Ban order
Single-molecule and early bans, 1983 to 2012
Last checked 20 September 2026. Parsed from the CDSCO notification PDF; status per CDSCO footnotes
Amidopyrine, phenacetin, cisapride, astemizole, terfenadine, rosiglitazone, gatifloxacin and other Section 26A bans from CDSCO’s consolidated list.95 entries are listed below with their notification number, date and current status.
| Drug / combination | Action | Notification | Date | Status note |
|---|---|---|---|---|
| Flupenthixol + Melitracen for Human UseFixed-dose combination · other | Banned | GSR 377(E)under verification | 18 June 2013 | Prohibited vide GSR 377(E) 18.06.2013 and GSR 498(E) 11.07.2014. Karnataka HC litigation; CDSCO public notice 13.02.2019 re-examined safety/efficacy, court status, being verified |
| Analgin and All Formulations containing Analgin for Human UseSingle molecule · painkillers | Ban revoked | GSR 378(E) | 18 June 2013 | Suspension vide GSR 378(E) 18.06.2013 revoked vide GSR 86(E) dated 13.02.2014, allowing use with conditions (label restriction). Analgin FDCs banned in the 1990s remain prohibited. |
| Pioglitazone and All Formulations containing Pioglitazone for Human UseSingle molecule · diabetes | Ban revoked | GSR 379(E) | 18 June 2013 | Suspension vide GSR 379(E) 18.06.2013 revoked vide GSR 520(E) dated 31.07.2013, allowing use with conditions (boxed warning; not first-line therapy). |
| Dextropropoxyphene and Formulations containing Dextropropoxyphene for Human UseSingle molecule · painkillers | Restricted | GSR 332(E) | 23 May 2013 | Prohibition revoked with conditions vide G.S.R. 367(E) dated 13.04.2017: cancer pain only, daily dose not to exceed 300 mg, mandatory labelling (CDSCO consumer list footnote **). |
| Serodiagnostic Test Kits for Diagnosis of TuberculosisSingle molecule · antibiotics | Banned | GSR 432(E) & GSR 433(E) | 7 June 2012 | In force per CDSCO consumer list (1983-2017) |
| Letrozole for Induction of Ovulation in Anovulatory InfertilitySingle molecule · other | Banned | GSR 752(E) | 12 October 2011 | In force per CDSCO consumer list (1983-2017) |
| Human Placental Extract and its Formulations for Human Use except its 1. Topical Application for Wound Healing, and 2. Injection for Pelvic Inflammatory DiseaseSingle molecule · skin | Banned | GSR 418(E) | 30 May 2011 | Entry text as substituted vide GSR 418(E) dated 2011-05-30; original 1983/1988 notification superseded. |
| Gatifloxacin Formulation for Systemic Use in Human by any Route Including Oral and InjectableSingle molecule · antibiotics | Banned | GSR 218(E) | 16 March 2011 | In force per CDSCO consumer list (1983-2017) |
| Tegaserod and its FormulationsSingle molecule · gi | Banned | GSR 218(E) | 16 March 2011 | In force per CDSCO consumer list (1983-2017) |
| Nimesulide Formulations for Human Use in Children Below 12 Years of AgeSingle molecule · painkillers | Banned | GSR 82(E) | 10 February 2011 | In force per CDSCO consumer list (1983-2017) |
| Cisapride and its Formulations for Human UseSingle molecule · gi | Banned | GSR 82(E) | 10 February 2011 | In force per CDSCO consumer list (1983-2017) |
| Phenylpropanolamine and its Formulations for Human UseSingle molecule · cough-cold | Stayed | GSR 82(E) | 10 February 2011 | Presently stayed by the Hon'ble High Court of Madras (CDSCO consumer list footnote *). |
| Sibutramine and its Formulations for Human UseSingle molecule · other | Banned | GSR 82(E) | 10 February 2011 | In force per CDSCO consumer list (1983-2017) |
| R-Sibutramine and its Formulations for Human UseSingle molecule · other | Banned | GSR 82(E) | 10 February 2011 | In force per CDSCO consumer list (1983-2017) |
