Drugs Information Portal: Banned Drugs

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15/12/2017 - Judgment of the honourable Supreme Court of India on banning of the 349 Fixed Dose Combinations <view/download>

On the basis of the recommendations of the Expert Committee and in exercise of powers conferred by Section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government prohibited the manufacture for sale, sale and distribution for human use of the following Fixed Dose Combination Drugs with effect from 08th June 2017.

1) Nimesulide + Levocetirizine
2) Ofloxacin + Ornidazole Injection
3) Gemifloxacin + Ambroxol
4) Glucosamine + Ibuprofen
5) Etodolac + Paracetamol

Extraordinary Gazette Notification No. 1644 <view / download>

On the basis of the recommendations of the Expert Committee and in exercise of powers conferred by Section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government prohibited the manufacture for sale, sale and distribution for human use of the 344 Fixed Dose Combination Drugs with effect from 10th March 2016.

Extraordinary Gazette Notification No. 608 <view / download>

LIST OF BANNED DRUGS IN INDIA SINCE 1983

*In exercise of powers conferred in Section 26A of the Drugs and Cosmetics Act 1940, the Government of India has prohibited the manufacture for sale, sale and distribution of the following Drugs;*

G.S.R. No. 578 (E) dated 23-07-1983
	1.	Amidopyrine.
	2.	Fixed dose combinations of vitamins with anti-inflammatory agents and tranquilizers.
	3.	Fixed dose combinations of Atropine and Analgesic and Antipyretics.
	4.	Fixed dose combinations of Strychnine and Caffeine in tonics.
	5.	Fixed dose combinations of Yohimbine and Strychnine with Testosterone and Vitamins.
	6.	Fixed dose combinations of Iron with Strychnine, Arsenic and Yohimbine.
	7.	Fixed dose combinations of Sodium Bromide/chloral hydrate with other drugs.
	8.	Phenacetin.
	9.	Fixed dose combinations of antihistaminic with anti-diarrhoeals.
	10.	Fixed dose combinations of Penicillin with Sulphonamides.
	11.	Fixed dose combinations of Vitamins with Analgesics.
	12.	Fixed dose combinations of Tetracycline with Vitamin C.
	13.	Fixed dose combinations of Vitamins with Anti TB drugs except combination of Isoniazid with Pyridoxine Hydrochloride (Vitamin B6).
	14.	Penicillin skin/eye Ointment.
	15.	Tetracycline Liquid Oral preparations.
	16.	Nialamide.
	17.	Practolol.
	18.	Methapyrilene, its salts.
G.S.R. No. 49 (E) dated 31-01-1984
	19.	Methaqualone.
G.S.R. No. 322 (E) dated 03-05-1984
	20.	Oxytetracycline Liquid Oral preparations.
	21.	Demeclocycline Liquid Oral preparations.
G.S.R. No. 863 (E) dated 22-11-1985
	22.	Combination of Anabolic Steroids with other drugs.
	23.	Fixed dose combinations of Chloramphenicol with any other drug for internal use.
G.S.R. No. 743 (E) dated 10-08-1989
	24.	Fixed dose combination of Oestrogen and Progestin (other than oral contraceptives) containing per tablet Estrogen content of more than 50 mcg (equivalent to Ethinyl Estradiol) and Progestin content of more than 3 mg (equivalent to Norethisterone Acetate) and all fixed dose combination injectable preparations containing synthetic Oestrogen and Progesterone.
G.S.R. No. 999 (E) dated 26-12-1990
	25.	Fixed dose combinations of Sedatives/ hypnotics/anxiolytics with analgesics-antipyretics.
	26.	Fixed dose combination of Histamine H-2 receptor antagonists with antacids except for those combinations approved by Drugs Controller, India.
	27.	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.
	28.	All Pharmaceutical preparations containing Chloroform exceeding 0.5% w/w or v/v whichever is appropriate.
G.S.R. No. 69 (E) dated 11-02-1991
	29.	Fixed dose combination of Ethambutol with INH other than the following: INH Ethambutol 200 mg. 600 mg. 300 mg. 800 mg.
	30.	Fixed dose combination containing more than one antihistamine.
	31.	Fixed dose combination of anthelmintic with cathartic/purgative except for piperazine.
	32.	Fixed dose combination of laxatives and/or anti-spasmodic drugs in enzyme preparations.
