DRUGS CONTROL DEPARTMENT

List of Drugs Banned by the Goern!ent of "ndia under Se#tion $%A of the Drugs &
Cos!eti#s A#t '()*
1)Amidopyrine
2)Fixed dose combinations of Vitamins with anti-inflammatory agents and tranquilisers.
)Fixed dose combinations of Atropine in Analgesics and Antipyretics.
!)Fixed dose combinations of "trychine and #affeine in tonics
$)Fixed dose combinations of %ohimbine and "trychnine with &estosterone and Vitamins.
')Fixed dose combinations of (ron with "trychnine) Arsenic and %ohimbine.
*)Fixed dose combinations of "odium +romide,#hloralhydrate with other drugs.
-).henacetin
/)Fixed dose combination of anti-histaminics with anti-diarrhoeals.
10)Fixed dose combinations of .encillin with "ulphonamides.
11)Fixed dose combination of Vitamins with Analgesics
12)Fixed dose combination of &etracycline with Vitamin #
1)Fixed dose combination of 1ydroxyquimoline group of drugs with any other drug except for
preparations meant for external use.
1!)Fixed dose combination of #otricosteroids with any other drug for internal use.
1$)Fixed dose combinations of #hloramphenicol with any other drug for internal use.
1')Fixed dose combinations of crude 2rgot preparations except those containing 2rgotamine)
#affeine) Analgesics) Antithistamines for the treatment of migraine) headaches.
1*)Fixed dose combinations of Vitamins with Anti &+ drugs except combination of (sonia3id with
.yridoxine 1ydrochloride 4Vitamin +').
1-).encillin "5in,2ye 6intment.
1/)&etracycline 7iquid oral preparations.
20)8ialamide
21).ractolol
22)9ethapyrilene) its salts.
2)9ethaqualone
2!)6xytetracycline 7iquid 6ral preparations.
2$):emeclocycline 7iquid 6ral preparations.
2')#ombination of Anabolic steroids with other drugs.
2*)Fixed dose combinations of :estrogen and .rogestin 4other than oral contracepti;e) containing
per tablet estrogen content of more than $0mcg. 4equi;alent to 2thinyl 2stradiol) and of .rogestin
content of more than mg.4equi;alent to 8orethisterone Acetate) and all fixed dose combination
in<ectable preparations containing synthetic oestrogen and progestorone
2-)Fixed dose combination of "edati;es,hypnotics,anxiolytics with analgesic -antipyretics.
2/)Fixed dose combination of .yra3inamide with other antitubercular drugs except combination of
.yra3inamide with =ifampicin and (81 as per recommended daily dose gi;en below>-
Drugs Mini!u! Ma+i!u!
=ifampicin !$0mg '00mg
(81 00mg !00mg
.yra3inamide 100mg 1$00mg.
0)Fixed dose combination of histamine 12-receptor antagonists with antacids except for those
combinations appro;ed by the :rugs #ontroller) (ndia.
1)&he .atent and .roprietary medicines of fixed dose combinations of essential oils with alcohol
ha;ing percentage higher than 20? proof except preparations gi;en in the (ndian .harmacopoeia.
2)All .harmaceutical preparations containing chloroform exceeding 0.$? w,w or ;,; whiche;er
is appropriate.
)Fixed dose combination of 2thambutol with (81 other than the following>-
"N, Etha!buto-
200mg '00mg
00mg -00mg
!)Fixed dose combination containing more than one entihistamine.

$)Fixed dose combination of anthelmintic with cathetric,purgati;e except for .ipera3ine.
')Fixed dose combination of "albutamol or any other +ronchodilator with centrally acting
antitussi;e and,or antihistamine.
*)Fixed dose combination of laxati;es and,or antispasmodic drugs in en3yme preparations.
-)Fixed dose combination of 9etoclopramide with other drugs except for preparations containing
9etoclopramide and aspirin,paracetamol.
/)Fixed dose combinations or centrally acting antitussi;e with antihistamine ha;ing high atropine
li5e acti;ity in expectorants.
!0).reparations claiming to combat cough associated with asthma containing centrally acting
antitussi;e and,or an anti-instamine.