| RosiglitazoneSingle molecule · diabetes | Banned | GSR 910(E) | 12 November 2010 | In force per CDSCO consumer list (1983-2017) |
| RimonabantSingle molecule · other | Banned | GSR 884(E) | 11 December 2009 | In force per CDSCO consumer list (1983-2017) |
| Corticosteroids with any other Drug for Internal Use except for Preparations Meant for Meter Dose Inhalers and Dry Powder InhalersFixed-dose combination · other | Banned | GSR 738(E) | 9 October 2009 | Entry text as substituted vide GSR 738(E) dated 2009-10-09; original 1983/1988 notification superseded. |
| Diclofenac and its Formulations (for Animal Use)Single molecule · painkillers | Banned | GSR 499(E) | 4 July 2008 | In force per CDSCO consumer list (1983-2017) |
| Salbutamol or any other Bronchodilator with Centrally Acting Anti-Tussive And/or AntihistamineFixed-dose combination · cough-cold | Banned | GSR 290(E) | 16 April 2008 | Entry text as substituted vide GSR 290(E) dated 2008-04-16; original 1983/1988 notification superseded. |
| Valdecoxib and its FormulationsSingle molecule · painkillers | Banned | GSR 510(E) | 28 July 2005 | In force per CDSCO consumer list (1983-2017) |
| Rofecoxib and its FormulationsSingle molecule · painkillers | Banned | GSR 810(E) | 13 December 2004 | In force per CDSCO consumer list (1983-2017) |
| PhenforminSingle molecule · diabetes | Banned | GSR 780(E) | 1 October 2003 | In force per CDSCO consumer list (1983-2017) |
| AstemizoleSingle molecule · cough-cold | Banned | GSR 191(E) | 5 March 2003 | In force per CDSCO consumer list (1983-2017) |
| TerfenadineSingle molecule · cough-cold | Banned | GSR 191(E) | 5 March 2003 | In force per CDSCO consumer list (1983-2017) |
| 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 Pyrazinamide1000mg 1500 mgFixed-dose combination · antibiotics | Banned | GSR 100(E) | 11 February 2003 | Entry text as substituted vide GSR 100(E) dated 2003-02-11; original 1983/1988 notification superseded. |
| Metoclopramide with Systemically Absorbed Drugs except Fixed Dose Combination of Metoclopramide with Aspirin/paracetamolFixed-dose combination · painkillers | Banned | GSR 603(E) | 24 August 2001 | Entry text as substituted vide GSR 603(E) dated 2001-08-24; original 1983/1988 notification superseded. |
| Diazepam and Diphenhydramine HydrochlorideFixed-dose combination · cough-cold | Banned | GSR 169(E) | 12 March 2001 | In force per CDSCO consumer list (1983-2017) |
| Nitrofurantoin and TrimethoprimFixed-dose combination · antibiotics | Banned | GSR 170(E) | 12 March 2001 | In force per CDSCO consumer list (1983-2017) |
| Phenobarbitone with any Anti-Asthmatic DrugsFixed-dose combination · other | Banned | GSR 170(E) | 12 March 2001 | In force per CDSCO consumer list (1983-2017) |
| Phenobarbitone with Hyoscin And/or HyoscyamineFixed-dose combination · gi | Banned | GSR 170(E) | 12 March 2001 | In force per CDSCO consumer list (1983-2017) |
| Phenobarbitone with Ergotamine And/or BelladonnaFixed-dose combination · painkillers | Banned | GSR 170(E) | 12 March 2001 | In force per CDSCO consumer list (1983-2017) |
| Haloperidol with any Anti-Cholinergic Agent Including Propantheline BromideFixed-dose combination · gi | Banned | GSR 170(E) | 12 March 2001 | In force per CDSCO consumer list (1983-2017) |
| Nalidixic Acid with any Anti-Amoebic Including MetronidazoleFixed-dose combination · antibiotics | Banned | GSR 170(E) | 12 March 2001 | In force per CDSCO consumer list (1983-2017) |
| Loperamide Hydrochloride with FurazolidoneFixed-dose combination · antibiotics | Banned | GSR 170(E) | 12 March 2001 | In force per CDSCO consumer list (1983-2017) |
| Cyproheptadine with Lysine or PeptoneFixed-dose combination · other | Banned | GSR 170(E) | 12 March 2001 | In force per CDSCO consumer list (1983-2017) |
