A. THIS QUESTION POSES AN INTERESTING DILEMMA to the investments currently directed toward regulations requiring application of unique serialized codes to pharmaceutical packaging. Newton’s Third Law reminds us that for every (label security) action there will be an equal and opposite reaction (by counterfeiters). The fakesters won’t be denied. They will likely sell unpackaged, bulk pills via secondary channels or attempt to “copy and paste” legitimate bar codes onto falsified labels.
Brand protection experts remind us that multilevel protection is the best safeguard against counterfeits. In addition to package authentication marks, prudent brand owners should invest in markings on the product itself. Despite adding process complexity and cost for manufacturers, ultimately, it’s the pill that bears the burden of proving authentication. On–dose technologies such as Raman chemical imaging, micro-taggants, and DNA-like fingerprinting are viable complements to package markings.
Ron is president of LifeCare Services, LLC. He has more than 36 years of experience in the healthcare industry with J&J and is also a consultant on brand protection and supply integrity issues.