<p>The probe found that the company did not obtain informed consent from the women who consumed the drug. Also, there are serious questions on the subject recruitment process and the independence of the ethics panel that approved the studies.<br /><br />These studies are intended to show how much of the effective molecule is actually absorbed in the body for therapeutic purpose and whether two molecules have similar properties respectively.<br /><br />However, since these studies were not registered in the Clinical Trial Registry of India unlike regular clinical trials, it was difficult to figure out what exactly transpires in the name of bio-availability and bio-equivalence studies, sources told Deccan Herald. The firm conducted bio-equivalence studies of Exemestane tablets – used in treating breast cancer – between January 27 and February 15 -- allegedly adopting unfair means. The company did not properly inform the poor women the pros and cons of participating in the trial.<br /><br />In the age group of 25-45 years, the women were offered stay at good hotel, good food and cash for the trial. “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,” said a ministry official.<br /><br />While the State Human Rights Commission took up the issue suo moto, the DCGI's south zone office in Chennai and sub-zonal office in Hyderabad investigated the allegations to find out if the study was conducted in accordance with norms specified in Schedule-Y of the Drugs and Cosmetics Act of 1940 and the rules framed under the act.</p>
<p>The probe found that the company did not obtain informed consent from the women who consumed the drug. Also, there are serious questions on the subject recruitment process and the independence of the ethics panel that approved the studies.<br /><br />These studies are intended to show how much of the effective molecule is actually absorbed in the body for therapeutic purpose and whether two molecules have similar properties respectively.<br /><br />However, since these studies were not registered in the Clinical Trial Registry of India unlike regular clinical trials, it was difficult to figure out what exactly transpires in the name of bio-availability and bio-equivalence studies, sources told Deccan Herald. The firm conducted bio-equivalence studies of Exemestane tablets – used in treating breast cancer – between January 27 and February 15 -- allegedly adopting unfair means. The company did not properly inform the poor women the pros and cons of participating in the trial.<br /><br />In the age group of 25-45 years, the women were offered stay at good hotel, good food and cash for the trial. “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,” said a ministry official.<br /><br />While the State Human Rights Commission took up the issue suo moto, the DCGI's south zone office in Chennai and sub-zonal office in Hyderabad investigated the allegations to find out if the study was conducted in accordance with norms specified in Schedule-Y of the Drugs and Cosmetics Act of 1940 and the rules framed under the act.</p>
