India drug authorities are mounting a full-court press against their European counterparts in defense of GVK Biosciences, a contract research organization under fire for alleged manipulation of trial data. The pushback includes a threat to sue and another to take the matter to the World Trade Organization.
|India Commerce Secretary Rajeev Kher|
An unnamed official who may have been India Commerce Secretary Rajeev Kher told The Hindu that India was prepared to sue the European Union or its member countries as well as file a formal protest with the WTO. The official said India has presented "evidence" to the European authorities proving that GVK did not manipulate trial data.
The matter stems from 9 India trials conducted by GVK at one of its facilities between 2008 and last August when France's Agency for Medicines and Health Products Safety (ANSM) declared after inspections of the facility that the CRO had manipulated electrocardiogram data over the previous years in generic-drug studies. In response, the European Medicines Agency in January recommended suspension of all GVK-studied drugs from the EU markets.
GVK, in turn, called the European action "unprecedented and highly disproportional," noting the ANSM's own statements that the alleged infractions did not risk anyone's health. GVK promised "an appropriate and quick resolution to these issues."
According to Kher, GVK has won the backing of the India government in pressing the company's case to have the actions overturned and the firm exonerated. He added that GVK was not the only India company slurred by the actions, that drugmakers whose drugs were studied were also affected, several of them multinationals. All have provided ample evidence to European authorities showing the allegations were false, Kher said.