Anticounterfeiting And NIR: A Hong Kong Diary
The world marketplace is full of counterfeit drugs, as a recent trip showed. Imaging technologies promise to help keep fakes at bay.
By Sharon Flank, Infratrac.
The good news? It took some work to find counterfeits. The bad news? I found plenty. Since I didn’t speak Chinese, I presented my list of medicines. I went for the easy choices: although AIDS drugs, growth hormone, cancer drugs, and pain preparations are heavily counterfeited, nobody had those when I requested them (my initial list included Combivir, Diflucan, Epivir, Epogen, Procrit, Serostim, and Sustiva). So mostly I asked for medicines that a healthy person might buy in a drug store: Norvasc, Lipitor, Lamisil, Viagra, Cialis, and Levitra. None of the shops with herbal ingredients had them, but in one case a gesturing gentleman eagerly transcended the language barrier and walked me down the street a couple of store fronts to the larger shop that he thought could help me.
In Hong Kong markets, Western medicines are always displayed separately
from traditional Chinese medicines. In some shops, herbal and animal
ingredients and supplements are displayed openly, where packaged
pharmaceuticals are generally kept in glass display cases.
There amidst the shampoos, toothpastes, tiger extracts and liquor products, there were in fact some Western medicines. But buying them wasn’t like shopping in a pharmacy in the United States. There were many single-dose packages: one pill, or two or four. One package, of Pepzan, an H2 blocker made in New Zealand, was open. It contained a blister pack of 15 tablets, although the package claimed it contained 120 tablets. The price, written in pen on the flap, was HK$110 – a bit much, but I bought it. The cashier charged me HK$15 – the price for the partial pack, of course. I also found a pack of Viagra – one 50mg tablet, for HK$95. It looked like a genuine Pfizer product, with a blue Pfizer sticker on it, but nobody asked me any questions about prescriptions or why I, a woman, was buying it.
I had the list of top counterfeited drugs on my PDA, and I handed it to one English-speaking pharmacist and said I was interested in all of the drugs on the list. He handled the PDA with reverence, and pushed a few buttons, before handing it back and saying he didn’t have any of those drugs. From the look on his face, I could tell he was wondering why I was using a computer for something I could have accomplished with a piece of paper.
The pharmacies that did sell Western drugs were all glassfronted, with glass display cases, and all tiny by American standards, about 10’ x 12’. Many had “No Fakes” pledges on their windows, and many had displays claiming to be authorized dealers for Pfizer and Lilly. I asked for Norvasc, Lipitor, Lamisil, Viagra, Cialis, and Levitra, and found them all. In one case, a single shop had everything, and the pharmacist spoke excellent English. He wrote down his prices on my paper. All the products appeared genuine – or at least consistent with what I’d seen elsewhere.
And the pharmacist, finally, was curious: What was I doing asking for all these different drugs? I confessed that I was actually looking for counterfeits. His reply? “Do you work for Pfizer?” Then he asked if I was a journalist – and I explained that I worked for a company that could detect counterfeit pills, not just packages, and was looking for test materials. Still wary, he explained that I was in the wrong neighborhood. Sham Shui Po, on Kowloon, is a good place to buy genuine medicine, he said, but if you want counterfeits, you need to go where the tourists are.
The Hong Kong resident who buys a counterfeit, he said, will come back to your shop and complain. Tourists won’t. Western tourists who are looking for a bargain shop in the dispensaries near the tourist markets (themselves full of counterfeit watches, purses, and other designer goods). Visitors from mainland China also buy counterfeits, to resell in China.
I asked how to tell which shops had counterfeits. Would they be the ones without a ‘No Fakes’ pledge or authorized dealer stickers? Not at all: if you buy even one pill legally, you get a sticker, and the rest of your inventory may not be genuine. Price is the key. The profit margin on pharmaceuticals is thin, about HK$10, a little more than a dollar. So no one will bargain much on genuine product, because they’d lose money. He suggested that I offer to buy five or six, and see if the price started to move.
Tagging the Substance
Some existing technologies look to tag the substance, rather than the package. InfraTrac, Inc., founded in 2006, offers a technology originally conceived of as a “wet RFID.” The tag consists only of existing excipients, varied slightly to create a unique fingerprint, detectable by near-infrared spectroscopy.
Inventor Stephen Hoag made a presentation on the technology at an MIT Enterprise Forum showcase on emerging biotechnology. He and co-inventor James Polli had envisioned a pharmacy-based checker, where every prescription could be verififed for accuracy and quality. Before our company licensed the
technology, we set about testing various imaging methods on nonpharmaceutical
products, including gasoline, motor oil and paint.
Polli and Hoag had already tested tablets and capsules. In 2006, many pharmaceutical companies’ brand protection executives and
specialists expressed interest in a lightweight, formulation-based tag, but insisted that they didn’t have a counterfeiting problem and didn’t expect that they ever would. One year later, no company denied that counterfeiting was an issue for them.
Fingerprinting Within SUPAC-15% Is Distinguishable by NIR
In these prednisone tablets, formulated to show four variations in addition to the base formulation (Polli and Hoag 2004), the NIR spectra are clearly distinguishable.
As advocates of NIR will tell you, it can be used to monitor variability in processing and to identify counterfeit, diverted, or deteriorated product. The check takes one second, and testing can be done through glass or plastic.
There is a shift away from desktop lab instruments that require sample preparation, to
either in-process monitoring, or handheld instruments that can provide a reading in situ.
In a cost-benefi t analysis, NIR contributes to risk-based approaches that improve product quality, reduce waste, improve yields, and ultimately lower costs for consumers. It also helps deal with the scary problems: Counterfeiting, repackaging and diversion, and counterfeited or contaminated bulk raw ingredients, from China and elsewhere.
For these purposes, use of a handheld instrument offers advantages in speed, flexibility, and ease of use, so InfraTrac has begun to work with Polychromix’s PHAZIR Rx product, which weighs four pounds.