Banned Drugs in India
The
Government of India vide notifications published in the Gazette of India vide
G.S.R. No. 578 (E) dated 23/07/1983 and subsequent amendments, made under
Section 26 A of Drugs and Cosmetics Act, 1940 has prohibited the manufacture,
sale and distribution of the following categories of fixed dose combinations
which do not have any therapeutic justification or are likely to involve risk
to human beings:
FAQs
Also read: FAQs about New Drug, Banned drugs etc.
Updated: Banned Drugs List (518 items) as on 22-11-2021
Updated: Banned Drugs List (518 items) as on 22-11-2021, along with their notification numbers. Click on the following link:
Updated-Banned-Drugs-List-as-on-22-11-2021
Notifications of banned drugs
For notifications of banned drugs, click below link:
Notifications - Banned drugs
List of drugs prohibited for manufacture and sale by the Ministry of Health and Family Welfare via gazette notifications under Section 26a of the Drugs and Cosmetics Act 1940, with their current status as of November 22, 2021
Sr. No.Drugs NameNotification No. & Date1.Amidopyrine.GSR NO. 578(E) Dated 23.07.19832.Fixed dose combinations of vitamins with anti- inflammatory agents and tranquilizers.GSR NO. 578(E) Dated 23.07.19833.Fixed dose combinations of Atropine in Analgesics and Antipyretics.GSR NO. 578(E) Dated 23.07.19834.Fixed dose combinations of Strychnine and Caffeine in tonics.GSR NO. 578(E) Dated 23.07.19835.Fixed dose combinations of Yohimbine and Strychnine with Testosterone and Vitamins.GSR NO. 578(E) Dated 23.07.19836.Fixed dose combinations of Iron with Strychnine, Arsenic and Yohimbine.GSR NO.578(E) Dated 23.07.19837.Fixed dose combinations of Sodium Bromide/chloral hydrate with other drugs.GSR NO.578(E) Dated 23.07.19838.Phenacetin.GSR NO. 578(E) Dated 23.07.19839.Fixed dose combinations of antihistaminic with anti-diarrhoeals.GSR NO.578(E) Dated 23.07.198310.Fixed dose combinations of Penicillin with Sulphonamides.GSR NO. 578(E) Dated 23.07.198311.Fixed dose combinations of Vitamins with Analgesics.GSR NO. 578(E) Dated 23.07.198312.Fixed dose combinations of any other Tetracycline With Vitamin C.GSR NO. 578(E) Dated 23.07.1983
13.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 13.12.199514.Fixed dose combinations of Chloramphenicol with any other drug for internal use.Substituted vide GSR NO. 1057(E) Dated 03.11.198815.Fixed dose combinations of crude Ergot preparations except those containing Ergotamine, Caffeine, analgesics, antihistamines for the treatment of migraine, headache.Substituted vide GSR NO. 304 (E) Dated 07.06.199116.Fixed dose combinations of Vitamins with Anti TB drugs Except combination of Isoniazid with Pyridoxine Hydrochloride (Vitamin B6).GSR NO. 578 (E) Dated 23.07.198317.Penicillin skin/eye Ointment.GSR NO. 578 (E) Dated 23.07.198318.Tetracycline Liquid Oral preparations.GSR NO. 578 (E) Dated 23.07.198319.Nialamide.GSR NO. 578 (E) Dated 23.07.198320.Practolol.GSR NO. 578 (E) Dated 23.07.198321.Methapyrilene, its salts.GSR NO. 578(E)Dated2 3.07.198322.Methaqualone.GSR NO. 49 (E) Dated 31.01.198423.Oxytetracycline Liquid Oral preparations.GSR NO. 322 (E) Dated 03.05.198424.Demeclocycline Liquid Oral preparations.GSR NO. 322 (E) Dated 03.05.198425.Combination of anabolic Steroids with other drugs.GSR NO. 863 (E) Dated 22.11.198526.Fixed dose combination of Oestrogen and Progestin (other than oral contraceptive) containing per tablet Estrogen content of more than 50mcg (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 GSRNO. 743 (E) Dated 10.08.1989
