In January, the European Medicines Agency (EMA) recommended the suspension or withdrawal of medicines based on clinical studies conducted at contract research organisation (CRO) GVK Biosciences in Hyderabad, India, following concerns raised by the France’s regulatory body, the ANSM, over data manipulation at the site stretching back to 2008.
The ANSM said that during an inspection in May 2014 it found “falsifications of electrocardiograms” in nine studies it examined, accusing at least 10 GVK employees of being complicit in the manipulation of the ECG data.
But speaking with this publication, P.V. Appaji, Director General of Pharmexcil India – a council established by India’s Ministry of Commerce and Industry for the promotion of Pharmaceutical exports – said the ANSM’s findings were unfounded and the “[Indian] Government is highly disturbed with the unjustified decisions against the Indian CRO.”
'It takes years of hard work to build reputation and image but one careless report is enough to damage this'
He explained: “ANSM, the French regulatory agency, did not give any scientific evidence to show that data was manipulated. The fact that two other inspectors from MHRA who also audited GVK Bio at the same time did not consider it fit to include such point in their report clarifies the position.”
He added the data had also been reviewed by a doctor from the US Food and Drug Administration (FDA), as well as independent teams from India, Holland and Switzerland, all of whom did not find fault.
“GVK Bio itself has undergone 37 detailed audit and inspections by the world’s leading regulators but none of them have found any systemic issues which are questionable or are violations of GCP [Good Clinical Practice].”
Appaji stressed “there is no issue on quality of trials being conducted in India” and said ANSM’s report and the EMA’s recommendations damage the standing of the industry.
“It takes years of hard work to build reputation and image but one careless report is enough to damage this.”
ANSM Response
ANSM spokesperson Séverine Voisin told in-Pharmatechnologist.com that while electrocardiograms are not essential to demonstrate bioequivalence, they can track the health of people included in clinical trials and abnormalities such as the ANSM found during the inspection were a cause for concern.
“The presence of these abnormalities characterise a lack of compliance with Good Clinical Practices. Therefore, studies by GVK Bio cannot be considered valid.”
But Voisin made it clear that the observations found at GVK Bio were not evident of systematic problems with the quality of trials carried out in India.
“Deficiencies were observed during inspections carried out in countries other than India, including in the European Union. Inspections of bioequivalence studies are conducted and decisions are made if necessary, in the same way regardless of the country concerned.”
Legal Action?
Based on the inspection, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the suspension of hundreds of marketing authorisations of GVK-tested products that lack data from other studies (full list here).
“Following the CHMP’s January 2015 recommendation, some marketing authorisation holders have requested a re-examination,” an EMA spokesperson told us. “Upon receipt of the grounds for their requests, the CHMP will start a re-examination, which will conclude within 60 days.”
As for the Indian Government’s next steps, Appaji could not confirm reports in the Indian media that it is looking to take legal action against the European agencies involved, but did tell us “a very high level official delegation has met the concerned agencies in Brussels, Paris and London and made clear the Indian Government’s observations.”