rix e t p d a hn ACppe II 1.4 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 List of Banned Drugs and Fixed Dose Pharmacodynamics Combinations India (Mode of Action ofin Drugs) (Updated till January 2007) Amidopyrine Fixed dose combinations of vitamins with antiinflammatory agents and tranquilizers Fixed dose combinations of atropine and analgesics and antipyretics Fixed dose combinations of strychnine and caffeine in tonics Fixed dose combinations of yohimbine and strychnine with testosterone and vitamins Fixed dose combinations of iron with strychnine, arsenic and yohimbine Fixed dose combinations of sodium bromide/chloral-hydrate with other drugs Phenacetin Fixed dose combinations of antihistaminics with antidiarrhoeals Fixed dose combinations of penicillin with sulphonamides Fixed dose combinations of vitamins with analgesics Fixed dose combinations of tetracyclines with vitamin C Fixed dose combinations of hydroxyquinoline group of drugs with any other drug except for preparations meant for external use only Fixed dose combinations of corticosteroids with any other drug for internal use Fixed dose combinations of chloramphenicol with any other drug for internal use Fixed dose combinations of crude ergot preparations except those containing ergotamine, caffeine, analgesics, antihistamines for the treatment of migraine, headache Fixed dose combinations of vitamins with anti TB drugs except combination of isoniazid with pyridoxine hydrochloride (vitamin B6) Penicillin skin/eye ointment Tetracycline liquid oral preparations Nialamide Practolol Methapyrilene, its salts Methaqualone Oxytetracycline liquid oral preparations Demeclocycline liquid oral preparations Contd.… Appendices 474 …Contd 26 Combinations of anabolic steroids with other drugs 27 Fixed dose combinations of estrogen and progestin (other than oral contraceptive) containing per tablet estrogen content of more than 50 mcg (equivalent to ethinyl estradiol) and of progestin content of more than mg (equivalent to norethisterone acetate) and all fixed dose combination injectable preparations containing synthetic estrogen and progesterone 28 Fixed dose combination of sedatives/hypnotics/ anxiolytics with analgesics-antipyretics 29 Fixed dose combination of pyrazinamide with other antitubercular drugs except combination of pyrazinamide with rifampicin and INH as per recommended daily dose given below: Drugs Rifampicin INH Pyrazinamide Minimum 450 mg 300 mg 1000 mg Maximum 600 mg 400 mg 1500 mg 30 Fixed dose combination of histamine H2-receptor antagonists with antacids except for those combinations approved by the 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 200 mg 300 mg Ethambutol 600 mg 800 mg 34 Fixed dose combination containing more than one antihistaminic 35 Fixed dose combination of any anthelmintic with cathartic/purgative except piperazine 36 Fixed dose combination of salbutamol or any other bronchodialator with centrally acting antitussive and/or antihistaminics 37 Fixed dose combination of laxatives and/or anti-spasmodic drugs in enzyme preparations 38 Fixed dose combination of metoclopramide with systemically absorbed drugs except fixed dose combination of metoclopramide with aspirin/paracetamol 39 Fixed dose combination or centrally acting antitussive with antihistaminics having atropine like activity in expectorants 40 Preparations claiming to combat cough associated with asthma containing centrally acting antitussive and/or antihistaminics 41 Liquid oral tonic preparations containing glycerophosphates and/or other phosphates and/or central nervous system stimulant and such preparations containing alchohol 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 43 Chloral Hydrate as a drug 44 Dover’s powder IP 45 Dover’s powder tablets IP 46 Antidiarrhoeal formulations containing kaolin or pectin or attapulgite or activated charcoal 47 Antidiarrhoeal formulations containing phthalyl sulfathiazole or sulfaguanidine or succinyl sulphathiazole Contd.