The World Health Organisation (WHO) detailed its accusation in a notice of concern (NOC) published today which outlined deviations from manufacturing and clinical standards observed at two facilities – JP Nagar and Sakar Nagar Clinical Unit - last year.
Inspectors who visited the sites in January and December found evidence of data manipulation in a number of bioanalytical studies, which the WHO’s prequalification team (PQT) said indicates collusion by a number of the CROs staff.
“WHO is of the impression that to execute this type of manipulation several staff members on various levels within the organization have to be collaborating and coordinating” it said, adding that “The issue is thus not confined to a single person.”
The WHO advised drug companies not to submit “dossiers relying in whole or in part on involvement from Semler until the underlying issues have been verified to have been adequately resolved.”
The findings also bring in to question the validity of studies performed on certain prequalified drugs made by Mylan, Micro Labs, Lupin and Strides according to the WHO.
It said: “Applicants/sponsors are requested to submit bio-waivers, where applicable or new bioequivalence studies” and warned that for “products where the study data could have been manipulated” manufacturers may need to consider reformulation.
Publication of the NOC comes days after the US Food and Drug Administration (FDA) told drug companies with products approved based on data from trials carried out by Semler they would have to repeat the trials.
The US agency cited deviations observed during an inspection of the JR Nagar facility in September and gave drug companies for which Semler has conducted bioanalytical studies 30 days to respond.