AiMED to launch 3 major Medical Device Policies and schemes by Health Minister Mansukh Mandaviya

AiMED to Launch 3 Major Medical Device Policies and Schemes under Health Minister Mansukh Mandaviya:

In a significant move to boost the Indian medical device sector, the Association of Indian Medical Device Industry (AiMED), in collaboration with the Ministry of Health and Family Welfare, is set to launch three key policies and schemes aimed at strengthening the domestic medical device ecosystem. The announcement was made by Mansukh Mandaviya, India’s Union Health Minister, who emphasized the importance of these measures in fostering innovation, reducing dependence on imports, and promoting self-sufficiency in critical medical devices.

1. Medical Device Industrial Policy (2024):

The Medical Device Industrial Policy focuses on creating a robust ecosystem for manufacturing medical devices within India. The policy aims to:

• Promote Domestic Manufacturing: The policy targets the creation of a self-sufficient medical device industry in India by encouraging local production, reducing the reliance on imports, and ensuring a steady supply of essential devices.
• Increase Investments in Infrastructure: The policy plans to establish medical device parks across the country, which will provide incentives, tax exemptions, and world-class infrastructure to manufacturers.
• Skill Development and Innovation: A critical aspect of the policy is fostering research and development (R&D) in medical technologies, as well as improving the availability of skilled labor in the sector through specialized training programs.
• Regulatory Reforms: The policy also aims to streamline the regulatory framework to ensure quicker approvals for medical devices, making the industry more competitive globally.

2. Production Linked Incentive (PLI) Scheme 2.0 for Medical Devices:

The PLI Scheme 2.0 for medical devices is an upgraded version of the previous incentive scheme introduced by the Government of India in 2020. Key features of this scheme include:

• Increased Financial Support: The updated PLI scheme offers more substantial financial incentives to manufacturers producing critical medical devices, including diagnostic devices, implants, surgical instruments, and other essential medical products.
• Focus on Innovation and High-Value Products: The new PLI scheme encourages the production of high-value, high-quality medical devices, including complex equipment like diagnostic imaging devices, ventilators, and robotic surgery tools.
• Attracting Global Players: The scheme is designed to attract both domestic and international medical device companies to set up manufacturing units in India, helping to position the country as a global hub for medical device manufacturing.
• Boost to Exports: The scheme aims to increase India’s exports of medical devices by offering incentives based on incremental sales, thereby enhancing the country’s competitive edge in global markets.

3. National Medical Device Innovation and R&D Fund:

This new initiative, the National Medical Device Innovation and R&D Fund, will focus on driving innovation in the Indian medical device sector. The main objectives of the fund include:

• Promoting Research and Development: The fund will provide financial support for the development of new medical technologies and devices, with a focus on low-cost, affordable solutions for the Indian population.
• Partnership with Startups and Academia: The initiative will promote collaboration between startups, universities, and medical research institutions to accelerate the development of innovative medical solutions.
• Technology Incubators: The fund will also support the establishment of technology incubators and innovation hubs to nurture new ideas and transform them into commercially viable products.
• Regulatory Support for Innovations: The fund will provide assistance in navigating regulatory approvals, ensuring that innovative medical devices are able to enter the market quickly and efficiently.

Mandaviya’s Vision for the Medical Device Sector:

Health Minister Mansukh Mandaviya has underscored the importance of these initiatives in realizing the vision of India as a global leader in medical device manufacturing. In his statements, Mandaviya stressed the following:

• Reducing Dependency on Imports: India imports a significant proportion of its medical devices, leading to high costs for both healthcare providers and patients. The government aims to reduce this dependency by encouraging domestic production through policy support and incentives.
• Strengthening India’s Role in Global Healthcare: By focusing on innovation and world-class manufacturing, the government aims to position India as a key player in the global medical device market. India’s medical device sector is expected to see substantial growth, with projections indicating it could reach $50 billion by 2025.
• Affordable and Accessible Healthcare: The policies are aligned with the broader goal of ensuring affordable healthcare for all, particularly by making life-saving devices more accessible to Indian consumers and global markets at competitive prices.

Impact on the Indian Medical Device Industry:

These new policies and schemes are expected to have a transformative impact on the medical device industry in India. Some of the anticipated benefits include:

1. Increased Domestic Manufacturing: By promoting local production and innovation, India will reduce its reliance on imports, particularly from countries like China and the United States, which currently dominate the medical device market.
2. Job Creation: The establishment of medical device parks and the expansion of the manufacturing sector will generate a significant number of jobs in areas like manufacturing, R&D, and regulatory compliance.
3. Boost to Export Potential: With the introduction of the PLI scheme and the focus on high-quality production, India is poised to increase its medical device exports, especially to emerging markets in Asia, Africa, and Latin America.
4. Technological Advancements: The push for innovation through the R&D fund will encourage the development of new medical technologies that are both affordable and tailored to the unique needs of the Indian population, such as low-cost diagnostic tools, mobile health solutions, and telemedicine devices.
5. Improved Regulatory Environment: The streamlining of the regulatory framework will facilitate faster approval of medical devices, ensuring quicker market entry for new products and reducing the time-to-market for innovations.