|
LIST OF DRUGS PROHIBITED FOR
MANUFACTURE AND SALE THROUGH GAZETTE NOTIFICATIONS UNDER
SECTION 26A OF DRUGS & COSMETICS ACT 1940 BY THE MINISTRY
OF HEALTH AND FAMILY WELFARE
DRUGS PROHIBITED FROM THE
DATE OF NOTIFICATION
 1. Amidopyrine.
2. Fixed
dose combinations of vitamins with anti-inflammatory agents
and tranquilizers.
3. Fixed
dose combinations of Atropine in Analgesics 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.
B 12.Fixed
dose combinations of any other Tetracycline with Vitamin
C.
E
13.Fixed
dose combinations of Hydroxyquinoline group of drugs with any
other drug
except for preparations meant for external
use.
ccc
14.
Fixed
dose combinations of Corticosteroids with any other drug for
internal use.
ccc
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, 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.
Practolol.
22.
Methapyrilene,
its salts.
c
23.
Methaqualone.
& 24.
Oxytetracycline
Liquid Oral preparations.
&
25.
Demeclocycline
Liquid Oral preparations.
T
26.
Combination
of anabolic Steroids with other drugs.
cc 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 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)
*
28.Fixed
dose combination of Sedatives/
hypnotics/anxiolytics
with analgesics-antipyretics.
J*
29.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
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.
**
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.
B**35.Fixed
dose combination of any anthelmintic
with cathartic/purgative except for
piperazine/Santonim.
J **36.
Fixed
dose combination of Salbutamol or any other drug having
primarily bronchodilatory activity with centrally acting
anti-tussive
and/or antihistamine.
**
37.Fixed
dose combination of laxatives and/or anti-spasmodic drugs in
enzyme preparations.
G**
38.Fixed
dose combination of Metoclopramide
with systemically absorbed drugs except fixed dose combination
of metoclopramide
with aspirin/paracetamol
**
39.Fixed
dose combination of 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 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.
*** 43.
Chloral
Hydrate as a drug.
b
44.
Dovers
Powder I.P.
b
45.
Dover’s
Powder
Tablets I.P.
A 46.Antidiarrhoeal
formulations containing Kaolin or Pectin or Attapulgite
or Activated Charcoal.
A 47.Antidiarrhoeal
formulations containing Phthalyl
Sulphathiazole
or Sulphaguanidine
or Succinyl
Sulphathiazole.
A
48.Antidiarrhoeal
formulations containing Neomycin or Streptomycin or
Dihydrostreptomycin including
their respective salts or esters.
A 49.Liquid
Oral antidiarrhoeals or any other dosage form for pediatric
use containing Diphenoxylate Lorloperamide or Atropine or
Belladona including their salts or esters or metabolites
Hyoscyamine
or their extracts or their alkaloids.
A
50.Liquid
Oral antidiarrhoeals
or any other dosage form for pediatric use containing
halogenated hydroxyquinolines.
A
51.
Fixed
dose combination of antidiarrhoeals
with electrolytes.
C
52.
Patent
and Proprietary Oral Rehydration Salts other than those
conforming to the
D
53.
Fixed
dose combination of Oxyphenbutazone or Phenylbutazone with any
other drug.
H.D54.
Fixed
dose combination of Analgin
with any other drug.
D
55.
Fixed
dose combination of dextropropoxyphene with any other drug
other than anti-spasmodics and/or non-steriodal
anti-inflammatory drugs (NSAIDS).
D 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.
F 57.
Mepacrine
Hydrochloride (Quinacrine and its salts) in any dosage form
for use for female
sterilization or contraception.
F 58.
Fenfluramine
and Dexfenfluramine.
I 59.
Fixed
dose combination of Diazepam and Diphenhydramine Hydrochloride
.
K
60. Rimonabant.
L
61 Rosiglitazone
M
62 Nimesulide formulations for human use in children below
12 years of age.
M
63.
Cisapride and its formulations for human use.
M
64.
Phenylpropanolamine and its formulation for human use.
M
65.
Human Placental Extract and its formulations for human use.
M
66.
Sibutramine and its formulations for human use, and
M
67.
R-Sibutramine and its formulations for human use.
N 68. Gatifloxacin formulation for systemic use in human
by any route including oral and injectable
N 69. Tegaserod and its formulation for human use.
