Health ministry suspends AP clinical research firm nod for clinical study

NEW DELHI: The country’s drug regulator has suspended clinical research firm Axis Clinicals’ permission to conduct all bio-availability and bio-equivalence studies at its centre in Hyderabad after an investigation found violation of important regulatory norms.

Irregularities related to recruitment informed consent, independence of the Ethics Committee and it’s review and decision making process were found during a two-day scrutiny by the Drugs Controller General (India)’s South Zone Office, Chennai and sub-zonal office, Hyderabad.

“The Drugs Controller General India (DCGI) has therefore suspended the approval for conducting all bio-availability and bio-equivalence studies at their centres in Miyapur, Hyderabad in public interest,” a health ministry released said.

Hyderabad-based Axis Clinicals conducted studies on exemestane tablets in its Miyapur centre in Hyderabad between January end and February 15. It was alleged the firm conducted study by administering anti-cancer drug to poor women in Piduguralla town of Andhra Pradesh without securing their informed consent. As per reports, about 25 women, poor quarry workers, who volunteered in the trials ended up in hospitals with severe body ache and other illness.

DCGI will also investigate working of all bio-availability and bio-equivalence study centres in Andhra Pradesh in the next two months to ensure such studies are done in accordance with applicable regulatory provisions and prescribed guidelines, the release said.