Rapid identification of counterfeit drugs

Fake pharmaceutical products are a growing problem worldwide. A general and easy-to-use screening method rapidly identifies counterfeits to help identify and eliminate sources of counterfeit medicine.

Counterfeit medicine poses an ever-increasing threat to the health and well-being of patients around the world. The World Heath Organisation has estimated that sales of counterfeit drugs range from 1 to 2%, up to 30% or more of the market share, depending on country, and will continue to grow across all continents.

Given the seriousness of this problem, a variety of methods are being used to combat counterfeit medicines. There are two main approaches to detecting counterfeits: one is to mark packaging in some manner; the other is to test the product itself for authenticity. Both approaches are needed in the fight against counterfeit medicine and each has its strengths and weaknesses.

Packaging-based approaches offer many options – from overt and covert markings to barcode and RFID tracking. All involve additional manufacturing steps to add the required feature to the packaging. The more complex systems involve additional infrastructure to capture and manage data.

One drawback of packaging-based approaches is that counterfeit product may find its way into authentic packaging or counterfeiters may produce packaging with the same anti-counterfeiting feature that was intended to deter them. Because on-package anti-counterfeiting approaches are not always practical and can fail, testing the actual product to determine whether it is authentic or fake continues to be a valuable approach. The downside to product testing in the past has been the time and effort required to run tests. However, methods have been developed to reduce the time and effort needed to test products.

Product test

To address the need for a more efficient way to test products, SunChemical Security has developed a simple and general method to test products.

The key features of this approach are:

• Taggant-free – no markers are added and product is tested ‘as is’
• Applicable to a wide variety of medicines (pills, tablets, injectables and creams)
• Simple procedure allows testing near the collection site
• Immediate pass/fail and the ability to classify counterfeits

The principle behind SunScreen™ is a fingerprinting method based on fluorescent dyes. The light absorption and emission properties of fluorescent dyes are very sensitive to the chemical environment. When a product is mixed with an appropriate set of fluorescent dyes, a fluorescence pattern characteristic of that product is generated. By using an appropriate sample set (representing a certain time span or number of manufacturing sites) the typical fluorescence pattern for a given product is defined. Because brand-name products are produced consistently, fluorescent fingerprints fall into a predicable range.

By contrast, it is unlikely that a counterfeit will match all ingredients found in the genuine product. Hence, when a counterfeit sample is tested, the resulting fluorescence pattern is different from the authentic fingerprint and serves to identify the sample as fake (see Figure 1).

Simple and transportable

The fluorescent dye set for a product is replicated with very high precision in transportable test plates, which are shipped to field test sites. Samples are processed in a few simple steps and added to the test plate. SunScreen software directs a table-top reader to measure the sample and provides on-the-spot pass/fail results with no technical expertise required. The data can also be analysed using multivariate techniques to reveal relationships among the counterfeit products.

While high-quality data can be obtained by standard analytical methods, delays and the unreliability of shipping samples to laboratories present problems in many circumstances. In addition, standard analytical tests can be costly and if results are not provided quickly they may be of little value since counterfeiters often change. By testing samples near the point of collection and providing informative results quickly, problem areas can be identified and enforcement activity can be guided to address the most critical problems.

Company profile

SunChemical Security is a division of SunChemical, the world’s largest supplier of inks and pigments. Its global reach and experience in printing solutions enables SunChemical Security to provide brand owners effective approaches to brand protection through the use of overt and covert packaging security features in addition to its taggant-free SunScreen test. For more information, visit www.sunchemical.com/security.

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