| Haemoglobin in any Form (Natural or Synthetic)Fixed-dose combination · other | Banned | GSR 814(E) | 16 December 1999 | In force per CDSCO consumer list (1983-2017) |
| Pancreatin or Pancrelipase containing Amylase, Protease and Lipase with any other EnzymeFixed-dose combination · gi | Banned | GSR 814(E) | 16 December 1999 | In force per CDSCO consumer list (1983-2017) |
| Vitamin B1Vitamin B6 and Vitamin B12 for Human UseFixed-dose combination · vitamins | Banned | GSR 702(E) | 14 October 1999 | In force per CDSCO consumer list (1983-2017) |
| Centrally Acting, Antitussive with Antihistamine, Having High Atropine Like Activity in ExpectorantsFixed-dose combination · cough-cold | Banned | GSR 395(E) | 19 May 1999 | In force per CDSCO consumer list (1983-2017) |
| Preparations Claiming to Combat Cough Associated with Asthma containing Centrally Acting Antitussive And/ or an AntihistamineFixed-dose combination · cough-cold | Banned | GSR 395(E) | 19 May 1999 | In force per CDSCO consumer list (1983-2017) |
| Liquid Oral Tonic Preparations containing Glycerophosphates And/or other Phosphates and / or Central Nervous System Stimulant and Such Preparations containing Alcohol More than 20% ProofSingle molecule · vitamins | Banned | GSR 395(E) | 19 May 1999 | In force per CDSCO consumer list (1983-2017) |
| 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 AbsorbedFixed-dose combination · gi | Banned | GSR 395(E) | 19 May 1999 | In force per CDSCO consumer list (1983-2017) |
| Mepacrine Hydrochloride (Quinacrine and its Salts) in any Dosage Form for Use for Female Sterilization or ContraceptionSingle molecule · other | Banned | GSR 499(E) | 14 August 1998 | In force per CDSCO consumer list (1983-2017) |
| FenfluramineSingle molecule · other | Banned | GSR 499(E) | 14 August 1998 | In force per CDSCO consumer list (1983-2017) |
| DexfenfluramineSingle molecule · other | Banned | GSR 499(E) | 14 August 1998 | In force per CDSCO consumer list (1983-2017) |
| Parenteal Preparations Fixed Combination of Streptomycin with PencillinFixed-dose combination · antibiotics | Banned | GSR 93(E) | 25 February 1997 | In force per CDSCO consumer list (1983-2017) |
| Analgin with any other DrugFixed-dose combination · painkillers | Banned | GSR 405(E) | 3 June 1996 | In force per CDSCO consumer list (1983-2017) |
| Hydroxyquinoline Group of Drugs with any other Drug except for Preparations Meant for External UseFixed-dose combination · other | Banned | GSR 793(E) | 13 December 1995 | Entry text as substituted vide GSR 793(E) dated 1995-12-13; original 1983/1988 notification superseded. |
| Oxyphenbutazone or Phenylbutazone with any other DrugFixed-dose combination · painkillers | Banned | GSR 633(E) | 13 September 1995 | In force per CDSCO consumer list (1983-2017) |
| Dextropropoxyphene with any other Drug other than Anti-Spasmodics And/or Non-Steriodal Anti-Inflammatory Drugs (Nsaids)Fixed-dose combination · painkillers | Banned | GSR 633(E) | 13 September 1995 | In force per CDSCO consumer list (1983-2017) |
| A Drug, Standards of Which Are Prescribed in the Second Schedule to the Said Act with an Ayurvedic, Siddha or Unani DrugFixed-dose combination · other | Banned | GSR 633(E) | 13 September 1995 | In force per CDSCO consumer list (1983-2017) |
| 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 AgentFixed-dose combination · other | Banned | GSR 57(E) | 7 February 1995 | In force per CDSCO consumer list (1983-2017) |
| Antidiarrhoeal Formulations containing Kaolin or Pectin or Attapulgite or Activated CharcoalSingle molecule · gi | Banned | GSR 731(E) | 30 September 1994 | In force per CDSCO consumer list (1983-2017) |
