‘Disgraced’ manufacturer fined for lying about thyroid drug shelf-life
An ex-director may avoid jail time after a manufacturer submitted “falsified” shelf-life data to the medicines watchdog, the MHRA has revealed.
Medicines manufacturer Kappin Ltd and its “disgraced” former director Kamlesh Vaghjiani were last week (March 15) sentenced for “two charges of falsifying data” on a medicine’s shelf life, “adversely affecting its quality…to obtain a licence to sell the medicine in the UK”, the watchdog announced.
The criminal prosecution and sentence, as well as the termination of marketing authorisations in 2013, came after the Medicines and Healthcare products Regulatory Agency (MHRA) “brought the deceptions to light”, it said.
The MHRA said on Friday that it “began to investigate Kappin Ltd in 2008 following reports” that its hypothyroidism medicine Evotrox Oral Solutions “was not stable for the whole duration of the shelf-life claimed in the original licence application”.
“During these enquiries, the company continued to submit falsified data” on the levothyroxine drug’s “stability and effectiveness” to the MHRA, it added.
But in October 2023, Mr Vaghjiani and the company “changed their pleas to guilty for all charges”, it added.
Mr Vaghjiani, who was Kappin Ltd’s quality assurance manager when the investigation launched in 2008, “was sentenced to eight and seven months on two counts, to run concurrently, both suspended for 18 months” at Southwark Crown Court in London, the MHRA said.
It added that both Mr Vaghjiani and the company were each fined £50,000 “having previously paid a confiscation order of £1,075,589.88 – reflecting Kappin Limited’s profit from the crime”.
“Kappin Ltd was also ordered to pay prosecution costs of £82,262.20,” the MHRA said.
Last week’s sentencing saw the “UK’s first successful prosecution of a manufacturer for knowingly providing falsified data” to the watchdog in order to obtain a marketing authorisation, it added.
“Cover-up” put patients “at risk”
MHRA deputy director of criminal enforcement Andy Morling said it was “shocking” that the company “thought it was above the law”.
“The lengths to which [it was] prepared to go to cover up [its] wrongdoing are completely unacceptable,” he added.
He said that while the MHRA found “no evidence” that patients were harmed, by “knowingly supplying” them with a “substandard product” the “manufacturers were prepared to put them at risk”.
Mr Morling deemed the company’s actions “very concerning” and added that he was “pleased” to have “brought those responsible to justice” through an “extremely complex investigation”.
“The severity with which the courts have treated the case should serve as a warning to all medicines manufacturers,” he said.
C+D approached Kappin Ltd for comment.
Meanwhile, the Competition Appeal Tribunal (CAT) ruled earlier this month that manufacturers that hiked hydrocortisone prices by 10,000% and paid off competitors would not have to pay “nearly £100m of fines” after a successful appeal.
At the time, the Competition and Markets Authority (CMA) said that it would appeal the “fundamentally misconceived” decision to overturn the fines.
