The World Health Organization (WHO) issued a warning to Indian clinical research organization Quest Life Sciences of Chennai concerning “critical” lapses in a trial of HIV drugs, including the fact that two-thirds of patients’ electrocardiograms (ECGs) turned out to be duplicates.
“Subject details…and dates had been changed by the company, in the majority of cases, to make ECGs appear as if they were from each of the different subjects,” the warning, obtained by Profit.NDTV.com, stated.
The WHO inspectors also found substandard record-keeping in the trial, including apparent attempts to hide documents from inspectors. The United Nations (UN) health agency issued its “notice of concern” to Quest last week, according to Profit.NDTV.com.
Quest has approximately 100 clients that it serves on and off, but in the last two or three years the company has been focusing mainly on 25 clients. Quest’s work has been used to support drug applications in Australia, Europe, the Philippines, Russia, South Africa and the United States, Profit.NDTV.com reported. Joseph Kamlesh, Quest’s head of operations, told Reuters that the company had been visited by U.S., British and Spanish regulators since the WHO’s surprise audit of its facilities in October 2014.
“The FDA (U.S. Food and Drug Administration) has cleared our plant after making some initial observations, while the Spanish and U.K. (United Kingdom) authorities are yet to issue a final response,” Kamlesh said.
Quest’s trial of HIV drugs was performed on behalf of India’s Micro Labs, which received its own “notice of concern” from WHO in 2014, according to Profit.NDTV.com.
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from Parker Waichman http://www.yourlawyer.com/blog/world-health-organization-issues-notice-of-concern-to-indian-drug-company-over-critical-lapses-in-a-trial-of-hiv-drugs/
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