API Manufacturing: Bulk Drug Parks and PLI Progress

The Government of India is taking multiple steps to boost domestic Active Pharmaceutical Ingredient (API) production, reduce import dependence and enhance security of pharmaceutical supply chains. While the Production Linked Incentive (PLI) schemes do not provide for dedicated API parks, significant infrastructure support is being created through the Scheme for Promotion of Bulk Drug Parks.

Infrastructure Support Through Bulk Drug Parks

·         The Scheme for Promotion of Bulk Drug Parks has a budgetary outlay of ₹3,000 crore.

·         Three bulk drug parks have been approved and are under development in:

o    Andhra Pradesh

o    Gujarat

o    Himachal Pradesh

·         The total project cost exceeds ₹6,306.68 crore, with ₹1,000 crore Central assistance per park for common infrastructure such as:

o    Power and water supply

o    Effluent treatment systems

o    Steam and utilities

o    Solid waste management facilities

o    Warehousing

·         States have extended additional fiscal incentives like:

o    Capital investment subsidies

o    Interest subsidies

o    SGST reimbursement

o    Exemption of stamp duty and registration charges

·         Priority allotment is being accorded to units manufacturing products covered under the PLI Scheme for Bulk Drugs.

Progress Under Production Linked Incentive Schemes

Two PLI schemes implemented by the Department of Pharmaceuticals are supporting API and high-value pharmaceutical manufacturing through fiscal incentives and capacity-building.

1. PLI Scheme for Bulk Drugs (KSMs/DIs/APIs)

·         Budgetary outlay: ₹6,940 crore

·         Objective: Reduce dependence on imported critical APIs and ensure resilient supply chains for essential drugs.

·         Progress as of September 2025:

o    ₹4,763.34 crore invested, exceeding the committed investment of ₹4,329.95 crore.

o    Production capacity established for 26 critical APIs/KSMs/DIs earlier largely imported.

o    Cumulative sales: ₹2,315.44 crore

o    Exports: ₹508.12 crore

o    Import substitution achieved: ₹1,807.32 crore

·         Scheme validity: Up to FY 2029–30

2. PLI Scheme for Pharmaceuticals

·         Budgetary outlay: ₹15,000 crore

·         Objective: Boost domestic production of high-value pharmaceuticals such as biopharmaceuticals, complex generics, patented drugs, biologics and critical APIs outside the Bulk Drug PLI list.

·         Progress as of September 2025:

o    Committed investment: ₹17,275 crore

o    Actual investment achieved: ₹40,890 crore (significantly higher than commitment)

o    Products manufactured: 726 APIs/KSMs/DIs, including 191 produced domestically for the first time.

o    Cumulative domestic sales: ₹26,123 crore contributing significantly to import substitution.

·         Scheme validity: Up to FY 2028–29

Outcome

The coordinated approach of infrastructure support through bulk drug parks along with financial incentives under PLI schemes is accelerating domestic API production, fostering self-reliance, reducing vulnerability to global supply disruptions and positioning India as a manufacturing hub for high-value pharmaceuticals.

 

[ABS News Service/03.12.2025]

There is no provision for active pharmaceutical ingredient (API) parks under the Production Linked Incentive (PLI) schemes implemented by the Department of Pharmaceuticals. However, the Department of Pharmaceuticals is implementing another scheme, namely the scheme for Promotion of Bulk Drug Parks, with a budgetary outlay of ₹3,000 crore, under which three bulk drug parks have been approved and are at various stages of development in the States of Andhra Pradesh, Gujarat and Himachal Pradesh, through their respective State implementing agencies. The total project cost of these parks is over ₹6,306.68 crore, with Central assistance to the tune of ₹1,000 crore each for creation of common infrastructure facilities. These parks envisage land and utilities such as power, water, effluent treatment plant, steam, solid waste management and warehouse facilities at a subsidised rate to bulk drug or API manufacturers for units set up in the park. The State implementing agencies of the States concerned have also offered fiscal incentives in the form of capital subsidy on fixed capital investment, interest subsidy, State Goods and Services Tax reimbursement, exemption of stamp duty and registration charges, etc. Further, the scheme provides for applicants for allotment of land in the parks to set up units for manufacturing products prioritised in the PLI Scheme for Bulk Drugs to have priority in land allotment.

The details of the PLI schemes being implemented by the Department, including in respect of the investment attracted, number of drugs indigenously produced and reduction of import dependence and the timeframe for each scheme, are as follows: (i) 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 (also known as PLI scheme for Bulk Drugs): The scheme is aimed at avoiding disruption in supply of critical APIs used to make critical drugs for which there are no alternatives by reducing supply disruption risk due to excessive dependence on single source. The scheme has a budgetary outlay of ₹6,940 crore. Till September 2025, investment of ₹4,763.34 crore has already been made in three and a half years of scheme production period, against an investment commitment of ₹4,329.95 crore over the period of six years in greenfield projects. Further, production capacities have been created for 26 KSMs/DIs/APIs, which were earlier primarily imported. The scheme has resulted in cumulative sales of ₹2,315.44 crore reported till September 2025, including exports of ₹508.12 crore, thereby avoiding imports worth ₹1,807.32 crore. The tenure of the scheme is till the financial year 2029-30. (ii) PLI Scheme for Pharmaceuticals: The scheme is aimed at enhancing India’s manufacturing capabilities by increasing investment and production in the pharmaceuticals sector and contributing to product diversification to high-value goods in the pharmaceutical sector and incentivises production of high-value medicines such as biopharmaceuticals, complex generic drugs, patented drugs or drugs nearing patent expiry, auto-immune drugs, anti-cancer drugs, etc. as well as production of APIs/DIs/KSMs other than those notified under the PLI Scheme for Bulk Drugs. It has a budgetary outlay of ₹15,000 crore. As of September 2025, the committed investment of ₹17,275 crore targeted over the six-year period of the scheme stands substantially exceeded with cumulative investment of ₹40,890 crore made in three and a half years of scheme production period in both brownfield and greenfield projects. Further, 726 APIs/KSMs/DIs are being manufactured under the scheme, including 191 which have been manufactured for the first time under the scheme. Cumulative domestic sales of APIs/KSMs/DIs produced under the scheme till September 2025 is worth ₹26,123 crore and thereby contributing to import avoidance. The tenure of the scheme is till the financial year 2028-29.

This information was given by Union Minister of State in the Ministry of Chemicals and Fertilizers, Smt. Anupriya Patel, in a written reply in Rajya Sabha on 2 December, 2025.