Chennai, (IANS) City based clinical research organisation (CRO) Quest Life Sciences on Tuesday said it will redo the studies all over again to the satisfaction of World Health Organisation (WHO) so as to lift the notice of concern issued by the global body.
The WHO was not satisfied with the Quest’s responses to the concerns raised by it pertaining to data integrity and clinical trial records and had put the Indian company on notice recently.
“We will redo the entire study all over again to the satisfaction of WHO. Around 70 people were the subject for this clinical study,” Quest’s associate vice president and operations head Joseph Kamalesh told IANS.
According to him, 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 said.
He said 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 issues a Notice of Concern on an entity if its prequalification team (PQT) finds during an inspection serious deviations from Good Laboratory Practices (GLP) and Good Clinical Practices (GCP).
The WHO’s PQT inspected Quest’s facility located at the Madras Export Processing Zone (MEPZ) between October 13-17, 2014 focussing on the on a study for lamivudine, zidovudine and nevirapine (a combination general used in treatment of HIV patients) dispersible tablets from Bengaluru-based Micro Labs Ltd.
According to WHO, Quest responded to the findings in the inspection report only partially.
The WHO based on the inspection report findings said 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.
According to WHO, 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.
Kamalesh said the company’s studies for WHO governing regions is only minimal and the present issue would not impact the business in a major way.