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Banned Drugs

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Banned Drugs

Drugs Formulation Effective Notification
Analgin and all formulations containing Analgin for human use. With immediate effect GSR 378(E) dt: 18-06-2013
Fixed dose combination of Flupenthixol + Malitrecin fir human use With immediate effect GSR 377(E) dt: 18-06-2013
Pioglitazoneand all formulations containingPioglitazonefor human use. With immediate effect GSR 379(E) dt: 18-06-2013
Dextyropropoxyphene and formulations containing Dextyropropoxyphene for human use. With immediate effect GSR 332(E) dt: 23-05-2013



  1. Amidopyrine.
  2. Fixed dose combinations of vitamins with anti-inflammatory agents and tranquilizers.
  3. Fixed dose combinations of Atropine in Analgesics 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 any other Tetracycline with Vitamin C.
  13. Fixed dose combinations of Hydroxyquinoline group of drugs with any other drug except for preparations meant for external use.
  14. Fixed dose combinations of Corticosteroids with any other drug for internal use.
  15. Fixed dose combinations of Chloramphenicol with any other drug for internal use.
  16. Fixed dose combinations of crude Ergot preparations except those containing Ergotamine, Caffeine, analgesics, antihistamines for the treatment of migraine, headaches.
  17. Fixed dose combinations of Vitamins with Anti TB drugs except combination of Isoniazid with Pyridoxine Hydrochloride (Vitamin B6).
  18. Penicillin skin/eye Ointment.
  19. Tetracycline Liquid Oral preparations.
  20. Nialamide.
  21. Practolol.
  22. Methapyrilene, its salts.
  23. Methaqualone.
  24. Oxytetracycline Liquid Oral preparations.
  25. Demeclocycline Liquid Oral preparations.
  26. Combination of anabolic Steroids with other drugs.
  27. 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 progestin content of more than 3 mg (equivalent to Norethisterone Acetate) and all fixed dose combination injectable preparations containing synthetic Oestrogen and Progesterone. (Subs. By Noti. No. 743 (E) dt 10-08-1989).
  28. Fixed dose combination of Sedatives/ hypnotics/anxiolytics with analgesics-antipyretics.
  29. 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 1000mg 1500 mg
  30. Fixed dose combination of Histamine H-2 receptor antagonists with antacids except for those combinations approved by Drugs Controller, India.
  31. 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.
  32. All Pharmaceutical preparations containing Chloroform exceeding 0.5% w/w or v/v whichever is appropriate.
  33. Fixed dose combination of Ethambutol with INH other than the following: INH
    Ethambutol 200 mg. 600 mg. 300 mg. 800 mg.
  34. Fixed dose combination containing more than one antihistamine.
  35. Fixed dose combination of any anthelmintic with cathartic/purgative except for piperazine/ Santonin.
  36. Fixed dose combination of Salbutamol or any other drug having primarily bronchodilatory activity with centrally acting anti-tussive and/or antihistamine.
  37. Fixed dose combination of laxatives and/or anti-spasmodic drugs in enzyme preparations.
  38. Fixed dose combination of Metoclopramide with systemically absorbed drugs except fixed dose combination of metoclopramide with aspirin/paracetamol.
  39. Fixed dose combination of centrally acting, antitussive with antihistamine, having high atropine like activity in expectorants.
  40. Preparations claiming to combat cough associated with asthma containing centrally acting antitussive and/ or an antihistamine.
  41. 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.
  42. 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.
  43. Chloral Hydrate as a drug.
  44. Dovers Powder I.P.
  45. Dover’s Powder Tablets I.P.
  46. Antidiarrhoeal formulations containing Kaolin or Pectin or Attapulgite or Activated Charcoal.
  47. Antidiarrhoeal formulations containing Phthalyl Sulphathiazole or Sulphaguanidine or Succinyl Sulphathiazole.
  48. Antidiarrhoeal formulations containing Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts or esters.
  49. Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing Diphenoxylate Loperamide or Atropine or Belladona including their salts or esters or metabolites Hyoscyamine or their extracts or their alkaloids.
  50. Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing halogenated hydroxyquinolines.
  51. Fixed dose combination of antidiarrhoeals with electrolytes.
  52. Patent and Proprietary Oral Rehydration Salts other than those conforming to the follwoing parameters:
    1. Patent and Proprietary Oral Rehydration Salts on reconstitution to one litre shall contain:-
      Sodium- 50 to 90 millimoles.
      Total osmolarity – 240-290 millimoles.
      Dextrose: Sodium molar ratio-Not less than 1 : 1 and not more than 3 : 1.
    2. Patent and Proprietary cereal based Oral Rehydration Salts on reconstitution to one litre shall contain:-
      Sodium-50 to 90 millimoles.
      Total osmolarity-Not more than 290 milliosmoles.
      Precooked rice-Equivalent to not less than 50 gms and not more than 80 gms as total replacement of Dextrose.
    3. Patent and Proprietary Oral Rehydration Salts (ORS) may contain parameters specified above and labeled with the indication for “Adult Choleratic Diarrhoea only”.
    4. Patent and Proprietary Oral Rehydration Salts shall not contain Mono or Polysaccharides or saccharine sweetening agent.
  53. Fixed dose combination of Oxyphenbutazone or Phenylbutazone with any other drug.
  54. Fixed dose combination of Analgin with any other drug.
  55. Fixed dose combination of dextropropoxyphene with any other drug other than anti-spasmodic and/or non-steriodal anti-inflammatory drugs (NSAIDS).
  56. 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.
  57. Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception.
  58. Fenfluramine and Dexfenfluramine.
  59. Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride .
  60. Rimonabant.
  61. Rosiglitazone.
  62. Nimesulide formulations for human use in children below 12 years of age.
  63. Cisapride and its formulations for human use.
  64. Phenylpropanolamine and its formulation for human use.
  65. (*)Human Placental Extract and its formulations for human use.
  66. Sibutramine and its formulations for human use, and
  67. R-Sibutramine and its formulations for human use.
  68. Gatifloxacin formulations for systemic use in humans by any route including oral and injectable,
  69. Tegaserod and its formulations for human use.

