Medicines Healthcare Products Regulatory Agency
Todays sentencing concludes the UKs first successful prosecution of amanufacturer 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 Kappins product, Evotrox Oral Solution.
Vaghjiani and Kappin Ltd were both individually fined 50,000, having previously paid a confiscation order of 1,075,589.88, reflecting Kappin Limiteds profit from the crime. Kappin Ltd was also ordered to pay prosecution costs of 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 medicines 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 medicines 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 todays sentence.
Andy Morling, MHRA Deputy Director (Criminal Enforcement), 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 wrongdoing are completely unacceptable.
Whilst the MHRA found no evidence that patients were harmed, the fact that the manufacturers were prepared to put them at risk by knowingly supplying a substandard product is very concerning.
This was an extremely complex investigation that required the analysis and challenge of thousands of scientific data files. 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.
In October 2023, Kamlesh Vaghjiani and the company, Kappin Ltd, changed their pleas to guilty for all charges.
Other levothyroxine products currently available on the market are not affected.
ENDS
Notes to editors?
- The specific offences that the defendants were convicted of were: providing false data for the pH and assay values recorded in lab testing, as part of the licence application for Evotrox on 17 May 2006 and providing false chromatography data for the quality evaluation of Evotrox, between 21 and 26 November 2011.
- The Criminal Enforcement Unit is a dedicated law enforcement capability within the MHRA. The unit collects and analyses criminal intelligence to identify illegal activity involving medical products, and investigates cases to prevent and disrupt offending and bring offenders to justice.
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.? All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.?
- The MHRA is an executive agency of the Department of Health and Social Care (DHSC).?
- For media enquiries, please contact the newscentre@mhra.gov.uk, or cal