WHO says Semler Research manipulated data and warns repeat studies may needed

By Gareth Macdonald contact

- Last updated on GMT


Related tags: Pharmacology, Food and drug administration

The WHO has accused Semler Research of data fraud and said Mylan, Micro Labs, Lupin and Strides and others may need to repeat bioanalytical trials conducted by the CRO.

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​.”

Prequalified drugs

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.

Related news

Show more

Related products

Transforming Clinical Development

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

Related suppliers

Follow us


View more