Thursday, 16 February 2012

A list of fixed dose combinations of drugs banned for marketing in India

Up to date there are several Fixed Dose Combinations that have been banned for marketing, distribution and manufacturing in India; Several reasons such as eports of diseases, uneficacy and side effects have lead to the removal of drug combinations from the market. Such combinations are:
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.
 
Fixed dose combinations of vitamins with anti-inflammatory agents and tranquilizers.
 
Fixed dose combinations of Atropine in 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.
 
Fixed dose combinations of antihistaminic with anti-diarrhoeals.
 
Fixed dose combinations of Penicillin with Sulphonamides.
 
Fixed dose combinations of Vitamins with Analgesics.
 
Fixed dose combinations of  any other Tetracycline with Vitamin C. 
 
Fixed dose combinations of Hydroxyquinoline group of drugs with any other drug except for preparations meant for external use.
 
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, headaches.
 
Fixed dose combinations of Vitamins with Anti TB drugs except combination of Isoniazid with Pyridoxine Hydrochloride (Vitamin B6).
 
Fixed dose combination of Sedatives/ hypnotics/anxiolytics with   analgesics-antipyretics.
 
Fixed dose combination of Histamine H-2 receptor antagonists with antacids except for those combinations approved by Drugs Controller, India.
 
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.
 
All Pharmaceutical preparations containing Chloroform exceeding 0.5% w/w or v/v whichever is appropriate.
 
Fixed dose combination of Ethambutol with INH other than the following: INH Ethambutol 200 mg. 600 mg. 300 mg. 800 mg.
 
Fixed dose combination containing more than one antihistamine.
 
Fixed dose combination of any anthelmintic with cathartic/purgative except for piperazine/Santonim.
 
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 laxatives and/or anti-spasmodic drugs in enzyme preparations.
 
Fixed dose combination of Metoclopramide with systemically absorbed drugs except fixed dose combination of metoclopramide with aspirin/paracetamol.
 
Fixed dose combination of centrally acting, antitussive with antihistamine, having high atropine like activity in expectorants.
 
Preparations claiming to combat cough associated with asthma containing centrally acting antitussive and/ or an antihistamine.
 
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.
 
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.
 
Fixed dose combination of antidiarrhoeals with electrolytes.
 
Fixed dose combination of Oxyphenbutazone or Phenylbutazone with any other drug.
 
Fixed dose combination of Analgin with any other drug.
 
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 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 Diazepam and Diphenhydramine Hydrochloride.

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