European Union bans 700 GVK drugs for fraud trials
The European Union has banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by pharmaceutical...
The European Union has banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by 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 Medic-ines 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.
15 Dec 2019 7:43 AM GMT