27.Fixed dose combination of Sedatives/hypnotics/anxiolytics with analgesics-antipyretics.GSR NO. 999(E)Dated26. 12.199028.Fixed dose combination of Rifampicin, isoniazid and Pyrazinamide, except those which Provide daily adult dose given below: Drugs Minimum Maximum Rifampicin 450mg 600mg Isoniazid 300mg 400mg Pyrazinamide 1000mg 1500mgSubstituted vide GSR NO.100(E) Dated 11.02.200329.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 26.12.199030.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 26.12.199031.All Pharmaceutical preparations containing Chloroform exceeding 0.5%w/w or v/v whichever is appropriate.GSR NO. 999 (E) Dated 26.12.199032.Fixed dose combination of Ethambutol with INH other than the following: INH Ethambutol 200mg. 600mg. 300mg. 800mg.GSR NO. 69(E)Dated 11.02.199133.Fixed dose combination containing more than one antihistamine.GSR NO. 69(E)Dated 11.02.199134.Fixed dose combination of any anthelmintic with cathartic/purgative except for piperazine/Santonin.GSR NO. 69 (E) Dated 11.02.199135.Fixed dose combination of Salbutamol or any other bronchodilator with centrally acting anti-tussive and/or antihistamine.Substituted vide GSR NO. 290(E)Dated1 6.04.200836.Fixed dose combination of laxatives and/or anti-spasmodic drugs in enzyme preparations.GSR NO. 69(E)Dated 11.02.199137.Fixed dose combination of Metoclopramide with systemically absorbed drugs except fixed dose combination of metoclopramide with aspirin/paracetamolSubstituted vide GSR NO. 603(E)Dated2 4.08.200138.Fixed dose combination of centrally acting, antitussive with antihistamine, having high atropine like activity in expectorants.GSR NO. 395(E)Dated 19.05.199939.Preparations claiming to combat cough associated with asthma containing centrally acting antitussive and/or an antihistamine.GSR NO. 395(E)Dated 19.05.1999
40.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 19.05.199941.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 19.05.199942.Chloral Hydrate as a drug.GSR NO. 304(E)Dated 07.06.199143.Dovers Powder I.P.GSR NO. 612(E)Dated0 9.08.199444.Dover’s Powder Tablets I.P.GSR NO. 612(E)Dated0 9.08.199445.Antidiarrhoeal formulations containing Kaolin or Pectin or Attapulgite or Activated Charcoal.GSR NO. 731(E)Dated 30.09.199446.Antidiarrhoeal formulations containing Phthalyl Sulphathiazole or Sulphaguanidine or Succinyl Sulphathiazole.GSR NO. 731(E)Dated3 0.09.199447.Antidiarrhoeal formulations containing Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts or esters.GSR NO. 731(E)Dated3 0.09.199448.Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing Diphenoxylate L or loperamide or Atropine or Belladona including their salts or esters or Metabolites Hyoscyamine or their extracts or their alkaloids.GSR NO. 731(E)Dated3 0.09.199449.Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing halogenated hydroxyquinolines.GSR NO. 731(E)Dated3 0.09.199450.Fixed dose combination of antidiarrhoeals with electrolytes.GSR NO. 731(E)Dated 30.09.199451.Patent and Proprietary Oral Rehydration Salts other than those conforming to the following parameters: Patent and Proprietary oral rehydration salts on reconstitution to one litre shall contain: Sodium–50to90milliosmoles Total osmolarity–240-290 millios moles Dextrose: Sodium molar ratio–Not less than 1:1 and not morethan3:1 Patent and proprietary cereal based oral rehydration salts on reconstitution to one litre shall contain: Sodium–50 to 90 millios moles Total osmolarity–Not morethan 290 millios moles Precooked rice–equivalent to not less than 50gms and not more than 80gms as total replacement of dextroseGSR NO. 57(E) Dated07.02 .1995
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”Patent and proprietary oral rehydration salts (ORS) shall Not contain mono or polysaccharides or saccharin sweetening agent.
