Production Linked Incentive (PLI) Scheme for Promoting Domestic Manufacturing of Medical Devices

What is the PLI Scheme for Medical Devices?

The Production Linked Incentive (PLI) Scheme for Promoting Domestic Manufacturing of Medical Devices is a central sector scheme of the Department of Pharmaceuticals, under the Ministry of Chemicals and Fertilizers. According to the Department, the scheme has a total outlay of Rs 3,420 crore for the period FY 2020-21 to FY 2027-28.

The PLI Scheme for Medical Devices targets the high-end segment of the medical device market. The expensive, technology-intensive equipment that India largely imports. It rewards companies that set up greenfield projects to make these devices domestically, reducing import dependence and building manufacturing capability.

Main objectives

• Promote domestic manufacturing of high-end medical devices.
• Reduce India's high import dependence in critical medical equipment.
• Attract greenfield investment and create skilled employment.
• Improve access to affordable, domestically made medical devices.

Why was the PLI Scheme for Medical Devices introduced?

India imports a very large share of its high-end medical devices, particularly the capital-intensive equipment used in cancer treatment, imaging and critical care. This import dependence exposes hospitals and patients to foreign exchange costs and supply-chain risk. According to the Department of Pharmaceuticals, the PLI Scheme for Medical Devices was introduced to change this by making domestic manufacturing of these expensive devices financially attractive.

Unlike a subsidy paid upfront, the PLI Scheme for Medical Devices pays only on results. A company is reimbursed a percentage of its incremental sales, the increase in sales above an agreed base year, of devices actually made at its greenfield project. This ties public money to real production and sales rather than to promises, and rewards companies that scale up fastest.

What does the PLI Scheme for Medical Devices cover?

The scheme covers four target segments of high-end devices, per the Department of Pharmaceuticals guidelines:

Only greenfield (new) projects producing the eligible high-end devices are supported.

How much does the PLI Scheme for Medical Devices provide?

The scheme pays selected companies an incentive of 5% of incremental sales of eligible high-end medical devices, over a period of five years, according to the Department of Pharmaceuticals guidelines. The incentive is subject to the company meeting the minimum committed investment and the incremental-sales thresholds set out for the scheme.

Who is eligible for the PLI Scheme for Medical Devices?

A company can apply if it:

• Is a company registered in India setting up a greenfield project to make one or more eligible high-end devices in the four target segments.
• Meets the net-worth and financial-capability criteria in the guidelines.
• Commits to the minimum investment and incremental-sales thresholds.

You are not eligible if:

• You are an individual, student or job seeker seeking a personal grant — the PLI Scheme for Medical Devices is a company incentive scheme with no individual benefit.
• Your device does not fall within one of the four notified target segments.
• Your project is not a greenfield project, or cannot meet the investment and sales thresholds.

Anyone offering personal "Medical Devices PLI registration" to individuals for a fee is running a scam, the scheme has no citizen application.

How to apply for the PLI Scheme for Medical Devices

The PLI Scheme for Medical Devices has no citizen application; the process is entirely for companies and was conducted online through the Department of Pharmaceuticals:

1. Register your company on the Department of Pharmaceuticals PLI portal.
2. Identify the target segment and eligible high-end device your greenfield project will make.
3. Prepare the detailed project report, audited financials and proof of technical capability.
4. Submit the online application with the required documents and application fee.
5. If selected after appraisal by the supported Committee, execute the agreement, commission the project and claim the 5% incentive against verified incremental sales.

Note: the application window has closed and selected projects are being commissioned. Confirm the current status on the Department of Pharmaceuticals portal before acting on any claim about a reopened window.

How much progress has the scheme made?

According to Department of Pharmaceuticals and PIB updates, the scheme has moved from approvals into full production. As reported in PIB releases, 28 applicants had been approved under the scheme, and the approved projects reported actual investment of about Rs 1,153 crore. A total of 24 greenfield projects had been commissioned and domestic production had begun for 57 products that India previously imported almost entirely.

These are exactly the capital-intensive devices the scheme set out to localise, MRI and CT scanners, linear accelerators for cancer radiotherapy, mammography systems, C-arm imaging units, ultrasound machines, heart valves and coronary stents. Companies including Wipro GE Healthcare, Siemens Healthineers, Philips, Nipro India and Meril Life Sciences are among the approved manufacturers.

On the output side, PIB figures put cumulative eligible sales at around Rs 13,624 crore, of which roughly Rs 6,425 crore were exports, up to December 2025. On the payout side, the Department of Pharmaceuticals had released about Rs 266 crore in incentives up to FY 2024-25. Because incentive is paid only against verified incremental sales, disbursement lags production and rises each year as projects mature. These figures are revised periodically, so confirm the latest numbers on pharmaceuticals.gov.in and in current PIB releases before relying on them.

When does the scheme run?

The PLI Scheme for Medical Devices was notified with an overall period of FY 2020-21 to FY 2027-28, within which each selected company receives the incentive for five consecutive years measured from its own base year. The application window has closed; the scheme is now in its disbursement phase rather than accepting fresh applicants. Any claim of a reopened citizen or company window should be checked against an official Department of Pharmaceuticals notification before it is trusted.

The PLI Scheme for Medical Devices is one of three linked Department of Pharmaceuticals schemes, alongside the PLI Scheme for Pharmaceuticals and the PLI Scheme for Bulk Drugs, together targeting self-reliance across the pharmaceutical and medical-technology value chain. It sits beside the separate Promotion of Medical Device Parks scheme, which funds shared testing and infrastructure so that PLI manufacturers can plug into ready industrial clusters.

