Drugs: List of drugs prohibited for manufacture and sale in India before 2018
List of drugs prohibited for manufacture and sale through gazette notifications under section 26a of drugs & cosmetics act 1940 by the ministry of health and family welfare
Sr. No. / Drug Name / Notification No.
Amidopyrine. GSR NO. 578(E) Dated 23.07.1983
Fixed dose combinations of vitamins with antiinflammatory agents and tranquilizers GSR NO. 578(E) Dated 23.07.1983
Fixed dose combinations of Atropine in Analgesics and Antipyretics. GSR NO. 578(E) Dated 23.07.1983
Fixed dose combinations of Strychnine and Caffeine in tonics. GSR NO. 578(E) Dated 23.07.1983
Fixed dose combinations of Yohimbine and Strychnine with Testosterone and Vitamins. GSR NO. 578(E) Dated 23.07.1983
Fixed dose combinations of Iron with Strychnine, Arsenic and Yohimbine. GSR NO. 578(E) Dated 23.07.1983
Fixed dose combinations of Sodium Bromide/chloral hydrate with other drugs. GSR NO. 578(E) Dated 23.07.1983
Phenacetin. GSR NO. 578(E) Dated 23.07.1983
Fixed dose combinations of antihistaminic with antidiarrhoeals. GSR NO. 578(E) Dated 23.07.1983
Fixed dose combinations of Penicillin with Sulphonamides. GSR NO. 578(E) Dated 23.07.1983
Fixed dose combinations of Vitamins with Analgesics. GSR NO. 578(E) Dated 23.07.1983
Fixed dose combinations of any other Tetracycline with Vitamin C. GSR NO. 578(E) Dated 23.07.1983
Fixed dose combinations of Hydroxyquinoline group of drugs with any other drug except for preparations meant for external use. Substituted vide GSR NO. 793(E) Dated 13.12.1995
Fixed dose combinations of Corticosteroids with any other drug for internal use except for preparations meant for meter dose inhalers and dry powder inhalers. Substituted vide GSR NO. 738(E) Dated 09.10.2009
Fixed dose combinations of Chloramphenicol with any other drug for internal use. Substituted vide GSR NO. 1057(E) Dated 03.11.1988
Fixed dose combinations of crude Ergot preparations except those containing Ergotamine, Caffeine, analgesics, antihistamines for the treatment of migraine, headaches. Substituted vide GSR NO. 304(E) Dated 07.06.1991
Fixed dose combinations of Vitamins with Anti TB drugs except combination of Isoniazid with Pyridoxine Hydrochloride (Vitamin B6). GSR NO. 578(E) Dated 23.07.1983
Penicillin skin/eye Ointment GSR NO. 578(E) Dated 23.07.1983
Tetracycline Liquid Oral preparations. GSR NO. 578(E) Dated 23.07.1983
Nialamide. GSR NO. 578(E) Dated 23.07.1983
Practolol. GSR NO. 578(E) Dated 23.07.1983
Methapyrilene, its salts GSR NO. 578(E) Dated 23.07.1983
Methaqualone. GSR NO. 49(E) Dated 31.01.1984
Oxytetracycline Liquid Oral preparations GSR NO. 322(E) Dated 03.05.1984
Demeclocycline Liquid Oral preparations GSR NO. 322(E) Dated 03.05.1984
Combination of anabolic Steroids with other drugs. GSR NO. 863(E) Dated 22.11.1985
Fixed dose combination of Oestrogen and Progestin (other than oral contraceptive) containing per tablet Estrogen content of more than 50 mcg (equivalent to Ethinyl Estradiol) and content of more than 3 mg(equivalent to Norethisterone Acetate) and all fixed dose combination injectable preparations containing synthetic Oestrogen and Progesterone. Substituted vide GSR NO. 743(E) Dated 10.08.1989
Fixed dose combination of Sedatives/ hypnotics/anxiolytics with analgesics-antipyretics. GSR NO. 999(E) Dated 26.12.1990
Fixed dose combination of Rifanpicin, isoniazid and Pyrazinamide, except those which Provide daily adult dose given below:
Drugs Minimum Maximum
Rifampicin 450 mg 600 mg
Isoniazid 300 mg 400 mg
Pyrazinamide 1000mg 1500 mg Substituted vide GSR NO. 100(E) Dated 11.02.2003
Fixed dose combination of Histamine H-2 receptor antagonists with antacids except for those combinations approved by Drugs Controller, India GSR NO. 999(E) Dated 26.12.1990
The patent and proprietary medicines of fixed dose combinations of essential oils with alcohol having percentage higher than 20% proof except preparations given in the Indian Pharmacopoeia GSR NO. 999(E) Dated 26.12.1990
