Indian company found to be manipulating data
European Union countries have until 20 August to suspend the sale of 700 generic drugs made by Indian company GVK Biosciences (GVK Bio), after the firm was found to be manipulating data, the European Commission said.
The firm was hired by drug companies to test whether the impact of generic versions of drugs was equal to the original, but investigations last year showed irregularities in all nine trials inspected.
The European Medicines Agency (EMA) said the problems, 'which stretched back years, highlight critical deficiencies in the quality system in place' at the company.
Specifically, GVK Bio had been manipulating electrocardiograms (ECGs) at its site in Hyderabad, according to Francois Herbert, Deputy Head of France’s National Agency for Medicines and Health Products Safety (ANSM), which carried out the inspections.
But the Commission said there is no reason to believe the drugs, including common pain reliever ibuprofen, had caused any health issues. A few have been re-authorised based on data from other labs.
The EMA recommended suspension in May this year, but several European countries, including France, Germany, Belgium and Luxembourg, had already begun blocking sales as early as December 2014.