52.Fixed dose combination of Oxyphenbutazone or Phenyl butazone with any other drug.GSRNO. 633(E) Dated 13.09.199553.Fixed dose combination of Analgin with any other drug.GSR NO. 405 (E) Dated 03.06.199654.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)Dated1 3.09.199555.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 13.09.199556.Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception.GSR NO. 499 (E) Dated 14.08.199857.FenfluramineGSR NO. 499 (E) Dated 14.08.199858.Dexfenfluramine.GSR NO. 499 (E) Dated 14.08.199859.Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride.GSR NO. 169 (E) Dated 12.03.200160.Cosmetics Licensed as toothpaste/tooth powder containing tobacco.GSR NO. 444 (E) Dated 30.04.199261.Parenteal Preparations fixed combination of streptomycin with PencillinGSR NO. 93 (E) Dated 25.02.199762.Fixed dose combination of Vitamin B1 Vitamin B6 and Vitamin B12 for human useGSR NO. 702 (E) Dated 14.10.199963.Fixed dose combination of haemoglobin in any form (natural or synthetic).GSR NO. 814 (E) Dated 16.12.199964.Fixed dose combination of Pancreatin or Pancrelipase containing amylase, protease and lipase with any other enzyme.GSR NO. 814 (E) Dated 16.12.199965.Fixed dose combination of Nitrofurantoin and trimethoprim.GSR NO. 170 (E) Dated 12.03.2001
66.Fixed dose combination of Phenobarbitone with any anti- asthmatic drugs.GSR NO. 170(E)Dated 12.03.200167.Fixed dose combination of Phenobarbitone with Hyoscin and/or HyoscyamineGSR NO. 170(E)Dated 12.03.200168.Fixed dose combination of Phenobarbitone with Ergotamine and/or BelladonaGSR NO. 170(E)Dated 12.03.200169.Fixed dose combination of Haloperidol with any anti- cholinergic agent including Propantheline Bromide.GSR NO. 170(E)Dated 12.03.200170.Fixed dose combination of Nalidixic Acid with any anti-amoebic including Metronidazole.GSR NO. 170(E)Dated 12.03.200171.Fixed dose combination of Loperamide Hydrochloride with FurazolidoneGSR NO. 170(E)Dated 12.03.200172.Fixed dose combination of Cyproheptadine with Lysine or Peptone.GSR NO. 170(E)Dated 12.03.200173.AstemizoleGSR NO. 191(E)Dated0 5.03.200374.TerfinadineGSR NO. 191(E)Dated 05.03.200375.PhenforminGSR NO. 780 (E) Dated 01.10.200376.Rofecoxib and its formulationsGSR NO. 810(E)Dated 13.12.200477.Valdecoxib and its formulationsGSR NO. 510(E)Dated 28.07.200578.Diclofenac and its formulations (for animal use)GSR NO. 499(E)Dated 04.07.200879.Rimonabant.GSRNO.884 (E) Dated 11.12.200980.RosiglitazoneGSR NO. 910 (E) Dated 12.11.201081.Nimesulide formulations for human use in children below 12years of age.GSR NO. 82 (E) Dated 10.02.201182.Cisapride and its formulations for human use.GSR NO. 82 (E) Dated 10.02.201183. 1#Phenypropanol amine and its formulations for human use.GSR NO. 82 (E) Dated 10.02.2011
84.Human Placental Extract and its formulations for human use except its Topical application for wound healing, andInjection for pelvic inflammatory disease.Substituted vide GSR NO. 418 (E)Dated 30.05.2011
85.Sibutramine and its formulations for human use.GSR NO. 82(E) Dated 10.02.201186.R-Sibutramine and its formulations for human use.GSR NO. 82(E) Dated 10.02.201187.“Gatifloxacin formulation for systemic use in human by any route including oral and injectable”.GSR NO. 218(E) Dated 16.03.201188.Tegaserod and its formulationsGSR NO. 218(E) Dated 16.03.201189.Letrozole for induction of ovulation in anovulatory infertility.GSR NO. 752(E) Dated 12.10.201190.Serodiagnostic test kits for diagnosis of tuberculosisGSR 432 (E) Dated 07.06.2012 & GSR 433 (E) Dated 07.06.201291. 