!1)7iquid oral tonic preparations containing glycerophosphate and,or other phosphates and,or
central ner;ous system stimulant and such preparations containing alcohol more than 20o proof.
!2)Fixed dose combination containing .ectin and,or @aolin with any drug which is systemically
absorbed from A( tract except for combinations of .ectin and,or @aolin with drugs not
systemically absorbed.
!)#hloral 1ydrate as a drug. 4&ooth .astes,tooth powders containing tobacco cosmetics)
!!):o;ers .owder (..
!$. :o;ers .owder tablets (... 48ox-1101!,1,--:9" B .FA)
B. G.S.R. 731 (E) dated 30.09.94
!')Antidiarrhoeal formulations containing @aolin or .ectin or Attapulgite or Acti;ated #harcoal.
!*)Antidiarrhoeal formulations containing .hthalyl "ulphathia3ole or "ulphaguanidine or "uccinyl
"ulphathia3ole.
!-)Antidiarrhoeal formulations containing 8eomycin or "ceptomycin or :ihydrostreptomycin
including their respecti;e salts or esters.
!/)7iquid 6ral antidiarrhoeals or any other dosage form for pediatric use containing :iphenoxylate
or 7operamide or Atrophine or +elladonna including their salts or esters or metabolites
1yoscyamine or their extracts or their Al5aloids.
$0)7iquid oral antidiarrhoeals or any other dosage form for pediatric use containing halogenated
hydroxyquinolines.
$1)Fixed dose combination of antidiarrhoeals with electrolytes.
C. G.S.R 57(E) dated 07.02.95
$2).atent and .roprietary 6ral =ehydration "alts other than those conforming to the following
parameters>
a) .atent and .roprietary 6ral =ehydration "alts on reconstitution to one litre shall contain
"odium - $o to /0 millimoles. &otal 6smoloarity - 2!0 to 2/0 milliosmoles. :extrose "odium
9olar ratio - 8ot less than 1>1 and not more than >1
b) .atent and .roprietary cereal based 6ral =ehydration "alts on reconstitution to one litre shall
contain>- "odium - $0 to /0 millimoles. &otal osmolarity - 8ot more than 2/0 milliosmoles.
.recoo5ed rice - equi;alent to not less than $0gms and not more than -0 gms as total
replacement of :extrose.
c) .atent and .roprietary 6ral =ehydration "alts 46=") may contain aminoacids in addition to 6ral
=ehydration "alt conforming to the .arameters specified abo;e and labelled with the indication for
Adult #hloleratic :iarrhoea only.
D. G.S.R. 633(E) dated 13.09.95
$)Fixed dose combination of 6xyphenbuta3one or .hynylbuta3one with any other drug.
$!)Fixed dose combination of Analgin with any other drug.
$$)Fixed dose combination of dextropropaxyphene with any other drug other than anti-
spasmodics and,or nonsteroidal anti-inflammatory drugs 48"A(:")
$')Fixed dose combination of drug) standards of which are prescribed in the "econd "chedule to
the said Act with an Ayur;edic) "iddh or Cnani drug.
E. G.S.R. 499(E) dated 14.8.98
$*)9epaerine 1ydrochloride 4Duinacrine and its salts) in any dosage form for use for female
sterili3ation or ontracepti;es.
$-)Fenfluramine and :exofenfluramine.
F. G.S.R.702(E) 14.10.1999
$/)Fixed dose combinations of Vitamin +1 +') and +12 w.e.f. 1.1.2001 A. A.".=. 8o. 1*042)
dated 12..2001.
'0)Fixed dose combination of 8itrofurantoin and &rimethoprim
'1)Fixed dose combination of .henobarbitone with any anti-asthamatic drugs
'2)Fixed dose combination of .henobarbitone with 1yoscin and,or 1yoscyamine
')Fixed dose combination of .henobarbitone with 2rgotamine and ,or +elladona
'!)Fixed dose combination of 1aloperidol with any anti-cholinergic agent including .ropentheline
+romide.
'$)Fixed dose combination of 8alidixic acid with any anti-amoebics including 9etronida3ole.
'')Fixed dose combination of 7operamide 1ydrochloride with Fura3olidone.
'*)Fixed dose combination of #yproheptadine with 7ysine or .eptone.
'-)Astemi3ole
'/)&erfenadine