	33.	Fixed dose combination of centrally acting, antitussive with antihistamine, having atropine like activity in expectorants.
	34.	Preparations claiming to combat cough associated with asthma containing centrally acting antitussive and/ or an antihistamine.
	35.	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.
	36.	Fixed dose combination containing Pectin and/or Kaolin with any drug which is systemically absorbed from GI tract except for combination of Pectin and/or Kaolin with drugs not systemically absorbed.
G.S.R. No. 304 (E) dated 07-06-1991
	37.	Fixed dose combinations of crude Ergot preparation except those containing Ergotamine, Caffeine, analgesics, antihistamines for the treatment of migraine, headache.
	38.	Chloral Hydrate as a drug.
G.S.R. No. 612 (E) dated 09-08-1994
	39.	Dovers Powder I.P.
	40.	Dover's Powder Tablets I.P.
G.S.R. No. 731 (E) dated 30-09-1994
	41.	Antidiarrhoeal formulations containing Kaolin or Pectin or Attapulgite or Activated Charcoal.
	42.	Antidiarrhoeal formulations containing Phthalyl Sulphathiazole or Sulphaguanidine or Succinyl Sulphathiazole.
	43.	Antidiarrhoeal formulations containing Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts or esters.
	44.	Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing Diphenoxylate or Atropine or Belladona including their salts or esters or metabolites Hyoscyamine or their extracts or their alkaloids.
	45.	Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing halogenated hydroxyquinolines.
	46.	Fixed dose combination of antidiarrhoeals with electrolytes.
G.S.R. No. 57 (E) dated 07-02-1995
	47.	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 millimoles. Total osmolarity - 240 - 290 milli osmoles. 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 :- Total osmolarity - Not more than 2900 milli osmoles. Precooked rice- Equivalent to not less than 50 gm and not more than 80 gm as total replacement of Dextrose. (c) Patent and Proprietary Oral Rehydration Salts (ORS) may contain aminoacids in addition to Oral Rehydration Salt conforming to the parameters specified above and labeled with the indication for "Adult Choleratic Diarrhoea" only. (d) Patent and Proprietary Oral Rehydration Salts shall not contain Mono or Polysaccharides or saccharin sweetening agent.
G.S.R. No. 633 (E) dated 30-09-1995
	48.	Fixed dose combination of Oxyphenbutazone or Phenylbutazone with any other drug.
	49.	Fixed dose combination of dextropropoxyphene with any other drug other than anti-spasmodics and/or non-steriodal anti-inflammatory drugs (NSAIDS).
	50.	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.
G.S.R. No. 793 (E) dated 13-12-1995
	51.	Fixed dose combinations of Hydroxyquinoline group of drugs with any other drug except for preparations meant for external use only.
G.S.R. No. 405 (E) dated 03-06-1996
	52.	Fixed dose combination of Analgin with any other drug.
G.S.R. No. 93 (E) dated 25-02-1997
	53.	Parenteral preparations containing fixed dose combination of streptomycin with penicillins with effect from 01-01-1998.
G.S.R. No. 499 (E) dated 14-08-1998
	54.	Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception.
	55.	Fenfluramine.
	56.	Dexfenfluramine.
G.S.R. No. 702 (E) dated 20-10-1999 (with effect from 1-1-2001)
	57.	Fixed dose combination of Vitamin B1, Vitamin B6 and Vitamin B12 for human use with effect from 01-01-2001
G.S.R. No. 814 (E) dated 16-12-1999 (w.e.f. 01-09-2000)
	58.	Fixed dose combination of haemoglobin in any form (natural or synthetic).
	59.	Fixed dose combination of Pancreatin and Pancrelipase containing amylase, protease and lipase with any other enzyme.
G.S.R. No. 169 (E) dated 12-03-2001
	60.	Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride.
G.S.R. No. 170 (E) dated 12-03-2001 (with effect from 01-01-2002)
	61.	Fixed dose combination of Nitrofurantoin and trimethoprim.
	62.	Fixed dose combination of Phenobarbitone with any anti-asthmatic drug.
	63.	Fixed dose combination of Phenobarbitone with Hyoscin and/or Hyoscyamine.
