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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 Corticosteroids with
any other drug for internal use.
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.
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.
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