Clinical drug trial centres in Andhra to be probed

Clinical drug trial centres in Andhra to be probed

A Hyderabad-based drug research laboratory, Axis Clinicals Limited, allegedly administered trial drugs to a group of poor women from the Piduguralla town of Andhra Pradesh without taking their informed consent.

The Axis Clinical had conducted bio-equivalence studies on 'exemestane' tablets, an anti-cancer drug, from Jan 27 to Feb 15.

"It was alleged that the firm had conducted study by administering the anti-cancer drug to the poor women in Piduguralla town of Andhra Pradesh without securing their informed consent," the statement said.

A probe by health officials revealed various irregularities with respect to subject recruitment process, informed consent process, independence of the ethics committee and its review and decision making process.

"After a thorough two-day investigations on June 20 and 21 at the bio-equivalence study centre of M/s Axis Clinicals Ltd at Hyderabad, approval was suspended," an official health ministry statement said.

Following this, the DGCI has decided to investigate the working of all bio-availability and bio-equivalence study centres in Andhra Pradesh.

"Within a period of two months, we would ensure such clinical studies are performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines," the statement added.

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