Approved Projects and Industry Participation
Since its launch, the PLI scheme has approved multiple projects covering a wide range of medical devices and components. These projects are spread across different states, supporting the creation of regionally balanced manufacturing capacity. Details of approved units, product categories, locations and investments have been officially documented by the Department of Pharmaceuticals.
The scheme aims to reduce India’s dependence on imported medical devices by incentivising domestic value addition. It focuses on high-value segments such as diagnostic imaging, implants, critical care equipment and electronic medical devices.
Employment and Export Growth
According to government data, the approved projects under the PLI scheme have contributed to direct and indirect employment generation across manufacturing, quality assurance, logistics and allied services. Alongside job creation, exports of medical devices from participating units have also shown encouraging growth.
Officials note that the PLI framework is helping Indian manufacturers integrate into global supply chains by improving scale, quality and cost competitiveness. Export performance under the scheme is being closely monitored to assess long-term impact.
Revised Thresholds to Encourage Wider Participation
To expand industry participation, the government reviewed the minimum threshold sales criteria under the scheme in 2023. A new Category-B of eligible projects was introduced with lower sales thresholds, making the scheme accessible to a broader range of manufacturers, including emerging players.
Following this revision, three additional rounds of applications were invited, taking the total number of rounds to five. However, with the scheme scheduled to close in March 2027 and a mandatory one-year gestation period, no further application rounds are currently under consideration.
Boost to Research, Innovation and Startups
Complementing the PLI scheme, the Promotion of Research and Innovation in Pharma-MedTech Sector (PRIP) scheme has been launched to support innovation-led growth. The scheme provides financial assistance to industries, MSMEs and startups for research projects in priority areas, including novel medical devices.
PRIP support can also be utilised for clinical safety validation and performance testing required for regulatory approvals. A dedicated Centre of Excellence for medical devices has been established at the National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad, with an outlay of ₹110 crore.
Mentorship and Ecosystem Support
In addition to financial incentives, industry and startups are being supported through mentorship initiatives such as MedTech Mitra and Patent Mitra, led by the Department of Health Research. These programmes assist innovators in navigating regulatory pathways, intellectual property protection and commercialization challenges.
Together, these initiatives aim to create a supportive ecosystem that encourages innovation, reduces time-to-market and improves global competitiveness of Indian medical devices.
Regulatory Reforms and Global Alignment
The Central Drugs Standard Control Organisation (CDSCO) continues to regulate medical devices under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017. An online licensing portal has been operationalised to improve transparency, accountability and ease of doing business.
CDSCO has also published guidance documents, FAQs and updated device classification lists to provide regulatory clarity. To promote international harmonisation, the regulator has become an affiliated member of the International Medical Device Regulators Forum.
Building a Competitive MedTech Industry
The PLI scheme, along with the Medical Device Parks Scheme, Strengthening of Medical Device Industry scheme and PRIP initiative, represents a coordinated policy approach to strengthen India’s MedTech sector. These efforts focus on infrastructure creation, capital investment, research support and regulatory efficiency.
Government officials believe that this integrated strategy will position India as a global hub for medical device manufacturing while ensuring affordable, high-quality healthcare solutions for domestic needs.
