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. Country2020-21

 

2021-22

 

2022-23

 

2023-24

 

2024-25

 

1CHINA P RP1864620982237912585027032
2U S A12351215928737691
3SINGAPORE79010428991000917
4ITALY8037778469701089
5JAPAN547598755748650
6GERMANY471560541873693
7SPAIN534541641630704
8BELGIUM480441444517367
9HONG KONG413427366606167
10FRANCE355409465271391
11AUSTRIA267485494373257
12KOREA RP386549283191170
13NETHERLAND228261320279428
14DENMARK322354254272263
15SWITZERLAND172214215221376
16TAIWAN226226292229172
17MEXICO155156235287294
18MALAYSIA149200259231189
19U K187198178149303
20INDONESIA971921433352
21SLOVENIA1601131127932
22HUNGARY7311165102104
23CZECH REPUBLIC83938410384
24PORTUGAL565111211458
25VIETNAM SOC REP2745417384
26MACAO4545613247
27AUSTRALIA3827394589
28BULGARIA4317305846
29THAILAND2228385146
30RUSSIA414922314
31U ARAB EMTS867162114
32IRELAND196911148
33IRAN1011542125
34BRAZIL2520291414
35SLOVAK REP291091327
36ISRAEL2014191916
37MADAGASCAR1630121315
38MALTA718101835
39SOUTH AFRICA212391411
40GREECE710181730
41ROMANIA4592222
42CANADA1520895
43UNSPECIFIED20611313
44ARGENTINA1617921
45COLOMBIA51016108
46POLAND7382111
47FINLAND3413119
48TURKEY75898
49CROATIA1121128
50EGYPT A RP76731
51UKRAINE151010
52LATVIA43129
53SWEDEN32615
54CHILE112110
55PUERTO RICO81000
56SAUDI ARAB20410
57KENYA21111
58JORDAN00304
59ECUADOR00430
60MYANMAR04000
61TANZANIA REP30000
62MOROCCO00022
63OMAN01021
64BANGLADESH PR02000
65PHILIPPINES20000
66ALGERIA00030
67ESTONIA00003
68RWANDA02100
69SUDAN10100
70MOZAMBIQUE20000
71NEW ZEALAND20000
72LUXEMBOURG10100
73BELARUS10100
74PAKISTAN IR00100
75CYPRUS00200
76SRI LANKA DSR00100
77PERU00001
78SWAZILAND01000
79SENEGAL10000
80TUNISIA10000
81GHANA01000
82NIGERIA10000
84LESOTHO10000
Grand Total2736130783332513542236124

Annexure II

Details of India’s import value (in ₹ crore) of APIs, KSMs and Drug Intermediates since 2020, (Item-wise)

