Anti-cancer drug was given to poor women without their consent
Sonal Matharu | June 24, 2011
The drugs controller general of India (DCGI) under the health ministry on Friday suspended the approval of a private firm conducting clinical trials in Hyderabad after it was found that the firm is administering anti-cancer drug to poor women in Piduguralla town of Andhra Pradesh without securing their informed consent.
Investigations conducted by the DCGI’s south zone office in Chennai and sub-zonal office in Hyderabad on June 20 and 21, 2011 have confirmed that M/s Axis Clinicals Ltd., Hyderabad, did not follow rules 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 at the Bio-equivalence study centre of M/s Axis Clinicals Ltd. situated at Serlingampally, Miyapur, Hyderabad. It was found that the company was violating norms specified in schedule Y of the drugs and cosmetics rules for conducting clinical trials.
“The DCGI 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,” said a press note from the health ministry.
The office of the DCG(I) has further decided to investigate the working of all Bio-availability 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.
M/s 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.
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