PLI scheme for Pharmaceuticals

Dec 17, 2025 India Shipping News

NEW DELHI: The Production Linked Incentive (PLI) schemes implemented by the Department of Pharmaceuticals have led to avoidance of imports worth ₹3,591 crore of active pharmaceutical ingredients (APIs) and their key starting materials (KSMs) and drug intermediates (DIs), thereby reduction in import dependency. Scheme-wise details are as under:

1. PLI Scheme for promotion of domestic manufacturing of critical KSMs/DIs/APIs in India (commonly known as the PLI Scheme for Bulk Drugs): The scheme aims to avoid 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. As of September 2025, manufacturing capacity has been created for 26 KSMs/APIs resulting in cumulative sales of ₹2,315 crore from the beginning of the scheme, including exports of ₹508 crore, thereby avoiding imports worth ₹1,807 crore.
2. PLI Scheme for Pharmaceuticals: The scheme aims to enhance India’s manufacturing capabilities by increasing investment and production in the sector and contributing to product diversification to high-value goods in the pharmaceutical sector. It 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 KSMs/DIs/APIs other than those notified under the PLI Scheme for Bulk Drugs, thereby contributing to self-reliance. 191 KSMs/DIs/APIs have been produced for the first time under the scheme resulting in cumulative sales of ₹8,110 crore from the beginning of the scheme till September 2025, including exports of ₹6,326 crore, thereby avoiding imports worth ₹1,784 crore.

Under the PRIP scheme, financial assistance is provided for the following:

1. Financial assistance is provided to industry, MSMEs and startups to support research and development (R&D) for development of products and technologies (outputs) or expeditious validation of R&D outputs for market launch and large-scale commercialisation in three priority areas, namely new medicines, complex generics and biosimilars, and novel medical devices. Biosimilars are biological products aligned to reference products, which are similar in terms of quality, safety and efficacy to reference biological product licensed or approved in India, or any innovator product approved in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) member countries. Thus, biosimilars include drugs that may be similar to drugs nearing patent expiry. Similarly, novel medical devices may include advanced diagnostic devices.
2. Financial assistance is provided to the seven National Institutes of Pharmaceutical Education and Research for strengthening of research infrastructure through the setting up of Centres of Excellence at these institutes.

The tenure of the scheme under which three bulk drug parks have been approved is till March 2027. Details of the progress made in respect of the three parks are at Annexure.

Under the two pharmaceuticals PLI schemes, cumulative sales of ₹3,19,112 crore by approved pharmaceutical applicants have been reported since the beginning of the scheme till September 2025. This includes exports worth ₹2,04,238.12 crore, reflecting their global competitiveness.

Annexure

Details of progress made in respect of implementation of the projects approved for the bulk drug parks in Andhra Pradesh, Gujarat and Himachal Pradesh under the Scheme for Promotion of Bulk Drug Parks

Andhra Pradesh (status as of August 2025):

1. Tender for development of internal roads, power, water, drainage and other utility buildings have been awarded and approximately 30% of the work has been completed on site.
2. Fencing posts have been installed along a stretch of 29.3 km, external water pipeline has been procured and laying work is in progress.

Gujarat (status as of October 2025):

1. Tenders for all common infrastructure facility (CIF) related works for development of road, drainage, water infrastructure, effluent collection and rack system have been awarded and approximately 75% of work has been completed on site.
2. CIF utility tenders for development of common effluent treatment plant, solvent recovery, treatment storage and disposal facilities have been awarded in October 2024 and approximately 16% of work has been completed on site.
3. A technical consultant has been appointed, for finalising the technical specifications and tender preparation for the Centre of Excellence.
4. The Government of Gujarat has completed construction of an approach road of 4 km length and has initiated installation of a water pipeline to draw surface water from Narmada Canal located approximately 40 km from the park site.

Himachal Pradesh (status as of October 2025):

1. Tender for the development of internal roads, drainage, bridges and water infrastructure has been awarded and work is in progress.
2. Tender for site demarcation, grading and land levelling has been awarded, and work is in progress in park area covering 900 acres.

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 Tuesday.