EMA recommends sale suspension of medicines based on GVK Bio’s ‘flawed’ clinical data

The European drug regulator said that the authorization was given based on ‘flawed studies’ conducted by the Indian company.

European Medicines Agency said that the recommendation for the suspension of the generic drugs is based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad facilities on behalf of marketing authorisation holders.

Earlier, French regulators which had raised concern over the ways studies conducted at the GVK Biosciences’ facilities between 2008 and 2014 and carried out an inspection at the facilities.

European Medicines Agency said in a statement, "The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines.

"These manipulations appeared to have taken place over a period of at least five years.

"Their 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."

After concerns were raise, EMA’s Committee for Medicinal Products for Human Use (CHMP) looked at over 1,000 pharmaceutical forms and strengths of medicines studied at the GVK site.

Following the study, CHMP has recommended suspension of sale of medicines that lack data from other sources, "unless they are of critical importance for patients because alternatives will not be able to meet patients’ needs".

About 300 medicines will however continue to be sold for which there are sufficient data available from other sources.

European Medicines Agency said there is no evidence of harm or lack of effectiveness linked to the study carried out by GVK Biosciences.

Image: GVK Biosciences is a clinical research organization based in Hyderabad, India. Photo courtesy of GVK Biosciences