The World Health Organization (WHO) issues a Notice of Concern on an entity if its pre-qualification team (PQT), during an inspection, finds serious deviations from Good Laboratory Practices (GLP) and Good Clinical Practices (GCP). The WHO's PQT had inspected Quest's facility located at the Madras Export Processing Zone (MEPZ) between October 13-17, 2014, focusing on the on a study for lamivudine, zidovudine and nevirapine (a combination generally used in treatment of HIV patients) dispersible tablets from Bengaluru-based Micro Labs Ltd.
The global health body was not satisfied with Chennai-based clinical research organization (CRO), the Quest Life Sciences, over responses to the concerns raised by it pertaining to data integrity and clinical trial records. According to WHO, Quest responded to the findings in the inspection report only partially. Amid all this, Quest has revealed that it will redo the studies all over again to the satisfaction of WHO so as to lift the notice of concern issued by them.
AdvertisementQuest's associate vice president and operations head Joseph Kamalesh said, "We will redo the entire study all over again to the satisfaction of WHO. Around 70 people were the subject for this clinical study. The culprit is an electronic cardio graph (ECG) machine which churned out wrong reports which were filed by the company staff without checking. We are now using the traditional ECG machine that gives the report in a thermal paper. We take a photocopy of the report and it is signed by the clinical trial subject."
Kamalesh further added that the damage to the business due to WHO action may not be high though it has to be seen how the issue gets played up. Kamalesh said, "The company with around 120 employees is promoted by T.S.Jaishankar."
The WHO based on the inspection report findings said, "The retrospective corrective action was not considered possible for the study under review and corrective actions would be required only for the purposes of removing the Notice of Concern from its website. The Notice of Concern would be removed if another sponsor in the future, submitted in a dossier to WHO-PQT a study from Quest's site that was accepted for inspection and found to be GCP and GLP compliant."