HYDERABAD:Chennai-based Quest Life Sciences has come under the scanner of the World Health Organization (WHO) for ‘critical’ lapses in conducting clinical trials for Micro Labs’ HIV drugs. The WHO had issued a ‘notice of concern’ to Quest last week following an inspection in October 2014.
This is the second such instance in the recent past where homegrown Clinical Research Organisations (CRO) have been pulled up for non-compliance by global health regulators.
Last year, the European Medicines Agency (EMA) had found fault with the BE/BA studies conducted by Hyderabad-based GVK Biosciences on behalf of several companies, including multi-nationals.
Quests’ ‘critical’ lapses were found in a trial it had done on Micro Labs’ HIV-treatment drugs Lamivudine Zidovudine Nevirapine dispersible tablets.
“The inspection revealed critical and major deviations from the WHO Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) standards as specified in WHO publications,” the WHO said in its notice issued to Quest.
It added that more than 67 per cent of the pre-study electrocardiograms (ECGs) were duplicates and in one instance, a single ECG was reused up to nine times for different subjects.
“This means that the 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,” the WHO noted, adding, “An apparent attempt was made to hide documents from inspectors by laboratory staff of Quest.”