DRUGS
CONTROL DEPARTMENT
List
of Drugs Banned by the Government of India under Section
26A of the Drugs & Cosmetics Act 1940
1)Amidopyrine
2)Fixed dose combinations of Vitamins with anti-inflammatory
agents and tranquilisers.
3)Fixed dose combinations of Atropine in Analgesics and
Antipyretics.
4)Fixed dose combinations of Strychine 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/Chloralhydrate
with other drugs.
8)Phenacetin
9)Fixed dose combination of anti-histaminics with anti-diarrhoeals.
10)Fixed dose combinations of Pencillin with Sulphonamides.
11)Fixed dose combination of Vitamins with Analgesics
12)Fixed dose combination of Tetracycline with Vitamin C
13)Fixed dose combination of Hydroxyquimoline group of drugs
with any other drug except for preparations meant for external
use.
14)Fixed dose combination of Cotricosteroids with any other
drug for internal use.
15)Fixed dose combinations of Chloramphenicol with any other
drug for internal use.
16)Fixed dose combinations of crude Ergot preparations except
those containing Ergotamine, Caffeine, Analgesics, Antithistamines
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)Pencillin Skin/Eye Ointment.
19)Tetracycline Liquid oral preparations.
20)Nialamide
21)Practolol
22)Methapyrilene, its salts.
23)Methaqualone
24)Oxytetracycline Liquid Oral preparations.
25)Demeclocycline Liquid Oral preparations.
26)Combination of Anabolic steroids with other drugs.
27)Fixed dose combinations of Destrogen and Progestin (other
than oral contraceptive) containing per tablet estrogen
content of more than 50mcg. (equivalent to Ethinyl Estradiol)
and of Progestin content of more than 3mg.(equivalent to
Norethisterone Acetate) and all fixed dose combination injectable
preparations containing synthetic oestrogen and progestorone
28)Fixed dose combination of Sedatives/hypnotics/anxiolytics
with analgesic -antipyretics.
29)Fixed dose combination of Pyrazinamide with other antitubercular
drugs except combination of Pyrazinamide with Rifampicin
and INH as per recommended daily dose given below:-
| Drugs |
Minimum |
Maximum |
| Rifampicin
|
450mg
|
600mg |
| INH |
300mg
|
400mg |
| Pyrazinamide
|
100mg
|
1500mg. |
30)Fixed
dose combination of histamine H2-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.
33)Fixed dose combination of Ethambutol with INH other than
the following:-
| INH
|
Ethambutol |
| 200mg
|
600mg |
| 300mg
|
800mg |
34)Fixed
dose combination containing more than one entihistamine.
35)Fixed dose combination of anthelmintic with cathetric/purgative
except for Piperazine.
36)Fixed dose combination of Salbutamol or any other Bronchodilator
with centrally acting antitussive and/or antihistamine.
37)Fixed dose combination of laxatives and/or antispasmodic
drugs in enzyme preparations.
38)Fixed dose combination of Metoclopramide with other drugs
except for preparations containing Metoclopramide and aspirin/paracetamol.
39)Fixed dose combinations or centrally acting antitussive
with antihistamine having high atropine like activity in
expectorants.
40)Preparations claiming to combat cough associated with
asthma containing centrally acting antitussive and/or an
anti-instamine.
41)Liquid oral tonic preparations containing glycerophosphate
and/or other phosphates and/or central nervous system stimulant
and such preparations containing alcohol more than 20o 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.
43)Chloral Hydrate as a drug. (Tooth Pastes/tooth powders
containing tobacco cosmetics)
44)Dovers Powder I.P
45. Dovers Powder tablets I.P. (Nox-11014/1/83-DMS & PFA)
B. G.S.R. 731 (E) dated
30.09.94
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 Sceptomycin
or Dihydrostreptomycin including their respective salts
or esters.
49)Liquid Oral antidiarrhoeals or any other dosage form
for pediatric use containing Diphenoxylate or Loperamide
or Atrophine or Belladonna 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.
C.
G.S.R 57(E) dated 07.02.95
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 - 5o to 90 millimoles.
Total Osmoloarity - 240 to 290 milliosmoles. 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:- Sodium
- 50 to 90 millimoles. Total osmolarity - Not more than
290 milliosmoles. Precooked rice - equivalent to not less
than 50gms and not more than 80 gms 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 labelled
with the indication for “Adult Chloleratic Diarrhoea only”.
D. G.S.R.
633(E) dated 13.09.95
53)Fixed
dose combination of Oxyphenbutazone or Phynylbutazone with
any other drug.
54)Fixed dose combination of Analgin with any other drug.
55)Fixed dose combination of dextropropaxyphene with any
other drug other than anti-spasmodics and/or nonsteroidal
anti-inflammatory drugs (NSAIDS)
56)Fixed dose combination of drug, standards of which are
prescribed in the Second Schedule to the said Act with an
Ayurvedic, Siddh or Unani drug.
E. G.S.R.
499(E) dated 14.8.98
57)Mepaerine
Hydrochloride (Quinacrine and its salts) in any dosage form
for use for female sterilization or ontraceptives.
58)Fenfluramine and Dexofenfluramine.
F. G.S.R.702(E)
14.10.1999
59)Fixed
dose combinations of Vitamin B1 B6, and B12 w.e.f. 1.1.2001
G. G.S.R. No. 170(E) dated 12.3.2001.
60)Fixed dose combination of Nitrofurantoin and Trimethoprim
61)Fixed dose combination of Phenobarbitone with any anti-asthamatic
drugs
62)Fixed dose combination of Phenobarbitone with Hyoscin
and/or Hyoscyamine
63)Fixed dose combination of Phenobarbitone with Ergotamine
and /or Belladona
64)Fixed dose combination of Haloperidol with any anti-cholinergic
agent including Propentheline Bromide.
65)Fixed dose combination of Nalidixic acid with any anti-amoebics
including Metronidazole.
66)Fixed dose combination of Loperamide Hydrochloride with
Furazolidone.
67)Fixed dose combination of Cyproheptadine with Lysine
or Peptone.
68)Astemizole
69)Terfenadine
