Lok Sabha Question No. 3577 (UNSTARRED), answered on 2026-03-13
Subject: Extension of PLI Scheme to API
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Smt. Supriya Sule

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION NO. 3577 TO BE ANSWERED ON THE 13 TH  MARCH 2026

## Extension of PLI Scheme to API

## 3577. Smt. Supriya Sule:

## Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

(a) whether the Government is aware that pharmaceutical and medical technology experts have sought extension of the Production-Linked Incentive (PLI) scheme  to cover  Active Pharmaceutical  Ingredients  (APIs)  and  if  so,  the  details  thereof  and  the  reasons  for  not extending the scheme so far, despite Maharashtra being a major pharmaceutical manufacturing hub;

(b) whether the continued dependence on imported APIs has adversely affected domestic drug manufacturing and health security, particularly in Maharashtra and if so, the details thereof and the corrective measures taken/proposed to be taken in this regard;

(c)  whether  the  Government proposes to introduce structured policy support for healthcare innovation in view of growing medical research and start-up ecosystem of Maharashtra and if so, the details thereof; and

(d) whether the Government intends to rationalise import duties on advanced cancer radiation equipment to improve access beyond major cities in Maharashtra and if so, the timeline and details thereof?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF CHEMICALS  AND FERTILIZERS

(SMT. ANUPRIYA PATEL)

(a):  The  Department  of  Pharmaceuticals  has  received  representations  from  the  approved applicants  under 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') regarding the extension of scheme tenure. In this regard, the Government has decided not to give extension to the said scheme as it will result in an unfair benefit to non-performers and thereby, will be against the interest of those beneficiaries those have made efforts to meet the timelines.

(b):  i.  India's  dependence  on  imported APIs,  particularly  from  a  single  source  country,  has posed  supply  chain  vulnerability  risks  for  domestic  drug  manufacturing.  The  COVID-19 pandemic further highlighted the risks associated with excessive dependence on imports for critical APIs and KSMs, which had the potential to disrupt domestic pharmaceutical production and thereby affect health security.

- ii. In this regard, the Government has proactively notified 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 (also

known PLI scheme for bulk drugs) with a budgetary outlay of ₹6,940 crore, specifically to address this structural vulnerability by incentivizing domestic manufacturing of 41 identified critical APIs/ KSMs that were previously largely imported.

iii. With respect to the State of Maharashtra specifically, it may be noted that 3 projects have been approved under the PLI Scheme for Bulk Drugs in the State, with an investment of ₹159 crore as of December 2025. Under these projects, domestic manufacturing capacity of approximately 17,680 MT per annum has already been established, contributing significantly to the State's API manufacturing base and thereby reducing import vulnerability for critical drug  inputs. At  the  national  level,  as  of  December  2025,  38  projects  covering  28  notified products have been commissioned under the Scheme, resulting in establishment of domestic manufacturing  capacity  of  approximately  56,800  MT  per  annum,  progressively  reducing dependence on single-source imports.

- (c): i. With a view to strengthening the domestic biopharmaceutical sector and enhancing global competitiveness in biologics and bio-similars, the Government has announced the Biopharma SHAKTI scheme with an outlay of ₹10,000 crore over five years with an objective to build a globally competitive domestic ecosystem for biologics and bio-similars to support affordable healthcare  in  India  and  enable  India  to  emerge  as  a  global  biopharma  manufacturing  and innovation  hub.  By  supporting  research and  development,  strengthening  clinical trial infrastructure  and  promoting  collaboration  between  academia,  research  institutions  and industry, the Scheme seeks to encourage domestic innovation and manufacturing capabilities in the biopharmaceutical sector.
- ii. The Scheme for "Promotion of Research and Innovation in Pharma MedTech sector (PRIP)" has been launched by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers with the goal of transforming India into a global powerhouse for R&D in the Pharma MedTech sector. The scheme has a total financial outlay of ₹5000 crores, which includes ₹700 crores to establish Centers of Excellence (CoEs) at seven National Institutes of Pharmaceutical Education  &  Research  (NIPERs),  and  ₹4200  crores  to  accelerate  investments  in  the  R&D ecosystem within the sector.

iii. Department of Science and Technology (DST), through the "Therapeutic Chemicals" program of Technology Translation and Innovation (TTI) Division, is pursuing to have selfreliance in health care sector.  As a top-down approach, DST has created 5 clusters ((i) Chennai Tirupati Bengaluru Cluster (ii) Hyderabad Cluster (iii) Mumbai Pune Cluster (iv) Dehradun Himachal  Cluster  (v)  Kolkata  Guwahati  Cluster)  under  this  initiative  of  "Therapeutic Chemicals"  program  for  the  development  of  KSMs,  Intermediates  and  raw  materials. This cluster is expected to collaborate with relevant industry for their inputs to identify the priority chemicals and also for commercialization of the identified chemicals for which the feasibility report is under process.

(d):  Rationalization  of  import  duties  is  undertaken  during  the Annual  Budget  exercise  or through specific notifications based on representations from stakeholders and recommendations from relevant technical bodies. Such decisions involve an assessment of the balance between providing affordable access to advanced medical equipment, such as cancer radiation technology, and encouraging domestic value addition. Matters relating to customs duties on imported medical equipment, including advanced cancer radiation equipment, are reviewed  by  the  Government  from  time  to  time  in  consultation  with  the  concerned Ministries/Departments,  taking  into  account  various  relevant  factors  such  as  domestic manufacturing capacity, public health considerations and revenue implications.