In countries around the world, the sale of counterfeit drugs is a significant problem for the pharmaceutical industry. It is estimated that global sales of counterfeit drugs now total more than $350 billion every year. In addition to lost revenue for drug marketers, falsified drugs also pose a significant risk to the safety and well being of consumers. They often contain impurities that can affect their efficacy and put patients at risk.
On a global scale, regulatory agencies are recognizing this problem and working to address it. In 2011, the FDA released a new Guidance for Industry entitled, “Incorporation of Physical Chemical Identifiers (PCIDs) into Solid Oral Dosage Form Drug Products for Anti-Counterfeiting,” and Congress passed the Drug Quality and Security Act in 2013, establishing a list of incremental steps pharmaceutical manufacturers must take to ensure that the quality and authenticity of any given product can be tracked and traced through every step of the distribution chain. In many cases the new guidelines call for improvements in security based on the use of traceable lot numbers, bar codes and expiration dates. For many manufacturers, deadlines to meet these new anti-counterfeiting standards are looming. They will soon need to find a way to verifiably track and trace drugs, encrypt secure information, and confirm that the product is real at every step of the supply chain.
Most current methods of authentication rely on the use of bar codes, serial numbers or distinct packaging features. But in many cases these measures may be insufficient, especially when a drug becomes separated from its packaging. In order to verify authenticity throughout the distribution chain, oral and infused drugs should have identifiable and traceable indicia added to both their formulations and their packaging that can be observed independently and together. Some drug manufacturers are targeting improved performance in authentication through the use of colored dyes, microchips or subtle physical imprints, but these solutions are not without limitations, including:
- If a drug is separated from packaging at any point, these measures often can no longer be used to confirm that product and package are from the same unit.
- Many physical identifiers can be easily identified and copied, and counterfeiters may simply refine their processes to work around them.
- Adding materials to drug formulations can affect the uniformity of the product.
- Applying special coatings or bar codes to the surface of pills can significantly increase production time and costs.
The key to time and cost-efficient drug authentication may lie in the unique properties of a common allotrope of carbon: diamond. Carbon is an inert substance that is included on the FDA’s list of inactive ingredients that can be added to pharmaceuticals. The natural variations in diamond’s crystal lattice structure allow it to produce a nearly infinite range of spectral signatures that are as unique as fingerprints and almost impossible to replicate. Microscopic diamond particles are invisible to the naked eye, but can be seen using available hand-held technology. (Fig. 1) When present in drugs in even trace amounts, these particles can emit specific spectral signatures, providing an instant capability to confirm authenticity of both drug and packaging together or separately. Based on these characteristics, the pharmaceutical industry is now exploring the possibility of adding low concentrations of diamond to drug formulations, packaging and ink in efforts to meet or exceed global standards in tracking and tracing in the years ahead.
With the addition of diamond powder to drug or packaging, simple handheld detection devices can be programmed to observe the specific spectral signature and compare it to a range of spectra in a database. This process can then instantly confirm authenticity at any stage from manufacturing to consumer.
The use of diamond powder provides a unique advantage in regard to drug packaging as well. The same random mixture of diamond powder added to a drug can be added to the ink used in printing the packaging. The spectral signatures can be detected through opaque packaging, making it possible to confirm authenticity at every level of distribution, from box to bundle to individual units. (Fig. 2) Diamond can also be added to product and packaging without disruption to most established manufacturing protocols and can be added to ink without requiring new printing technology or processes.
The first industrial use of diamond to combat counterfeit medication is expected soon. This new technology may also have implications in other industries prone to fakes, forgeries and tampering, including cosmetics, food and beverages, vitamins and processed foods.
Filed Under: Drug Discovery