**Executive Summary**
This report outlines the implementation status and financial disbursements of the Production Linked Incentive (PLI) Schemes for Pharmaceuticals and Bulk Drugs as of December 2025. Both schemes have exceeded their initial investment targets, contributing significantly to export growth, domestic sales, and the manufacturing of critical materials for the first time in India. The document also highlights mandatory environmental compliance requirements and the growth of manufacturing units in regional districts.
**Key Points / Main Content**
**PLI Scheme for Pharmaceuticals (Status as of December 2025)**
* **Investment:** Achieved cumulative investment of ₹41,943 crore in brownfield and greenfield projects, exceeding the ₹17,275 crore target.
* **Sales Performance:** Total sales reached ₹3,35,036 crore, including exports valued at ₹2,15,248 crore.
* **Product Development:** 1,988 products are being manufactured, including 726 APIs, KSMs, and DIs.
* **Innovation and Import Reduction:** 191 products were manufactured in India for the first time, contributing to ₹28,067 crore in cumulative domestic sales and reduced import dependence.
**PLI Scheme for Bulk Drugs (Status as of December 2025)**
* **Investment:** Cumulative investment of ₹4,814 crore made in greenfield projects, surpassing the ₹4,329.95 crore commitment.
* **Capacity:** A manufacturing capacity of 56,800 metric tonnes per annum has been created for 28 critical materials, against a total committed capacity of 91,077 metric tonnes for 33 products.
* **Sales:** Generated cumulative sales of ₹2,720 crore, with exports totaling ₹527.96 crore.
* **Regional Growth:** Six new manufacturing units have been commissioned in the Vishakapatnam district of Andhra Pradesh.
**Incentive Disbursements (FY 2022–2025)**
* **Pharmaceuticals:** Incentives released grew from ₹655.15 crore in FY2022-23 to ₹2,330 crore in FY2024-25.
* **Bulk Drugs:** Incentives released increased from ₹5.95 crore in FY2022-23 to ₹21.30 crore in FY2024-25.
**Regulatory and Environmental Framework**
* **Industry Classification:** Bulk drug manufacturing units are classified as "red-category" industries.
* **Legal Compliance:** All industries must adhere to the Environment (Protection) Act 1986, the Water Act 1974, and the Air Act 1981.
**Impact Analysis**
**Pharmaceutical and Bulk Drug Manufacturers**
**Impact**
Manufacturers benefit from financial incentives and expanded production capabilities for high-value medicines and critical materials. However, they are subject to stringent "red-category" environmental regulations.
**Action Required**
Companies must obtain statutory clearances, including Environmental Clearance (EC), Consent to Establish (CTE), and Consent to Operate (CTO) from regulatory authorities before starting operations.
**Ministry of Chemicals and Fertilizers / Department of Pharmaceuticals**
**Impact**
The department has successfully incentivized the sector to exceed investment targets and reduce reliance on single-source suppliers for critical materials.
**Action Required**
The Ministry must continue to monitor the implementation of the schemes and manage the disbursement of incentives as per the reported fiscal year growth.
Key Entities Referenced
PLI Scheme for Pharmaceuticals: A scheme approved in 2021 to enhance India’s manufacturing capabilities by incentivizing the production of high-value medicines, complex generics, and pharmaceutical ingredients.
PLI Scheme for Bulk Drugs: A program aimed at promoting domestic manufacturing of critical Key Starting Materials (KSMs), Drug Intermediates (DIs), and Active Pharmaceutical Ingredients (APIs) to reduce import dependence.
Department of Pharmaceuticals: The nodal department under the Ministry of Chemicals and Fertilizers responsible for overseeing the implementation and fund release of the PLI schemes.
Environment (Protection) Act, 1986: A key legislation governing environmental compliance and the requirement for statutory clearances for red-category industries like bulk drug manufacturing.
Ministry of Environment, Forest & Climate Change (MoEF&CC): The regulatory authority responsible for administering environmental acts and granting necessary permissions for industrial operations.
Ministry of Chemicals and Fertilizers :
Department of Pharmaceuticals
Production Linked Incentive Scheme
Posted On: 20 MAR 2026 3:03PM by PIB Delhi
The Production Linked Incentive (PLI) scheme for Pharmaceuticals was approved in 2021 with an
objective to enhance India’s manufacturing capabilities by increasing investment and production in the
pharmaceuticals sector. The scheme intends to incentivize production of high value medicines, complex
generics etc. as well as Active Pharmaceutical Ingredients (APIs) /Drug Intermediates (DIs) /Key Starting
Materials (KSMs) (other than those covered under PLI Scheme for Bulk Drugs).
The status of implementation of the PLI scheme for Pharmaceuticals is as follows:
As of December 2025, cumulative investment of ₹41,943 crore was made under the scheme in both
brownfield and greenfield projects. This substantially exceeds the targeted committed investment of
₹17,275 crore over the six-year period of the scheme.
The cumulative sales figure till December 2025 stands at ₹3,35,036 crores which has been derived
from sale of 1988 products being manufactured under the scheme. This figure includes exports to
the tune of ₹2,15,248 crores.
Out of 1988 products, 726 APIs/KSMs/DIs are being manufactured under the scheme, including 191
which have been manufactured for the first time in the country. Sale of these APIs/KSMs/DIs have
resulted in cumulative domestic sales worth ₹28,067 crores and this has contributed to import
reduction in the sector.
The Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of critical
Key Starting Materials (KSMs) / Drug Intermediates (DIs) and Active Pharmaceutical Ingredients
(APIs) in India (commonly known as “PLI scheme for Bulk Drugs”) was approved in 2020 and it is
aimed at avoiding supply disruption risk due to excessive dependence on single source.
The status of implementation of this scheme is as follows:
· Till December 2025, investment of ₹4,814 crore has been made against an investment
commitment of ₹4,329.95 crore over the period of six years in greenfield projects.
· Total capacity amounting to 91,077 metric tonnes per annum is committed for 33
products against the originally envisaged capacity of 82,270 metric tonnes per annum
for 41 products identified under the scheme. Further, manufacturing capacity of 56,800
metric tonnes per annum has been created for 28 critical KSMs, DIs, and APIs till
December, 2025. The scheme has resulted in cumulative sales of ₹2,720 crore,
including exports of ₹527.96 crores.
The details of amount released under the said schemes during the last three years are given below:
Scheme Name FY2022-23 FY2023-24 FY2024-25PLI scheme for Bulk Drugs 5.95 11.66 21.30
PLI Scheme for Pharmaceuticals 655.15 1,552.46 2,330.00
(In crore ₹)
Under the PLI Scheme for Bulk Drugs, six new manufacturing units have been commissioned in
Vishakapatnam district of Andhra Pradesh, which is an aspirational district.
Environmental compliances for all industries including chemical industries are addressed through the
Environment (Protection) Act, 1986, The Water (Prevention and Control of Pollution) Act 1974 and The
Air (Prevention and Control of Pollution) Act, 1981 administered by Ministry of Environment, Forest &
Climate Change (MoEF&CC). All industries including chemical industries are required to take necessary
permissions in terms of these regulations.
Bulk drug manufacturing units are classified as red-category industries under the environmental regulatory
framework and are accordingly required to obtain statutory clearances including Environmental Clearance
(EC), Consent to Establish (CTE) and Consent to Operate (CTO) from concerned regulatory authorities
prior to commencement of operations.
This information was given by Minister of State for Chemicals and Fertilizers, Smt. Anupriya Patel, in a
written reply in the Lok Sabha today.
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