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There are several Drugs that for different reasons have been banned for marketing, distribution and manufacturing in India; Side effects, eports of diseases, uneficacy between others, have lead to the removal of some drugs from the market. The latest drugs banned from the Indian market are: Amidopyrine. Antidiarrhoeal formulations containing Kaolin or Pectin or Attapulgite or Activated Charcoal. Antidiarrhoeal formulations containing Phthalyl Sulphathiazole or Sulphaguanidine or Succinyl Sulphathiazole. Antidiarrhoeal formulations containing Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts or esters. Belladona including their salts or esters or metabolites Hyoscyamine or their extracts or their alkaloids. Combination of anabolic Steroids with other drugs. Chloral Hydrate as a drug. Demeclocycline Liquid Oral preparations. Dovers Powder I.P. Dover’s Powder Tablets I.P. Fenfluramine and Dexfenfluramine. Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing Diphenoxylate Lorloperamide or Atropine or Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing halogenated hydroxyquinolines. Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception. Methapyrilene, its salts. Methaqualone.
Dte.Nialamide. Oxytetracycline Liquid Oral preparations Phenacetin.GHS. Rimonabant. Ministry of Health and Family Welfare. Penicillin skin/eye Ointment. Government of India Central Drugs Standard Control Organization Archive Feedback downloads Home Site Map Contact Drugs Banned In India . Rosiglitazone Sibutramine and R-Sibutramine Tetracycline Liquid Oral preparations. Practolol.
Phenacetin. Tetracycline Liquid Oral preparations. headaches.Fixed dose combinations of Vitamins with Anti TB drugs except combination of Isoniazid with Pyridoxine Hydrochloride (Vitamin B6).Fixed dose combinations of Hydroxyquinoline group of drugs with any other drug for preparations meant for external use. analgesics.Fixed dose combinations of Yohimbine and Strychnine with Testosterone and Vitamins. Fixed dose combinations of Iron with Strychnine. 4. except ccc ccc . Fixed dose combinations of vitamins with anti-inflammatory agents and tranquilizers. Fixed dose combinations of Vitamins with Analgesics. 2. 7. 11. 3. Fixed dose combinations of Corticosteroids with any other drug for internal use. antihistamines for the treatment of migraine. 14. 5. 16. 18. 19. Amidopyrine. 8. 10. Fixed dose combinations of Chloramphenicol with any other drug for internal use. Caffeine. 15.Fixed dose combinations of any other Tetracycline with Vitamin C. Fixed dose combinations of antihistaminic with anti-diarrhoeals. Arsenic and Yohimbine. 17. B E 12. 6. Fixed dose combinations of Penicillin with Sulphonamides. 9.Fixed dose combinations of crude Ergot preparations except those containing Ergotamine. Fixed dose combinations of Atropine in Analgesics and Antipyretics. 13.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. Fixed dose combinations of Sodium Bromide/chloral hydrate with other drugs. Penicillin skin/eye Ointment. Fixed dose combinations of Strychnine and Caffeine in tonics.
22. Fixed dose combination containing more than one antihistamine. Fixed dose combination of Histamine H-2 receptor antagonists with antacids except for those combinations approved by Drugs Controller.Fixed dose combination of Rifampicin. Demeclocycline Liquid Oral preparations. its salts. except those which provide daily adult dose given below: Drugs Rifampicin Isoniazid Pyrazinamide * 1000mg Minimum 450 mg Maximum 600 mg * J* 300 mg 400 mg 1500 mg 30.Fixed dose combination of Sedatives/ hypnotics/anxiolytics with analgesics-antipyretics. Methaqualone. ** 34. . 800 mg. Practolol. & 25. * * ** 33.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. 31. 24.Fixed dose combination of Ethambutol with INH other than the following: INH Ethambutol 200 mg. 21. By Noti. 32. 600 mg. India. All Pharmaceutical preparations containing Chloroform exceeding 0. 743 (E) dt 10-08-1989) 28. Methapyrilene.20.5% w/w or v/v whichever is appropriate. (Subs. c & 23. isoniazid and Pyrazinamide. Oxytetracycline Liquid Oral preparations. 27.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. T cc 26. Nialamide. 29. 300 mg. No. Combination of anabolic Steroids with other drugs.
Dovers Powder I. ** 37. of any anthelmintic with cathartic/purgative except for J **36.Antidiarrhoeal formulations containing Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts or esters.Preparations claiming to combat cough associated with asthma containing centrally acting antitussive and/ or an antihistamine. Patent and Proprietary Oral Rehydration Salts other than those conforming to the . Dover’s Powder Tablets I. 46. ** 41. having high atropine like activity in expectorants.B**35. Fixed dose combination of antidiarrhoeals with electrolytes. A 48. *** 43. Fixed dose combination of Salbutamol or any other drug having primarily bronchodilatory activity with centrally acting anti-tussive and/or antihistamine.Fixed dose combination of centrally acting. ** 42.P.Antidiarrhoeal formulations containing Kaolin or Pectin or Attapulgite or Activated Charcoal.Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing halogenated hydroxyquinolines.Antidiarrhoeal formulations containing Phthalyl Sulphathiazole or Sulphaguanidine or Succinyl Sulphathiazole.Fixed dose combination piperazine/Santonim.Fixed dose combination of laxatives and/or anti-spasmodic drugs in enzyme preparations. b b A 44.P.Fixed dose combination of Metoclopramide with systemically absorbed drugs except fixed dose combination of metoclopramide with aspirin/paracetamol ** 39. Chloral Hydrate as a drug.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. 45. A 51. A 49. ** 40.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. G** 38. A 47. antitussive with antihistamine.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. C 52.