	64.	Fixed dose combination of Phenobarbitone with Ergotamine and/or Belladona.
	65.	Fixed dose combination of Haloperidol with any anti-cholinergic agent including Propantheline Bromide.
	66.	Fixed dose combination of Nalidixic Acid with any anti-amoebic including Metronidazole.
	67.	Fixed dose combination of Loperamide Hydrochloride with Furazolidone.
	68.	Fixed dose combination of Cyproheptadine with Lysine or Peptone
G.S.R 603 (E) dated 24-08-2001 (with effect from 01-09-2002)
	69.	Fixed dose combination of Metoclopramide with other drugs except combination of Metoclopramide with Aspirin/ Paracetamol with effect from 1st September, 2002.
G.S.R 100 (E) dated 11-02-2003 (with effect from 11-02-2003)
	70.	Fixed dose combination of Rifampicin, 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 1000 mg 1500 mg
G.S.R 191(E) dated 05-03-2003 (with effect from 01-08-2003)
	71.	Astemizole.
	72.	Terfinadine.
G.S.R. No. 780 (E) dated 01-10-2003 (with effect from 01-10-2003)
	73.	Phenformin for human use.
G.S.R. No. 810 (E) dated 13-12-2004 (with effect from 13-12-2004)
	74.	Rofecoxib and its formulations for human use.
G.S.R. No. 510 (E) dated 25-7-2005 (with effect from 25-7-2005)
	75.	Valdecoxib and its formulations for human use.
G.S.R 290 (E) dated 16-04-2008
	76.	Fixed dose combination of Salbutamol or any other bronchodilator with centrally acting anti-tussive and/or antihistamine.
G.S.R. No. 499 (E) dated 4-7-2008 (with effect from 5-7-2008)
	77.	Diclofenac and its formulations for animal use.
G.S.R 738 (E) dated 9-10-2009
	78.	Fixed dose combinations of Corticosteroid with any other drug for internal use except for preparations meant for meter dose inhalers and dry powder inhalers.
G.S.R. No. 885 (E) dated 11-12-2009 (with effect from 11-12-2009)
	79.	Rimonabant.
G.S.R. No. 910 (E) dated 12-11-2010 (with effect from 12-11-2010)
	80.	Rosiglitazone and its formulations for human use.
G.S.R. No. 82 (E) dated 10-2-2011 (with effect from 10-2-2011)
	81.	Nimesulide formulations for human use in children below 12 years of age.
	82.	Cisapride and its formulations for human use.
	83.	Phenylpropanolamine and its formulations for human use. (Presently stayed by the Honourable High Court of Madras)
	84.	Sibutramine and its formulations for human use.
	85.	R-Sibutramine and its formulations for human use.
G.S.R. No. 218 (E) dated 16-3-2011 (with effect from 16-3-2011)
	86.	Gatifloxacin formulation for systemic use in human by any route including oral and injectable.
	87.	Tegaserod and its formulations for human use.
G.S.R. No. 418 (E) dated 30-5-2011 (with effect from 30-5-2011)
	88.	Human Placental Extract and its formulations for human use except its, (i) Topical application for wound healing, and (ii) Injection for pelvic inflammatory disease
G.S.R. No. 752 (E) dated 12-10-2011 (with effect from 12-10-2011)
	89.	Letrozole for induction of ovulation in anovulatory infertility.
G.S.R. No. 432 (E) dated 7-6-2012 (with effect from 7-6-2012)
	90.	Serodiagnostic test kits for diagnosis of tuberculosis.
G.S.R. No. 332 (E) dated 23-5-2013 (with effect from 23-5-2013)
	91.	Dextropropoxyphene and formulations containing Dextropropoxyphene for human use.
G.S.R. No. 378 (E) dated 18-6-2013 (with effect from 18-6-2013)
	92.	Analgin and all formulations containing Analgin for human use. (Allowed use of the drug with certain condition vide G.S.R. No.86(E)dated 13.2.2014)
G.S.R. No. 498 (E) dated 11-7-2014 (with effect from 11-7-2014)
	93.	Fixed dose combination of Flupenthixol and Melitracen for human use
G.S.R. No. 379 (E) dated 18-6-2013 (with effect from 18-6-2013)
	94.	Pioglitazone and all formulations containing Pioglitazone for human use. (Allowed use of the drug with certain condition vide G.S.R. No. 520 (E) dt 31-07-2013)

In addition to the above-mentioned drugs, manufacture and sale of all Cosmetics and all Ayurvedic Drugs licensed as toothpaste, tooth powders containing tobacco have been prohibited under G.S.R. 443 (E) and 444(E) dated 30.4.1992

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Banned Drugs