Ministry Extends Medical Devices PLI Scheme with Simplified Guidelines
The Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers has invited fresh applications under the Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices (PLI-MD), extending the scheme validity up to 2035-36. Approximately ₹2700 crore outlay remains available under the scheme, with applications to be submitted through an online portal operational within the next 10 days.
The scheme, launched in 2021-22, has already achieved significant results with domestic manufacturing of over 60 high-end medical devices and components including X-ray tubes and detectors, 1.5T MRI, LINAC, CT scanners, mammography machines, Cathlab, orthopaedic and cardiac implants, and dialyzers. This has resulted in production valued at over ₹16,000 crore to date.
Key Modifications to Scheme Guidelines
Based on learnings from the first phase, several simplifications have been implemented to enhance Ease of Doing Business. The minimum sales threshold requirement to claim incentive has been discontinued, and the minimum investment requirement has been trimmed. Applicants will be allowed 3 years to set up manufacturing facilities across four Target Segments: medical consumables, disposables and implants (TS 1); critical components (TS 2); high-end medical devices at nascent domestic manufacturing stage (TS 3); and high-end medical devices presently only assembled in India (TS 4).
Incentive Structure and Manufacturing Focus
The tapering incentive rate averages approximately 5% for TS 1, 9% for TS 2 & TS 3, and 6% for TS 4. The scheme emphasizes creating manufacturing scale and world-class quality in consumables and disposables, while priority for value chain integration is given to TS 3 and TS 4 to increase competitiveness and quality of Made in India devices. The focus on critical component manufacturing aims to achieve value chain integration and boost the MSME sector.
Application Process and Strategic Objectives
Applicants are free to submit any number of applications in one or more target segments, with the application window remaining continuously open over an extended period. PLI-MD 2.0 aims to fulfil the vision of Atmanirbhar Bharat and Make in India by developing indigenous supply chains, attracting investment, generating employment, improving quality of Indian-made devices, reducing medical device prices, and enhancing India's global competitiveness in high-end medical technologies. The scheme specifically targets promoting deep manufacturing of medical devices and high-end equipment like 3T MRI, PET-CT, ultrasound probes & consoles, and high-throughput IVD analyzers that are currently not manufactured in the country.