Can Food Coloring Combat Counterfeits?
Despite ongoing efforts to develop new technology solutions, legislative actions, or enforcement strategies to combat counterfeit drugs, it seems no one has yet found the weapon to finally bring down the $800 billion (and growing) counterfeit drugs industry. But pharmaceutical manufacturers, take note. The US Food & Drug Administration (FDA) recently released a document – “Guidance for Industry Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anti-counterfeiting” – that states that incorporating physical chemical identifiers (PCIDs) into drug formulations could be a cost-effective way of differentiating the genuine from the counterfeit.
According to an article on the subject by Gareth Macdonald for in-pharmatechnologist.com, ideal PCID candidates are pharmacologically inactive and would be “food additives, colorants, or excipients with established safety profiles”. Macdonald said that just like other anti-fake labeling methods, PCIDs can easily be detected in the laboratory. But what’s different – and better – about them is that they can also be easily identified by patients, medical practitioners and pharmacies. The draft guidance also emphasized that the PCIDs should be tested for potential toxicity, and for any interaction they may have with the drug’s release technology.
A security printing and imaging blogger has some worries, though. According to a post by Steven Simske for communities.hp.com, the FDA advice:
Goes against a trend to include less, rather than more, exogenous chemicals — dyes, expedients, etc. — in food and drugs
Does not clarify if the list of PCIDs to add is public knowledge (“with established safety profiles”) – and therefore easier for the would-be counterfeiter to obtain – or that PCIDs used should only be sold by authorized suppliers to authorized buyers to prevent insidious insiders who order PCIDs and sell them for profit to counterfeiters
Does not consider that incorporating PCIDs may complicate the authentication process –requiring the deployment of specialized analysis equipment and personnel – while track and trace and authentication through the appropriate combination of security printing may be easier, and more cost-effective, scalable, and effective
Meanwhile, should pharmaceutical manufacturers heed FDA’s advice, Colorcon is ready to offer exclusive tablet identification and authentication systems. A world leader in film coatings, modified release technologies, functional excipients, and tablet branding services, Colorcon provides a complete line of customized film coating and ink formulations that can be used to give a unique appearance to solid oral dosage forms (SODFs) — making it easier for a patient or pharmacists to identify the product at a glance. According to the company, these excipients offer established safety profiles, do not interact with core components, and have no potential effect on the quality, performance, and stability of the SODF — all of the important pharmacological and toxicological considerations covered in the FDA guidance document.
Incorporating PCIDs into pharmaceuticals may have its pros and cons – but with the FDA behind it, it’s surely an idea worth examining. As recently appointed FDA commissioner Margaret Hamburg said, “Drug counterfeiting is a serious public health concern,” and the agency is committed to ensuring that fake products are stamped out.
However, big pharmaceutical companies managed to enter market niches and are continuously increasing their market share. India is the 2nd country after the USA owning the most important number of production units approved by the FDA. To complete their rise, Indian laboratories are trying to develop their marketing network within the main world markets. When they will have completed this stage, we can bet that they will be conquering more market shares…
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