How does the PLI Scheme for Medical Devices differ from a subsidy?

The PLI Scheme for Medical Devices is a performance-linked incentive, not a grant or a capital subsidy. Three features set it apart:

• Paid on incremental sales, not on setting up. A company earns the 5% incentive only on the increase in sales of eligible devices over its base year, so it must genuinely produce and sell more.
• Greenfield only. The device must be made at a new project, which is why the scheme adds capacity rather than merely shifting existing production.
• Thresholds must be met every year. If a company misses its committed investment or incremental-sales targets in a year, its incentive for that year can be reduced or withheld, per the Department of Pharmaceuticals guidelines.

Because of this design, the scheme's real disbursement depends on how much selected companies actually manufacture and sell. It is not a guaranteed payout.

Help and where to verify details

There is no citizen helpline for the PLI Scheme for Medical Devices because it has no individual application. Companies raise queries through the Department of Pharmaceuticals PLI portal. Detailed guidelines, the eligible-device list, the list of selected applicants and disbursement updates are published on pharmaceuticals.gov.in and in PIB releases.

Treat any offer of personal "medical device PLI registration", any demand for a fee to "add your name", or any request for OTPs or bank details in the scheme's name as a scam. The scheme deals only with registered companies and never with individual beneficiaries.

How to check your application status

The PLI Scheme for Medical Devices has no citizen-facing tracking system, since there is no individual application to track. For a company that has already applied or been selected, status checking works differently at each stage of the scheme's lifecycle.

If your company applied during the (now closed) application window:

1. Log in to the Department of Pharmaceuticals PLI portal account used at the time of submission. Approval status, appraisal outcomes and any deficiency notices are communicated through this portal account, not by public tracking number.
2. Check for correspondence from the Project Management Agency or the Department's appraisal committee, appointment of an empowered committee is usually where outcome letters originate.
3. If the portal shows no update and a reasonable time has passed since submission, raise a written query through the same PLI portal rather than a general helpline, since the scheme has no citizen call centre.

If your company has already been selected and signed the agreement:

1. Incentive disbursement status against a specific year's incremental sales claim is tracked through the same Department of Pharmaceuticals PLI portal account, where claims are filed and verified.
2. Disbursement is released only after verification of the claimed incremental sales, so a pending claim shows as "under verification" rather than rejected until the Department completes its check.
3. For year-on-year progress figures at the scheme level (total approved applicants, commissioned projects, cumulative sales, total incentives released), the Department of Pharmaceuticals and PIB publish periodic updates on pharmaceuticals.gov.in, useful for benchmarking your own company's disbursement pace against the scheme's overall trend, though these are aggregate figures, not a lookup for one company's individual claim.

If you are not a company applicant and are trying to verify whether a scheme window is open, whether your device qualifies, or whether an intermediary's claim about "checking your PLI status" is genuine: there is no such lookup for individuals. Confirm directly on pharmaceuticals.gov.in or through an official PIB release rather than through any third party offering a status check.

Common reasons for rejection

Rejections and stalled claims under the PLI Scheme for Medical Devices happen almost entirely at the company and project level, since there is no individual applicant pool. The recurring reasons, and the fix for each, are:

• Project is not genuinely greenfield. An expansion of an existing production line, or a relabelled brownfield facility, does not meet the scheme's greenfield requirement. Fix: the project must be a new manufacturing facility set up specifically for the eligible high-end device, documented clearly in the detailed project report and site details submitted with the application.

• Device falls outside the four notified target segments. Applications proposing devices that do not fall under cancer care and radiotherapy, radiology and imaging, anaesthetics and cardio-respiratory and renal care, or implants are not eligible, however high-end the device may otherwise be. Fix: confirm the specific device against the Department of Pharmaceuticals' notified list for the applicable segment before applying, rather than assuming a general "medical device" description qualifies.

• Net worth or financial capability criteria not met. Companies that cannot demonstrate the minimum net worth or financial standing specified in the guidelines are screened out at appraisal. Fix: audited financial statements must clearly establish the company's net worth against the threshold before submission, this is not something that can be argued around after the fact.

• Weak or incomplete detailed project report. A project report that does not credibly establish the investment plan, projected sales trajectory and technical approach for the specific device gives the appraisal committee no basis to approve the project. Fix: the report needs to tie the investment commitment, the production timeline and the sales projection together consistently, vague or inconsistent figures across sections are a common cause of deficiency queries or rejection.

• Insufficient proof of technical capability. Selection favours applicants who can show they actually have the engineering, quality-certification or manufacturing know-how to produce the specific high-end device named, not just an intent to enter the segment. Fix: submit concrete evidence, technical collaborations, existing certifications, prior manufacturing experience in adjacent products, rather than a general statement of capability.

• Committed thresholds missed after selection. Even after approval, a company that fails to meet its committed investment or incremental-sales threshold in a given year does not forfeit the whole agreement, but its incentive for that year can be reduced or withheld. Fix: track committed thresholds against actual investment and sales continuously rather than only at claim time, so a shortfall is caught and can be explained or corrected before the annual claim is filed.

• Individuals or ineligible entities applying by mistake. Since the scheme is open only to companies registered in India, any application or enquiry from an individual, proprietorship without company registration, or an entity outside the eligible structure is turned away at the outset. Fix: there is no workaround here, the scheme structurally excludes non-company applicants, and any party claiming to offer individual "PLI registration" is not describing this scheme.