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FIXED DOSE OF COMBINATIONS OF DRUGS
BANNED BY THE GOVT. OF INDIA.
The principle notification Under Section 26-A of the Drugs and Cosmetics act, 1940 prohibiting manufacture, sale and distribution of certian fixed dose combination of drugs was published in the Gazette of india vide G.S.RR. NO.578(E) dated 23.07.83 and was subsequently amended.
1. Amidopyrine.
2. Fixed dose combinations of vitamins with anti-inflamatory agents and tranquillisers.
3. Fixed dose combinations of Atopine in Analgesics and Antipyretics.
4. Fixed dose combinations of Strychnine and Caffeine in tonics.
5. Fixed dose combinations of Yohimbine and Stychnine 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. Phenecatin.
9. Fixed dose combinations of anti-histaminics with anti-diarrhoeals.
10. Fixed dose combinations of penicllin with Sulphonamides.
11. Fixed dose combination of Vitamins with Analgesics.
12. Fixed dose combination of Tetracycline with Vitamin C.
13. Fixed dose combination of Hydoxyquinoline group of drugs with any other drug except for preparations meant external use.
14. Fixed dose combination of corticosteroids with any other drug for internal use.
15. Fixed dose combination of Chloramphenicol with any other drug for internal use.
16. Fixed dose combination of crude Ergot preparations except those containing Ergotamine, Caffeine, analgesics, antihistamines for the
tretament of migraine, headaches.
17.Fixed dose combination of vitamins with anti-T.B. drugs except combination of isoniazide with Pyridoxine Hydrochloride (Vitamin B-6).
18. Penicillin skin/ eye ointment.
19. Tetracycline liquid oral preparation.
20. Nialamide.
21. Practolol.
22. Metapyrilene, its salts.
23. Methaqualone.
24. Oxytetracycline liquid Oral preparations.
25. Demeclocycline liquid Oral Preparations.
26. Combinations of Anabolic Steroids with other drugs.
27. Fixed dose combination of Oestrogen and progestin ( other than oral contraceptive ) containing per table testrogen content of more than 50 mcg (equivalent to Ethinyle Estradiol) and all fixed dose combination injectable preparations coating 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 adult dose given below:- substituted by GSR100(e) dtd 11-02-03 for GSR 578 (e) 23-07-83.
Drugs Minimum Maximum
Rifampicin 450 mg. 600 mg.
INH 300 mg. 400 mg.
Pyrazinamide 1000 mg. 1500 mg.
30. Fixed dose combination of histamine H2-receptor anagonists with antacids except for those combination approved by the drugs
Controller, india.
31. The patent and proprietary medicines of fixed dose combination of essential oils with alcohol having percentage higher than 20% prof
excwpt preparations given in the indian Pharmacopoeia.
32. All Pharmaceutical preparations containing Chloroform exceeding 0.5% w/w or v/v whichever is approiate.
33. Fixed dose combination of ethambutol with INH other than the following:
IH Ethtambutol
200 mg. 600 mg.
300 mg. 800 mg.
34. Fixed dose combination containing more than one antihistamine.
35. Fixed dose combination of aanthelmintic with cathetric / purgative except for piperazine.
36. Fixed dose combination of Salbutamol or any other bronchodilator with centrally acting anti-tussive and/or a antihistamine.
37. Fixed dose combination of laxatives and /or a anti-spasmodic drugs in gnzyme preparations.
38. Fixed dose combination of Metoclopramide with systemically absorbed drugs except fixed dose combinatiin of metoclopramide with
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-tissive and / or an antihistamine.
41. Liquid oral tonic preparations contaning glycero phosphates and / or other phosphates and / or central nervous system stimulate and such preparation containing aicohol more than 200 proof.
42. Fixed dose combination containing pectin and/or kaolin with any drug which is systematically absorbed from GL tract except for combinations of pectin and /or kaolin with drugs not systematically absorbed.
43. Chloral Hydrate as a drug.
44. Dover's Powder I.P.
45. Dover's Powder Tablets I.P.
46. Antidiarrhoeal formulation containing Kaolin or Pectin or Attapulgite or Activated Charcoal.
47. Anti-diarrhoeal formulation containing Phthalyl sulphatiazole or Sulphaguanidine or Succinyl Sulphatiazole.
48. Anti-diarrhoeal formulation containing Neomycin orn Streptomycin or Dihydrostreptomycin or Succinyl Sulphathiazole.
49. Liquid Oral antidiarrhoeals or any other dosage form for paediatric use containing Diphnoxylate or Loperamide or Atropine or Belladonna including thier salts or esters or metabolites Hyoscyamine or thier extracts or thier alkaloids.
50. Liquid oral antidiarrhoeals or any other dosage from for paediatric 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 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 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 millimoles.
otal osmolarity -not more than 290 milli osmoles.
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 (OSR) may contain aminoacids in addition to Oral Rehydration Salt conforming
to the parameters specified above and labelled with indication for "adult Choleratic Diarrhoea only".
(d) Patent and Proprietary Oral Rehydration Salts shall not contain mono or Polysaccharides or saccharin 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 durug other than anti-spasmodics and/or non-steroidal anti-inflomamatry 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 from for use for female sterlization or contraception.
58. Fenfluramine and Dexfenfluramine.
59. parenteral preparations containing fixed dose combination of streptomycin with penicillins.
60. Fixed dose combination of Fixed dose combination ofitamin B 1 Vitamin B6 and Vitamin B 12.
61. Fixed dose combination of haemoglobin in any form (natural or synthetic).
62. Fixed dose combination of Pancreatin or Pancrelipase containing amylase, protease and lipase with any other enzyme.
63. parenteral preparations containing fixed dose combination of streptomycin with penicillins with effect from 1st january, 1998.
64. All Cosmetics licensed as tooth pastes / tooth powders containing tobacco.
65. Fixed dose combination of Vitamin B1, Vitamin B6 and Vitamin B12 for human use with effect from 1st january 2001.
66. Fixed dose combination of Nitrofurantion and Trimethoprim.
67. Fixed dose combination of Phenobarbitone with any anti asthmatic drugs.
68. Fixed dose combination of Phenobarbitone with Hyoscine and / or Hyoscyamine.
69. Fixed dose combination of Phenobarbitone with Ergotamine and /or Belfadona.
70. Fixed dose combination of Haloperidol with anti- Cholinergic agent including propenthaline Bromide.
71. Fixed dose combination of Nalixidic acid with any amoebics including metronidazone.
72. Fixed dose combination of Loperaminde Hydro Chloride with Furazolidone.
73. Fixed dose combination of Cyproheptadine with Lysine or Peptone.
74. Manufacture, Sale or Distribution of Phenformin for Human use w.e.f 1-10-2003.
75. Astemizole, Terfinadine for human use w.e.f 01-04-03 (GSR 191(e) dtd 05-03-03
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