HYDERABAD:Chennai-based research firm Quest Life Sciences has been issued a warning by the WHO over violation of procedures during clinical trials for HIV drugs. Quest is the second such Indian company after GVK Biosciences to have come under regulatory scrutiny.
“Subject details... and dates had been changed by the company, in the majority of cases, to make the ECGs appear as if they were from each of the different subjects,” the WHO said in its notice issued to Quest..
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The UN health regulator also criticised the standard of record-keeping in the trial, including apparent attempts to hide documents from inspectors.
However, unlike GVK Bio, which was under the scanner by multiple regulators, Quest has got notice only from the WHO. According to Joseph Kamalesh, associate vice president & head-operations, Quest, the issue of duplicate ECGs was not part of the original audit findings but was a retrospective finding. “We took the safety of subjects as the primary concern and provided a detailed CAPA, which included demonstrating that the subjects involved in the study had no underlying cardiac problem, but unfortunately WHO has not accepted it and has issued a notice of concern,” he said. The issue was raised regarding a clinical study conducted in mid-2013, he added.
“Based on the necessary action suggested by WHO, we are in the process of conducting the entire clinical study again at our own cost to ensure that the NOC is lifted at the earliest,” Kamalesh said.
In GVK Bio’s case, the EMA investigated every clinical trial from 2008 to 2014 and banned more than 80 generic medicines across major markets in Europe.