EMA Recommends Suspension of 700 Drugs Tested at GVK Site

The European Medicines Agency (EMA) has issued a recommendation that 700 medicines authorized for use in the European Union (EU) should be suspended, based on concerns about how GVK Biosciences, a contract research organization in Hyderabad, India, conducted clinical studies. GVK Biosciences, in response, argued “the action is unprecedented and highly disproportional.”

An inspection of the GVK facility by the French medicines agency (ANSM) in May 2014 revealed data manipulations of electrocardiograms (ECGs) during studies of generic drugs over a period of five years, EMA reports. ANSM concluded that there is a lack of compliance with good clinical practices, and studies conducted at GVK’s Hyderabad clinical facility could not be considered valid.

“Their [GVK Biosciences] systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the way trials were performed at the site generally and on the reliability of data generated at that site,” EMA reports in a press statement.

EMA’s Committee for Medicinal Products for Human Use (CHMP) looked at more than 1000 pharmaceutical forms and strengths of medicines studied at the GVK site and found sufficient supporting data from other sources for more than 300 products. For the 700 medicines that lack data from other studies, the CHMP recommended suspension unless the drugs are of critical importance to patients because alternatives drugs will not meet patients’ needs. CHMP noted “there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences.”

On its website, GVK Biosciences argues that the check-out ECGs are not essential for the demonstration of bioequivalence and only track the health of participants in clinical trials. The company also stated that the questioned ECG results from nine studies were extrapolated to all studies conducted at the facility, although ANSM stated “the observations made during the inspection of GVK BIO’s clinical activities in Hyderabad should not be extrapolated to other trial-related activities at the same site (bioanalytical, pharmacokinetic, and statistical activities) or to their other site in Ahmedabad, which are not directly affected by these observations.”

The national authorities of EU member states will decide whether a medicine is critical for patients depending on the situation in their country. For medicines that are considered critical, companies are given 12 months to submit additional data.

The CHMP’s recommendation will be sent to the European Commission for a legally binding decision, which will apply to all member states.

CHMP has posted a list of medicines that it recommends suspension online. EMA recommends that patients should continue to take their medicines as prescribed.

Sources:
European Medicines AgencyGVK Bioscience