The Counterfeiting Problem.

Counterfeiting presents a significant worldwide problem across multiple industries. It is responsible for hundreds of billions of dollars of lost revenues annually in sectors as diverse as pharmaceuticals, cosmetics and fragrances, textiles and clothing, food, luxury goods, consumer products, electronics, paints, inks, currency and packaging.

In the pharmaceutical industry alone, according to the World Health Organization, an estimated $431 billion in counterfeit products are now sold each year. But with pharmaceuticals, counterfeiting involves much more than lost revenues. It poses a significant health and safety risk for millions of people. Counterfeit pharmaceuticals are often found to include either only inactive ingredients or dangerous impurities, Counterfeiting is a problem in all classes of medicine including branded, generic and OTC products and in all dosage forms including orals, injectables and topicals.

In healthcare, the issue of counterfeiting is so significant that most regulatory and advocacy agencies have made introduction of anti-counterfeiting standards and policies a top priority. In the U.S., the FDA maintains a dedicated Division of Supply Chain Integrity within its Office of Compliance. Interpol similarly has established the Medical Product Counterfeiting and Pharmaceutical Crime Unit and the Pharmaceutical Industry Initiative to Combat Crime.

Counterfeiting Problem

On a global scale, regulatory agencies are targeting introduction of significantly higher standards in “track and trace” capabilities in pharmaceutical manufacturing. These policies and standards are positioned to completely reshape pharmaceutical development and manufacturing in the years ahead. Already in the United States, counterfeiting has led FDA to publish a Guidance for Industry entitled Incorporation of Physical Chemical Identifiers (PCIDs) into Solid Oral Dosage Form Drug Products for Anti-Counterfeiting (2011). In addition Congress passed and the President signed into law the Drug Quality and Security Act (2013). Title II of the Act outlines steps to build a system to identify and trace prescription drugs through their distribution chain. Key aspects of the law outline requirements related to the use of lot numbers, expiration dates, bar codes and other unique identifiers.

Many industry insiders project that regulatory guidance will not stop here. As concern for patient safety continues to expand in the U.S. and in countries around the world, it is anticipated that even more stringent regulatory requirements supporting higher standards in track and trace capabilities will be introduced. These will likely rely on a technology able to encrypt both a product and its packaging, supporting instant mobile verification to confirm that an authentic label corresponds with authentic drug, or that drug analyzed outside a package can be confirmed as authentic.

Taaneh has developed an authentication technology platform able to conclusively and instantly confirm the authenticity of package or drug and relate them to each other at any stage in the supply chain from manufacturer to patient.

The Authentication Solution

Based on the current and anticipated regulatory requirements, effective authentication technology must be designed with several distinct advantages, including:

  • a proven track and trace capability
  • advanced capabilities in encryption and authentication;
  • immediate mobile verification at any point in a supply chain using readily accessible technology;
  • standards that meet or exceed global regulatory requirements and that position drug manufacturers to comply effectively;
  • use of proven inert materials that are available in quantities to support global production;
  • materials and protocols that have a negligible impact on production protocols, costs and timelines; and,
  • minimal and readily incorporated refinements to manufacturing, processing, packaging and distribution.

Authentication technologies based on encrypting either the label/package or the product can provide some benefits, but cannot conclusively demonstrate that both product and label are authentic at any stage in the supply chain or when product is removed from packaging. Meanwhile, current technologies used to encrypt both label and product cannot provide the levels of security and customized variability that drug manufacturers need. They also cannot provide robust instant remote verification. Despite the available options for authentication including imprints, colorants, electronic microchips, inert materials and other alternatives, counterfeiting remains a major problem in pharmaceutical manufacturing. Here’s why:

  • No one-to-one link between product and drug. Many authentication technologies work on either label or product, but not both. In these cases, there is no way to confirm that the product and label are the same unit at every stage in the supply chain.
  • Unwieldy technology. Options that do tag both product and label often require costly and time-consuming remote authentication. Industry needs an on-site and immediate technology solution that provides a constant link between product and package to ensure that both are authentic.
  • Complex manufacturing. Options that tag product can introduce additional steps and costs to the manufacturing process.
  • Visibility. Many options to tag both product and labeling are readily visible, making them easier for counterfeiters to work around. Meanwhile, others that are invisible to the naked eye cannot be easily visually inspected in the field. Industry needs a tag and trace capability based on visible and invisible inert materials that can be observed and verified on demand at any stage in the supply chain.
  • Materials added to drug formulations. Materials used to support authentication must be inert and they cannot adversely affect the manufacturing process. Materials must mix well with current formulations. For injectables specifically, prevailing guidelines limit the number of particles that are allowed to be >10µm. Materials in the nanometer range will meet these guidelines while others in the micrometer range can present limitations.

The Regulatory Environment

Introduction of achievable standards in authentication that deliver the highest levels of protection for patients and a workable solution for industry is now a top priority for the FDA and other regulatory agencies. The prevailing FDA standards represent an important benchmark for industry to consider. According to the FDA Guidance for Physical Chemical Identifiers (PCIDs), materials used to support authentication protocols:
  • must be pharmacologically inactive;
  • must be "a substance or combination of substances possessing a unique physical or chemical property that unequivocally identified a drug product";
  • must not affect identity, strength, quality, purity, potency or bioavailability, and
  • may rely on previously established safety criteria if included on either the GRAS list for food additives or the database of inactive ingredients for approved drug products.
In light of these requirements, the long term comprehensive authentication solution will be based on the use of an inert semicovert/covert/forensic identifier that is difficult or impossible to replicate.