The European Union (EU) has banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by Hyderabad-based GVK Biosciences. The German regulator, Federal Institute for Medicines and Medical Products (BfArM), said the EU-wide suspension of sales and distribution of generic drugs will come into effect on August 21 and will be applicable to all 28 member nations.
FE had first reported on September 26, 2014, that GVK Bio had received a letter from the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh), a European drug agency, along with France-based Agency for Medicines and Health Products Safety (ANSM), following a ‘good clinical practice’ (GCP) inspection citing deficiencies that stretch back to 2008. The French drug regulator ANSM found out during a routine control of medical reports earlier this year that GVK Bio had forged the outcome of a study of a heart drug.
In a statement made by the German regulator, 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, drug stores and other outlets, the agency said. Pharmaceutical companies can appeal against the suspension of marketing approvals, but it will have no immediate effect and the ban will remain in force, the statement said. EU member states now have to implement this in accordance with the decision.
“GVK Bio is disappointed with the fact that even after multiple appeals, a deeper scientific dialogue was not undertaken. GVK Bio will continue to work with the government of India and our customers to help resolve this,” a GVK Bio spokesperson 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 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”.