LIST OF GAZETTE NOTIFICATION
PUBLISHED
The
Principal Notification GSR 578 (E)
dt.23.7.83.
c
Added
b GSR 4(E) dated 31.01.1984
& Added
b GSR 322(E) dated 03.05.1984\
T Amended
by GSR 863(E) dated 22.11.1985
cc Amended by GSR
743(E) dated 10.08.1989
ccc Amended
by GSR 1057(E) dated 03.11.1988
* Added by
GSR 999(E) dated 26.12.1990
* Added
by GSR 69(E) dated 11.02.1991
xxx
Added
by GSR 304(E) dated 7.06.1990
@
Added
by GSR 444(E) dated 7.06.1992
b
Added
by GSR 111(E) dated 22.02.1994
A Added
by GSR 731(E) dated 30.09.1994
B
Added
by GSR 848(E) dated 7.12.1994
C
Added
by GSR 57(E) dated 7.02.1995
D
Added
by GSR 633(E) dated 13.09.1995
E
Added
by GSR 793(E) dated 13.03.1995
Added
by GSR 93(E) dated 25.05.1997
F
Added
by GSR 499(E) dated 14.08.1998
G
Added
by GSR 394(E) dated 19.05.1999
H
Added
by GSR 405(E) dated 3.06.1999
I Added
by GSR 169(E) dated 12.03.2001
J Added
by GSR 290(E) dated 16.04.2008
K Added by GSR 885(E) dated
11.12.2009
L. Added
by GSR 910(E) dated 12.11.2010
M. Added
by GSR 82(E) dated 10.03.2011
N. Added
by GSR 218(E) dated 16.03.2011
LIST
OF DRUGS PROHIBITED FOR IMPORT
1. Nialamide
2. Practolol
3. Amidopyrine
4. Phenacetin
5. Methapyrilene and its salts
a 6. Methaqualone
b 7. Chloral Hydrate as a drug
c 8. Mepacrine Hydrochloride ( Quinacrine and
its Salts) in any dosage form for use for female sterilization
or contraception.
9. Fenfluramine and Dexfenfluramine]
d 10. Rimonabant
LIST OF GAZETTE NOTIFICATION
PUBLISHED
a Added by GSR 48(E) dated 31.1.1984
b Added by GSR 303(E) dated 7.6.1991
c Added by GSR 498(E) dated 14.8.1998
d Added by GSR 884(E) dated 11.12.2009
DRUGS
PROHIBITED FOR MANUFACTURE , SALE AND DISTRIBUTION FROM
SUBSEQUENT DATE
Drugs
Formulation
Effective
date
Notification
1.Cosmetics
Licensed as toothpaste/tooth
With immediate
GSR 444(E)
powder
containing tobacco.
effect
dt.30.4.92
2.Parenteal
Preparations fixed dose
Jan
1,1998
GSR 93(E)
combination of
streptomycin with
dt.25.2.97
Pencillin
3.Fixed
dose combination of Vitamin B1,
Jan 1,2001
GSR 702(E)
Vitamin B6 and
Vitamin B12 for
dt.14.10.99
human use
4.Fixed
dose combination of haemoglobin
Sep 1,2000
GSR 814(E)
in any form (natural or
synthetic).
dt.16.12.99
5.Fixed
dose combination of Pancreatin or
Sept. 1,2000
GSR 814(E)
Pancrelipase
containing amylase, protease
dt.16.12.99
and lipase with any
other enzyme.
6.
Fixed dose combination of Nitrofurantoin
Jan 1,2002
GSR 170(E)
and
trimethoprim.
dt.12.3.01
7.Fixed
dose combination of Phenobarbitone
Jan
1,2002
GRS 170(E)
with any anti-asthmatic
drugs.
dt.12.3.01
8.Fixed
dose combination of Phenobarbitone
Jan 1,2002
GSR 170(E)
with
Hyoscin
and/or Hyoscyamine
dt.12.3.01
9.Fixed
dose combination of Phenobarbitone
Jan 1,2002
GSR 170(E)
with Ergotamine and/or
Belladona
dt.12.3.01
10.Fixed
dose combination of Haloperidol
Jan 1,2002
GSR 170(E)
with
any anti-cholinergic agent including
dt.12.3.01
Propantheline Bromide.
11.Fixed
dose combination of Nalidixic Acid
Jan 1,2002
GSR
170(E)
with
any anti-amoebic including Metronidazole.
dt.12.3.01
12.Fixed
dose combination of Loperamide
Jan 1,2002
GSR 170(E)
Hydrochloride with
Furazolidone
dt.12.3.01
13.Fixed
dose combination of Cyproheptadine
Jan 1,2003
GSR 170(E)
with Lysine or
Peptone.
dt.12.3.01
14.Astemizole Apr.1,2003 GSR
191(E)
dt.5.3.03
15.Terfinadine Apr.1,2003 GSR
191(E)
dt.5.3.03
16.Fenformin
Oct.1,2003
GSR 780(E)
dt.1.10.03
17.Rafecoxib
Dec
13,2004
GSR
810(E)
dt. 13.12.04
18.Valdecoxib
July
25,2005
GSR 510(E)
and it's
formulation
dt. 25.07.05
19.Diclofenac
and its
formulations
July 4,
2008
GSR 499(E)
for animal
use
dt.4.07.08
|