Chennai-based research organisation, Quest Life Sciences, which has been hit by a World Health Organisation (WHO) notice citing deviations from good clinical and laboratory practices, on Tuesday said it was willing to conduct the clinical study once again to the satisfaction of the international regulator.
“It is just an isolated and single study that the WHO has found fault with and it does not affect the other business of the company...,” said Joseph Kamalesh, head, Operations of Quest Life Sciences Pvt Ltd. “We are in the process of conducting the entire clinical study again at its own cost, to ensure lifting of the NOC.”
The research company has been served a notice by the WHO, holding it guilty of major critical and major deviations from the WHO good clinical practices (GCP) and good laboratory practices (GLP) standards. Last year, the WHO had asked Quest to respond to a series of serious observations after an inspection during trials of HIV treatment drugs from Bengaluru-based Micro Labs.
Quest Life Sciences was sent the inspection report on March 26, 2015. The WHO said the response was unsatisfactory.