The health ministry has suspended the sale of two drugs - painkiller Analgin and anti-diabetes drug Pioglitazone and all its combinations .
While the ban on Analgin in India has come after almost 36 years after the drug was banned in the US (which banned it in 1977), Pioglitazone was pulled out of France in 2011 for an increased risk of bladder cancer.
This decision comes in the wake of a strong stand by the government on suspending marketing of all drugs prohibited for sale in other countries like the US, the UK, EU and Australia.
The ministry of health and family welfare has suspended the manufacture and sale of all three drugs under Section 26A of the Drugs and Cosmetics Act, 1940 with immediate effect, through a notification issued on June 18, informed sources told TOI. While the ministry has been dilly-dallying on withdrawing analgin and deanxit for years now, despite pressure from a parliamentary panel, the decision on the diabetes drug pioglitazone has taken the industry completely by surprise.
The decision to ban pioglitazone and its combinations will hit the Rs 700-crore market for such drugs and adversely impact a clutch of companies including Abbott, Sun Pharma, USV, Lupin, Ranbaxy and Wockhardt.
Drugs Banned In India
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.
B35.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
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While the ban on Analgin in India has come after almost 36 years after the drug was banned in the US (which banned it in 1977), Pioglitazone was pulled out of France in 2011 for an increased risk of bladder cancer.
This decision comes in the wake of a strong stand by the government on suspending marketing of all drugs prohibited for sale in other countries like the US, the UK, EU and Australia.
The ministry of health and family welfare has suspended the manufacture and sale of all three drugs under Section 26A of the Drugs and Cosmetics Act, 1940 with immediate effect, through a notification issued on June 18, informed sources told TOI. While the ministry has been dilly-dallying on withdrawing analgin and deanxit for years now, despite pressure from a parliamentary panel, the decision on the diabetes drug pioglitazone has taken the industry completely by surprise.
The decision to ban pioglitazone and its combinations will hit the Rs 700-crore market for such drugs and adversely impact a clutch of companies including Abbott, Sun Pharma, USV, Lupin, Ranbaxy and Wockhardt.
Drugs Banned In India
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.
B35.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
READ ALSO
What is surrogacy
Walnuts Increase Male Sperm Counts and Fertility
How to Increase Your Sperm Count
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