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	FY2024-25
PLI 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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