Lok Sabha Question No. 1146 (UNSTARRED), answered on 2025-07-25
Subject: Reform in Pharmaceutical Sector
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Dhairyasheel Sambhajirao Mane, Shri Godam Nagesh, Shri Chintamani Maharaj, Shri Chavan Ravindra Vasantrao, Smt. Kamlesh Jangde, Shri Praveen Patel, Shri Yogender Chandolia, Ms Kangna Ranaut, Shri Hasmukhbhai Somabhai Patel, Shri Bhartruhari Mahtab, Dr. Prashant Yadaorao Padole, Shri P C Mohan, Shri Bidyut Baran Mahato, Dr. K Sudhakar, Smt. Bijuli Kalita Medhi, Dr. Sanjay Jaiswal, Shri Manish Jaiswal, Shri Alok Sharma, Smt. Shobhanaben Mahendrasinh Baraiya, Shri Radheshyam Rathiya, Shri Trivendra Singh Rawat, Shri Damodar Agrawal, Shri Lumbaram Choudhary, Dr. Manna Lal Rawat, Shri Suresh Kumar Kashyap, Shri Khagen Murmu, Smt. Aparajita Sarangi, Smt. Kamaljeet Sehrawat, Dr. Bhola Singh, Shri Manoj Tiwari, Shri Dineshbhai Makwana

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS

## DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION NO.1146

TO BE ANSWERED ON 25 th  JULY, 2025

## Reform in Pharmaceutical Sector

†1146  Dr. Manna Lal Rawat:

Shri Chintamani Maharaj:

Dr. Bhola Singh:

Dr. K Sudhakar:

Shri Yogender Chandolia:

Shri Alok Sharma:

Smt. Shobhanaben Mahendrasinh Baraiya:

Shri Hasmukhbhai Somabhai Patel:

Shri Praveen Patel:

Shri Dhairyasheel Sambhajirao Mane:

Shri Chavan Ravindra Vasantrao:

Shri. Manish Jaiswal:

Shri Radheshyam Rathiya:

Shri Bidyut Baran Mahato:

Shri Damodar Agrawal:

Shri Dineshbhai Makwana:

Shri P C Mohan:

Shri Lumbaram Choudhary:

Smt. Kamaljeet Sehrawat

Dr. Prashant Yadaorao Padole:

Shri Khagen Murmu:

Shri Bhartruhari Mahtab:

Smt. Bijuli Kalita Medhi:

Smt. Aparajita Sarangi:

Shri Manoj Tiwari:

Shri Suresh Kumar Kashyap:

Smt. Kamlesh Jangde:

Shri Trivendra Singh Rawat:

Ms Kangna Ranaut:

Shri Godam Nagesh:

Dr. Sanjay Jaiswal:

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

- (a) the steps being taken to realize the vision of Atmanirbhar Bharat in the pharmaceutical sector;
- (b) the manner in which the Government is likely to support domestic innovation and reducing reliance on pharmaceutical imports;

(c) the manner in which the recent reforms and schemes have strengthened India's position as a global pharma hub;

(d) the manner in which the Pradhan Mantri Bhartiya Janaushadhi Pariyojna (PMBJP) is likely to be contributed to improve affordability, assessibility and outreach across the country, Statewise; and

(e) whether the Government is implementing any schemes for the promotion of Micro, Small & Medium Enterprises (MSMEs) in pharmaceutical sector and 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  and  to  support  domestic  innovation  and  reduce  reliance  on pharmaceutical imports, including 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 including MSMEs 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  selfreliance. 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.

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 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.
- (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.

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. State- and Union-territory-wise number of JAKs opened are at Annexure.

(e):  MSMEs  in  the  pharmaceutical  sector  are  being  promoted  through  the  Strengthening  of Pharmaceutical Industry scheme and the PRIP scheme, details of which are given in the reply to parts (a) to (c) above. Further, 13 MSMEs have been approved under the PLI Scheme for Bulk Drugs and 20 MSMEs under the PLI Scheme for Pharmaceuticals and are eligible for productionlinked incentive.

## Annexure referred to in the reply to part (d) of Lok Sabha Unstarred Q. No. 1146 for answer on 25.7.2025

## State- and Union-territory-wise number of JAKs opened till 30.6.2025

| S. No.   | State / Union territory                  | Number of JAKs opened   |
|----------|------------------------------------------|-------------------------|
| 1        | Andaman and Nicobar Islands              | 9                       |
| 2        | Andhra Pradesh                           | 281                     |
| 3        | Arunachal Pradesh                        | 35                      |
| 4        | Assam                                    | 179                     |
| 5        | Bihar                                    | 900                     |
| 6        | Chandigarh                               | 14                      |
| 7        | Chhattisgarh                             | 316                     |
| 8        | Dadra and Nagar Haveli and Daman and Diu | 40                      |
| 9        | Delhi                                    | 552                     |
| 10       | Goa                                      | 22                      |
| 11       | Gujarat                                  | 812                     |
| 12       | Haryana                                  | 465                     |
| 13       | Himachal Pradesh                         | 75                      |
| 14       | Jammu and Kashmir                        | 335                     |
| 15       | Jharkhand                                | 163                     |
| 16       | Karnataka                                | 1,480                   |
| 17       | Kerala                                   | 1,629                   |
| 18       | Ladakh                                   | 2                       |
| 19       | Lakshadweep                              | 1                       |
| 20       | Madhya Pradesh                           | 592                     |
| 21       | Maharashtra                              | 723                     |
| 22       | Manipur                                  | 61                      |
| 23       | Meghalaya                                | 26                      |
| 24       | Mizoram                                  | 15                      |
| 25       | Nagaland                                 | 22                      |
| 26       | Odisha                                   | 753                     |
| 27       | Puducherry                               | 33                      |
| 28       | Punjab                                   | 520                     |
| 29       | Rajasthan                                | 545                     |
| 30       | Sikkim                                   | 12                      |
| 31       | Tamil Nadu                               | 1,432                   |
| 32       | Telangana                                | 203                     |
| 33       | Tripura                                  | 31                      |
| 34       | Uttar Pradesh                            | 3,550                   |
| 35       | Uttarakhand                              | 331                     |
| 36       | West Bengal                              | 753                     |
|          | Total                                    | 16,912                  |

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