Clinical drug trial centres in Andhra to be probed

After reports surfaced of a pharma company using poor women as guinea pigs for unauthorised drug trials in Andhra Pradesh, the Drugs Controller General of India (DCGI) has decided to probe all clinical trial centres in the state.

Last Updated: Jun 25, 2011, 15:22 PM IST

New Delhi: After reports surfaced of a pharma company using poor women as guinea pigs for unauthorised drug trials in Andhra Pradesh, the Drugs Controller General of India (DCGI) has decided to probe all clinical trial centres in the state.

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.

IANS