All Pharmaceutical preparations containing Chloroform exceeding 0.5% w/w or v/v whichever is appropriate. GSR NO. 999(E) Dated 26.12.1990
Fixed dose combination of Ethambutol with INH other than the following:
INH Ethambutol 200 mg. 600 mg. 300 mg. 800 mg GSR NO. 69(E) Dated 11.02.1991
Fixed dose combination containing more than one antihistamine. GSR NO. 69(E) Dated 11.02.1991
Fixed dose combination of any anthelmintic with cathartic/purgative except for piperazine/Santonim GSR NO. 69(E) Dated 11.02.1991
Fixed dose combination of Salbutamol or any other bronchodilator with centrally acting anti-tussive and/or antihistamine Substituted vide GSR NO. 290(E) Dated 16.04.2008
Fixed dose combination of laxatives and/or antispasmodic drugs in enzyme preparations. GSR NO. 69(E) Dated 11.02.1991
Fixed dose combination of Metoclopramide with systemically absorbed drugs except fixed dose combination of metoclopramide with aspirin/paracetamol Substituted vide GSR NO. 603(E) Dated 24.08.2001
Fixed dose combination of centrally acting, antitussive with antihistamine, having high atropine like activity in expectorants. GSR NO. 395(E) Dated 19.05.1999
Preparations claiming to combat cough associated with asthma containing centrally acting antitussive and/ or an antihistamine GSR NO. 395(E) Dated 19.05.1999
Liquid oral tonic preparations containing glycerophosphates and/or other phosphates and / or central nervous system stimulant and such preparations containing alcohol more than 20% proof. GSR NO. 395(E) Dated 19.05.1999
Fixed dose combination containing Pectin and/or Kaolin with any drug which is systemically absorbed from GI tract except for combinations of Pectin and/or Kaolin with drugs not systemically absorbed GSR NO. 395(E) Dated 19.05.1999
Chloral Hydrate as a drug. GSR NO. 304(E) Dated 07.06.1991
Dovers Powder I.P. GSR NO. 612(E) Dated 09.08.1994
Dover’s Powder Tablets I.P. GSR NO. 612(E) Dated 09.08.1994
Antidiarrhoeal formulations containing Kaolin or Pectin or Attapulgite or Activated Charcoal. GSR NO. 731(E) Dated 30.09.1994
Antidiarrhoeal formulations containing Phthalyl Sulphathiazole or Sulphaguanidine or Succinyl Sulphathiazole. GSR NO. 731(E) Dated 30.09.1994
Antidiarrhoeal formulations containing Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts or esters. GSR NO. 731(E) Dated 30.09.1994
Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing Diphenoxylate Lorloperamide or Atropine or Belladona including their salts or esters or metabolites Hyoscyamine or their extracts or their alkaloids. GSR NO. 731(E) Dated 30.09.1994
Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing halogenated hydroxyquinolines. GSR NO. 731(E) Dated 30.09.1994
Fixed dose combination of antidiarrhoeals with electrolytes. GSR NO. 731(E) Dated 30.09.1994
Patent and Proprietary Oral Rehydration Salts other than those conforming to the following parameters:
(a) Patent and Proprietary oral rehydration salts on reconstitution to one litre shall contain:
Sodium – 50 to 90 milliosmoles
Total osmolarity – 240-290 milliosmoles
Dextrose: Sodium molar ratio – Not less than
1:1 and not more than 3:1
(b) Patent and proprietary cereal based oral rehydration salts on reconstitution to one litre shall contain:
Sodium – 50 to 90 milliosmoles
Total osmolarity – Not more than 290 milliosmoles
Precooked rice – equivalent to not less than 50gms and not more than 80gms as total replacement of dextrose
(c) Patent and proprietary oral rehydration salts (ORS) may contain amino acids in addition to oral rehydration salts conforming to the parameters specified above and labelled with the
indication for “Adult Chloretic Diarrhea Only”
(d) Patent and proprietary oral rehydration salts (ORS) shall not contain mono or polysaccharides or saccharin sweetening agent. GSR NO. 57(E) Dated 07.02.1995
Fixed dose combination of Oxyphenbutazone or Phenylbutazone with any other drug. GSR NO. 633(E) Dated 13.09.1995
