- Saturday, April 27, 2024
This is UK’s first successful prosecution of a manufacturer for knowingly providing falsified data to the MHRA to obtain a marketing authorisation
By: Shajil Kumar
A Harrow-based pharmaceutical company and its former director were sentenced by a London court after pleading guilty to two charges of falsifying data regarding the shelf life of a medicine for treating hypothyroidism.
Southwark Crown Court, London sentenced Kamlesh Vaghjiani, former director of Kappin Ltd, to eight and seven months on two counts, to run concurrently, both suspended for 18 months, 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 £50,000, having previously paid a confiscation order of £1.07 million, reflecting Kappin Limited’s profit from the crime. Kappin Ltd was also ordered to pay prosecution costs of £82,262.
This is UK’s first successful prosecution of a manufacturer for knowingly providing falsified data to the MHRA to obtain a marketing authorisation.
Evotrox Oral Solutions (a liquid solution containing the active ingredient levothyroxine) was licensed in 2006.
As part of any licence application, manufacturers must provide evidence for how long their product remains stable, effective and safe.
In 2008, MHRA began to investigate Kappin, following reports that Evotrox was not stable for the whole duration of the shelf-life claimed in the original licence application.
Vaghjiani was then the quality assurance manager at Kappin.
During MHRA investigations Kappin submitted falsified data to support its claim about the medicine’s stability and effectiveness.
A series of independent tests by the MHRA, along with a detailed analysis of data retrieved from laboratory computers brought the deceptions to light.
MHRA terminated Kappin’s marketing authorisation in 2013 and launched a criminal prosecution.
MHRA Deputy Director (Criminal Enforcement) Andy Morling said, “This was an extremely complex investigation that required the analysis and challenge of thousands of scientific data files.”
