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‘Disgraced’ pharma director convicted after lying to obtain MHRA licence


‘Disgraced’ pharma director convicted after lying to obtain MHRA licence

Southwark Crown Court (iStock)

A “disgraced” pharmaceutical company director has been handed a suspended jail sentence by Southwark Crown Court after an MHRA investigation found his company had deliberately falsified data on the shelf life of its liquid levothyroxine product.

On Friday March 15, Kamlesh Vaghjiani, former director and quality assurance manager at Kappin, was handed concurrent sentences of eight and seven months, suspended for 18 months, for providing false data for pH and assay values as part of the licence application for three strengths of Evotrox Oral Solutions in May 2006 and for providing false chromatography data during a quality evaluation for the drug in November 2011.

The MHRA first launched its investigation in 2008 after receiving reports that the company’s hypothyroidism treatment “was not stable for the whole duration of the shelf life claimed in the original licence application”.

Kappin continued to provide falsified data during the MHRA’s investigation, but the watchdog’s independent testing of the drug and analysis of data obtained from Kappin laboratory computers “brought the deception to light,” resulting in the marketing authorisations being withdrawn in 2013 and the criminal prosecution last week.

In addition to the suspended sentences, Mr Vaghjiani and Kappin were both fined £50,000, having already paid a confiscation order on profits from Evotrox amounting to £1,075,589, with Kappin also ordered to pay an additional £82,262 to cover prosecution costs.

Mr Vaghjiani and Kappin had changed their plea to guilty on all counts in October last year.

Andy Morling, deputy director for criminal enforcement with the MHRA, said: “This is a shocking case of a pharmaceutical company that thought it was above the law and was not required to uphold our stringent standards for safety, quality and effectiveness.

“The lengths to which they were prepared to go to cover up their wrongdoings are completely unacceptable.”

Mr Morling said that although there was “no evidence” that patients had come to harm as a result of the company’s wrongdoing, it had been “prepared to put them at risk by knowingly supplying a substandard product”.

Welcoming the outcome of a complex investigation that involved analysing “thousands” of scientific data files, he commented: “I am pleased that we have brought those responsible to justice and the severity with which the courts have treated the case should serve as a warning to all medicines manufacturers.”

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