London-based pharmaceutical manufacturer, Syri Ltd, has been fined £51,000 and ordered to pay costs of £104,898 by Aylesbury Crown Court, after being convicted of supplying a medicinal product which failed to meet the quality specified in a prescription.
The decision follows an investigation by the Medicines and Healthcare products Regularly Agency (MHRA) and a prosecution brought by the Crown Prosecution Service (CPS).
The investigation was prompted by a child suffering multiple seizures, which eventually led to the hospitalisation. The child was prescribed magnesium glycerophosphate to prevent seizures, but the medicine manufactured by the company contained just 12 per cent of the strength specified in the prescription.
The MHRA was informed about the issue through a report from Milton Keynes University Hospital.
After an inspection, the regulator found that the manufacturing method and the checks to ensure appropriate standards were not met for the medicine, jeopardizing the health of the child.
Dr Alison Cave, MHRA chief safety officer, said: “Pharmaceutical companies such as Syri Ltd have a legal obligation to ensure they produce and supply medicines that work and are manufactured to the required standards. The patient has recovered, but the consequences could have been much more serious if it hadn’t been for the swift action of hospital staff.
“Patient safety is our top priority. The Agency will not hesitate to take robust enforcement action when serious failings that put patients at risk are identified.”
Laura Walters, special crown prosecutor of the Crown Prosecution Service said: “Syri Limited, as with all pharmaceutical providers, have a vital responsibility to produce medicines accurately and safely, in the form specified in a prescription. Fortunately, the mistake they made was not fatal in this case. This was not an isolated mistake although our prosecution was only concerned with this one serious incident.
“These types of prosecutions are thankfully rare, but this conviction and sentence should serve as a reminder for all pharmaceutical companies of the need for absolute care in providing essential medications to the public.”
