Sep 09, 2010Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) has approved the use of an RFID system to authenticate pharmaceutical products to combat counterfeiters, as well as protect the safety and quality of medications sold in that country. The agency intends to require all Nigerian pharmacies to adopt the system once a large percentage of the nation's drugs are tagged. The solution employs technology developed by Verayo, a manufacturer of what are described as unclonable RFID chips, and readers made by SkyeTek.
GlobalPCCA, a Houston-based provider of health-care solutions, will sell the readers to Nigerian pharmacies and consumers. In 2009, the company met with NAFDAC officials to present an RFID-based solution to reduce the risk of counterfeit pharmaceuticals. The country's counterfeiting problem is significant, the agency indicates, and NAFDAC has been addressing the issue aggressively. In 2001, the rate of counterfeit drugs in that country was 70 percent, according to the agency's reports, but that number has since dropped to about 35 percent. In 2008, to combat the problem, NAFDAC blacklisted 22 Indian pharmaceutical firms from importing and distributing drugs in Nigeria, and also banned 40 drugs from use in the country because they were found to have copied NAFDAC's registration numbers.
Counterfeit drugs impact not only drug manufacturers' sales, but also the health of consumers who take a medication that may contain inappropriate quantities of active ingredients, which could be improperly absorbed by the body or may contain ingredients not on the label. NAFDAC had already been looking into technology solutions, including RFID, says Steve Ams, GlobalPCCA's CEO, but found most systems to be too expensive and not readily available for the many pharmacies located throughout Nigeria. What the agency needed, he says, was an affordable solution that could be made available at little cost to the nation's thousands of pharmacies, as well as consumers, and that would not require the installation of new infrastructure.
GlobalPCCA began working with Verayo and SkyeTek early this year. By March, the two companies had developed a prototype solution that included tags made with Verayo's Vera M1 and M4 RFID chips, designed to prevent counterfeiting, and two interrogators from SkyeTek that can verify whether a tag (and, thus, the drug to which it is attached) is authentic—the pen-sized Pentesta and the tray-style Traytesta, for pharmacy counter tops. Each reader will illuminate either a green LED light (indicating the tag has been successfully read) or a red light (warning that it has not, and that the tag and product, therefore, may not be authentic).
The Vera chips will be incorporated into RFID tags produced by a variety of RFID vendors, says Vivek Khandelwal, Verayo's marketing manager. The passive 13.56 MHz tags will be based on the ISO 14443-A standard, and could come in multiple form factors.
The principle behind Verayo's RFID chips is what the company calls Physical Unclonable Functions (PUF) technology (see PUF Technology Catches Clones and What Is PUF Technology?), which the company describes as electronic DNA or fingerprint technology for semiconductor ICs. PUF technology takes advantage of the fact that the silicon fabrication process has unavoidable, random variations. While these variations do not impact a chip's operations or functionality, they do affect the PUF circuit that Verayo integrates into its chips' design. The PUF circuit in every silicon chip, therefore, exhibits slightly different electrical behavior unique to that particular chip.
When the Pentesta or Traytesta device reads the chip, it issues a random challenge and calculates the response it expects the chip to provide. The chip responds with a unique string of numbers and letters. Verayo software running on the SkyeTek reader verifies that the response is correct for that chip, and the device illuminates either a green or red light, indicating whether the chip is authentic or counterfeit. The Pentesta model is battery-powered, says Josh Peifer, SkyeTek's director of business development, and comes with a USB port so that its lithium ion battery can be recharged, or so that firmware updates can be installed. The Traytesta plugs into a standard electric power outlet.
The tags could be read by consumers or pharmacists at the point of sale before a customer purchases a medication, but they could also be read at the time that a pharmacist receives the products from a distributor, thereby verifying that the items are, in fact, authentic.
The next challenge for the developers, Khandelwal says, is to ensure that pharmaceutical manufacturers can attach the RFID tags to product bottles and blister wrap without significant additional cost. The tags themselves, when purchased in very large volume, cost less than 10 cents apiece.
"What we have suggested is that it be left to the end of the manufacturing process," Ams says, at which time the tags could be attached to packaging, or directly to product containers. Most drug manufacturers have expressed a favorable opinion of the solution, he says, since it helps assure them that their products will not be counterfeited in Nigeria.
The readers, when purchased in quantities close to a million, would be priced at approximately $20 each. Ams says he expects pharmaceutical product importers and manufacturers to order the tags in quantities of as much as 100 million per month. However, he adds, it is difficult to predict how soon manufacturers will begin attaching tags to drugs destined for Nigeria, and until that occurs, the government will not require pharmacies to acquire readers.
GlobalPCCA is also marketing a similar solution for tracking documents in entirely different industries, Ams indicates, such as college diplomas or banking documents. Discussions with end users are currently underway, he says, though no customers can yet be named.
