**Executive Summary**
The Department of Pharmaceuticals has implemented Production Linked Incentive (PLI) schemes to reduce import dependency in the pharmaceutical sector. As of September 2025, these schemes have avoided imports worth ₹3,591 crore in active pharmaceutical ingredients (APIs), key starting materials (KSMs), and drug intermediates (DIs). The schemes aim to boost domestic manufacturing and reduce reliance on single-source suppliers. The tenure of the scheme for bulk drug parks is until March 2027.
**Key Points / Main Content**
* **PLI Scheme for Bulk Drugs:**
* Aims to avoid supply disruption of critical APIs by promoting domestic manufacturing of KSMs/DIs/APIs.
* As of September 2025, the scheme has created manufacturing capacity for 26 KSMs/APIs, resulting in cumulative sales of ₹2,315 crore.
* ₹1,807 crore worth of imports have been avoided under this scheme.
* **PLI Scheme for Pharmaceuticals:**
* Aims to enhance India’s manufacturing capabilities by increasing investment and production.
* Incentivises production of high-value medicines and KSMs/DIs/APIs.
* As of September 2025, cumulative sales of ₹8,110 crore, including exports of ₹6,326 crore.
* ₹1,784 crore worth of imports have been avoided under this scheme.
* **Financial Assistance under PRIP Scheme:**
* Supports R&D in industry, MSMEs and startups for new medicines, complex generics, biosimilars, and novel medical devices.
* Strengthens research infrastructure at the seven National Institutes of Pharmaceutical Education and Research.
* **Progress of Bulk Drug Parks:**
* **Andhra Pradesh (August 2025):** Tender for internal infrastructure awarded, 30% work completed; fencing and water pipeline work in progress.
* **Gujarat (October 2025):** Tenders for common infrastructure awarded, 75% work completed; utility tenders awarded, 16% work completed; technical consultant appointed; approach road and water pipeline initiated.
* **Himachal Pradesh (October 2025):** Tender for internal infrastructure awarded, work in progress; tender for site work awarded, work in progress.
* **Overall Impact:**
* The cumulative sales of the pharmaceuticals PLI schemes since inception till September 2025 is ₹3,19,112 crore, with exports worth ₹2,04,238.12 crore.
**Impact Analysis**
**Industry, MSMEs, and Startups**
* **Impact:** Benefit from financial assistance under the PRIP scheme to support research and development of new products and technologies.
* **Action Required:** Identify relevant opportunities for R&D in priority areas like new medicines, generics, biosimilars, and novel medical devices, and apply for available grants and assistance.
**National Institutes of Pharmaceutical Education and Research**
* **Impact:** Strengthened research infrastructure through the establishment of Centres of Excellence.
* **Action Required:** Utilize the enhanced research infrastructure to improve research quality and output.
**Department of Pharmaceuticals**
* **Impact:** Successful implementation of PLI schemes leading to reduced import dependency and increased domestic manufacturing.
* **Action Required:** Continue monitoring progress, addressing challenges, and ensuring effective implementation of the PLI and PRIP schemes.
**Bulk Drug Park Developers (Andhra Pradesh, Gujarat, Himachal Pradesh)**
* **Impact:** Oversight and implementation of bulk drug parks.
* **Action Required:** Continue infrastructure development and implementation of parks to meet the March 2027 deadline.
Key Entities Referenced
PLI scheme for Pharmaceuticals: Umbrella term for Production Linked Incentive schemes implemented by the Department of Pharmaceuticals, including those aimed at APIs/KSMs/DIs and the broader pharmaceutical sector.
PLI Scheme for Bulk Drugs: Specifically targets promotion of domestic manufacturing of critical KSMs/DIs/APIs to reduce import dependency and supply disruption risk.
Scheme for Promotion of Bulk Drug Parks: Scheme aiming to promote the development of bulk drug parks in India. Specific examples in Andhra Pradesh, Gujarat and Himachal Pradesh are mentioned
PRIP scheme: A scheme providing financial assistance for R&D to industry, MSMEs, and startups and strengthening of research infrastructure at National Institutes of Pharmaceutical Education and Research.
Department of Pharmaceuticals: The primary government department implementing the PLI schemes mentioned in the document.
Ministry of Chemicals and Fertilizers :
Department of Pharmaceuticals
PLI scheme for Pharmaceuticals
प्रव तथ: 16 DEC 2025 3:34PM by PIB 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:
i. 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.
ii. 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:
i. 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.
ii. 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):
i. 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.
ii. 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):
i. 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.
ii. 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.
iii. A technical consultant has been appointed, for finalising the technical specifications and tender
preparation for the Centre of Excellence.
iv. 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):
i. Tender for the development of internal roads, drainage, bridges and water infrastructure has been
awarded and work is in progress.
ii. 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 today.
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