Draft guidance issued by the US FDA suggests that greater use of inks, pigments, flavours and other physical chemical identifiers (PCIDs) will help combat counterfeit drugs.
IMS health recently estimated that the counterfeit drugs “market” generates almost $800bn annually and is growing at almost 6 per cent a year.
While regulatory agencies and technology developers are working on sophisticated analysis methods and tracking solutions to combat the problem, no one technology has emerged as the leader.
The Food and Drug Administration’s (FDA) new document argues that incorporating PCIDs into drug formulations could be a cost effective way of differentiating genuine products from fakes.
The agency went on to say that PCIDs used in drugs should be pharmacologically inactive and suggests that: “food additives, colorants, or excipients with established safety profiles,” would be ideal candidates.
While in common with other anti-fake labelling methods, PCIDs can be easily detected in the laboratory, their big advantage over traditional methods is that they can be readily identified by patients, healthcare practitioners and pharmacies.
The FDA also suggests that any PCIDs that are selected should be tested for potential toxicity, unless they comply with generally recognised as safe (GRAS) guidelines, as well as any interaction they have with release technology employed by the drug.
Commenting on the guidance, recently appointed FDA commissioner Margaret Hamburg said that: “Drug counterfeiting is a serious public health concern,” and added that the agency is committed to ensuring fake products are stamped out.
The full draft guidance can be accessed here .