutions to ensure the availability of skilled labour for advanced manufacturing and research, as well as for developing futuristic medical technologies.
- This will help create a future-ready workforce in the MedTech sector, and establish partnerships with international academic and business institutions for the development of medical technology to keep pace with the global market.
- The policy proposes the creation of a dedicated Export Promotion Council under the Department to address various market access issues and promote exports in the medical device sector.
- This council will focus on identifying and resolving issues that are hindering exports, promoting exports, and expanding market access for Indian medical devices worldwide. It will also work towards developing international partnerships and collaborations for the sector’s growth and expansion.
