Parliament Question: PLI Scheme for Bulk Drugs

GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS LOK SABHA UNSTARRED QUESTION NO.3241 TO BE ANSWERED ON THE 7TH AUGUST 2026 PLI Scheme for Bulk Drugs

3241. Shri Radhakrishna:

Shri G Lakshminarayana:

Will the Minister of Chemicals and Fertilizers be pleased to state:

(a) the number of projects approved under the Production Linked Incentive (PLI) Scheme for Active Pharmaceutical Ingredients (APIs), Key Starting Materials (KSMs) and Drug Intermediates, indicating the committed, approved and actual investment made thereunder, State-wise;

(b) the details of funds allocated/sanctioned/released/utilized and production capacity approved and commissioned under the scheme, State-wise;

(c) the quantity and value of production achieved by approved units during the last three years, State-wise and year-wise;

(d) the details of incentives sanctioned and disbursed under the said scheme along with the number of projects that have not commenced commercial production;

(e) whether any assessment has been made regarding reduction in import dependence for approved APIs and KSMs since commencement of the said scheme, if so, the details thereof indicating the reductions achieved in import dependence for specific APIs identified for import substitution, API-wise; and

(f) the details of APIs, if any where import dependence has not reduced despite scheme approval? ANSWER THE MINISTER OF STATE IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SMT. ANUPRIYA PATEL)

(a) to (e): 48 projects have been approved 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 (also known as the PLI Scheme for Bulk Drugs). The scheme has an approved outlay of ₹6,940 crore out of which ₹87.70 crore has been utilized in disbursement of incentive to approved applicants as of March,

2026. Further, production capacity has been created for 28 APIs/KSMs/DIs. Out of these 10 have not achieved commercial production. As of March 2026, cumulative investment of ₹5,070.45 crore has been achieved against a committed investment of ₹4,329.95 crore. The State-wise details of approved projects, committed investment, actual investment made, production capacity approved, capacity created, quantity and value of production achieved and incentive disbursement are placed at Annexure-A.(f): The list of 41 products approved under PLI scheme for Bulk Drugs is placed at Annexure- B., Out of these, production of following 18 APIs has commenced, thereby reducing import dependency – Penicillin G, Clavulanic Acid, Dexamethasone, Prednisolone, Para Amino Phenol, 1,1 Cyclohexane Diacetic Acid (CDA), Dicyandiamide (DCDA), Atorvastatin, Levofloxacin, Sulfadiazine, Ofloxacin, Norfloxacin, Artesunate, Telmisartan, Lopinavir, Carbamazepine, Oxcarbazepine and Diclofenac Sodium.Annexure-A Annexure referred to in the reply to part (a) to (e) of the Lok Sabha Unstarred Question No. 3241, to be answered on 7.8.2026 Name of No. Investment(in Capacity (in Production Qty.(in MT) Production value(in Ince State of crore ₹) MT) crore ₹) ntive proj Commi Actua Commi Install 2023- 2024- 2025- 2023- 2024 2025 relea ects tted l tted ed 24 25 26 24 - 25 - 26 sed appr (in oved cror e ₹) Andhra 10 1,745.7 2,676 24,390 16,46 224.4 1,207. 5,498. 63.2 258. 865. 31.9 Pradesh 8 4 6 4 7 1 Gujarat 8 330.9 407.3 14,270 13,95 7,028.7 4,170 5,572. 209.5 133. 162. 11.3 9 7 1 9 Haryana* 1 81 37 800 NIL NIL NIL NIL NIL NIL NIL NIL Himachal 2 806.8 502.6 1,100 400 0.01 69.9 172.1 0 115. 242. 11.9 Pradesh 9 6 8 Jammu & 1 185 338.6 1,000 NIL NIL NIL NIL NIL NIL NIL NIL Kashmir* 5 Karnataka 3 96.9 201.4 37 16.7 0 0 0.9 0 0 3.12 NIL Madhya 2 280 101.8 1,015 15 3.63 4.93 0.32 24.71 33.3 3.2 NIL Pradesh 7 Maharasht 5 308.4 168.8 40,185 19,18 611.9 500.3 1.14 27.51 26.4 0.01 NIL ra 0 1 Punjab 1 137.7 161.1 180 206 91.4 79.6 58.15 119.5 96.9 72.0 27.1 3 1 8 Tamil 2 31.5 45.6 280 280 3.1 0.002 5.73 0.8 0.01 1.24 NIL Nadu 5 Telangana 13 326.02 430.2 7,820 7,820 103.1 89.4 108.0 87.4 85.8 101. 5.23 3 5 * Projects in state of Haryana and UT of J&K are under commissioning stage.Annexure-B Annexure referred to in the reply to part (f) of the Lok Sabha Unstarred Question No.

3241, to be answered on 7.8.2026 S. No. Name of KSM/DI/API Key Fermentation based KSMs / Drug Intermediates 1 Penicillin G 2 7-ACA 3 Erythromycin Thiocynate

(TIOC) 4 Clavulanic Acid Fermentation based niche KSMs I Drug Intermediates I APIs 5 Neomycin 6 Gentamycin 7 Betamethasone 8 Dexamethasone 9 Prednisolone 10 Rifampicin 11 Vitamin BI 12 Clindamycin Base 13 Streptomycin 14 Tetracycline Key Chemical Synthesis based KSMs I Drug Intermediates 15 1,1 Cyclohexane Diacetic Acid (CDA) 16 2-Methyl-5Nitro-lmidazole (2-MNI) 17 Dicyandiamide (DCDA) 18 Para amino phenol Other Chemical Synthesis based KSMs I Drug Intermediates / APIs 19 Meropenem 20 Atorvastatin 21 Olmesartan 22 Valsartan 23 Losartan 24 Levofloxacin 25 Sulfadiazine 26 Ciprofloxacin 27 Ofloxacin 28 Norfloxacin 29 Artesunate 30 Telmisartan 31 Aspirin 32 Diclofenac Sodium 33 Leveti racetam34 Carbidopa 35 Ritonavir 36 Lopinavir 37 Acyclovir 38 Carbamazepine 39 Oxcarbazepine 40 Vitamin B6 41 Levodopa *****