Counterfeit Drugs Threaten Health, Pharmaceutical Industry

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The globalization of medicine trade has led to the growth of pharmaceutical counterfeiting, a significant threat that put millions of patients at risk but has been largely unaddressed. Analytical authentication technologies are some of the most effective methods to identify active pharmaceutical ingredients and impurities, but most of these techniques are expensive and require highly-skilled staff. To address this problem, Colorcon has developed a disruptive cost-effect product to fight drug counterfeit.

“Whenever a person does an online search for medicines, around 50 percent of them are led to a fake website,” said Gary Pond, Global Product Authentication Lead at Colorcon. Drug counterfeiting costs about 1 million lives per year, he explained. For the global pharmaceutical industry, this problem costs US$200 billion per year.

Moreover, the COVID-19 pandemic led to an exponential increase in the false postings of medicines in online websites, added Pond. The pandemic also made criminals bolder. Eight months prior to its development, a supposed COVID-19 vaccine was already being offered online. “In Mexico, a fake Pfizer vaccine have been identified in the market recently. The problem is that these fake drugs do reach the market.”

Despite of the numbers and the known dangers of counterfeit medicines, this problem has grown by over 70 percent from 2015 to 2019. “This is a low-risk, high reward activity, with very low penalties and with free access to high-technology to carry it out.” According to Pond, there are over 600 illegal pharmacies entering the market each month.

Mexico ranks sixth in the Top 10 illegal medication markets and about 60 percent of the medicines sold in the country are stole, expired or falsified, according to AMIIF. “As a result, the measures agencies take to prevent counterfeit are already being evaluated, since everything is focused on packages,” said Pond.

“Current tracking protections are always on the secondary package, rarely on the primary package and almost never on the tablet itself.” Pond explains that this secondary-package protection can be easily falsified. “Barcodes/tacking numbers can be easily copied, packages are discarder and reused, the ability to verify an individual pack is not global and only limited to a specific country or region, and illegal online pharmacies are driving growth of falsified medicines.”

To address this problem, Colorcon has developed an On-Dose Authentication Compliments Serialization called SoteriaRX, which is a covert microtaggant, a molecular DNA taggant and a silica taggant incorporating directly onto the tablet via the film coating. This technology is not detectable to the naked eye. “SoteriaRX is a tablet coating with a built-in taggant, meaning that the tablet becomes the barcode itself,” said Pond.

“SoteriaRX is a tagged fil coating with invisible taggants, containing coded information, placed into Opadry film coating or primary packaging inks. Its detection method is decoded and read by custom software using desktop reader or standard smartphone.

Colorcon offers two different taggant solutions. The first are molecular taggants made with synthetic DNA. These are very difficult to detect and use fully synthetic, non-biological DNA in part per billion levels (ppb). The tagging has no impact on analytical measurements such as chemical/API assays. Second, is a silica based microtaggant, that takes advantage of the common use of silica dioxide as an excipient because it is chemically inert, extremely resilient and considered GRAS by FDA. Tt has an inclusion level approximately 0.03 percent of tablet.

“These solutions are easy to adopt in existing Opadry Fil Coating, as it already has the taggant mixed in it, so the coating process does not have to change and there is not major investment required in the manufacturing process of the tablets,” explained Pond.

The taggants can be detected through a PCR MCHINE or a Portable PCR that can be connected to a phone. Pond shared that a smartphone application is under development and will broaden access, leading the way for a wider digitalization of medicines. The app will take a picture of the tablet and determine if it is real or not in seconds by reading a customizable message by the manufacturer of the drug. The app can also include patient support reminders to ensure they follow their treatment and give them information about the product.

“The microtaggant we are utilizing is described by the FDA as a physical-chemical identifier (PCID) and the agency recommends using these technologies in addition to serialization,” said Pond bout the regulatory status of the development. It is a NoTox Primary Pharmaceutical Packaging Ink, allowing drug delivery applications beyond solid oral dose with no need to open package to authenticate available for blister packs, bottle seals, desiccants, transdermal patches, inserts and other applications. Pond explains that de FDA marked SoteriaRX as an excipient submitted on a level 1 report.

The product benefits the supply chain by enhancing the quality assurance processes to counter fraud. These solution offers a broad range of benefits for patients, supply chains operators, pharmacists, hospitals, markets and regulatory agencies. This technology can also be applied outside of the pharmaceutical sector. “Nutraceutical companies can also include on-dose authentication with little change to their typical film coating manufacturing process, as the microtaggants are added directly into the coating system. With this innovation, companies are now able to uniquely tag their tablets and authenticate them in the field using a desktop reader.” SoteriaRX will be commercially available soon and the app will be ready to download in 2022.