In working to protect the supply of medicines from breaches, import testing has been labelled as ‘redundant’ by experts.
Commentators have ventured to state that manufacturers should have the option to sidestep this process and that import testing could actually incur drug shortages.
Authors of a study published this year proposed that import testing, which usually occurs in the central stages of the supply chain, ‘does not add any significant value to the quality and safety of drugs nor reduces risks, provided the manufacturers apply good practices (GDP and GMP)’
Instead, postmarketing surveillance testing should address supply interruptions according to the experts, as this is more appropriate for controlling the quality of medicines without delays.
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) supports the findings of this study adding that import testing drains drug shelf life. Also it can trigger global recalls of material that is, in fact, fit for use. Also because these assessments happen at the point of entering a country the IFPMA feels it is not very useful for detecting counterfeit products.
The body admits: “ Although post-market testing does not cover every lot, it does provide data on medicines in the market nearer to the direct supply to the patient.”