NanoGuardian: Ensuring the Your Medicine is Safe
I was packaged April 28, 2008, in Puerto Rico. My Batch Number is AA6-73P008. I will expire on January 15, 2012. I am associated with 2-D barcode KBDCHDH1528. I was packaged for distribution in Canada. I can tell you as much information as you design me to tell. My codes are undetectable to the human eye so no one can copy me. I am traceable anywhere in the world. I will tell you and only you this information. And I can tell you all of this for less than a penny. (Image published with permission)
So read the ad for NanoGuardian, a state-of-the-art protection system against those who would hope to counterfeit real drugs for a quick profit, or divert real drugs from their intended destination. I found it in the August 2008 issue of Pharmaceutical Executive magazine and was so intrigued by the concept that I had to find out more. So I took note of the web site and immediately started an investigation.
The technology that makes tagging this pill possible, NanoEncryption(TM), was developed by a company named “NanoGuardian (a division of NanoInk).” Using this method, as the ad implies, pharmaceutical companies can add an invisible layer of encrypted data to each dosage of their medications, linking it to an authentication at every stage of their supply chain. Only special tools can actually decipher this code, which links the dose to the package using a proprietary nanolithographic encryption on the dose itself, and Radio Frequency ID tags (RFID) and bar codes on the package. Therefore, if the pill is separated from the package before it reaches the patient, there’s a way to find out.
The technology probably couldn’t have come soon enough, given the growing counterfeit market out there. Email marketing from dubious online pharmacies, which I explored on this blog before, is just one of the many ways these groups can hawk their bogus wares. To me, the biggest concern isn’t even the lost revenue that counterfeiters cause the pharmaceutical companies in creating these fake pills, which NanoInk estimates around $35 billion worldwide. The biggest problem are the patients who are getting their hands on these drugs and endangering their health by taking them.
The process does not chemically alter the drug, and implementing the technology in the manufacturing process requires minimal changes. In fact, a client of NanoGuardian has already submitted a plan to the FDA to implement brand protection through use of the product and has been approved. It wouldn’t surprise me, if this first implementation can be executed successfully, to see other companies start publicly touting the added protection they’re giving patients who rely on their products.
The whole thing actually reminds me a little of a story that came out earlier in the year, where a Silicon Valley company, Gemory, had developed a process for permanently inscribing microscopic versions of photos on a diamond. But while their process may be a novelty and something that is a luxury for people with the money to do it, NanoGuardian’s product seems to be almost a necessity.
The one thing that’s unclear to me is exactly how the patient ends up being protected in this process. The web site for the company is clearly designed to “sell” the product to the industry, which it completely should be. But how do I know as a consumer that what I’m buying is a legitimate drug? The NanoGuardian site indicates that the encryption can only be detected using specialized equipment at the NanoGuardian Authentication Centers…but does that mean that as a consumer I have to send my drugs there before using them? Do pharmacies need to authenticate their medications before stocking them on their shelves? And if it’s not a requirement, what is the impetus for sending the drug for authentication in the first place? If counterfeiters are really good enough to make drugs that look nearly identical to the product they’re duplicating, how would I know that I even need to authenticate? And what’s the cost of authentication? Putting the information on the pill may not cost much…but ensuring a pill has the right information before it reaches the consumer? What does that cost?
I’m sure some of these questions are obvious to some that are entrenched in the industry and familiar with the supply chain. And maybe my brief exposure to the process is naive in that I’m thinking the authentication will be applied in a singular place in the process. I’d love to understand this process more, and would welcome comments from anyone who understands its application better than me. In the meantime, I look forward to seeing the first real products that can ensure their quality because of the tiny writing on the pill.
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As if we needed more proof that this may be a necessary validation technique in the near future, Pharmaceutical Executive just published an article indicating that “Brand Jacking,” or the selling of counterfeit medications, is on the rise. A study by Mark Monitor in June 2008 found more than 20,000 web sites abusing drug trademarks, with a total estimated annual sales of nearly $13 billion.
Click here to read the article, “Fake Pharmacies Brand Jacking on the Rise.”