INDIAN DRUGS WITHDRAWN FOR TESTING IRREGULARITIES

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At the request of the European Medicines Agency, the Spanish Ministry of Health has suspended the sale of 29 generic medicinal drugs after finding that the company who provide them have been using unauthorised practices prior to them being approved for sale.

However, the Ministry has stressed that there is no evidence of any risk to patients taking the medication as the chemical compound is exactly the same as those drugs which are approved, and that treatment should continue as normal for those who are in possession of the drugs.

An audit of over 1,000 presentations of generic drugs was carried out by the health department, resulting in the withdrawal of the 29 different drugs manufactured by the GVK Biosciences company in Hyderabad, India, where evidence of a breach of the rules of Good Clinical Practice in bioequivalence studies were found.

The drugs in question are a range of antihistamines such as ‘Ebastina’ or ‘Desloratadina’, antihypertensive ‘Valsartán/hidroclorotiazida’ or ‘Irbesartán/hidroclorotiazida’, the antidepressant ‘Escitalopram’, antidiabetic ‘Repaglinida’ and Alzheimer´s treatment ‘Donepezilo’, amongst others.

Once again though, it is stressed that there is no evidence that the drugs are harmful and patients should continue treatment, the action is as a sanction towards the company and is not for the protection of the public.

Filed under: http://www.theleader.info/article/46245/

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