Banned Drugs in India

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:

FAQs

Also read: FAQs about New Drug, Banned drugs etc.

Updated Banned Drugs List as on 22-11-2021

Click below link:

Updated-Banned-Drugs-List-as-on-22-11-2021

Notifications of banned drugs

For notifications of banned drugs, click below link:

Notifications - Banned drugs

List of 444 banned drugs along with the Notification No. and date

Click below PDF file

List-of-444-banned-drugs-along-with-the-Notification-No.-and-date

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) dtd 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) dtd 03-11-1988

(14)   Fixed
dose combinations of Corticosteroid with any other drug for internal use except
for preparations meant for meter dose inhalers and dry powder inhalers.

(15)   Fixed
dose combinations of Chloramphenicol with any other drug for internal use.

G.S.R.
No. 304 (E) dtd 07-06-1991

(16)   Fixed
dose combinations of crude Ergot preparation except those containing
Ergotamine, Caffeine, analgesics, antihistamines for the treatment of migraine,
headache.

G.S.R.
No. 578 (E) dtd 23-07-1983

- (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)   Fixed dose combinations of Iron with
Strychnine, Arsenic and Yohimbine.

G.S.R.
No. 49 (E) dtd 31-01-1984

(23)   Methaqualone.

G.S.R.
No. 322 (E) dtd 03-05-1984

- (24)   Oxytetracycline Liquid Oral
preparations.

- (25)   Demeclocycline Liquid Oral
preparations.

G.S.R.
No. 863 (E) dtd 22-11-1985

(26)   Methaqualone.

G.S.R.
No. 743 (E) dtd 10-08-1989

(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) dtd 26-12-1990

(28)   Fixed
dose combinations of Sedatives/ hypnotics/anxiolytics with
analgesics-antipyretics.

G.S.R 100 (E) dtd 11-02-2003 (with effect from 11-02-2003)

(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

1000 mg

1500 mg

G.S.R.
No. 999 (E) dtd 26-12-1990

- (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) dtd 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.

Substituted
vide G.S.R 290 (E) dtd 16-04-2008

(36)   Fixed
dose combination of Salbutamol or any other bronchodilator with centrally
acting anti-tussive and/or antihistamine.

G.S.R.
No. 69 (E) dtd 11-02-1991

(37)    Fixed
dose combination of laxatives and/or anti-spasmodic drugs in enzyme
preparations.

Substituted vide G.S.R 603 (E) dtd 24-08-2001 (with effect from 01-09-2002)

(38)   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. 69 (E) dtd 11-02-1991

- (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) dtd 07-06-1991

(43)   Chloral
Hydrate as a drug.

G.S.R.
No. 612 (E) dtd 09-08-1994

- (44)   Dovers Powder I.P.

- (45)   Dover's Powder Tablets I.P.

G.S.R.
No. 731 (E) dtd30-09-1994

- (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) dtd 07-02-1995

(43)   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) dtd 30-09-1995, GSR No. 123 (E) dtd 11-03-1996 and GSR No. 230 (E)
dtd 04-06-1996

- (53)   Fixed dose combination of
Oxyphenbutazone or Phenylbutazone with any other drug.

- (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) dtd 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) dtd 14-08-1998

- (57)   Mepacrine Hydrochloride (Quinacrine
and its salts) in any dosage form for use for female sterilization or
contraception.

- (58)   Fenfluramine and Dexfenfluramine.

- (59)   Fixed dose combination of
haemoglobin in any form (natural or synthetic).

- (60)   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) dtd 17-8-1999.

Sr. No. 59 & 60
omitted by G.S.R. 704(E) dtd 20-10-1999.)

G.S.R.
No. 169 (E) dt 12-03-2001

(59)  
Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride.

G.S.R. No. 885 (E) dtd 11-12-2009 (with effect from 11-12-2009)

(60)  
Rimonabant.

G.S.R. No. 702 (E) dtd 20-10-1999 (with effect from 1-1-2001)

(61)  
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) dtd 16-12-1999 (w.e.f. 01-09-2000)

- (62)   Fixed dose combination of
haemoglobin in any form (natural or synthetic).

- (63)   Fixed dose combination of
Pancreatin and Pancrelipase containing amylase, protease and lipase with any
other enzyme.

G.S.R.
No. 170 (E) dtd 12-03-2001 (with effect from 01-01-2002)

- (64)   Fixed dose combination of
Nitrofurantoin and trimethoprim.

