With reference to the report headlined “A love story that cost GVK its international reputation” (Oct.9, 2015), GVK Biosciences Ltd. has written to deny that “a torrid love affair between two employees resulted in the international scrutiny of GVK Biosciences and a ban on marketing of around 700 generic drugs tested by the facility.” The company reiterated (as in its statement published as a part of the report) that the ex-employee was not dismissed by it; he resigned in September 2011 to sort out personal issues. The company insisted in its statement that he was no whistle-blower but a “disgruntled employee”.
The company added that the inspection that was triggered in 2012 based on his e-mails did not reveal any irregularities in the clinical studies and that all the international regulators cleared the clinical studies at the company. “There was nothing further to it,” said the company.
The company further stated that the EU ban on drugs manufactured by GVK Biosciences was with respect to allegations made by the ANSM [National Agency for Medicines and Health Products Safety] inspector in May 2014 on the checkout ECGs conducted in the studies. This was a regular inspection and had no connection with the ex-employee’s e-mails, the company added.