MHRA says supplier qualification ‘gaps’ expose patients to risk

The UK drugs regulator has warned of numerous cases where unscrupulous actors have tried to sell falsified and stolen medicines into the legitimate supply chain.

In a blog post, the Medicines and Healthcare products Regulatory Agency (MHRA) says that the emerging trend stems from the exploitation of “gaps in the qualification processes of suppliers,” and raises the risk of patients being supplied with substandard medicines.

In the article MHRA Good Distribution Practice (GDP) inspector Peter Brown warns of several cases in which individuals or groups have stolen the identity of legitimate companies, for example by setting up cloned email addresses and phishing scams, in an attempt to bypass safeguards such as validation via the EU’s EudraGMP database.

“There have been further examples of fake websites created in order to mimic legitimate companies, with the intent to deceive prospective businesses into purchasing from them,” he writes.

Brown also cites one incident in which a company claiming to be a wholesale dealer from Hungary attempted to enter a supplier relationship with a UK organisation. The company was found on investigation to have no licenses allowing it to distribute medicines and all supporting documents were falsified.

Meanwhile, another attempt to introduce falsified medicines into the legitimate supply chain occurred very recently, when counterfeit copies of Takeda’s leukaemia drug Iclusig were found in the global supply chain. An unlicensed company attempted to supply Iclusig in both English and German language packaging into European markets.

The cases make it imperative that companies carry out due diligence checks without relying on information from suppliers, for example by checking official sources of information such as Companies House in the UK, ensuring details provided by an organisation match its online presence, and calling numbers or testing contact details obtained independently.

“MHRA recognises that determined efforts by unauthorised persons or criminals can be convincing,” writes Brown.

“Nonetheless, there is an expectation that licence holders have appropriate systems to safeguard the supply chain.”