Parliament Question: Reform in Pharmaceutical Sector

GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS LOK SABHA UNSTARRED QUESTION NO.1146 TO BE ANSWERED ON 25th 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 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 thescheme 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 grant- in-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 forupgrade 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, anti- diabetic, 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 production- linked incentive.Annexure 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 *****