Lok Sabha Question No. 1043 (UNSTARRED), answered on 2025-07-25
Subject: Atmanirbhar Pharma Sector
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Smt. Smita Uday Wagh

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

LOK SABHA UNSTARRED QUESTION NO.1043 TO BE ANSWERED ON 25 th  JULY, 2025

## Atmanirbhar Pharma Sector

## 1043. Smt. Smita Uday Wagh:

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

(a) the key initiatives undertaken by the Government to realize the vision of Atmanirbhar Bharat in the pharmaceutical sector, especially in Maharashtra;

(b)  the  measures  being  taken  to  promote  indigenous  pharmaceutical  innovation,  reduce dependency on imports and strengthen local manufacturing hubs, particularly in Jalgaon Lok Sabha constituency in Maharashtra;

(c)  the  progress  made  under  recent  policy  reforms  and  incentive  schemes  (such  as  PLI)  in enhancing India's global competitiveness as a pharmaceutical hub;

(d) the impact of the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) on improving affordability  and  accessibility  of  quality  medicines,  with  specific  data  or  outcomes  from Maharashtra particularly in Jalgaon district; and

(e) whether the Government has any plans to expand bulk drug parks, R&D infrastructure or pharma clusters in Maharashtra, specially in Jalgaon district, if so, the details thereof?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SMT. ANUPRIYA PATEL)

(a) to (c): Number of schemes are being implemented to realise the vision of Atmanirbhar Bharat in the pharmaceutical sector, promote indigenous pharmaceutical innovation, reduce dependency on imports and strengthen local manufacturing hubs throughout the country, including in the State of Maharashtra and Jalgaon district. These include the following:

- (i) Promotion of Research and Innovation in Pharma MedTech Sector (PRIP) scheme;
- (ii) Production Linked Incentive (PLI) Scheme for Pharmaceuticals;
- (iii) PLI Scheme for promotion of domestic manufacturing of critical Key Starting Materials (KSMs) / Drug Intermediates (DIs) / Active Pharmaceutical Ingredients (APIs) in India (also known as the PLI Scheme for Bulk Drugs);
- (iv) Scheme for Promotion of Bulk Drug Parks; and
- (v) Strengthening of Pharmaceutical Industry scheme.

The PRIP scheme has been launched with an outlay of ₹ 5,000 crore to transform India's Pharma MedTech sector from cost- to innovation-based growth by strengthening research and to promote  industry-academia  linkage  for  research  and  development  in  priority  areas  in  drug discovery and development and medical devices. Under this, seven Centres of Excellence (CoEs) have been set up, one at each of the seven National Institutes of Pharmaceutical Education and Research (NIPERs), with total budgetary support to the tune of ₹ 700 crore, to create research infrastructure and promote R&D in identified areas. The CoEs are in the areas of anti-viral and anti-bacterial drug discovery and development, medical devices, bulk drugs, flow chemistry and continuous  manufacturing,  novel  drug  delivery  system,  phytopharmaceuticals  and  biological therapeutics, and have so far approved 104 research projects under the scheme and have filed two patents. The scheme also includes an outlay of ₹4,250 crore for support to industry and startups, including in collaboration with academia, for undertaking research and innovation projects in priority areas. As and when applications are invited under the scheme, applicants from any State or Union Territory can apply.

The PLI Scheme for Pharmaceuticals 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 APIs/KSMs/DIs  other  than  those  notified  under  the  PLI  Scheme  for  Bulk  Drugs,  thereby contributing to self-reliance. The scheme has enabled enhanced investment and production in eligible products. As of March 2025, the committed investment of ₹17,275 crore targeted over the six-year period of the scheme stands substantially exceeded with cumulative investment of ₹37,306 crore made by the scheme's third year, and cumulative sales of approved products of ₹2,66,528 crore have been made, including exports of ₹1,70,807 crore. Under the scheme, 60 manufacturing and R&D units of 14 applicants are located in the State of Maharashtra.

The PLI Scheme for Bulk Drugs, which has a total budgetary outlay of ₹6,940 crore, aims to avoid disruption in supply of critical active pharmaceutical ingredients (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 March 2025, the committed investment of ₹3,938.5 crore  under  projects  approved  under  the  scheme  for  investment  over  the  six-year  production period of the scheme stands substantially exceeded with cumulative investment of ₹4,570 crore made  by  the  scheme's  third  year.  Further,  production  capacity  has  been  created  for  25 APIs/KSMs/DIs. Under the scheme, cumulative sales of ₹1,817 crore have been reported over the period from FY2022-23 till FY2024-25, including exports of ₹455 crore, thereby avoiding imports worth ₹1,362 crore. Under the scheme, six projects have been approved in the State of Maharashtra, including one in Jalgaon district.

