Centre sets up a fact-finding committee on claims of data integrity issues at GVK Biosciences

The Centre has appointed a six-member committee to look into the allegation of data integrity issues leveled by the French drug regulator ANSM against Hyderabad-based GVK Biosciences Limited.

"The government has been pursuing the GVK Bio case. A six-member multi-disciplinary committee have been appointed to look into the issue. The fact-finding team visited GVK Bio facility yesterday," Sudhanshu Pandey, joint secretary, Department of Commerce, Government of India said on Wednesday.

In July, European Union banned 700 generic drugs that were tested for bioequivalance and efficacy at GVK Bio's Hyderabad facility on the alleged discrepancies in ECG reports of volunteers involved in the tests.

Pandey, who is a part of the six member panel, said they would look into the primary data and allegation of data integrity in full fairness: "We are looking at the allegation that ECGs were falsified. However, no manipulation was found. We will be submitting a report to the Government soon,"he said.

Last month Government of India had deferred the trade talks with European Union in a gesture of protest against the banning of drugs tested by GVK Bio.

Pandey also said they had sought some more details from the ANSM on its findings regarding the data issues at GVK Bio's clinical research facility in Hyderabad.

It may be recalled that based on the French regulator's observations made in May 2014, the EMA suspended the marketing authorisation of these drugs and subsequently confirmed its decision in January.

GVK Bio, one of the largest research and contract manufacturing organisations (CROs) in Asia with close to 2,400 scientists and staff on its rolls, had stoutly denied the claims of data integrity issues.

Responding to a question, the Commerce Ministry official said they have been discussing with drug regulators of 11 neighboring South Asian countries on issues related to inspection of drug manufacturing facilities.