Nearly a month after the licence of Axis Clinicals was suspended for irregularities in conducting trials on poor illiterate women, officials of the Drug Controller General of India (DCGI) found similar violations by nine Clinical Research Organizations (CROs) in the state. Highly-placed sources said that there are glaring violations in the recruitment process of `subjects' and in taking their informed consent in almost all these organizations, where the gullible are becoming guinea pigs.
In fact, Actimus Bio Sciences, Visakhapatnam, which is the latest to get embroiled in the clinical trial controversy, was one among the eight CROs recently inspected by the DCGI officials.
It was after Axis Clinicals was found to have administered anti-cancer drug to poor women from Piduguralla in Guntur district without securing their consent in June this year, DCGI had decided to investigate the working of all bioavailability and bioequivalence 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.
The officials, who are yet to submit the final report to DCGI, Delhi, revealed that they concentrated on the issues pertaining to the recruitment process and the ethical committee's approval process adopted by these CROs during their course of investigations. "None of them is fully following either the guidelines of the Indian Council for Medical Research or the rules framed in the Schedule Y, which are necessary for manufacturing new drugs," said an official adding that some documents were seized during the investigation.
Besides, the Standard Operating Procedure drafted for every study was given a go by. "They should practise and follow what is there in the SOP. Further, if video recording of subjects is done prior to the study, it would be beneficial for these organizations though it's not mandatory. None of them is adopting this practice," said the official adding that more than 50 studies are being done annually by these CROs.
Aizant, Sipra, Bio Serve, Vimta, CR Bio, Nicholas Piramal, GVK Bio are the other CROs operating in the state. The DCGI officials said that the final report would be submitted to DCGI in about a week or so. He added that a team would again visit Actimus Bio Sciences in Visakhapatnam on Wednesday to study the case of two students who were subjected to clinical tests for two days.
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