- (65)   Fixed dose combination of
Phenobarbitone with any anti-asthmatic drug.

- (66)   Fixed dose combination of
Phenobarbitone with Hyoscin and/or Hyoscyamine.

- (67)   Fixed dose combination of Phenobarbitone
with Ergotamine and/or Belladona.

- (68)   Fixed dose combination of
Haloperidol with any anti-cholinergic agent including Propantheline Bromide.

- (69)   Fixed dose combination of Nalidixic
Acid with any anti-amoebic including Metronidazole.

- (70)   Fixed dose combination of
Loperamide Hydrochloride with Furazolidone.

- (71)   Fixed dose combination of
Cyproheptadine with Lysine or Peptone.

G.S.R 603 (E) dtd 13-08-2001 (with effect from 01-09-2002)

(72)  
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) dtd 29-10.2002, Amended vide GSR 191(E) dtd 05-03-2003 (with effect from 01-08-2003)

- (73)   Astemizole.

- (74)   Terfinadine

G.S.R 100 (E) dtd 11-02-2003 (with effect from 11-02-2003)

(75)   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) dtd 01-10-2003 (with effect from 01-10-2003)

(76)  
Phenformin for human use.

G.S.R. No. 810 (E) dtd 13-12-2004 (with effect from 13-12-2004)

(77)  
Rofecoxib and its formulations for human use.

G.S.R. No. 510 (E) dtd 25-7-2005 (with effect from 25-7-2005)

(78)  
Valdecoxib and its formulations for human use.

G.S.R. No. 499 (E) dtd 4-7-2008 (with effect from 5-7-2008)

(79)  
Diclofenac and its formulations for animal use.

G.S.R. No. 910 (E) dtd 12-11-2010 (with effect from 12-11-2010)

(80)  
Rosiglitazone and its formulations for human use.

G.S.R. No. 82 (E) dtd 10-2-2011 (with effect from 10-2-2011)

- (81)   Nimesulide formulations for human
use in children below 12 years of age.

- (82)   Cisapride and its formulations for
human use.

- (83)   Phenylpropanolamine and its
formulations for human use,*

- (84)   Human Placental Extract and its
formulations for human use except its,

(i)
 Topical application for wound healing, and(ii)  Injection for pelvic
inflammatory disease

- (Substituted vide G.S.R. No. 418 (E) dtd 30-5-2011 (with effect from 30-5-2011)

- (85)   Sibutramine and its formulations for human use, and

- (86)   R-Sibutramine and its formulations for human use.

G.S.R. No. 218 (E) dtd 16-3-2011 (with effect from 16-3-2011)

- (87)   Gatifloxacin formulation for
systemic use in human by any route including oral and injectable; and

- (88)   Tegaserod and its formulations for
human use.

G.S.R. No. 752 (E) dtd 12-10-2011 (with effect from 12-10-2011)

(89)  
Letrozole for induction of ovulation in anovulatory infertility.

G.S.R.
No. 432 (E) dtd 7-6-2012 (with effect from 7-6-2012)

(90)  
Serodiagnostic test kits for diagnosis of tuberculosis.

G.S.R.
No. 332 (E) dtd 23-5-2013 (with effect from 23-5-2013) ƫ

(91)  
¢ and formulations
containing Dextropropoxyphene for human use.

G.S.R.
No. 377 (E) dt 18-6-2013 (with effect from 18-6-2013)

(Quashed in WP Nos
28354/2013 c/w 32766-32768/2013 Lundbeck India Pvt Ltd v. UOI and others, High
Court of Karnataka, D/d 14.8.2013)

(92)  
Fixed dose combination of Flupenthixol+Melitracen for human use.

G.S.R.
No. 498 (E) dtd 11-7-2014 (with effect from 11-7-2014)

Fixed
dose combination of Flupenthixol and Melitracen for human use

G.S.R.
No. 378 (E) dtd 18-6-2013

(revoked allowing the
use of drug with condition “The drug is indicated for Severe pain or pain due
to tumor and also for bringing down temperature in refractory cases when other
antipyretics fail to do so.” vide G.S.R. No.86(E) dtd 13-02-2014)

(93)  
Analgin and all formulations containing Analgin for human use.

