The series of high profile pharmaceutical counterfeiting cases that made headlines in 2003 emphasized serious vulnerabilities in the drug manufacturing and packaging processes. The inability to verify authentic pharmaceuticals at the individual unit level leaves room for criminal product diversion and counterfeiting. The end result is a financial and public safety crisis that is acute and growing.

To respond to the problem, drug manufacturers and product packagers are retooling their manufacture and distribution methods and employing new technologies that enable the authentication of pharmaceuticals down to the smallest unit levels.

“The pharmaceutical industry needs to demonstrate to authorities all over the world that there are existing and cost-effective ways to protect consumers from the growing threat of counterfeit pharmaceuticals,” said Michael Simmons, CEO of Orbid Corporation, a developer of a security coding system used to protect products of all types from diversion and counterfeiting. CCL Label, recently announced the Security Content Label (Patent Pending). Designed by Jim Yonge, Director of New Business Development, the SCL is a unique die cut label that gives the pharmaceutical industry a packaging option that offers an unparalleled level of security.

“We are confident that this long-awaited security packaging system is the key to stopping counterfeiting, theft and diversion,” stated Rob Ryckman, Director of Marketing and Product Development of CCL’s Healthcare Solution Group. “We are responding to a public safety issue, first of all, and answering the problem of erosion of the public’s trust in the effectiveness of longstanding, well-known pharmaceutical brands”CCL Label’s Security Content Label can combine a number of technologies–overt, covert, forensic and RFID systems–that make it possible to absolutely determine a drug’s origin and cross-check for authenticity from manufacturing site, through distribution, to pharmacies, and ultimately to patients.

“Criminal diverters and counterfeiters have been playing a very lucrative game, so they are willing to employ very sophisticated and expensive techniques to keep themselves in business,” said Ryckman. “However, if faced with a new packaging system that employs several new and innovative security features, we believe that many counterfeiters will not be able to counter the packaging, evade prosecution, or be profitable.” The design of CCL’s Security Content Label lends itself to high-speed application, and is machine and human readable. The Security Content Label is available in a prime label format and booklet/concertina format. It incorporates standard bar codes with state of the art 2DMI codes developed by Orbid Corporation, and a color shifting ink from Flex Products called Secure Shift Ink.

CCL’s base label acts as a prime label with the ability to have individual die cut pressure sensitive parts that are coded and removable. This SCL label is attached to a bulk bottle of product that will later be dispensed in smaller prescription dosages by a pharmacist in a new smaller bottle. The bulk base label and the tabs are printed using ink or laser with an Orbid 2DMI code and Secure Shift&reg Ink printed on the main label and each individual security tab for ultimate security. This tab is defoliated from the bulk SCL label by the pharmacist then affixed permanently to the smaller end user (patient) bottle (see picture # 1). CCL can create as many tabs as needed and with sequential numbering. Each base label can have its own sequential number as part of the Orbid 2DMI code.

Orbid’s 2DMI system utilizes two-dimensional security marks that appear as unintelligible graphical representations of encrypted data. Because 2DMI is a closed system, only the manufacturer of the pharmaceutical label will hold the unique algorithm that unlocks the data represented by the marks, making mass reproduction of marks by counterfeiters impossible. 2DMI can be incorporated unobtrusively into any packaging designs, printed in virtually any color, in any size, and on any surface while remaining rapidly scanable by commercial-off-the-shelf cameras and standard imagers. Orbid’s 2DMI marks give each label its own unique and traceable identity that cannot be copied or removed.

“The pharmaceutical industry can now accurately track and trace their products throughout the supply chain, from manufacturer, to distributor, to pharmacy, to consumer,” said Michael J. Simmons, CEO of Orbid Corporation. “Authorities and personnel in the field will be able to scan suspicious drug shipments and know instantaneously whether they are authentic or counterfeit or diverted product. This is a very powerful capability.”

The SCL label also relies on Flex Products SecureShift&reg color shifting technology as it’s primary overt (eye verifiable) security layer. SecureShift&reg is based on the principles of Flex’s color shifting technology which is currently used to protect the currency of over 90 countries. The unique color shifting effect of SecureShift&reg is easy for pharmacists, company personnel and the public to verify, yet is highly resistant to attempts to counterfeit. SecureShift&reg is currently used by over 8 of the top 20 pharmaceutical manufacturers on multiple brands with combined sales of over $8 billion a year.

“It is very fitting that we are incorporating technologies that are already being used to protect paper currency because as an industry, by giving counterfeiters enough leeway that they have been able to use fake pharmaceuticals as a substitute for printing their own money. That time is over now,” said CCL’s Ryckman.