| Antidiarrhoeal Formulations containing Phthalylsulphathiazole or Sulphaguanidine or SuccinylsulphathiazoleSingle molecule · gi | Banned | GSR 731(E) | 30 September 1994 | In force per CDSCO consumer list (1983-2017) |
| Antidiarrhoeal Formulations containing Neomycin or Streptomycin or Dihydrostreptomycin Including Their Respective Salts or EstersSingle molecule · antibiotics | Banned | GSR 731(E) | 30 September 1994 | In force per CDSCO consumer list (1983-2017) |
| Liquid Oral Antidiarrhoeals or any other Dosage Form for Pediatric Use containing Diphenoxylatelorloperamide or Atropine or Belladonna Including Their Salts or Esters or Metaboliteshyoscyamine or Their Extracts or Their AlkaloidsSingle molecule · gi | Banned | GSR 731(E) | 30 September 1994 | In force per CDSCO consumer list (1983-2017) |
| Liquid Oral Antidiarrhoeals or any other Dosage Form for Pediatric Use containing Halogenated HydroxyquinolinesSingle molecule · gi | Banned | GSR 731(E) | 30 September 1994 | In force per CDSCO consumer list (1983-2017) |
| Antidiarrhoeals with ElectrolytesFixed-dose combination · gi | Banned | GSR 731(E) | 30 September 1994 | In force per CDSCO consumer list (1983-2017) |
| Dovers Powder I.pSingle molecule · other | Banned | GSR 612(E) | 9 August 1994 | In force per CDSCO consumer list (1983-2017) |
| Dover's Powder Tablets I.pSingle molecule · other | Banned | GSR 612(E) | 9 August 1994 | In force per CDSCO consumer list (1983-2017) |
| Cosmetics Licensed as Toothpaste/tooth Powder containing TobaccoSingle molecule · other | Banned | GSR 444(E) | 30 April 1992 | In force per CDSCO consumer list (1983-2017) |
| Crude Ergot Preparations except Those containing Ergotamine, Caffeine, Analgesics, Antihistamines for the Treatment of Migraine, HeadachesFixed-dose combination · painkillers | Banned | GSR 304(E) | 7 June 1991 | Entry text as substituted vide GSR 304(E) dated 1991-06-07; original 1983/1988 notification superseded. |
| Chloral Hydrate as a DrugSingle molecule · other | Banned | GSR 304(E) | 7 June 1991 | In force per CDSCO consumer list (1983-2017) |
| Ethambutol with INH other than the Following: INH Ethambutol 200 Mg. 600 Mg. 300 Mg. 800 mgFixed-dose combination · other | Banned | GSR 69(E) | 11 February 1991 | In force per CDSCO consumer list (1983-2017) |
| Fixed Dose Combination containing More than One AntihistamineFixed-dose combination · cough-cold | Banned | GSR 69(E) | 11 February 1991 | In force per CDSCO consumer list (1983-2017) |
| Any Anthelmintic with Cathartic/purgative except for Piperazine/santonimFixed-dose combination · other | Banned | GSR 69(E) | 11 February 1991 | In force per CDSCO consumer list (1983-2017) |
| Laxatives And/or Anti-Spasmodic Drugs in Enzyme PreparationsFixed-dose combination · other | Banned | GSR 69(E) | 11 February 1991 | In force per CDSCO consumer list (1983-2017) |
| Sedatives/ Hypnotics/anxiolytics with Analgesics-AntipyreticsFixed-dose combination · painkillers | Banned | GSR 999(E) | 26 December 1990 | In force per CDSCO consumer list (1983-2017) |
| Histamine H-2 Receptor Antagonists with Antacids except for Those Combinations Approved by Drugs Controller, IndiaFixed-dose combination · gi | Banned | GSR 999(E) | 26 December 1990 | In force per CDSCO consumer list (1983-2017) |
| 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 PharmacopoeiaFixed-dose combination · other | Banned | GSR 999(E) | 26 December 1990 | In force per CDSCO consumer list (1983-2017) |
| All Pharmaceutical Preparations containing Chloroform Exceeding 0.5% w/w or V/v Whichever Is AppropriateSingle molecule · cough-cold | Banned | GSR 999(E) | 26 December 1990 | In force per CDSCO consumer list (1983-2017) |
