Drugs and Fixed Dose Combinations Banned in India
Single drug preparations (or combinations of)
- Amidopyrine
- Phenacetin
- Nialamide
- Methaqualone
- Methapyriline (and its salts)
- Practolol
- Penicillin skin/ eye ointment
- Tetracycline/Oxytetracycline/Demeclocycline liquid oral preparations
- Chloral hydrate
- Dover’s powder and Dover’s powder tablets IP
- Chloroform exceeding 05% w /w or v /v in pharmaceutical preparations
- Mepacrine HCl (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception
- Fenfluramine
- Dexfenfluramine
- Terfenadine
- Astemizole
- Phenformin
- Rofecoxib
- Valdecoxib
Fixed dose combination with any other drug
- Corticosteroids with any other drug for internal use
- Chloramphenicol with any other drug for internal use
- Sodium bromide/chloral hydrate with other drugs
- Ergot with any drug except preparations containing ergotamine, caffeine, analgesics, antihistamines for treatment of migraine
- Anabolic steroids with other drugs
- Metoclopramide with other drugs (except with aspirin/ paracetamol)
- 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
- Hydroxyquinolines with any other drug except in preparations for external use
- Oxyphenbutazone or phenylbutazone with any other drug
- Dextropropoxyphene with any other drug except antispasmodics and/ or NSAIDs
- Analgin (metamizol) with any other drug
Fixed dose drug combinations of
- Penicillins with Sulfonamides
- Tetracyclines with vitamin C
- Antitubercular drugs with Vitamins (except Isoniazid with Pyridoxine HCl)
- Vitamins with Analgesics/ Antiinflammatory drugs
- Vitamins with Tranquillisers
- Atropine and Analgesic-antipyretics
- Yohimbine and Strychnine with Testosterone and Vitamins
- Strychnine and Caffeine in tonics
- Iron with Strychnine, Arsenic and Yohimbine
- Antihistaminics with Antidiarrhoeals
- More than one Antihistamine in the same preparation
- Sedatives/Hypnotics/ Anxiolytics with Analgesic-antipyretics
- Hz receptor antagonists with Antacids (except those combinations approved by Drugs Controller, India)
- Anthelmintics (except Piperazine) with a Cathartic/Purgative
- Salbutamol (or any other bronchodilator) with centrally acting Antitussive and/ or an Antihistamine
- Centrally actingAntitussives with Antihistamines having atropine like activity in expectorants
- Centrally acting Antitussive and/or Antihistamine in preparations for cough associated with asthma
- Laxatives and/or antispasmodic drugs in enzyme preparations
- Glycerophosphates and/ or other phosphates, and / or CNS stimulant in liquid oral tonics
- Estrogen and Progestin (other than oral contraceptives) containing per tablet estrogen more than 50 pg ethinylestradiol (or equivalent) and progestin more than 3 mg of norethisterone acetate (or equivalent), and all fixed dose combination injectable preparations containing synthetic estrogen and progesterone
- Ethambutol with Isoniazid, except in the following daily doses:
– Isoniazid 200 mg + Ethambutol 600 mg or
– Isoniazid 300 mg + Ethambutol 800 mg - Pyrazinamide with other antitubercular drugs, except that which provide the following daily doses:
– Rifampicin 450 to 600 mg
– Isoniazid 300 to 400 mg
– Pyrazinamide 1000 to 1500 mg - Essential oils with Alcohol having percentage higher than 20% proof (except preparations given in the IP)
- Liquid oral tonic preparations containing alcohol more than 20% proof
- Streptomycin with penicillin in parenteral preparation
- Antidiarrhoeals containing adsorbants like kalolin, pectin, attapulgite, activated charcoal etc
- Antidiarrhoeals containing phthalylsulfathiazole, succinyl sulfathiazole, sulfaguanidine, neomycin, streptomycin, dihydrostreptomycin
- Antidiarrhoeal formulations for pediatric usecontaining diphenoxylate, loperamide, atropine, hyoscyamine, halogenated hydroxyquinolines
- Antidiarrhoeals with electrolytes
- Fixed dose combinations of haemoglobin in any form
- Pancreatine or pancrelipase containing amylase, protease and lipase with any other enzyme
- Oral rehydration salts other than those conforming to the following parameters:
– Oral rehydration salts on reconstitution to one litre shall contain: sodium-50 to 90 mM; total osmolarity-240 to 290 mOsm; dextrose: sodium molar raticr-not less than 1 : 1 and not more than 3:1
– Cereal based ORS on reconstitution to one litre shall contain: total osmolarity not more than 2900 mOsm Precooked rice equivalent to not less than 50 g and not more than 80 g as total replacement of dextrose
– ORS may contain amino acids in addition to ORS conforming to the parameters specified above and labelled with the indication for”Adult Cholera tic Diarrhoea” only
– ORS shall not contain mono or polysaccharides or saccharin sweetening agent - A drug, standards of which are prescribed in the 2″ schedule to Drugs and Cosmetics Act with an Ayurvedic, Siddha or Unani drug
- Vitamin B1, vit B6, and vit B12 for human use
- Diazepam with diphenhydramine HCl
- Nitrofurantoin with trimethoprim
- Phenobarbitone with any antiasthmatic drug, or with hyoscine and/ or hyoscyamine, or ergotamine and I or belladonna
- Haloperidol with any anticholinergic agent including propantheline Br
- Nalidixic acid with any antiamoebic including metronidazole
- Loperamide with furazolidone
- Cyproheptadine with lysine or peptone