*Prohibition revoked vide Gazette Notification GSR No. 418(E) dated 30 May 2011.


  1. Nialamide
  2. Practolol
  3. Amidopyrine
  4. Phenacetin
  5. Methapyrilene and its salts
  6. Methaqualone
  7. Chloral Hydrate as a drug
  8. Mepacrine Hydrochloride (Quinacrine and its Salts) in any dosage form for use for female sterilization or contraception.
  9. Fenfluramine and Dexfenfluramine
  10. Rimonabant


S. No. Drugs Formulation Effective date Notification
1. Cosmetics Licensed as toothpaste/tooth powder containing tobacco. With immediate effect GSR 444(E) dt.30.4.92
2. Parenteral Preparations fixed dose combination of streptomycin with Pencillin Jan 1,1998 GSR 93(E) dt.25.2.97
3. Fixed dose combination of Vitamin B1, Vitamin B6 and Vitamin B12 for human use Jan 1,2001 GSR 702(E) dt.14.10.99
4. Fixed dose combination of haemoglobin in any form (natural or synthetic). Sep 1,2000 GSR 814(E) dt.16.12.99
5. Fixed dose combination of Pancreatin or Pancrelipase containing amylase, protease and lipase with any other enzyme. Sept. 1,2000 GSR 814(E) dt.16.12.99
6. Fixed dose combination of Nitrofurantoin and trimethoprim. Jan 1,2002 GSR 170(E) dt.12.3.01
7. Fixed dose combination of Phenobarbitone with any anti-asthmatic drugs. Jan 1,2002 GRS 170(E) dt.12.3.01
8. Fixed dose combination of Phenobarbitone with Hyoscin and/or Hyoscyamine Jan 1,2002 GSR 170(E) dt.12.3.01
9. Fixed dose combination of Phenobarbitone with Ergotamine and/or Belladona Jan 1,2002 GSR 170(E) dt.12.3.01
10. Fixed dose combination of Haloperidol with any anti-cholinergic agent including Propantheline Bromide. Jan 1,2002 GSR 170(E) dt.12.3.01
11. Fixed dose combination of Nalidixic Acid with any anti-amoebic including Metronidazole. Jan 1,2002 GSR 170(E) dt.12.3.01
12. Fixed dose combination of Loperamide Hydrochloride with Furazolidone Jan 1,2002 GSR 170(E) dt.12.3.01
13. Fixed dose combination of Cyproheptadine with Lysine or Peptone. Jan 1,2003 GSR 170(E) dt.12.3.01
14. Astemizole Apr.1,2003 GSR 191(E) dt.5.3.03
15. Terfinadine Apr.1,2003 GSR 191(E) dt.5.3.03
16. Fenformin Oct.1,2003 GSR 780(E) dt.1.10.03
17. Rofecoxib Dec 13,2004 GSR 810(E) dt. 13.12.04
18. Valdecoxiband it's formulation July 25,2005 GSR 510(E) dt. 25.07.05
19. Diclofenac and its formulations for animal use July 4, 2008 GSR 499(E) dt.4.07.08
20. Letrozole for induction of ovulation in anovulatory infertility Oct12, 2011 GSR 752(E) dt.12.10.11