Although estimates about the scale of the global counterfeiting problem vary, it is widely recognised that the number of fake drugs being made is growing year on year as criminals are increasingly attracted by the high returns and low risks that such activity represents.
And, while regulatory bodies worldwide are ramping-up efforts to seize fakes and remove them from the pharmaceutical supply chain, the ease with which counterfeits can be produced make it a near insurmountable task.
As a result, regulators are increasingly asking manufacturers across the drug supply chain to help make faking a less attractive proposition by making it more expensive to produce convincing counterfeits.
In July for example, the Food and Drug Administration (FDA) issued guidance advocating greater use of physical chemical identifiers (PCIDs) in drug formulations as a cost-effective way of authenticating genuine products from fakes.
US Drug coating specialist Colorcon and development partner ARmark Authentication Technologies are among the first to respond to this call with mark On-Dose ID, a technology base on microscopic covert "micro-tags" exclusively licensed for tablet film coatings from ARmark.
The tags can hold encrypted information ranging from lot and batch numbers to logos, text and other brand identification symbols.Tablets labelled with the 75 – 110 micron sized tags can be read using the portable “Vision” optical viewing system also developed by ARmark.
Colorcon’s general manager of film coatings, Kamlesh Oza, explained that the key driver for development was the desire to supply the drug industry with an “on dose” tagging system that can be incorporated into existing manufacturing operations.
Oza told in-PharmaTechnologist that: “The micro-tags are covered under the FDA guidance for Physical-Chemical Identifiers (PCIDs) and can be incorporated into an existing immediate release film coating as a SUPAC level 1 annual reportable change.
He added that the tags are virtually impossible for fakers to copy and provide a non-destructive means of detecting and authenticating legitimate dosage forms even when separated from their packaging.
Oza also stressed that the tags have no impact on film coating performance and explained that they are made from approved excipient materials that are generally regarded as safe (GRAS) and covered by the FDA’s inactive ingredient guide (IIG).