Human Placental Extract and its formulations for human use. Amidopyrine 4. and M 67. Rimonabant. D 55. Tegaserod and its formulation for human use.D54. L 61 Rosiglitazone M 62 Nimesulide formulations for human use in children below 12 years of age. Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception.D 53. LIST OF DRUGS PROHIBITED FOR IMPORT 1. standards of which are prescribed in the Second Schedule to the said Act with an Ayurvedic. M 64. Sibutramine and its formulations for human use. Cisapride and its formulations for human use. Fixed dose combination of a drug. Fixed dose combination of Oxyphenbutazone or Phenylbutazone with any other drug. M 65. M 66. Fenfluramine and Dexfenfluramine. F 58. N 68. K 60. H. Siddha or Unani drug. Phenylpropanolamine and its formulation for human use. D 56. Gatifloxacin formulation for systemic use in human by any route including oral and injectable N 69. M 63. Practolol 3. F 57. I 59. Fixed dose combination of dextropropoxyphene with any other drug other than antispasmodics and/or non-steriodal anti-inflammatory drugs (NSAIDS). Nialamide 2. Phenacetin . R-Sibutramine and its formulations for human use. Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride . Fixed dose combination of Analgin with any other drug.
2000 GSR 814(E) dt.99 Effective date Notification GSR 444(E) dt. 6. 1. Methapyrilene and its salts a 18.104.22.168 GSR 814(E) dt. Chloral Hydrate as a drug c 8. protease and lipase with any other enzyme.25.99 Jan 1.92 GSR 93(E) dt.Cosmetics Licensed as toothpaste/tooth powder containing tobacco. Mepacrine Hydrochloride ( Quinacrine and its Salts) in any dosage form for use for female sterilization or contraception.2002 GSR 170(E) Sept.12.2.1998 . Methaqualone b 7.Fixed dose combination of Pancreatin or Pancrelipase containing amylase. 22.214.171.124 With immediate effect Jan 1. Fenfluramine and Dexfenfluramine] d 10. Vitamin B6 and Vitamin B12 for human use 4.12.14. Fixed dose combination of Nitrofurantoin Jan 1. 5.Fixed dose combination of haemoglobin in any form (natural or synthetic). 9.2000 Sep 1.4.Fixed dose combination of Vitamin B1.2001 GSR 702(E) dt.10. Rimonabant DRUGS PROHIBITED FOR MANUFACTURE .Parenteal Preparations fixed dose combination of streptomycin with Pencillin 3. SALE AND DISTRIBUTION FROM SUBSEQUENT DATE Drugs Formulation 1.
01 GSR 170(E) dt.and trimethoprim.1.1.12.03 15.12. 12.01 GRS 170(E) dt.2002 Jan 126.96.36.199.Fixed dose combination of Phenobarbitone with Hyoscin and/or Hyoscyamine 9.2002 Jan 1. 13.01 GSR 170(E) dt.3.03 16.03 17.2002 Jan 1.2003 GSR 191(E) dt. 188.8.131.52.3. 7.Fixed dose combination of Loperamide Hydrochloride with Furazolidone 13.Fixed dose combination of Phenobarbitone with Ergotamine and/or Belladona 10.2003 GSR 780(E) dt.2002 Jan 1.12.Astemizole Apr.01 GSR 170(E) dt.2003 Jan 1.Rafecoxib Dec 13.01 GSR 170(E) dt.184.108.40.2065 .2003 Jan 1.Fenformin Oct.2002 Jan 1.2002 dt.01 GSR 170(E) dt. 14.01 GSR 191(E) dt.10.Valdecoxib July 25.12.3.Terfinadine Apr.5.Fixed dose combination of Phenobarbitone with any anti-asthmatic drugs.1. 11.3.04 GSR 510(E) 18.Fixed dose combination of Haloperidol with any anti-cholinergic agent including Propantheline Bromide.3.12.Fixed dose combination of Cyproheptadine with Lysine or Peptone.2004 GSR 810(E) dt.3.12.01 GSR 170(E) dt.Fixed dose combination of Nalidixic Acid with any anti-amoebic including Metronidazole.
2008 dt.4.08 .05 GSR 499(E) dt.07.Diclofenac and its formulations for animal use July 4.07.and it's formulation 19. 25.
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