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DCGI suspends Axis Clinicals’ research license

By Gareth Macdonald , 28-Jun-2011

India’s DCGI has banned CRO Axis Clinicals from conducting bio-availability and bio-equivalence studies at its facility in Miyapur, Hyderabad.

The move, detailed in a release by the government press bureau, followed a number of reports that a trial run by Axis had violated Schedule Y of the Drugs and Cosmetics Rules.

The allegation was that, during a trial of the anticancer treatment exemestane conducted earlier this year, Axis had administered the drug to a group of women in Piduguralla, Andhra Pradesh without obtaining consent.

This prompted the Drugs Controller General of India (DCGI) to carry out a two-day inspection at the facility earlier this month, which uncovered a number of violations.

The investigations have revealed various irregularities in conduct of the above said studies with respect to subject recruitment process, informed consent process, independence of the Ethics Committee and its review and decision making process.

The trial watchdog said has “suspended the approval of the said firm for conducting all Bio-availability and Bio-equivalence studies at their centres in Miyapur, Hyderabad in public interest.”

The DCGI has also decided to investigate all studies conducted in Andhra Pradesh over a two month period to ensure they are “performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines.”

Axis, which has operated since late 2004 with facilities in Miyapur, the Eastern India port of Vizag and a Mexico, has not yet commented on the news.

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