… Appendix-II List of Banned Drugs and Fixed Dose Combinations in India 475 …Contd 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 paediatric use containing diphenoxylate or atropine or belladonna including their salts and esters or metabolites, hyoscyamine or their extracts or their alkaloids 50 Liquid oral antidiarrhoeals of any other dosage form for paediatric use containing halogenated hydroxyquinolines 51 Fixed dose combination of anti-diarrhoeals with electrolytes 52 Patent and proprietary oral rehydration salts other than those conforming to the specified parameters 53 Fixed dose combination of oxphenbutazone or phenylbutazone with any other drug 54 Fixed dose combination of analgin with any other drug 55 Fixed dose combination of dextropropoxyphene with any other drug other than anti-spasmodics and/ or non-steroidal antiinflammatory 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 57 Mepacrine hydrochloride (Quinacrine and its salts) in any dosage form for female sterilization or contraception 58 Fenfluramine and dexfenfluramine 59 Fixed dose combination of diazepam and diphenhydramine hydrochloride 60 Cosmetics licensed as toothpaste/tooth powder containing tobacco 61 Parenteral preparations containing fixed dose combination of streptomycin with penicillin 62 Fixed dose combination of vitamin B1, vitamin B6, and vitamin B12 for human use 63 Fixed dose combination of haemoglobin in any form (natural or synthetic) 64 Fixed dose combination of pancreatin or pancrelipase containing amylase, protease and lipase with any other enzyme 65 Fixed dose combination of nitrofurantoin and trimethoprim 66 Fixed dose combination of phenobarbitone with any anti-asthamatic drugs 67 Fixed dose combination of phenobarbitone with hyoscine and/or hyoscyamine 68 Fixed dose combination of phenobarbitone with ergotamine and/or belladona 69 Fixed dose combination of haloperidol with any anti-cholinergic agent including propantheline bromide 70 Fixed dose combination of nalidixic acid with any anti-amoebics including metronidazole 71 Fixed dose combination of loperamide hydrochloride with furazolidone 72 Fixed dose combination of cyproheptadine with lysine or peptone 73 Astemizole 74 Terfenadine 75 Phenformin 76 Rofecoxib 77 Valdecoxib & its formulation List of drugs and fixed dose combination prohibited for manufacturing and sale through Govt of India (Ministry of Health & Family Welfare) Gazette notification GSR 578 (E) Dated 23-7-83 Amended from time to time (Published in the Gazette of India, Extraordinary Part-II; Section Subsection (i), Ministry or Health & Family Welfare, Govt of India notification) This page intentionally left blank Index Index A Abciximab 246 Abrasions 12 Absorption 25, 26 Acacia Acarbose 277, 280 Accelerin 240 Aceclofenac 84, 90 Acenocoumarol 244, 245 Acetazolamide 204, 207, 304 Acetyl salicyclic acid 84 Acetyl stropanthidin 171 Acetylcholine 112, 154, 156 Acetyl-CoA 32 Acetylcysteine 230, 231 Acromegaly 270 Acute barbiturate poisoning 71 Acute iron poisoning 249 Acyclovir 337, 338 Addison’s disease 271, 284 Adenochrome monosemicarbazone 241 Adrenaline 125, 133, 190, 232 Adrenergic receptors 131 Adrenocorticotrophic hormone (ACTH) 269, 271 Aerosols 6, 10, 14 Affinity 43 Agonists 43 Albendazole 361, 362 Aldosterone 281, 282 Aldosterone antagonist 204, 208 Alfacalcidol 383, 385 Alkaloids Alkylating agents 372 Allopurinol 84, 94 Allylestrenol 289 Alpha blockers 145, 148 Alpha receptors 131 Alphadone 66 Alprazolam 70, 73, 99 Alprenolol 148, 151 Alprostadil 149 Aluminium hydroxide gel 261, 263 Alzheimer’s disease 121 Amantadine 125, 126, 338 Amikacin 327, 329, 365 Amiloride 204, 207 Aminophylline 204 Amiodarone 190, 192 Amitriptyline 101 Amlodipine 176, 183 Ammonium chloride 204, 210, 231 Amodiaquine 350 Amoebiasis 355 Amoxycillin 318, 320 Amphetamine 119, 138 Amphotericin-B 345 Ampicillin 318, 320 Amrinone 173 Amyl nitrate 186 Anabolic steroids 289, 290 Anaemia 247, 388 Analeptics 119 Anaphylactic reaction 48 Androgens 289, 290 Angina pectoris 185 Angiotensin antagonists 181 Antacids 261 Antagonism 54 Anterior pituitary hormones 269 Antiandrogens 290, 291 Anticholinergics 68, 161, 234 Anticholinesterases 158 Anticoagulants 243 Antidepressents 95, 99 Antiemetics 68, 257 Antiestrogens 285, 287 Antihaemophilic factor 240 Antimetabolites 374 Antimuscarinics 164 Antiparkinsonism 218 Antiprogestin 289 Antisnake venom Antitussive 231 ... Antidiarrhoeal formulations containing neomycin or streptomycin or dihydrostreptomycin including their respective salts or esters 49 Liquid oral antidiarrhoeals or any other dosage form for paediatric... peptone 73 Astemizole 74 Terfenadine 75 Phenformin 76 Rofecoxib 77 Valdecoxib & its formulation List of drugs and fixed dose combination prohibited for manufacturing and sale through Govt of India... hyoscyamine or their extracts or their alkaloids 50 Liquid oral antidiarrhoeals of any other dosage form for paediatric use containing halogenated hydroxyquinolines 51 Fixed dose combination of anti-diarrhoeals