National Medical Devices Policy
The Indian Government has initiated the National Medical Devices Policy to implement the PLI Scheme for medical devices and set up four Medical Devices Parks in Himachal Pradesh, Madhya Pradesh, Tamil Nadu, and Uttar Pradesh. Currently, 26 projects worth Rs. 1206 crore have been approved under the scheme, and an investment of Rs. 714 crore has been realized.
National Medical Devices Policy: Key Highlights
- To date, 14 projects producing 37 different medical products have been established, including high-end medical devices such as Linear Accelerators, MRI Scans, Mammograms, CT-Scans, C-Arms, high-end X-ray tubes, and MRI Coils, which are now being manufactured within the country. The remaining 12 products are expected to be produced soon.
- Five projects have recently been approved under Category B of the National Medical Devices Policy for the domestic production of 87 products or product components.
- A comprehensive policy framework is urgently needed to further enhance growth in the medical devices sector and fully realize its potential.
- At present, there is a lack of coordination in the initiatives taken by various government departments to promote the growth of the medical device sector.
- Hence, there is a need to integrate regulations, skilling, and trade promotion for the medical device industry in a coordinated manner to facilitate targeted and effective support from the authorities.
National Medical Devices Policy: Aim
- The National Medical Devices Policy 2023 seeks to enhance and expand on these initiatives to promote the systematic development of the medical device industry.
- The medical device sector is projected to expand from $11 billion to $50 billion by 2030.
- The policy aims to establish an environment that supports medical device manufacturing and innovation, simplifies regulations, promotes training and capacity building initiatives, and nurtures talent and skilled resources that align with industry needs.
- The policy will also promote domestic investment and production of medical devices, aligning with the government's 'Atmanirbhar Bharat' and 'Make in India' initiatives.
- The policy encompasses six main areas of policy interventions which include regulatory simplification, enabling infrastructure, promoting research and development and innovation, attracting investments, developing human resources, and creating brand awareness.
- The policy seeks to improve the ease of conducting research and business, establish high-quality shared infrastructure facilities, encourage research and development as well as innovation, entice private investments, cultivate skilled workforces, and set up a specialized Export Promotion Council for the medical device sector.
Important aspects of the National Medical Devices Policy for 2023:
Vision:
Over the next 25 years, we aim to capture 10-12% of the rapidly growing global market by pursuing an accelerated growth trajectory with a focus on patient-centricity. Our goal is to become the world leader in the manufacturing and innovation of medical devices. By 2030, we expect the medical device industry to grow from its current revenue of $11 billion to $50 billion.
Mission:
The policy sets out a roadmap for the rapid growth of the sector to achieve the following goals: universal and equitable access, affordability, quality, patient-centered care, prevention and promotion of health, security, research and innovation, and skilled workforce.
Promotional tactics for the medical equipment industry:
The medical device industry will be supported and guided by a set of plans that cover six major areas of government interventions.
Regulatory simplification:
To promote ease of doing research and business while ensuring patient safety and product innovation, the policy proposes several measures. These include developing a "Single Window Clearance System" for licensing medical devices, involving all relevant departments/organizations such as AERB, MeitY, and DAHD, strengthening the role of Indian Standards such as BIS, and designing coherent pricing regulations.
Enabling infrastructure:
The National Industrial Corridor Programme and the proposed National Logistics Policy 2021, which come under the Prime Minister's Gati Shakti initiative, aim to establish and strengthen large medical device parks, clusters, and facilities equipped with state-of-the-art common infrastructure. These parks will be located in close proximity to economic zones and have the necessary logistics connectivity.
Fostering innovation and research:
The policy aims to support the Department's proposed National Policy on R&D and Innovation in the Pharma-MedTech Sector in India while also promoting research and development in the country. It also aims to establish innovation centers, 'plug and play' infrastructures, centers of excellence at academic and research institutions, and provide support for startups.
Boosting investment in the sector:
In addition to current initiatives and programmes like Make in India, Ayushman Bharat, Heal-in-India, and the Start-up Mission, the policy promotes private investments, rounds of funding from venture capitalists, and public-private partnerships (PPP).
Human resources development:
- The policy seeks to ensure a continuous supply of skilled professionals across the entire value chain, including scientists, regulators, healthcare professionals, managers, technicians, and more..
- The resources of the Ministry of Skill Development and Entrepreneurship can be utilized to provide skill development, reskilling, and upskilling opportunities for professionals in the medical device industry.
- In order to ensure the availability of skilled labour for cutting-edge manufacturing and research as well as futuristic medical technologies, the policy will support specialised multidisciplinary courses for medical devices in existing institutions.
- This will create future-ready MedTech human resources and meet the sector’s changing needs to establish collaborations with international academic and business institutions in the development of medical technology in order to keep up with the global market.
Brand positioning and raising consumer awareness:
The policy calls for the establishment of an Export Promotion Council specifically for the sector inside the Department, which will make it possible to address a variety of market access issues:
- Initiate studies and projects to learn from the best manufacturing and skilling systems worldwide to assess the feasibility of implementing such successful models in India.
- The policy seeks to promote the establishment of additional forums that will facilitate the exchange of knowledge and expertise among different stakeholders, creating strong networks across the industry.
- The policy is expected to provide the necessary support and direction for the medical device industry to become a competitive, self-reliant, resilient, and innovative sector that caters to the healthcare needs not only in India but also around the world.
In summary, the National Medical Devices Policy of 2023 aims to bolster the medical device industry, making it more competitive, self-sufficient, resilient, and innovative, in order to cater to the healthcare requirements of the world and meet the changing healthcare needs of patients in India.
