Govt panel looking into GVK Bio data issue, says official

The concerns raised by French drug regulator ANSM over the data integrity of GVK Bio have no basis, but the Centre is still pursuing the matter, a senior official said today.
A government-appointed committee comprising officials from various departments visited the facility of GVK Bio here yesterday and will soon submit its report, said Sudhanshu Pandey, Joint Secretary, Department of Pharmaceuticals.
"The aim of the panel is very simple - to look into the issue with objectivity and fairness. The panel simply wants to know what has been alleged is true or not. The allegation of data integrity - we have gone through the data extensively and no data manipulation has been found."

"The government is still pursuing the matter. The government has set up a panel and that panel visited GVK Bio (unit) yesterday, interacted with the company and went into the primary data and a whole lot of things," Pandey told reporters.
EU drug regulator, the European Medicines Agency (EMA), in January had suspended the marketing authorisation of some of the drugs on grounds that they were based on clinical trials allegedly manipulated by the Hyderabad-based company.
EMA issued the order based on the French regulator's (ANSM) allegation that data were manipulated by the company.

Replying to a query, Pandey said they have sought some more details from ANSM (French National Agency for Medicines and Health Products Safety) which are yet to be received.

The official said discussions are going on with health regulators of 11 South Asian countries on the issues related to inspection of drug manufacturing facilities.
He said the government is of the opinion that common standards can be set up for inspections and related issues so as to cut down repeated and multiple scrutiny of a manufacturing unit by regulators.