| Oestrogen and Progestin (other than Oral Contraceptive) containing per Tablet Estrogen Content of More than 50 mcg (Equivalent to Ethinylestradiol) and Content of More than 3 Mg(equivalent to Norethisterone Acetate) and All Fixed Dose Combination Injectable Preparations containing Synthetic Oestrogen AndprogesteroneFixed-dose combination · other | Banned | GSR 743(E) | 10 August 1989 | Entry text as substituted vide GSR 743(E) dated 1989-08-10; original 1983/1988 notification superseded. |
| Chloramphenicol with any other Drug for Internal UseFixed-dose combination · antibiotics | Banned | GSR 1057(E) | 3 November 1988 | Entry text as substituted vide GSR 1057(E) dated 1988-11-03; original 1983/1988 notification superseded. |
| Anabolic Steroids with other DrugsFixed-dose combination · other | Banned | GSR 863(E) | 22 November 1985 | In force per CDSCO consumer list (1983-2017) |
| Oxytetracycline Liquid Oral PreparationsSingle molecule · antibiotics | Banned | GSR 322(E) | 3 May 1984 | In force per CDSCO consumer list (1983-2017) |
| Demeclocycline Liquid Oral PreparationsSingle molecule · antibiotics | Banned | GSR 322(E) | 3 May 1984 | In force per CDSCO consumer list (1983-2017) |
| MethaqualoneSingle molecule · other | Banned | GSR 49(E) | 31 January 1984 | In force per CDSCO consumer list (1983-2017) |
| AmidopyrineSingle molecule · painkillers | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
| Vitamins with Anti-Inflammatory Agents and TranquilizersFixed-dose combination · vitamins | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
| Atropine in Analgesics and AntipyreticsFixed-dose combination · painkillers | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
| Strychnine and Caffeine in TonicsFixed-dose combination · vitamins | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
| Yohimbine and Strychnine with Testosterone and VitaminsFixed-dose combination · vitamins | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
| Iron with Strychnine, Arsenic and YohimbineFixed-dose combination · vitamins | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
| Sodium Bromide/chloral Hydrate with other DrugsFixed-dose combination · other | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
| PhenacetinSingle molecule · painkillers | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
| Antihistaminic with Anti-DiarrhoealsFixed-dose combination · gi | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
| Penicillin with SulphonamidesFixed-dose combination · antibiotics | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
| Vitamins with AnalgesicsFixed-dose combination · painkillers | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
| Any other Tetracycline with Vitamin CFixed-dose combination · antibiotics | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
| Vitamins with Anti TB Drugs except Combination of Isoniazid with Pyridoxine Hydrochloride (Vitamin B6)Fixed-dose combination · antibiotics | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
| Penicillin Skin/eye OintmentSingle molecule · eye | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
| Tetracycline Liquid Oral PreparationsSingle molecule · antibiotics | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
| NialamideSingle molecule · other | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
| PractololSingle molecule · cardiac | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
| Methapyrilene, its SaltsSingle molecule · cough-cold | Banned | GSR 578(E) | 23 July 1983 | In force per CDSCO consumer list (1983-2017) |
Official sources and primary records
- Gazette
- Regulator
- Primary notification for this waveGazettecdsco.gov.in