Sl. No. Item DescriptionHS Code2020-212021-222022-232023-242024-25
1Other Antibiotics2941909048015780493168296666
2Other Diloxanide Furoate, Cimetidine,     Famotidine Nes2942009033233314280627502808
3Other2933199923041863249330402159
46 – Apa2941105012531551284834863592
5Erthromycin And Its Drvtvs Slts Thereof294150001141112094013651439
6Penicillins And Its Salts294110109341031171320661902
7Other Penicillins And Thr Drvtvs Wth A      Pentcillianic Ac29411090892840716506697
8Other Compnds Cntng An Unfused Imidazole  Ring (W/N Hydrgntd29332990797726715648678
9Methionine293040007561081114711711476
10Other Rifampicin And Its Salts29419019661748634610471
11Othr Steroidal Hormons Thr Drvtvs And     Strctl Anlges293729005997218201088917
121-Cyanoguanidine(Dicyandiamide)29262000568952909647607
13Other Glycosides Ntrl/Rprdcd By Synthsis Andthr Slts Ethrs D29389090520421544610654
14Lysine And Its Esters Salts Thereof2922410048810139958961130
15Oestrogens And Progestogens29372300417351372440510
16Hydroquinone (Quinol) And Its Salts29072200328350579330329
17Vitamin C (Ascorbic Acid) And Its Drvtvs29362700315223323216216
18Pyridine And Its Salts29333100297361553258205
19Other Derivatives of Pyradine2933391925731951300
20Cortisone,Hydrocortisone,Prednisone (Dehy-Drocortisone)And F29372100255227311351333
21Mannitol29054300248255283424439
22Salicylic Acid29182110240260279207215
23Sugrs Chmcly Pure Othr Thn Sucrose        Lactosemaltose Etc29400000234684385374495
24Eth0xy Methylene Mal0nate,Diethyl Mal0nate29171970230221295164167
25Vitamin B12 (Cynocobalamin)29362610214235275280224
26Rifampicin2941901120225515876347
27Doxycylime And Its Salts29413010198308177202188
28Amoxycilline And Its Salts29411030196146371386363
29Ibuprofane29420012192127838765
30Insulin And Its Salts29371200182241243292285
31Other Tetracyclines And Thr Drvtvs Slts29413090169103180244208
32Halgntd Drvtvs Of Corti Costeroidal29372200167175246190235
33Beta Pic0line ( 3-Methyl Pyridine )29333916140167173109124
34Vitamins A And Their Derivatives29362100137185158296128
35Cephalexin And Its Salts29419020131117182242291
36Concentrates Of Poppy Straw Cmpnds Of     Morphin, Codeine,29391100128159164141226
37L-Cystine (Alpha-Amino Beta-Thio          Propionicacid)-Sul29309040126153201171158
38Vitamin E And Its Derivatives29362800124190227307359
39M-Phenylenediamine (M-Diaminobenzene)29215120124159534234
40Other Polypeptide Hormones Thr Dtvtvs And   Strctl Anlges29371900123221408223396
41D-Or Dl-Pantothenic Acid (Vitamin B3      Or Vitamin B5) And29362400108106010582
42Other Vitamins And Thr Drvtvs293629901077566132159
43Vitamin B1i(Thiamine, Aneurine) And Its Salt2936221010614915899159
44Amino Acetic Acid (Glycine)2922491099154220117217
45D(-) Para Hydroxy Danes Salts2942001697102185174230
46Gelatin Capsules,Empty960200309481855751
47Methyl Dopa(L-Alpha Methyl-3,             4-Dihydroxyphenyla292142368379112114102
48Tetracycline/Oxytetra – Cycline And Hr Salts2941302082120798997
49Vitamin B2 (Riboflavin, Lactoplavin) And  Its Salts293623107888557999
50Phenylacetic Acid And Its Salts291634007667552949
51Para Acetyl Aminophenol(Paracetamol)2922293374125109520
52Ciprofloxacine And Its Salts2941903071781236880
53Monochloroacetic Acid,Thr Salts And Esters291540106981915519
54Danes Salt Of D (-) Phenyl Glycine294200156885109153161
55Vitamin B6 And Its Drvts29362500667388100123
56Hydantoin And Its Derivatives293321006523323534
57Calcium Gluconate291816106473555877
58D-Glucitol (Sorbitol)290544006057707989
59O- Phenylenediamine2921511056130126101133
