The company, specializing in DNA-based supply chain, anti-counterfeiting, and anti-theft technology, presented the ink and printing options at the Medical Japan Expo in Osaka.
The inks, powered by botanical-based SigNature DNA, allow for seamless marking at the point-of-manufacture, ensuring that original raw materials or ingredients used to produce pharmaceuticals are fully protected and traceable to point-of-sale, according to the company.
Completed trials, conducted in partnership with Nissha Printing Co. and Kishu Giken Kogyo Co., Ltd., demonstrated that the technology satisfies FDA guidelines for inclusion in pharmaceutics. It also is applicable for use in food and cosmetic products.
Regulations covering more than 75 percent of global medicine supply by 2018 include packaging directives or standards from FDA’s Title II of the Drug Supply Chain Security Act and Japan’s Ministry of Health, Labor and Welfare, according to Applied DNA.
“The scalability of SigNature DNA for pharmaceuticals solves many supply chain challenges,” Dr. James A. Hayward, president and CEO, of Applied DNA, said. “Many of our clients that are using SigNature DNA know that forensic tagging and authentication will protect them from the risk of legal liability and product recall while maintaining profitability and market differentiation.”
To emphasize his point, Dr. Hayward pointed to the article, “Authentic Drugs Tagged with Plant DNA Could Help Snare Fake Meds” (Scientific American, January 12, 2016), which labeled the technology a “possible game changer” for pharmaceuticals.
Counterfeit drugs make up from 25 to 70 percent of the available pharmaceuticals in countries like India and Nigeria, which have weaker regulatory systems, according to the article, adding that as many as a million people worldwide die annually because counterfeit drugs contain too much or too little of the active ingredient specified.
Applied DNA Sciences, Inc. offers security and authentication services to help protect products, brands, supply chains, and intellectual property from theft, counterfeiting, fraud and diversion. Its products provide a forensic chain of evidence that can be used to prosecute perpetrators.
(Sources: Marketwire, Applied DNA Sciences, Inc., Scientific American)