PROHIBITED DRUGS

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.

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

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