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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. |