Disgraced company director convicted of falsifying medicine quality data .(Kamlesh Vaghjiani of Kappin Ltd)
| Published date | 18 March 2024 |
M2 PRESSWIRE-March 18, 2024-: Disgraced company director convicted of falsifying medicine quality data
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RDATE:15032024
A company director and his pharmaceutical manufacturing company were sentenced in court today after pleading guilty to two charges of falsifying data that supported the shelf life of a medicine, adversely affecting its quality in order to obtain a licence to sell the medicine in the UK.
Today's sentencing concludes the UK's first successful prosecution of a manufacturer for knowingly providing falsified data to the MHRA in order to obtain a Marketing Authorisation.
Kamlesh Vaghjiani, former director of pharmaceutical company Kappin Ltd, was sentenced to eight and seven months on two counts, to run concurrently, both suspended for 18 months, at Southwark Crown Court, London following investigations by the Medicines and Healthcare products Regulatory Agency (MHRA) into Kappin's product, Evotrox Oral Solution.
Vaghjiani and Kappin Ltd were both individually fined [pounds sterling]50,000, having previously paid a confiscation order of [pounds sterling]1,075,589.88, reflecting Kappin Limited's profit from the crime. Kappin Ltd was also ordered to pay prosecution costs of [pounds sterling]82,262.20.
Evotrox Oral Solutions (a liquid solution containing the active ingredient levothyroxine) was licensed in 2006 in three strengths for the treatment of hypothyroidism (underactive thyroid).
As part of any licence application, manufacturers must provide evidence for how long their product remains stable and hence fit for purpose, effective and safe. This is known as a medicine's 'shelf-life.'
The MHRA began to investigate Kappin Ltd in 2008, following reports that Evotrox was not stable for the whole duration of the shelf-life claimed in the original licence application. At this time, Kamlesh Vaghjiani was the Quality Assurance Manager at Kappin Ltd.
During these enquiries, the company continued to submit falsified data to the MHRA to try to support the medicine's stability and effectiveness. A comprehensive series of independent testing by the MHRA, together with detailed analysis of data retrieved from laboratory computers brought the deceptions to light. This culminated in the termination of the marketing authorisations by the MHRA in 2013 and subsequent criminal prosecution which resulted in today's sentence. Andy Morling, MHRA Deputy Director (Criminal Enforcement), said:
This is a shocking case of a pharmaceutical...
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