Chennai-based contract research firm, Quest Life Sciences has been issued a warning by WHO over violation of procedures during clinical trials for HIV drugs, second such Indian company after GVK Biosciences to have come under regulatory scrutiny.
The World Health Organisation has issued a 'Notice of Concern' after inspection of the company's facility revealed critical deviations from 'Good Clinical Practises', over data integrity, subject safety and quality assurance.
In March, WHO had asked Quest to respond to a series of serious observations after an inspection in October 2014 during trials of HIV treatment drugs Lamivudine, Zidovudine and Nevarapine dispersible tablets from Micro Labs.
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WHO inspectors had found that "over 67 per cent of pre- study electrocardiograms were duplicates of each other" and "in one instance a single ECG was reused for up to nine times for different subjects".
"This means that ECGs may not have been performed or were unreliable and therefore ineligible/unfit subjects could have been used in the study and protocol requirements have not been met," WHO said.
"An apparent attempt was made to hide documents from inspectors" by laboratory staff of Quest, it added.
This case comes on the heels of GVK Biosciences coming under the scanner of European drug regulators resulting in withdrawals of various drugs based on the studies conducted by the company.
In a letter to Quest Life Sciences Additional Director Gayathri Sivakumar, WHO said the company's partial response to WHO email of March 26, 2015 was evaluated and "recommendation has been made for the study to be rejected and a notice of concern (NOC) to be issued."
When contacted, Quest Life Sciences Associate Vice President & Head - Operations, Joseph Kamalesh said the issue of "duplicate ECGs" pointed out by WHO was not part of the original audit findings but was a retrospective finding and the company did not have an opportunity to defend it on site.
"We had taken 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 have issued a notice of concern," he added.
The issue was raised regarding a clinical study which was conducted in mid 2013 at the company's facility, he said.
However, right from December 2013, "we have changed the ECG machine to a completely 21 CFR Part 11 compliant machine", 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.
Over the past couple of years, the company has upgraded its quality and systems tremendously and the company's global expansion plans are underway, he added.
"Apart from WHO we have been audited by various other regulatory agencies on a regular basis and this isolated event would not be affecting the warm relationship we share with our customers," he said.
