The Drugs Controller General of India (DCGI) has suspended the clearance given to Hyderabad-based Axis Clinicals for conducting bio-availability and bio-equivalence studies at their centres in Miyapur 'in public interest', in the wake of the recent controversies for allegedly using women in Piduguralla as trial subjects.
“The Drugs Controller General (India)’s South Zone Office, Chennai and Sub-zonal office, Hyderabad has conducted investigations in the matter of recent reports about certain irregularities in conduct of clinical study by Axis Clinicals Ltd., Hyderabad in violation of the norms specified in Schedule Y of the Drugs and Cosmetics Rules. 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 investigations were conducted on 20th and 21st June 2011 at the bio-equivalence study centre of Axis Clinicals Ltd. situated at Serlingampally, Miyapur, Hyderabad,” according to official statement here.
The Drugs Controller General (India) has therefore 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, it said.
The office of the DCG(I) has further decided to investigate the working of all bio-availbility and bio-equivalence study centres in Andhra Pradesh within a period of two months to ensure that such studies are performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines.
“Axis Clinicals Ltd., Hyderabad had conducted bio-equivalence studies on Exemestane tablets in its Serlingampally, Miyapur, Hyderabad centre during the period 27th January 2011 to 15th February 2011. 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 added.
