| 1. |
Amidopyrine. |
| 2. |
Fixed dose combinations of Vitamins with anti-inflammatory agents
and tranquilizers. |
| 3. |
Fixed dose combinations of Atropine and Analgesics and Antipyretics.
|
| 4.
|
Fixed
dose combinations of Strychnine and Caffeine in tonics. |
| 5. |
Fixed dose combinations of Yohimbine and Strychnine and 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 combination of crude Ergot preparations except those containing
Ergotamine, Caffeine, Analgesics, antihistamines for the treatment
of migraine headaches.
|
| |
| 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. 578 (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 contraceptive)
containing per tablet Estrogen content of more than 50 mcg (equivalent
to Ethinyl Estradiol) and of 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 combination of Sedatives/hypnotics/anxiolytics with analgesic-antipyretics.
|
| 29. |
Fixed dose combination of Pyrazinamide, other anti-tubercular drugs
except combination of Pyrazinamide with Rifampicin and INH as per
recommended daily dose given below:
|
| |
Drugs
Rifampicin
INH
Pyrazinamide
|
Minimum
450 mg
300 mg
1000 mg
|
Maximum
600 mg
400 mg
1500 mg
|
| 30. |
Fixed
dose combination of Histamine H-2 receptor antagonists with antacids
except for those combinations approved by the 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. |
|
34.
|
Fixed
dose combination containing more than one antihistamine.
|
| 35.
|
Fixed
dose combination of anthelminthic 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 on 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 combinations
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. |
Dover's 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 Attopulgite 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 metabolities Hyoscyamine or their extractors
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, G.S.R.
No. 123 (E) dt 11- 03 - 1996 and
G.S.R. 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. 196 (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. |
| |
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)
|
| Source:
Central Drugs Standard Control Organisation, Govt. of India - http://cdsco.nic.in/ |