2#Dextropropoxyphene and formulations containing Dextropropoxyphene for human useG.S.R.332 (E) dated 23.5.201392.Pioglitazone and all formulations containing Pioglitazone for human useInitial suspension vide G.S.R.No. 379 (E) dt 18- 6-201393.Fixed dose combination of Flupenthixol +Melitracen for human useG.S.R.377 (E) dated 18.6.2013 and 498 (E) Dated 11.07.201494.Analgin and all formulations containing analgin for human useInitial Suspension vide G.S.R. No 378 (E) dated 18.6.2013 Was revoked allowing the use of drug with certain condition vide G.S.R. No.86 (E) dated 13.2.2014 Was revoked allowing the use of drug with certain condition vide for internal use except for preparations meant for meter dose inhalers and dry powder inhalers.Substituted vide GSR NO. 255(E) Dated 07.04.2021
1# Presently stayed by the Hon’ble High Court of Madras.
2# Prohibition was revoked with following conditions vide G.S.R. No. 367 (E) dated 13.04.2017: -
- The manufacturer shall indicate in a conspicuous manner on the package-inserts and promotional literature of the dextropropoxyphene and its formulations: -- “Use of drug for cancer pain only”, and
- “Daily administered dose shall not exceed 300mg. per day”.
- The container of the medicine containing dextropropoxyphene shall be labeled with the following words: -- Use of drug for cancer pain only”, and
- “Daily administered dose shall not exceed 300 mg per day”
- The manufacturer shall advise the registered medical practitioners to administer or prescribe the said drug and its formulations for use in patients with cancer pain only.
3# As per Hon'ble Supreme Court order dated 15.12.2017, the list of 15 FDCs were claimed prior to 1988. The matter is still under examination in consultation with Expert Committee.
4# As per Hon'ble Supreme Court order dated 14.02.2019, the list of 04 FDCs were claimed prior to 1988. The matter is still under examination in consultation with Expert Committee.
5# The notification of S.O. No. 705 (E) dated 10.03.2016 was quashed by Hon’ble Delhi High Court vide its order dated 13.03.2019. The CDSCO has filed an appeal against the order dated March 13, 2019, and the matter is sub judice.
The Notification of S.O. No. 760 (E) dated 10.03.2016 was quashed by Hon’ble Delhi High Court vide its order dated 18.02.2019 The CDSCO has filed an appeal against the order dated 18.02.2019 and the matter is sub judice.
The Notification of S.O. No. 806 (E) dated 10.03.2016 & S.O. No. 807 (E) dated 10.03.2016 were quashed by Hon’ble Delhi High Court vide its order dated 13.02.2019. The CDSCO has filed an appeal against the order dated 13.03.2019 and the matter is sub judice.
The Notification of S.O. No. 814 (E) dated 10.03.2016 was quashed by Hon’ble Delhi High Court vide its order dated 22.02.2019. The CDSCO has filed an appeal against the order dated 22.02.2019 and the matter is sub judice.
The notification of S.O. No. 1855 (E) dated 08.06.2017 pertaining to FDC of S(+) Etodolac + Paracetamol was quashed by the Hon’ble Delhi High Court vide its order dated 22.01.2020.
Note: The above list of prohibited drugs is prepared as per the records available with this office.
If discrepancy is observed, the same may be brought to the notice of this office along with documentary evidence for necessary action.
Drug dosage
Drug Dosage and Administration
Storage conditions of drugs
Good storage practice of medicines at Medical Store
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