The World Health Organization (WHO) has issued a ‘notice of concern’, or NoC, to Chennai-based contract research organisation Quest Life Sciences Pvt Ltd for ‘critical’ lapses and deviations from standards in its clinical trials.
Inspectors from WHO’s prequalification team had visited the firm’s facilities in October 2014 and inspected the clinical trial of Lamivudine, Zidovudine and Nevirapine — a combination of drugs for treating HIV patients. Quest was carrying out the trials for Bengaluru-based Micro Labs.
Quest Life Sciences has said it will conduct the entire clinical study again at its own cost, to ensure the lifting of the NoC.
|WHAT THE AGENCY FOUND|
During the inspection, the WHO team observed lack of data integrity in clinical trial records, failures in protection of subject safety, inadequate quality assurance, among others.
It said 67 per cent of the subject pre-study electrocardiograms (ECGs) were duplicates, with the details of the patients and dates having been changed to make the ECGs appear as if they were from different subjects who had participated in the study.
“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 may not have been met,” WHO said.
It may be noted that in 2014, Hyderabad-based contract research organisation GVK Biosciences, too, had to opt for redoing all clinical trials, which were pointed out by the regulatory authorities in Europe.
WHO also noted that a number of forms relating to the study were in the process of being completed during the inspection, implying that they had not been filled at the time of the activity.
Besides, several blank forms were found in binders relevant to the study, which is a risk as these could be in filled in later.
WHO sent an inspection report on March 26, 2015 and Quest Life Sciences gave its response on April 30. However, WHO found the response to be unsatisfactory and it recommended the study to be rejected and an NoC to be issued.
It added it would publish the NoC on its website and it would remain on the site until satisfactory corrective action, such as a new bioequivalence study, was taken.
Joseph Kamalesh, associate vice-president and head of operations at Quest Life Sciences, said WHO’s saying it would lift the NoC upon submission of a repeat study shows that such bioequivalence was indeed established.
“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,” he said. He added that the ‘duplicate ECGs’ pointed out by the WHO was not part of the original audit findings, but was a retrospective finding regarding a clinical study conducted in 2013 at the site.
“However, right from December 2013, we have changed the ECG machine to a completely 21 CFR Part 11 compliant machine,” he said.
The audit was jointly done by WHO and US Food and Drug Administration (FDA), wherein the US FDA issued five 483s (investigators' observations of conditions which may constitute to violation of the regulations), which were immediately complied with and that particular audit has been closed.
“Apart from WHO, we have been audited by various other regulatory agencies on a regular basis and this isolated event would not affect the warm relationship we share with our customers,” said Kamalesh.