Fixed dose combination of Analgin with any other drug. GSR NO. 405(E) Dated 03.06.1996
Fixed dose combination of dextropropoxyphene with any other drug other than anti-spasmodics and/or non-steriodal anti-inflammatory drugs (NSAIDS). GSR NO. 633(E) Dated 13.09.1995
Fixed dose combination of a drug, standards of which are prescribed in the Second Schedule to the said Act with an Ayurvedic, Siddha or Unani drug. GSR NO. 633(E) Dated 13.09.1995
Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception GSR NO. 499(E) Dated 14.08.1998
Fenfluramine GSR NO. 499(E) Dated 14.08.1998
Dexfenfluramine GSR NO. 499(E) Dated 14.08.1998
Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride . GSR NO. 169(E) Dated 12.03.2001
Cosmetics Licensed as toothpaste/tooth powder containing tobacco GSR NO. 444(E) Dated 30.04.1992
Parenteal Preparations fixed combination of streptomycin with Pencillin GSR NO. 93(E) Dated 25.02.1997
Fixed dose combination of Vitamin B1Vitamin B6 and Vitamin B12 for human use GSR NO. 702(E) Dated 14.10.1999
Fixed dose combination of haemoglobin in any form (natural or synthetic). GSR NO. 814(E) Dated 16.12.1999
Fixed dose combination of Pancreatin or Pancrelipase containing amylase, protease and lipase with any other enzyme. GSR NO. 814(E) Dated 16.12.1999
Fixed dose combination of Nitrofurantoin and trimethoprim. GSR NO. 170(E) Dated 12.03.2001
Fixed dose combination of Phenobarbitone with any anti-asthmatic drugs GSR NO. 170(E) Dated 12.03.2001
Fixed dose combination of Phenobarbitone with Hyoscin and/or Hyoscyamine GSR NO. 170(E) Dated 12.03.2001
Fixed dose combination of Phenobarbitone with Ergotamine and/or Belladona GSR NO. 170(E) Dated 12.03.2001
Fixed dose combination of Haloperidol with any anticholinergic agent including Propantheline Bromide GSR NO. 170(E) Dated 12.03.2001
Fixed dose combination of Nalidixic Acid with any anti-amoebic including Metronidazole. GSR NO. 170(E) Dated 12.03.2001
Fixed dose combination of Loperamide Hydrochloride with Furazolidone GSR NO. 170(E) Dated 12.03.2001
Fixed dose combination of Cyproheptadine with Lysine or Peptone. GSR NO. 170(E) Dated 12.03.2001
Astemizole GSR NO. 191(E) Dated 05.03.2003
Terfinadine GSR NO. 191(E) Dated 05.03.2003
Phenformin GSR NO. 780(E) Dated 01.10.2003
Rofecoxib and its formulations GSR NO. 810(E) Dated 13.12.2004
Valdecoxib and its formulations GSR NO. 510(E) Dated 28.07.2005
Diclofenac and its formulations (for animal use) GSR NO. 499(E) Dated 04.07.2008
Rimonabant GSR NO. 884(E) Dated 11.12.2009
Rosiglitazone GSR NO. 910(E) Dated 12.11.2010
Nimesulide formulations for human use in children below 12 years of age. GSR NO. 82(E) Dated 10.02.2011
Cisapride and its formulations for human use GSR NO. 82(E) Dated 10.02.2011
Phenypropanolamine and its formulations for human use. *GSR NO. 82(E) Dated 10.02.2011
Human Placental Extract and its formulations for human use except its
- Topical application for wound healing, and
- Injection for pelvic inflammatory disease Substituted vide GSR NO. 418(E) Dated 30.05.2011
Sibutramine and its formulations for human use. GSR NO. 82(E) Dated 10.02.2011
R-Sibutramine and its formulations for human use. GSR NO. 82(E) Dated 10.02.2011
“Gatifloxacin formulation for systemic use in human by any route including oral and injectable” GSR NO. 218(E) Dated 16.03.2011
Tegaserod and its formulations GSR NO. 218(E) Dated 16.03.2011
Letrozole for induction of ovulation in anovulatory infertility. GSR NO. 752(E) Dated 12.10.2011
Serodiagnostic test kits for diagnosis of tuberculosis GSR 432(E) dated 07.06.2012 & GSR 433(E) dated 07.06.2012
Dextropropoxyphene and formulations GSR NO. 332(E) Dated 23.05.2013
Fixed dose combination of Flupenthixol and Melitracen GSR NO. 377(E) Dated 18.06.2013
Analgin and all formulations containing analgin. GSR NO. 378(E) Dated 18.06.2013
Pioglitazone and all formulations containing pioglitazone. GSR NO. 379(E) Dated 18.06.2013
