PLI Scheme for Medical Devices extended up to 2035–36; Fresh applications invited

The Government of India has invited fresh applications under the Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices (PLI-MD), which has now been extended up to 2035–36. Approximately Rs 2700 Cr outlay available under the Scheme will be utilised for the purpose. The applicants can submit applications through an online portal, which would be operational in the next 10 days.

Launched in 2020-21, the PLI-MD scheme has led to 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, dialyzers etc till date. The scheme has resulted in production valued at over ₹16,000 crore.

On the basis of learnings in the first phase of the Scheme, a number of simplifications have been done in the eligibility conditions as well as procedure for claiming incentive by the applicants.

The applicants shall be allowed 3 years for setting up their manufacturing facilities in any of the 4 Target Segments (TS) viz. medical consumables, disposables and implants (TS 1), Critical components (TS2), high-end medical devices which are presently at a nascent stage of domestic manufacturing (TS3), and high-end medical devices that are presently only assembled in the country (TS4). The tapering incentive rate would be averaging ~5 per cent for TS1, ~9 per cent for TS2 & TS3, and 6 per cent for TS4. In the Consumables and Disposables segment, the focus shall be on creating manufacturing scale and world class quality. In the TS 3 & 4, priority shall be given for value chain integration, so that there is an overall increase in competitiveness and quality of Made in India devices. The focus on critical component manufacturing under the Scheme, would help achieve value chain integration and also give a boost to the MSME sector.

Under the Scheme, minimum sales threshold requirement to claim incentive has been discontinued, and minimum investment requirement has also been trimmed.  To enhance Ease of Doing Business (EoDB), the scheme guidelines have been made easier and investor friendly.  The applicants shall be free to submit any number of applications in one or more TS and the application window shall remain continuously open over a long period of time.

PLI-MD 2.0 aims to fulfil the vision of Atmanirbhar Bharat and Make in India, develop indigenous supply chains, attract investment, generate employment, improve quality of Made in India devices, reduce price of medical devices, and enhance India’s global competitiveness in high-end medical technologies. The objective of the Scheme is to promote deep manufacturing of medical devices, as well as manufacturing of high-end medical equipment like 3T MRI, PET-CT, Ultrasound probes & consoles, high-throughput IVD analyzers etc which are currently not being manufactured in the country.

Commenting on the anouncement, Himanshu Baid, Managing Director, Poly Medicure mentions, “I would like to sincerely thank the Department of Pharmaceuticals (DoP) and the Government of India for this progressive announcement, which marks an important step forward in the form of PLI 2.0 or the extension of the existing PLI Scheme for the medical devices sector. The enhanced focus on critical component manufacturing is particularly significant, as components are the backbone of the MedTech industry. Developing a robust indigenous component ecosystem will help reduce import dependence, strengthen supply chain resilience and enable deeper domestic manufacturing.”

“Equally encouraging are the investor-friendly reforms introduced to improve Ease of Doing Business. Simplification of scheme guidelines, discontinuation of the minimum sales threshold requirement for claiming incentives and reduction in the minimum investment requirement will make the scheme more accessible, flexible and attractive to both existing manufacturers and new investors. These changes reflect the Government’s responsiveness to industry requirements and will encourage wider participation and fresh investments”, he added.

He also said, “Together, these measures will accelerate technology development, promote domestic vendor capabilities, create opportunities for MSMEs and generate employment across the value chain. Most importantly, they will help India move beyond assembly-led manufacturing towards a stronger, self-reliant and globally competitive MedTech ecosystem, advancing the vision of Atmanirbhar Bharat and Make in India.”

Rajiv Nath , Forum Coordinator, AiMeD, “The Association of Indian Medical Device Industry (AiMeD) warmly welcomes the Government’s continued commitment to strengthening domestic medical device manufacturing through the Production Linked Incentive (PLI) Scheme(V2.0), which aims to boost local manufacturing and attract investments into India’s medical technology sector. This is a significant step towards building a globally competitive, self-reliant MedTech ecosystem under the Make in India vision. AiMeD congratulates the Department of Pharmaceuticals and all stakeholders for enabling growth, innovation, employment generation, and enhanced healthcare security. This festive season, the announcement soon after the recent invitation to applications under the SMDI(Strengthening of Medical Devices of India scheme) brings renewed confidence and optimism for India’s medical device manufacturers.”

“We have been assured that all the limitations of PLI 1.00 are being addressed.”

“With medical device imports expected to exceed Rs 1 lakh crore this year, India stands at a critical juncture. The choice before us is clear: continue importing technology or create a policy ecosystem that attracts investments, builds indigenous manufacturing capacity, generates high-skilled employment, and strengthens healthcare self-reliance. A supportive framework comprising tariff rationalisation, a dedicated medical devices law, procurement preference for genuine manufacturers, and balanced trade margin policies can transform India from a large consumer market into a global MedTech manufacturing powerhouse”, added Nath