The European drug regulator has recommended suspension of a number of medicines whose authorisation was mainly based on the clinical trials conducted by Hyderabad-based GVK Biosciences.
“A number of medicines for which authorisation in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India, should be suspended,” European Medicines Agency (EMA) said in a statement.
The recommendation is based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on behalf of marketing authorisation holders, it added.
Upon the request of the European Commission, EMA’s Committee for Medicinal Products for Human Use (c) looked at over 1,000 pharmaceutical forms and strengths of medicines studied at the GVK site.
“For medicines that lack data from other studies, the CHMP recommended suspension unless they are of critical importance for patients because alternatives will not be able to meet patients’ needs,” it added.
Inspection of GVK that led to the CHMP’s recommendation was carried out by the French medicines agency (ANSM).
In nine studies investigated by the French authorities, they found out that all of them were partly manipulated.
The EMA had in July written to all manufacturers of generic drugs in the EU, seeking details of their cooperation with GVK Bio.
“The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines,” it added.
It further said: “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,” it said.
The CHMP’s recommendation will be sent to the European Commission for a legally binding decision.
“This decision will apply to all Member States irrespective of whether or not they have taken interim measures to suspend medicines,” the drug regulator said.