G.S.R.
No. 379 (E) dtd 18-6-2013 (with effect from 18-6-2013)

(94)  
Pioglitazone and all formulations containing Pioglitazone for human use.

G.S.R
. 29 (E) dtd 17-01-2014 (Remained effective from 17-01-2014 to 30-06-2018)

(95)   The
drug oxytocin shall be manufactured for sale or for distribution or sold in the
manner specified below, in addition to the provisions contained in the Act and
Rules made thereunder, namely:-

(i)  The
manufacturers of bulk oxytocin drug shall supply the active pharmaceutical drug
only to the manufacturers licensed under the Drugs and Cosmetics Rules, 1945
for manufacture of formulations of the said drug.(ii)  The formulations
meant for veterinary use shall be sold to the veterinary hospitals only.

S. O.
1352 (E) dtd 23-03-2018 (with effect from 23-03-2018)

(96)  
Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of malaria.

G.S.R.
411 (E) dtd 27-04-2018 (with effect from 01-09-2018)Extended vide G. S. R.
602 (E) dtd 29-06-2018

(97)  
The Oxytocin in any form or name shall not be allowed to be sold through retail
Chemist.

S. O.
4379 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(98)  
Fixed dose combination of Aceclofenac + Paracetamol + Rabeprazole.

S. O.
4380 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(99)  
Fixed dose combination of Nimesulide + Diclofenac.

S. O.
4381 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(100)  
Fixed dose combination of Nimesulide + Cetirizine + Caffeine.

S. O.
4382 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(101)  
Fixed dose combination of Nimesulide + Tizanidine.

S. O.
4383 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(102)  
Fixed dose combination of Paracetamol + Cetirizine + Caffeine.

S. O.
4384 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(103)  
Fixed dose combination of Diclofenac + Tramadol + Chlorzoxazone.

S. O.
4385 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(104)  
Fixed dose combination of Dicyclomine + Paracetamol + Domperidone.

S. O.
4386 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(105)  
Fixed dose combination of Diclofenac + Tramadol + Paracetamol.

S. O.
4387 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(106)  
Fixed dose combination of Diclofenac + Paracetamol + Chlorzoxazone +
Famotidine.

S. O.
4388 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(107)  
Fixed dose combination of Naproxen + Paracetamol.

S. O.
4389 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(108)  
Fixed dose combination of Nimesulide + Serratiopeptidase.

S. O.
4390 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(109)  
Fixed dose combination of Paracetamol + Diclofenac + Famotidine.

S. O.
4391 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(110)  
Fixed dose combination of Nimesulide + Pitofenone + Fenpiverinium + Benzyl
Alcohol.

S. O.
4392 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(111)  
Fixed dose combination of Omeprazole + Paracetamol + Diclofenac.

S. O.
4393 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(112)  
Fixed dose combination of Nimesulide + Paracetamol Injection.

S. O.
4394 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(113)  
Fixed dose combination of Tamsulosin + Diclofenac.

S. O.
4395 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(114)  
Fixed dose combination of Paracetamol + Phenylephrine + Chlorpheniramine +
Dextromethorphan + Caffeine.

S. O.
4396 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(115)  
Fixed dose combination of Diclofenac + Zinc Carnosine.

S. O.
4397 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(116)  
Fixed dose combination of Diclofenac + Paracetamol + Chlorpheniramine Maleate +
Magnesium Trisillicate.

S. O.
4398 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(117)  
Fixed dose combination of Paracetamol + Pseudoephedrine + Cetirizine.

S. O.
4399 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(118)  
Fixed dose combination of Phenylbutazone + Sodium Salicylate.

S. O.
4400 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(119)  
Fixed dose combination of Lornoxicam + Paracetamol + Trypsin.

S. O.
4401 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(120)  
Fixed dose combination of Paracetamol + Mefenamic Acid + Ranitidine +
Dicyclomine.

S. O.
4402 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(121)  
Fixed dose combination of Nimesulide + Dicyclomine.

S. O.
4403 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(122)  
Fixed dose combination of Heparin + Diclofenac.

S. O.
4404 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(123)  
Fixed dose combination of Glucosamine + Methyl Sulfonyl Methane + Vitamin D3 +
Manganese + Boron + Copper + Zinc.

S. O.
4405 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(124)  
Fixed dose combination of Paracetamol + Tapentadol.

S. O.
4406 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(125)  
Fixed
https://thehealthmaster.com/drugs/banned-drugs/