60Other Alkaloids Of Opium Andthr Drvtvs,Salts293919005473134130150
61Gentamycin And Its Salts294190405462576772
62Caffeine And Its Salts293930005486203200200
63Vitamin D2936294051798870124
64Other Vitamin B12 And Its Derivatives29362690502613612
65Other, Incl. Natural Concentrts2936900047259610
66Guaiacol290950104253702317
67Folic Acid (Vitamin B9)293629104036393628
68Sulphamide293590244025797
69P-Phenylenediamine292151303777963443
70Chloramphenicol And Its Drvtvs Slts Thereof294140003440462621
71Metronidazole Metronidiazole Benzoate2933292032421207192
72Isoniazid29280010311013014
73Other Vitamin B1i And Its Drivatives293622903120272629
74Acetanilide29242910315783101113
75Other Streptomycine And Drvtvs, Salts294120903140173819
76Neomycin294190503027233121
77Vitamin H (Bi0lin)293629502921221513
78Streptomycins294120102952391839
79Malonylurea (Barbituric Acid)  And  Its Sals293352002960644539
80Sodium Citrate291815202823393419
81Cysteanune Hcl294200262836282124
82Cefadroxil29420011282724914
83Cmpnds Cntng A Phenothiazine Ring-System  (W/N Hydrgntd ) Nt293430002528455258
84Prostaglandins, Tiromboxamesand             Leukotrienesthr293750002340394077
85Cimetidine294200322134875
86Analgin293319702017242438
87Norfloxacin And Its Salts2941906020161830104
88Albendaz0le29332950193121613
89Quinine Sulphate29392030198864
90Sulphadimidine293590141923151512
91Ranitidine29420014193111
92Sulphadiazine293590131817345
933,4,5-Trimethoxy-Benzaldehyede29124940182693
94Potassium Citrate29181510177121115
95L-Tyrosine(P-Hydroxyphenylamine)292250151629392724
96Gamma Picoline(4-Methyl Pyridine)2933391315103142
97Methyl Salicylate291823101417362112
98Nctnc Acid And Nctnmd(Niacinamide/Niacine293629201415202215
99Vitamin K (Menaphthonum B.P.)293629301320252018
100Coumarin, Methylcoumarins And   Ethylcoumarins293220101211535
101Ampicilline And Its Salts294110201251563
102Alpra Zolam, Camazepam And Other Cmpnds Of  Zepam, Salts The293391001211202219
103Salbutamol Sulphate29051420125002
104Rutoside (Rutin) And Its Derivatives293810001047523439
105Dextrose Other Than Solid17024039989911
106Rifa Or Rifa S Sodium (Rifaint)294190139261470131
107Somatotropin, Its Drvtvsand Strctl Analogves2937110094000
108Lutidine (Dimethyle Pyridine)29333918823825
109Piperan0l2932930081672722
110Meprobamate (Inn)2924110081413617
111Phenyl-Methyl Pyrazolone293319408182047
112Piperidine And Its Salts2933320074292960
113Thymol2907193062111
114Amino-Acid Derivatives293790206692993
1151(2:5 Dchlr-4-Slphphnyl)-3-Mthyl-5-Pyrazln293319206105111
116Other Theophylline And Aminophylline Thr  Drvtvs, Salts2939590068141735
117Glutamic Acid29224210510836
118Phenazone (Antipyrin) And Its Derivatives293311005671010
119Choline And Its Salts292310005791125
120Amfetamine Benzfetamine Etc Thr Salts2921460051133
121Atenolol, Propronalol29420027528310
122Other Ergometrine Salts2939619049301
123Fluoro-3-(Difluoromethyl)-1-Methyl-1  H- Pyrazole-4-Carbonyl29331991444100
1241-Phnyl-5-Pyrazln-3-Crboxylc Acd Ethylestr2933195042000
125Ergotamine Tartarate2939621048836
126Famotidine2942003441312
127Benzyl Benzoate2916312047585
128Other Derivatives Of Malonylurea          (Barbituric Acid )29335400411523
129Amino Salicylate2918232040000
130Frusemide2922502142104
131Aminorex, Brotizolam And Other Like       Cmpnds, Salts Ther29349100300120
132Other Compounds Containing Quinoline/Isoquinoline Ring-Syste2939490034055
133Allobarbital And Othr Barbital Compnds    Andits Salts29335300320000
134Para-Amino-Salicylic Acid2922501131003
135N-Methyl Taurine292249203101179
