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Anticounterfeiting And NIR: A Hong Kong Diary

By Sharon Flank, Infratrac.

PharmaManufacturing.com

The world marketplace is full of counterfeit drugs, as a recent trip showed. Imaging technologies promise to help keep fakes at bay.

Many people in the world today will never know whether the drugs they’re taking are genuine. In some parts of the world, including many African nations, China, India and Russia, the odds are increasing that your next prescription will be filled with counterfeit medicine.

Today, nearly $39 billion worth of fake drugs are sold each year, roughly 11% of the total annual global. The Center for Medicines in the Public Interest expects this figure to reach $75 billion by 2010. The scope of the counterfeiting problem varies widely by country. Pharmacy sales in the U.S. can be expected to be genuine, and 99% of them are, according to estimates by the World Health Organization (WHO).

However, the case is very different for drugs that U.S. citizens buy on the Internet, roughly half of which are likely to be fake. In Angola and Nigeria, up to 70% of the drug supply is likely counterfeit, according to WHO’s International Medical Products Anti-Counterfeiting Taskforce (IMPACT). In parts of Africa, Asia and Latin America, the figure is over 30%, IMPACT estimates, while in some former Soviet republics, it is higher than 20%; in developing nations it is, on average, over 10%.

No Time for Complacency

According to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), counterfeiting is greater in those regions where regulatory and legal oversight is weaker. However, the diminished presence of fakes in developed countries with effective regulatory systems and market control (such as the U.S., EU, Australia, Canada, Japan and New Zealand) should not be a cause for complacency, since the trend is toward an increase in counterfeit medicines even in developed countries.

In May 2007, the FDA issued a report warning of counterfeits on the Internet. This followed a 2006 warning about Internet counterfeits of Lipitor, Diovan, Actonel, Nexium, Hyzaar, Ezetrol (known as Zetia in the United States), Crestor, Celebrex, Arimidex, and Propecia. The 2007 report cited Xenical, a Roche weight-loss drug, that contained either no active ingredient, or a different active ingredient, sibutramine. Other cases involved Tamifu and Cialis. These cases fit the typical drug counterfeiting profile: the drugs are relatively expensive, and, in the case of Tamiflu, they may be in short supply.

A wide variety of product protection technologies have been developed for use on pharmaceutical products. Overt verification tools, such as holograms or color-shifting ink, can be seen by consumers. Unfortunately, they are relatively easy to copy. Covert tools, such as invisible printing and digital watermarks, are more expensive and require special devices to check. There is a movement to make the verification easier, whether it is by UV light, or via a camera phone as used by YottaMark.

However, both overt and covert methods tag the package, rather than the product. And both rely on a kind of “arms-race” approach to protection, based on the assumption that the more expensive and complex the technology, the less likely the counterfeiter is to use it. There are obvious flaws to this approach: it makes sense only on expensive drugs, and as counterfeiters become increasingly sophisticated, and the cost of technologies drops, manufacturers are forced to select more and more expensive countermeasures.

Lab-based techniques, including near-infrared, mid-infrared, and Raman spectroscopy, X-ray powder diffraction, thermal gravimetric analysis, microscopy and various forms of chromatography have been used to check the authenticity of samples. Although powerful, these tend to be slow, limiting their use in prosecution of counterfeiting. Forensic technology, essentially chemical or biological tags built into medicines or packaging, are even more secure, but often significantly more costly.

Serialization or track-and-trace systems, using technologies such as bar codes and radio frequency identification (RFID), help provide authentication by allowing a medicine to be tracked through the supply chain. These require an expensive technical infrastructure and are not completely immune to “hacking.” There is still some uncertainty about RFID interaction with liquids and biologics.

Furthermore, RFID tracks the pallet and the package, but not the drug itself, and, before it reaches the consumer, the tag is removed. There are now documented cases in which an RFID-tagged package has been shown to contain counterfeit product, as noted by Novartis’s CSO James Christian in an article published last year in CIO magazine (see References).

The European Federation of Pharmaceutical Industries and Associations (EFPIA) announced last May that it had selected the 2-D barcode as the preferred anti-counterfeit tool “instead of the less reliable and more expensive RFID.” These technologies cannot stop counterfeiting on their own. RFID is indeed expensive, and the whole armsrace approach will be unable to protect less-expensive products, whether drugs destined for developing world markets, or generics for developed countries.

Anti-counterfeiting, for better or for worse, is likely to be a growth business for years to come, with increasing opportunities for less expensive solutions. In an attempt to investigate the counterfeiting problem firsthand, I took some time during a trip to Hong Kong to seek out counterfeit products. Counterfeit luxury goods were everywhere. Pharmaceuticals were harder to track down.

Shopping For Counterfeits in Hong Kong

Counterfeit medicines are not being peddled in flea markets in Hong Kong. Instead, they are sold in regular shops, alongside legitimate Chinese and Western medicines. The shops are clean, with shining glass counters, and are staffed by pharmacists, some more knowledgeable than others. The fake drugs come in packages that look real, and sometimes they are even covered with special “anticounterfeiting” tapes and stickers.