Introduction: PLI Scheme for Medical Devices

India’s medical device sector is entering a high-growth phase. However, high import dependency, manufacturing costs, and limited domestic value addition have long restricted expansion. To address this gap, the Government of India launched the PLI Scheme for Medical Devices, offering direct financial incentives linked to incremental sales.

This scheme is not only about incentives. Instead, it is a long-term manufacturing opportunity for companies planning expansion, greenfield units, or medical device parks in India.

Finraja Consultancy Private Limited, a professional subsidy consultancy, explains the scheme with financial clarity, investment thresholds, and how manufacturers can maximise benefits without compliance risks.

Understanding the PLI Scheme for Medical Devices

The PLI Scheme for Medical Devices is implemented by the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, to promote domestic manufacturing of high-value medical devices.

Under this scheme, selected manufacturers receive a 5% incentive on incremental sales of eligible medical devices manufactured in India.

Key Objective of the Scheme

• Reduce import dependency
• Encourage large-scale manufacturing
• Promote medical device parks
• Support R&D-led manufacturing
• Generate skilled employment

PLI Incentive for Medical Devices Manufacturing

The incentive is calculated only on incremental sales, not on total turnover.

However, incentive payout is subject to:

• Category-wise sales thresholds
• Annual incentive ceilings
• Maximum cumulative incentive limits

Therefore, financial planning is critical before applying.

Medical Devices Manufacturing Subsidy in India

Unlike traditional capital subsidies, this is a performance-linked subsidy.

Why Manufacturers Prefer PLI:

• Direct cash incentive
• Predictable incentive structure
• Multi-year benefit (up to FY 2027-28)
• Suitable for both large players and MSMEs
• Works alongside state subsidies

Because of these advantages, demand for PLI medical device approvals is extremely competitive.

PLI Scheme Eligibility for Medical Devices

Eligibility depends on project type, investment strength, and product segment.

Mandatory Conditions:

• Project must be a Greenfield manufacturing project
• Manufacturing must be done in India
• Applicant must meet net worth criteria
• Products must fall under approved target segments

PLI Scheme Category a Medical Devices

Category A is designed for large manufacturers.

Category A – Key Financials

Parameter	Details
Incentive Rate	5%
Maximum Incentive	₹121 crore per applicant
Minimum Incremental Sales	₹60 Cr → ₹280 Cr (FY 2022–27)
Target Players	Large domestic & global manufacturers

Who Should Apply Under Category A?

• Companies planning large capacity expansion
• Export-oriented manufacturers
• High-value equipment producers (CT, MRI, LINAC, implants)

PLI Scheme Category B Medical Devices

Category B supports MSMEs and emerging manufacturers.

Category B – Key Financials

Parameter	Details
Incentive Rate	5%
Maximum Incentive	₹40 crore per applicant
Minimum Incremental Sales	₹20 Cr → ₹29.28 Cr
Target Players	MSMEs, startups, niche manufacturers

This category allows lower entry barriers, but still demands strict compliance.

Minimum Investment for PLI Medical Devices

Investment is a core eligibility criterion.

Eligible Investment Includes:

• New plant & machinery
• Clean rooms and utilities
• R&D infrastructure
• Testing & certification equipment
• Technology transfer costs

Not Eligible:

• Land and building costs
• Second-hand machinery
• Working capital

Because investment certification is audited, professional structuring is essential.

Incremental Sales Requirement – Why Financial Projections Matter

Incremental sales are calculated over the base year (FY 2019-20).

If projected sales:

• Are over-estimated → risk of incentive rejection
• Are under-estimated → loss of incentive potential

Therefore, sales forecasting must align with eligibility thresholds, which Finraja structures professionally.

Medical Device Park PLI Scheme India – Added Advantage

Medical device parks significantly reduce:

• Infrastructure costs
• Regulatory delays
• Utility expenses

When combined with PLI:

• ROI improves
• Faster break-even achieved
• State subsidies can be layered

Finraja assists in integrated PLI + state subsidy structuring.

How to Apply for the PLI Medical Devices Scheme with Finraja Consultancy

The application process involves:

• Financial evaluation
• Eligibility scoring
• Investment certification
• Incremental sales modelling
• Bank guarantee structuring
• Multi-year compliance planning

Why Manufacturers Prefer Consultant-Led Applications

• Zero rejection risk
• Accurate financial modelling
• Faster approvals
• Smooth incentive disbursement
• End-to-end compliance handling

FAQs: PLI Scheme for Medical Devices Manufacturing & Park

1. What is the PLI Scheme for Medical Devices?

The PLI Scheme for Medical Devices is a Government of India initiative that offers a 5% incentive on incremental sales to eligible manufacturers producing notified medical devices in India. The scheme aims to boost domestic manufacturing and reduce import dependency.

2. How much incentive is available under the PLI Scheme for Medical Devices?

Under the scheme, manufacturers can receive:

• Up to ₹121 crore (Category A)
• Up to ₹40 crore (Category B)

The incentive is calculated at 5% of incremental sales, subject to annual and overall caps defined in the guidelines.

3. Who is eligible for the PLI Scheme for Medical Devices?

Eligibility depends on:

• Category (A or B)
• Net worth and investment capability
• Manufacturing of approved medical device segments
• Greenfield project requirement

Since eligibility involves financial screening and scoring, professional assessment is strongly recommended before applying.

4. What is the difference between Category A and Category B in the PLI Scheme?

• Category A targets large manufacturers with higher sales thresholds and allows incentives up to ₹121 crore.
• Category B is designed for MSMEs and emerging manufacturers with lower thresholds and incentives up to ₹40 crore.

Choosing the wrong category can reduce incentive eligibility, which is why expert evaluation is critical.

5. What is the minimum investment required for PLI medical devices?

The minimum investment depends on the chosen category and product segment. Eligible investments include:

• New plant & machinery
• R&D facilities
• Testing and quality infrastructure

Land, building, and working capital are not eligible. Investment certification must be audit compliant.

6. How are incremental sales calculated under the PLI Scheme?

Incremental sales are calculated over a defined base year turnover. Only the additional sales generated after approval are considered for incentive calculation.

Incorrect sales projections can lead to incentive reduction or rejection, so financial modelling should be done professionally.

7. Can medical device parks avail benefits under the PLI Scheme?

Yes. Units set up in medical device parks can avail PLI benefits along with state-level infrastructure and capital subsidies. When structured properly, this combination significantly improves project viability and ROI.

8. Is the PLI Scheme application a one-time process?

No. While approval is granted once, the scheme requires:

• Annual performance tracking
• Incentive claims every year
• Continuous compliance for up to 7 years

Therefore, long-term professional support is crucial.

9. Is the PLI Scheme for Medical Devices financially beneficial?

Yes, if structured correctly. The scheme can generate:

• Predictable cash incentives
• Improved manufacturing margins
• Faster break-even
• Long-term competitive advantage

Conclusion: PLI Scheme for Medical Devices

The PLI Scheme for Medical Devices can deliver:

• Up to ₹121 crore in incentives
• Predictable cash flow support
• Long-term manufacturing advantage

However, the scheme is highly technical and compliance-driven.
That is why professional consultancy support is not optional — it is essential.

If you are planning to invest in medical device manufacturing or a medical device park, Finraja Consultancy can manage the entire PLI journey for you.

Call us now: +91 9373114747 or visit finraja.com/contact for quick assistance.