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:
G.S.R. No. 578 (E) dt 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.
G.S.R. No. 793 (E) dt 13-12-1995
13. Fixed dose combinations of Hydroxyquinoline group of drugs with any other drug except for preparations meant for external use only.
G.S.R. No. 1057 (E) dt 03-11-1988
14. Fixed dose combinations of Corticosteroid with any other drug for internal use except for preparations meant for meter dose inhalers and dry powder inhalers.[Substituted vide GSR 738 (E) dated 9.10.2009]
15. Fixed dose combinations of Chloramphenicol with any other drug for internal use.
G.S.R. No. 304 (E) dt 07-06-1991
16. Fixed dose combinations of crude Ergot preparation except those containing Ergotamine, Caffeine, analgesics, antihistamines for the treatment of migraine, headache.
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. Practolo.
22. Methapyrilene, its salts.
G.S.R. No. 49 (E) dt 31-01-1984
23. Methaqualone.
G.S.R. No. 322 (E) dt 03-05-1984
24. Oxytetracycline Liquid Oral preparations.
25. Demeclocycline Liquid Oral preparations.
G.S.R. No. 863 (E) dt 22-11-1985
26. Combination of anabolic Steroids with other drugs.
27. 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. (Subs. By Noti. No. 743 (E) dt 10-08-1989)
G.S.R. No. 999 (E) dt 26-12-1990
28. Fixed dose combinations of Sedatives/ hypnotics/anxiolytics with analgesics-antipyretics.
29. Fixed dose combinations of Pyrazinamide, other anti-tubercular drugs except combination of Pyrazinamide with Rifampicin and INH per recommended daily dose given below:
Drugs Minimum Maximum
Rifampicin 450 mg 600 mg
INH 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.
G.S.R. No. 69 (E) dt 11-02-1991
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 cathartic/purgative except for piperazine.
36. Fixed dose combination of Salbutamol or any other bronchodilator 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
G.S.R. No. 395 (E) dt 19-05-1999
39. Fixed dose combination of centrally acting, antitussive with antihistamine, having 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 combination of Pectin and/or Kaolin with drugs not systemically absorbed.
G.S.R. No. 304 (E) dt 07-06-1991
43. Chloral Hydrate as a drug.
G.S.R. No. 612 (E) dt 09-08-1994
44. Dovers Powder I.P.
45. Dover's Powder Tablets I.P.
G.S.R. No. 731 (E) dt 30-09-1994
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 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.
G.S.R. No. 57 (E) dt 07-02-1995
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 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) dt 30-09-1995, GSR No. 123 (E) dt 11-03-1996 and GSR No. 230 (E) dt 04-06-1996
53. Fixed dose combination of Oxyphenbutazone or Phenylbutazone with any other drug.
G.S.R. No. 405 (E) dt 03-06-1996
54. Fixed dose combination of Analgin with any other drug.
Clarification: Fixed dose combination of Analgin with any other drug other than antispasmodics were banned by the Government of India vide G.S.R. No. 633(E), dated 13.09.1995. However, the Drug Action Forum contended before the Supreme Court that the preparations of Analgin and antispasmodics should also be banned. Dr. J.S. Bajaj, being directed by the court, submitted his report supporting these contentions.
On 17th Dec. 1996, a learned additional Solicitor submitted that the Central Government has decided that all State/U.T. Drug Licensing Authorities will be given directions by the Government under Section 33-P of the Drugs and Cosmetics Act, to suspend manufacturing licenses of all fixed dose formulations of Analgin including Analgin with Antispasmodics till further notice. Accordingly, the Government of India, under letter dated 17th Dec.1996, issued such directives. In view of the above directives, the manufacture, sale and distribution of fixed dose combinations of Analgin and antispasmodics is prohibited.
55. Fixed dose combination of dextropropoxyphene with any other drug other than anti-spasmodics 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.
G.S.R. No. 93 (E) dt 25-02-1997
57. Parenteral preparations containing fixed dose combination of streptomycin with penicillins with effect from 01-01-1998.
G.S.R. No. 499 (E) dt 14-08-1998
58. Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception.
59. Fenfluramine and Dexfenfluramine.
60. Fixed dose combination of haemoglobin in any form (natural or synthetic).
61. Fixed dose combination of Pancreatin and Pancrelipase containing amylase, protease, and lipase with any other enzyme.
(Both 59 & 60 added by G.S.R. 590 (E) dt. 17-8-1999.
Sr. No. 59 & 60 omitted by G.S.R. 704(E) dt. 20-10-1999.)
G.S.R. No. 702 (E) dt 20-10-1999
62. 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) dt 16-12-1999 (w.e.f. 01-09-2000)
63. Fixed dose combination of haemoglobin in any form (natural or synthetic).
64. Fixed dose combination of Pancreatin and Pancrelipase containing amylase, protease and lipase with any other enzyme.
G.S.R. No. 169 (E) dt 12-03-2001
65. Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride.
G.S.R. No. 170 (E) dt 12-03-2001 (with effect from 01-01-2002)
66. Fixed dose combination of Nitrofurantoin and trimethoprim.
67. Fixed dose combination of Phenobarbitone with any anti-asthmatic drug.
68. Fixed dose combination of Phenobarbitone with Hyoscin and/or Hyoscyamine.
69. Fixed dose combination of Phenobarbitone with Ergotamine and/or Belladona.
70. Fixed dose combination of Haloperidol with any anti-cholinergic agent including Propantheline Bromide.
71. Fixed dose combination of Nalidixic Acid with any anti-amoebic including Metronidazole.
72. Fixed dose combination of Loperamide Hydrochloride with Furazolidone.
73. Fixed dose combination of Cyproheptadine with Lysine or Peptone.
G.S.R 603 (E) dt 13-08-2001 (with effect from 01-09-2002)
74. Fixed dose combination of Metoclopramide with other drugs except combination of Metoclopramide with Aspirin/ Paracetamol with effect from 1st September, 2002.
G.S.R. No. 732 (E) dt 29-10.2002, Amended vide GSR 191(E) dt 05-03-2003 (with effect from 01-04-2003)
75. Astemizole
Terfinadine
G.S.R 100 (E) dt 11-02-2003 (with effect from11-02-2003)
76. 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. No. 780 (E) dt 01-10-2003 (with effect from 01-10-2003)
77. Phenformin for human use.
G.S.R. No. 810 (E) dt 13-12-2004 (with effect from 13-12-2004)
78. Rofecoxib and its formulations for human use.
G.S.R. No. 510 (E) dt 25-7-2005 (with effect from 25-7-2005)
79. Valdecoxib and its formulations for human use.
G.S.R. No. 499 (E) dt 4/5-7-2008 (with effect from 4/5-7-2008)
80. Diclofenac and its formulations for animal use.
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 30.4.92
