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DRUGS

List of Banned Drugs
The Central Government, Ministry of Health and Family Welfare, Government of India has prohibited the Manufacturer, Sale and Distribution of the following Drugs

1. Amidopyrin.

2. Fixed dose combinations of Vitamins with anti-inflammatory agents and tranquilizers.

3. Fixed dose combinations of atropine in Analgesics and anti-pyretics.

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 anti-histaminic 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 Hydroxyquinoline group of drugs except 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 except those containing Ergotamine, caffeine, analgesics, antihistamines for the treatment of Migraine headaches.

17. Fixed dose combinations of Fixed dose combinations of Vitamins with Anti-T.B. Drugs except combination of Isoniazid with Pyridoxin Hydrochloride (Vitamin B6.)

18. Penicillin skin/eye ointment

19. Tetracycline liquid oral preparations.

20. Nialamide.

21. Practolol.

22. Methapyrilene, its salts.

23. Methaqulone.

24. Oxytetracycline Liquid Oral Preparations.

25. Democlocycline Liquid Oral Preparations.

26. Combinations of Anabolic steroids with other drugs.

27. Fixed dose combination of Oestrogen and Progestin(other than oral contraceptives) containing per tablet Oestrogen content of more than 50 mcg.(equivalent to Ethenyl Estradiol) and progestin content of more than 3mg (equivalent to Norethysterone Acetate and all fixed dose combination injectable preparations containing synthetic Oestrogen and progesterone.

28. Fixed dose combination of Sedatives/hypnotics/anxiolytics with analgesic –antipyretics.

29. Fixed dose combination of Pyrazinamide with other anti tubercular drugs except combination of Pyrazinamide with Rifampicin and INH as per recommended daily dose given below: -
                           Minimum   Maximum.
Rifampicin         450 mg   600 mg
INH                    300 mg   300 mg
Pyrazinamide  1000 mg   1500 mg.

30. Fixed dose combination of histamine H2 – receptor antagonists with antacids except those combinations approved by the Drugs Controller, India.

31. The patent and proprietary medicines of fixed dose combinations of essential oils with alcohol having a percentage higher than 20% proof except preparations given in the Indian Pharmacopoeia.

32. All Pharmaceutical preparations containing Chloroform exceeding 0.5% w/w or 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 anthelmintic with cathetric/ purgative except for piperazine.

36. Fixed dose combination of salbutamol or any other bronchodilator with centrally acting anti-tussive and/or antihistaminic.

37. Fixed dose combination of laxatives and/or anti-spasmodic drugs in enzyme preparations.

38. Fixed dose combination of Metaclopromide with other drugs except for preparations containing Metaclopromide and aspirin/ paracetamol.

39. Fixed dose combination of centrally acting anti-tussive with antihistamine having high atropine like activity in expectorants.

40. Preparations claiming to combat cough associated with asthma containing centrally acting anti-tussive and/or other antihistamine.

41. Liquid oral tonic preparations containing and/or otherphosphates 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. Dover’s Powder I.P.

45. Dover’s Powder Tablets I.P.

46. Anti diarrhoeal formulations containing Kaolin or Pectin or Attapulgite or activated charcoal.

47. Anti diarrhoeal formulations containing Phthalyl sulphathiazole or Sulphaguanidine or Succinyl Sulphathiazole.

48. Anti diarrhoeal formulations Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts and esters.

49. Liquid oral anti-diarrhoeals or any other dosage form for paediatric use containing Diphenoxylate or Loparamide or Atropine or Belladonna including their salts or esters or metabolites Hyoscyamine or their extracts or their alkaloids.

50. Liquid oral anti-diarrhoeals or any other dosage form for paediatric use containing halogenated hydroxyquinolines.

51. Fixed dose combination or anti-diarrhoeals with electrolytes.

52. 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 liter shall contain: -
      Sodium – 50 to 90 millimoles.
      Total osmolarity – not more than 290 millimoles.
      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 liter shall contain: -
      Sodium – 50 to 90 millimoles.
      Total osmolarity – not more than 290 millimoles.
     Precooked rice - equivalent to not less than 50 gms. And not more than 80 gms. As total replacement of dextrose.
  (c) Patent and Proprietary Oral Rehydration Salts (ORS) may contain aminoacids in addition to Oral Rehydration Salts conforming to the parameters specified above and labeled with the indication " For Adult Choletric Diarrhoea only."
  (d) 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.[ The words ‘other than anti-spasmodics’ omitted by G.O.I. notification no. 405(E) dt.03.06.1999.]

55. Fixed dose combination Dextropropoxyphene with any other drug other than anti-spasmodics and/or non-steroidal anti-inflammatory drugs (NSAIDS).

56. Fixed dose combination of a drug, standards of which are specified 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 combinations of diazepam and Diphenhydramine Hydrochloride.

60. Parenteral Preparations containing Fixed dose combination of Streptomycin with Penicillin’s.

61. Fixed dose combination of Vitamin B1 B6 and B12 for Human Use.

62. Fixed dose combination of Hemoglobin in any form (Natural or Synthetic).

63. Fixed dose combination of Pancreatin or Pancrelipase containing amylase, protease and lipase with any other enzyme.

64. Fixed dose combinations of Nitrofurantoin and Trimethoprim.

65. Fixed dose combination of Phenobarbitone with any anti histaminic drugs.

66. Fixed dose combination of Phenobarbitone with Hyoscin and/or Hyoscyamine.

67. Fixed dose combination of Phenobarbitone with Ergotamine and/or Belladonna.

68. Fixed dose combination of Haloperidol with any anti cholinergic agent including Propentheline Bromide.

69. Fixed dose combination of Nalidixic acid with any anti-ameobics including Metronidazole.

70. Fixed dose combination of Loparamide Hydrochloride with Furazolidne.

71. Fixed dose combination of Cyproheptadine with lysine or Peptone.

72. Astemizole for Human Use.

73. Terfinadine for Human Use.

74. Phenoformin for Human Use.

75. Rofecoxib and its formulation for Human Use.

76. Valdecoxib and its formulation for Human Use.

77. Dicleofenac and its formulation for Vetinary use.

78. Artemisine or its derivatives like Artesunates, Artemther or Combination containing any of the items.

79. Nimesulide formulations for Human Use in children below 12 years of age.

80. Cisapride and its formulations for Human Use.

81. Phenypropanolamine and its formulations for Human Use.

82. Human Placental Extract and its formulations for Human Use Except:-
     a) Its Topical Application for wound Healing and
     b) Injections for pelvic inflammatory disease.

83. Sibutramine and its formulations for Human Use.

84. R- Sibutramine and its formulations for Human Use.

85. Rosiglitazone and its formulations for Human Use.


The prohibition of the above said drugs/formulations has been effected due to the reason that the use of these drugs is likely to involve risk to Human Beings or the said drugs do not have therapeutic valve claim or purported to claimed for them or contain ingredients and in such quantity for which there is no therapeutic justification