1360-Acetylsalicylic Acid Its Salts And Estrs2918220031126
1373-Carboxy (Para Slphphnyl)-5 Pyrazolone2933191020011
138Glucose Solid1702302023246
139Digoxin2938901020100
140Other Vitamin B2 And Its Derivatives293623902142723
141Ferrous Fumerate2917194022000
142Trimethoprim2933592021012142
143Nifedipine2942001323500
144Amino Pyridine293339112221879
145Dextrose,Solid1702303112235
146Pyrazinamide(Pyrazine Carboxamide)29242960144812
147Cloxacilline And Its Salts2941104013235
148Sodium Salicylate2918212011111
149Timolol Maleate2942002113123
150Sulphamethoxazole2935901112000
151Quinine Alkaloids2939201012105
152Calcium Lactate29181120141083
153Ethambutol, Ethambutol Hcl29051410150138
154Benzocaine (Ethylpara-Amino Benzoate)2916315010000
155Glucose Liquid1702301011111
156Levorphanol (Inn) And Its Salts2933410000000
157Aminophylline(Cordophylin)2933591003016
158Tinidazole2933291000013
159D0mperid0ne2922502401000
160Chlorpheniramine Maleate2933391400001
161Dextropropoxyphene (Inn) And Its Salts2922140000000
162Digitalis Glycosides2938902000001
163Alpha Picoline(2-Methyl Pyridine)2933391200010
164Ergometrine2939611000000
165Glycerophosphate Acid2919901000000
166Dextrose Solid1702403100000
167Is0safr0le2932910000000
168Epinethrine2937901100000
169Mebendazole2933293000000
170Pseudo Ephedrine (Inn) And Its Salts2939420000000
171Procaine Hydrochloride2922501300000
172Chl0r0quine Ph0sphate2939204007200
173Amitryptyline Hcl2942002500000
174Quinine Hydrochloride2939202000000
175Sulphacetamide2935901500000
176Imipramine Hcl2942002400000
177Diphenoxylate Hydrochloride2933391500000
1783-Mthyl-1(4-Slpho-0-Toluyl-5-Pyrazoldne)2933193000000
179Terbutoline Sulphate2942002200000
1801 – Amino -4 – Methyl Piperazine (Rifaint)2941901400000
1811 – Amino-4methyl Piperazine2933594000000
1821-(M-Sulphophenyl)-3-Pyrazolone2933196000000
1833 Formyl Rifa S V (Rifa Int)2941901200000
1843-Quinuclidinol2933350000000
185Amfepra None(Inn), Methdone And             Mormethadonesalt2922310000000
186Bromazepam(Inn) And Its Salt2933331400450
187Cocaine, Ecgonine; Salts, Esters And Other Derivatives There2939720000131
188D(-) Phenyl Glycin Chloride Hcl (Dpgch)2942002300000
189Diethyl Carbanazine Citrate2933593000000
190D-Or Dl-Pantothenic Acid (Vitamin B5) And Its Derivatives29362400007410582
191Ephedrine And Its Salts (Alkaloids Of Ephedra And Their Deri2939410000000
192Ethchlorvynol (Inn)2905510000000
193Fenproporex (Inn) And Its Salts2926300000000
194Fentanyl (Inn) And Its Salt2933332100000
195Ferric Ammonium Citrate2918155000000
196Heliotropine (Piperonyl Aldehyde)2912492000000
197Iron Glycerophosphate2919903000000
198Loprazolam, Mecloqualone, Methaqualone ,  Ziperol, Salts The2933550000000
199Lysergic Acid And Its Salts2939630000000
200Methylphenidate (Inn) And Its Salt2933332300007
201Metroprolol Tartrate29181320018711
202Nalidixic Acid2918303000000
203Norephedrine And Its Salts (Alkaloids Of Ephedra And Their D2939440000100
204Other Ergotamine Salts2939629000011
205Other, Of Vegetal Origin2939690000313327
206Pethidine (Inn) And Its Salt2933332500101
207Pseudoephedrine (Inn) And Its Salts (Alkaloids Of Ephedra An2939420000102
208Safr0le2932940000000
209Sulphafurazole2935901200000
210Sulphamethiazole2935902200000
211Sulphamethoxypyridarine2935902100000
212Tetrahydrocannabinols (All Isomers)2932950000000
Grand Total2736130783332513542236124

This information was given by Minister of State for Chemicals and Fertilizers, Smt. Anupriya Patel, in a written reply in the Rajya Sabha today.

 

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