Under the Scheme for Promotion of Bulk Drug Parks, which has a total budgetary outlay of ₹3,000 crore, three 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  is  over  ₹  6,300  crore,  with  Central assistance to the tune of ₹1,000 crore each for creation of common infrastructure facilities. These parks would offer land and utilities such as power, water, effluent treatment plant, steam, solid waste management, warehouse facilities at a subsidised rate. The State Implementing Agencies of the three States are also offering 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 that applicants for allotment of land in the parks to set up units for manufacturing products prioritised in the PLI Scheme for Bulk Drugs will have priority in land allotment.

The Strengthening of Pharmaceutical Industry scheme supports realisation of the vision of Atmanirbhar Bharat through the following sub-schemes:

- (i) Assistance  to  Pharmaceutical  Industry  for  Common  Facilities  (API-CF): The  scheme aims to strengthen the existing infrastructure facilities by providing financial assistance to pharmaceutical clusters for creation of common facilities. It helps create tangible assets as common facilities, such as testing labs, R&D labs, effluent treatment plants and training centres, thereby supporting the long-term viability and growth of the clusters by enabling them to develop and leverage shared resources. Under API-CF, projects with total grantin-aid to the tune of ₹ 139.33 crore to pharmaceutical clusters have been approved for creation of common facilities and are at various stages of execution. Once these common facilities are created, they are expected to provide access to common facilities to around 1,300 existing pharmaceutical units, besides catalysing the augmentation of capacities at these  clusters  through  the  setting  up  of  new  pharmaceutical  units  and  expansion  of existing units. The projects under development include creation of a common facility for testing, quality control and process validating laboratory at Jejuri pharmaceutical cluster in Pune, Maharashtra. The project has been supported with the grant-in-aid of ₹7.18 crore, out  of  total  project  cost  of  ₹14.38  crore.  The  project  is  expected  to  provide  access  to common facilities to approximately 150 pharmaceutical units located in the cluster.
- (ii) Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS): The scheme  aims  to  support  upgrade  of  production facilities  of  small  and  medium pharmaceutical companies having average turnover of less than ₹ 500 crore, to attain the standards specified in the revised Schedule M to the Drugs Rules, 1945 and the World Health Organization - Good Manufacturing Practices (WHO-GMP), thereby improving their competitiveness, both domestically and globally. Under this, till 1.7.2025, support for  upgrade  to  attain  the  said  standards  has  been  approved  for  142  micro,  small  and medium pharmaceutical companies, with total sanctioned amount of ₹135.8 crore. This includes 16 companies in the State of Maharashtra with total sanctioned amount of ₹18.98 crore.

Enabled  by  these  schemes,  over  the  last  six  financial  years,  the  export  of  drugs  and pharmaceuticals has increased by 92%, from ₹1,28,028 crore in FY2018-19 to ₹2,45,962 crore in FY2024-25.

(d): The Government launched the Pradhan Mantri Bhartiya Janaushadhi Pariyojana scheme to make quality generic medicines available at affordable prices to all. Under the scheme, dedicated outlets  known  as  Jan  Aushadhi  Kendras  (JAKs)  are  opened  across  the  country  to  provide medicines at prices that are about 50% to 80% lower than those of leading branded medicines in the market. Till 30.6.2025, a total of 16,912 JAKs have been opened and on the average, about 10 to 12 lakh persons visit these Kendras daily and avail of quality medicines at affordable prices. 2,110  medicines  and  315  surgicals,  medical  consumables  and  devices  are  under  the  scheme product basket, covering all major therapeutic groups, such as cardiovascular, anti-cancers, antidiabetic,  anti-infectives,  anti-allergic  and  gastro-intestinal  medicines  and  nutraceuticals.  As  a result of the scheme, in the last 11 years, estimated savings of about ₹38,000 crore have accrued to citizens in comparison to the prices of branded medicines. Further, the scheme has provided self-employment  to  over  16,000  persons,  including  over  6,800  women  entrepreneurs.  Till

- 30.6.2025, a total of 723 JAKs have been opened in the State of Maharashtra, of which 14 JAKs have been opened in Jalgaon district.
- (e): No plan is currently under consideration to expand bulk drug parks or R&D infrastructure in Jalgaon district. However, the support for existing formulations industry is available under the Strengthening  Pharmaceutical  Industry  scheme.  Pharmaceutical  companies  in  the  State  of Maharashtra, including in Jalgaon district, may apply both for the API-CF sub-scheme as and when the Department of Pharmaceuticals invites applications under the said sub-scheme through its website and for RPTUAS, for which applications are currently invited by the Department.

*****