Rules and Regulations

List of Banned Drugs for Manufature, Sales and Distribution in India

There are number of drug that are banned for manufacture, sale and distribution in India. Here we are presenting a brief list of banned drugs in India for our readers:

  • All Pharmaceutical preparations containing Chloroform exceeding 0.5% w/w or v/v whichever is appropriate. 
  • Amidopyrine 
  • Antidiarrhoeal formulations containing Kaolin or Pectin or Attapulgite or Activated Charcoal. 
  • Antidiarrhoeal formulations containing Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts or esters. 
  • Antidiarrhoeal formulations containing Phthalyl Sulphathiazole or Sulphaguanidine or Succinyl Sulphathiazole. 
  • Astemizole Terfinadine 
  • Chloral Hydrate as a drug. 
  • Combination of anabolic Steroids with other drugs. 
  • Demeclocycline Liquid Oral preparations. 
  • Diclofenac and its formulations for animal use. In addition to the above-mentioned drugs, manufacture and sale of all Cosmetics and all Ayurvedic Drugs licensed as toothpaste, tooth powders containing tobacco have been prohibited 
  • Dovers Powder I.P. 
  • Dover’s Powder Tablets I.P. 
  • Fenfluramine and Dexfenfluramine. 
  • Fixed dose combination containing more than one antihistamine. 
  • 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. 
  • 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. 
  • Fixed dose combination of Analgin with any other drug Clarification
  • Fixed dose combination of anthelmintic with cathartic/purgative except for piperazine. 
  • Fixed dose combination of antidiarrhoeals with electrolytes. 
  • Fixed dose combination of centrally acting, antitussive with antihistamine, having atropine like activity in expectorants. 
  • Fixed dose combination of Cyproheptadine with Lysine or Peptone. 
  • Fixed dose combination of dextropropoxyphene with any other drug other than anti-spasmodics and/or non-steriodal anti-inflammatory drugs (NSAIDS). 
  • Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride. 
  • Fixed dose combination of Ethambutol with INH other than the following: INH Ethambutol 200 mg. 600 mg. 300 mg. 800 mg. 
  • Fixed dose combination of haemoglobin in any form (natural or synthetic). 
  • Fixed dose combination of haemoglobin in any form (natural or synthetic). 
  • Fixed dose combination of Haloperidol with any anti-cholinergic agent including Propantheline Bromide. 
  • Fixed dose combination of Histamine H-2 receptor antagonists with antacids except for those combinations approved by Drugs Controller, India. 
  • Fixed dose combination of laxatives and/or anti-spasmodic drugs in enzyme preparations. 
  • Fixed dose combination of Loperamide Hydrochloride with Furazolidone. 
  • Fixed dose combination of Metoclopramide with other drugs except combination of Metoclopramide with Aspirin/ Paracetamol 
  • Fixed dose combination of Metoclopramide with systemically absorbed drugs except fixed dose combination of metoclopramide with aspirin/paracetamo 
  • Fixed dose combination of Nalidixic Acid with any anti-amoebic including Metronidazole. 
  • Fixed dose combination of Nitrofurantoin and trimethoprim. 
  • 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. 
  • Fixed dose combination of Oxyphenbutazone or Phenylbutazone with any other drug. 
  • Fixed dose combination of Pancreatin and Pancrelipase containing amylase, protease and lipase with any other enzyme. 
  • Fixed dose combination of Pancreatin and Pancrelipase containing amylase, protease, and lipase with any other enzyme. 
  • Fixed dose combination of Phenobarbitone with any anti-asthmatic drug. 
  • Fixed dose combination of Phenobarbitone with Ergotamine and/or Belladona. 
  • Fixed dose combination of Phenobarbitone with Hyoscin and/or Hyoscyamine. 
  • Fixed dose combination of Rifampicin, Isoniazid and Pyrazinamide, except few 
  • Fixed dose combination of Salbutamol or any other bronchodilator with centrally acting anti-tussive and/or antihistamine. 
  • Fixed dose combination of Vitamin B1, Vitamin B6 and Vitamin B12 for human use 
  • Fixed dose combinations of antihistaminic with anti-diarrhoeals. 
  • Fixed dose combinations of Atropine and Analgesic and Antipyretics. 
  • Fixed dose combinations of Chloramphenicol with any other drug for internal use. 
  • Fixed dose combinations of Corticosteroid with any other drug for internal use except for preparations meant for meter dose inhalers and dry powder inhalers. 
  • Fixed dose combinations of crude Ergot preparation except those containing Ergotamine, Caffeine, analgesics, antihistamines for the treatment of migraine, headache. 
  • Fixed dose combinations of Hydroxyquinoline group of drugs with any other drug except for preparations meant for external use only. 
  • Fixed dose combinations of Iron with Strychnine, Arsenic and Yohimbine. 
  • Fixed dose combinations of Penicillin with Sulphonamides. 
  • Fixed dose combinations of Pyrazinamide, other anti-tubercular drugs except combination of Pyrazinamide with Rifampicin and INH per recommended daily dose 
  • Fixed dose combinations of Sedatives/ hypnotics/anxiolytics with analgesics-antipyretics. 
  • Fixed dose combinations of Sodium Bromide/chloral hydrate with other drugs. 
  • Fixed dose combinations of Strychnine and Caffeine in tonics. 
  • Fixed dose combinations of Tetracycline with Vitamin C. 
  • Fixed dose combinations of Vitamins with Analgesics. 
  • Fixed dose combinations of Vitamins with Anti TB drugs except combination of Isoniazid with Pyridoxine Hydrochloride (Vitamin B6). 
  • Fixed dose combinations of vitamins with anti-inflammatory agents and tranquilizers. 
  • Fixed dose combinations of Yohimbine and Strychnine with Testosterone and Vitamins. 
  • 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. 
  • Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing halogenated hydroxyquinolines. 
  • 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. 
  • Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception. 
  • Methapyrilene, its salts. 
  • Methaqualone 
  • Nialamide. 
  • Oxytetracycline Liquid Oral preparations. 
  • Parenteral preparations containing fixed dose combination of streptomycin with penicillins 
  • Patent and Proprietary Oral Rehydration Salts other than those conforming to the following parameters: 
  • Penicillin skin/eye Ointment. 
  • Phenacetin. 
  • Phenformin for human use. 
  • Practolo. 
  • Preparations claiming to combat cough associated with asthma containing centrally acting antitussive and/ or an antihistamine. 
  • Rofecoxib and its formulations for human use. 
  • Tetracycline Liquid Oral preparations. 
  • 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. 
  • Valdecoxib and its formulations for human use.

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