EU bans 700 generic drugs for manipulation of trials by GVK
The European Union has banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by India’s pharmaceutical research company GVK Biosciences. The largest EU-wide suspension of sales and distribution of generic drugs ordered by the European Commission will come into effect on August 21 and it will be applicable to all 28 member nations, according to Germany’s drug regulator, the Federal Institute for Medicines and Medical Products (BfArM). Medicines affected by the sales ban will lose their validity for use in the EU from that date and they should no longer be distributed or sold by pharmaceutical companies, wholesale dealers, drugs stores and other outlets, the agency based in Bonn said in a press statement on Thursday. Pharmaceutical companies have the possibility to appeal against the suspension of marketing approvals, but it will have no immediate effect and the ban will remain in force, the statement said. The commission’s decision taken last week is in response to a recommendation by the EU drug regulator European Medicines Agency (EMA) in January that marketing authorisation of these drugs should be suspended as they were based on clinical trial data allegedly manipulated by the Hyderabad- based company. EMA’s Committee for Medicinal Products for Human Use (CHMP) had examined the marketing authorisation given to over 1,000 generic drugs from EU member nations on the basis of bio-equivalence studies conducted by GVK Bio during the period between 2004 and 2014 after an inspection of the company’s facility in Hyderabad by the French Medicines Agency (ANSM) in May, last year showed “systematic manipulation of clinical trial data.” The inspection revealed “data manipulation of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appeared to have taken place over a period of at least five years,” London-based EMA said in a statement earlier. “Their systematic nature, the extended period of time during which they took place and the number of member of staff involved cast doubt on the integrity of the conduct of the trials at the site generally and on the reliability of data generated,” the agency said.
July 25, 2015 | 7:59 pm IST.