HYDERABAD: European Union health regulators are investigating alleged irregularities committed by Hyderabad-based contract research and clinical trials firm GVK Bio in certifying results of human clinical trials conducted on behalf of several European generic drug manufacturers.Regulators in many European countries including Germany are reportedly evaluating whether to suspend the use of over 100 medicines, because of the suspicion that the drug makers obtained clearances based on allegedly fraudulent medical reports of human trials provided by GVK Bio. The European regulators suspect that the fraud occurred over a period of five years, between 2008 and 2013, at GVK Bio’s clinical facility in India. The attention of other European regulators may have draw because of a probe by France ’s health regulator.Acknowledging the receipt of a letter from the Franch health regulator ANSM , the Hyderabad headquartered clinical trials firm said regulators had concluded that the bioequivalence studies conducted by it were not sufficient to support marketing authorisation for the approved medicines. The crux of the problem appears to be that the French authorities have questioned the authenticity of data on ECGs on the volunteers participating in the clinical trial. GVK Bio said it had provided all relevant evidence on activities pertaining to trials.But the French regulator is not convinced as the employees who may have fudged the ECG data were also involved in other aspects of the clinical trial. “We are disappointed that despite providing detailed clarifications, unfortunately CHMP (Committee for Medicinal Products for Human use) has concluded that though the ‘check-out’ ECGs may have no direct relevance to the quality of the testing of drugs, the fact that the same employees were involved in other critical activities, left an element of doubt on the bio-equivalence results,” the company said in a statement on Friday evening.Expecting that the marketing authorisation holders would need to repeat the studies in the next 12-15 months, GVK Bio said it believes that “the studies conducted are in accordance with the GCP guidelines.” “We honour the conclusion made by CHMP,” the company said, adding that it was working with its “clinical development customers to provide new data that meets all regulatory requirements.” However the company spokesperson declined to provide details of drugs and companies involved in the probe by the regulators.