Self reliance in APIs

Under the scheme for “Promotion of Bulk Drug Parks”, three Bulk Drug Parks each in Andhra Pradesh, Gujarat and Himachal Pradesh have been approved. The Government has approved 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), with a total budgetary outlay of ₹6,940 crore and scheme tenure from FY2022-23 to FY2028–29. The Scheme aims to boost domestic manufacturing of 41 identified critical products, reduce import dependence and mitigate supply chain risks arising from excessive reliance on a single source. Significant progress has been achieved under the Scheme towards attaining self-reliance in critical APIs. Out of 41 notified products, 33 have been subscribed and 48 greenfield projects have been approved with committed investment of ₹4,329.95 crore. Against this commitment, actual investment of ₹4,814.1 crore has already been completed. As of December 2025, 38 projects covering 28 notified products have been commissioned, resulting in establishment of domestic manufacturing capacity of approximately 56,800 MT per annum. Key products now being manufactured under the Scheme include Penicillin G, Clavulanic Acid, Atorvastatin, Telmisartan, Para Amino Phenol, Oxcarbazepine, Olmesartan, Sulfadiazine, Diclofenac Sodium and Artesunate, among others, catering to critical therapeutic areas such as antibiotics, cardiovascular diseases, pain management, seizure disorders and infections. Cumulative sales of ₹2,720 crore have been achieved under the Scheme, including exports of ₹527.96 crore. Net of exports, domestic requirement of approximately ₹2,192 crore has been met through indigenous production, progressively substituting imports. Total incentive of ₹59.43 crore has been disbursed as of February 2026. With commissioning of remaining projects and stabilization of production, the Scheme is expected to significantly strengthen India's self-reliance in critical APIs within the overall scheme outlay. The Government has taken several measures to reduce import dependence on critical APIs, KSMs and Drug Intermediates. These include the Production Linked Incentive (PLI) Scheme for Bulk Drugs and the Scheme for Promotion of Bulk Drug Parks, which aim to strengthen domestic manufacturing capacity and promote domestic production of critical fermentation-based and chemical synthesis-based bulk drugs. The details of India’s import of APIs, KSMs and Drug Intermediates since 2020, country-wise and item-wise is given at Annexure I and Annexure II respectively. There is no private sector investment in Bulk Drug Park Scheme. It is purely funded by Central and State funds. Under the PLI Scheme for Bulk Drugs and PLI Scheme for Pharmaceuticals, investment commitment of ₹21,605 crore stands substantially exceeded with cumulative investment of ₹46,734 crore made under the scheme till December, 2025 Under both PLI Schemes, production/ sales target of ₹2,94,000 crore stands substantially exceeded with cumulative sales of ₹3,36,556 crore made under the scheme till December, 2025. The tenure of the PLI Scheme for Bulk Drugs is till the financial year 2029-30. The tenure of the PLI Scheme for Pharmaceuticals is till the financial year 2028-29. Annexure I Details of India’s import value (in ₹ crore) of APIs, KSMs and Drug Intermediates since 2020, (Country-wise) Sl. No. Country 2020-21 2021-22 2022-23 2023-24 2024-25 1 CHINA P RP 18646 20982 23791 25850 27032 2 U S A 1235 1215 928 737 691 3 SINGAPORE 790 1042 899 1000 917 4 ITALY 803 777 846 970 1089 5 JAPAN 547 598 755 748 650 6 GERMANY 471 560 541 873 693 7 SPAIN 534 541 641 630 704 8 BELGIUM 480 441 444 517 367 9 HONG KONG 413 427 366 606 167 10 FRANCE 355 409 465 271 391 11 AUSTRIA 267 485 494 373 257 12 KOREA RP 386 549 283 191 170 13 NETHERLAND 228 261 320 279 428 14 DENMARK 322 354 254 272 263 15 SWITZERLAND 172 214 215 221 376 16 TAIWAN 226 226 292 229 172 17 MEXICO 155 156 235 287 294 18 MALAYSIA 149 200 259 231 189 19 U K 187 198 178 149 303 20 INDONESIA 97 192 143 33 52 21 SLOVENIA 160 113 112 79 32 22 HUNGARY 73 111 65 102 104 23 CZECH REPUBLIC 83 93 84 103 84 24 PORTUGAL 56 51 112 114 58 25 VIETNAM SOC REP 27 45 41 73 84 26 MACAO 45 45 61 32 47 27 AUSTRALIA 38 27 39 45 89 28 BULGARIA 43 17 30 58 46 29 THAILAND 22 28 38 51 46 30 RUSSIA 41 49 2 23 14 31 U ARAB EMTS 8 67 16 21 14 32 IRELAND 19 69 11 14 8 33 IRAN 10 11 54 21 25 34 BRAZIL 25 20 29 14 14 35 SLOVAK REP 29 10 9 13 <