Drugs on hold over doubts about Indian trials – The Telegraph (Calcutta)
1Regulators in several European countries are suspending marketing approval for 25 generic drugs because of concerns over the quality of data from human studies conducted by an Indian contract research company, a French medical safety agency said on Friday.
Drug regulators in Belgium, France, Germany and Luxembourg have decided to suspend the marketing authorisation for the generic drugs after they discovered “irregularities” in documents relating to human studies conducted by GVK Bio in Hyderabad.”
This decision is taken as a precaution. No element at this stage has led to establish a true risk to human health or a lack of efficacy of these drugs,” France’s National Agency for Medication Safety and Health Products, or ANSM, said on its website.
Read more – The Telegraph (Calcutta)
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Nice to hear more details about this issue. Hopefully, as is suggested in this article, there were no serious safety risks due to this (still inexcusable) behavior.