Hand-held and mobile authentication technology
Hand-held devices that detect counterfeit or adulterated drugs can provide authentication in the field. A potential collaboration
between FDA and the US Pharmacopeia focuses on hand-held device applications and the development of references for rapid screening
of drugs. In addition, the use of mobile phones for authentication at the consumer level is underway. Pharmaceutical Technology discussed these topics with William Koch, PhD, chief metrology officer at USP and Alden Zecha, chief financial officer and
strategist of Sproxil (Boston, MA), a provider of brand-protection solutions.
PharmTech: Can you elaborate on the nature of the devices and applications under review by FDA and USP?
Koch: We are looking primarily at hand-held approaches. Companies have access to a variety of spectroscopic-based handheld instruments
to make measurements largely for identity purposes (e.g., Raman and near-infrared spectrometry). These hand-held instruments
are now becoming sufficiently robust to take into the field and acquire quality information about materials. This is a useful
first-line defense against the spread of substandard and counterfeit medicines. USP and FDA are discussing possibilities of
creating libraries of the various spectra to serve as a rapid reference when such tools are used in the field to distinguish
genuine products from substandards and counterfeits.
PharmTech: Will the requirements of this type of technology be integrated into USP s standards?
Koch: Hand-held devices at this time are limited in scope with respect to the types of physico-chemical properties and are intended
primarily for rapid screening purposes only. At this time, we do not foresee including hand-held methods in the USP compendia.
As technology advances, this may change.
Mobile authentication. Sproxil provides anticounterfeiting support in Nigeria that enables consumers to verify the authenticity of their prescription
drugs using mobile phones. Medications contain a scratch card on the package, and when a consumer scratches the card and sends
the unique numbers under the scratch material via text message for confirmation, a reply text will indentify the product as
legitimate or fake.
PharmTech: Can you discuss the drug-authentication initiative launched in Nigeria? Zecha: Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC), embraced the service and have openly encouraged,
but not mandated, that pharmaceutical companies use our solution. Our service is paid for by the pharmaceutical companies
operating in Nigeria. It delivers consumer goodwill as well as marketing benefits, and also allows the companies to displace
counterfeit products and thus sell more of their authentic products.
PharmTech: What regulatory issues arise with the use of Sproxil's technology?
Zecha: Using Sproxil's service usually requires getting regulatory approval for a packaging change. The change, how-ever, is often
very small and the Nigerian regulators have been very open to these changes as they see the benefit to the public. Our service
has already helped regulators and distributors to confiscate counterfeit medicines. Consumers identified fakes that did not
have our labels and have called us to report the suspected products. We shared that information and the authorities took swift
action.
PharmTech: Is Sproxil involved in any similar programs in the US or with any pharmaceutical companies?
Zecha: Sproxil does not currently have any initiatives in the US. We have been approached by some pharmaceutical companies to look
at adapting our service to help promote patient compliance, and we are in discussions with several large global pharmaceutical
companies.
PharmTech: Can you talk about the security of the technology?
Zecha: We can't openly discuss the details of the technology, but it is very secure. We recently went through an extremely detailed
technical review with the technical security team at a global pharmaceutical company, and after several discussions they were
comfortable that Sproxil met all of their security concerns. As for the counterfeiters trying to break the system, it's all
about money to them. If the cost and effort to defeat the system is too high, they'll stop counterfeiting our customers' products
because they won't be able to make a profit anymore. We have a tagline that says we are "making counterfeiting unprofitable."
PharmTech: Looking ahead, what is the next step for Sproxil?
Zecha: In the near future, in addition to launching some new customers, we'll be announcing our expansion to additional countries.
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