Pharmaceutical company fined for falsifying medicine quality data

Former director of the company was sentenced to eight and seven months on two counts  

Pharmaceutical company Kappin Ltd and its former director, Kamlesh Vaghjiani, were sentenced at the Southwark Crown Court, London on 15 March for proving falsified data to the the Medicines and Healthcare products Regulatory Agency (MHRA) to obtain a marketing authorisation.

Vaghjiani was sentenced for eight and seven months on two counts, to be served concurrently. However, both sentences were suspended for 18 months. The court's ruling came following investigations by the MHRA into Kappin’s product, Evotrox Oral Solution.

The court also imposed fines of £50,000 each on Vaghjiani and Kappin Ltd, with the company previously paying a confiscation order of £1,075,589.88, reflecting its profits from the crime. Additionally, Kappin Ltd was ordered to pay prosecution costs amounting to £82,262.20.

Evotrox Oral Solutions, which contains levothyroxine as the active ingredient, was licensed in 2006 to treat hypothyroidism (underactive thyroid).

The MHRA initiated an investigation in 2008 following reports suggesting that "Evotrox was not stable for the whole duration of the shelf-life claimed in the original licence application." Despite ongoing inquiries, Kappin Ltd continued to submit falsified data to the regulator.  Vaghjiani was the Quality Assurance Manager at the company at that time.

Andy Morling, MHRA Deputy Director (Criminal Enforcement), condemned the company's actions, highlighting the need to uphold stringent safety standards in pharmaceutical manufacturing.

"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," he said.

The deceptions were uncovered after extensive independent testing by the MHRA and a thorough analysis of data obtained from laboratory computers, culminating in the termination of Evotrox's marketing authorisations in 2013 and subsequent criminal proceedings.

Vaghjiani and Kappin Ltd changed their pleas to guilty for all charges in October 2023. Importantly, other levothyroxine products on the market remain unaffected by this case.

The severity of the court's sentencing serves as a stark warning to pharmaceutical manufacturers, underlining the importance of adhering to regulatory standards and ensuring the safety and efficacy of medical products.