P. 26-31 /

Falsified APIs
Are we solving the problems?

President of CEFIC’s Active Pharmaceutical Ingredients Committee (APIC)
Manager External Regulatory Affairs at DSM Anti-Infectives, P.O. Box 425, Delft, 2600 AK, The Netherlands


The problem of falsified Active PharmaceuticalIngredients (APIs) forms part of the overall, global problemof counterfeit medicines but has until recently receivedrelatively little attention. Recent fatalities caused by falsifiedAPIs have brought the issue into the limelight. Increasingevidence exists that the magnitude of the problem is verylarge. Several legislative initiatives aimed at resolving theproblem are now running in different parts of the world. Theauthor evaluates the progress and launches his ideas forreaching effective solutions in the shortest possible period oftime. Finally, he stipulates that if the API issues will be effectivelyresolved at the same time a large step forward will be madein the fight against the entire counterfeit medicines problem.