While R. Stahl, Waldenburg, Germany, is warning that dangerous knock-off products are circulating in the explosion-protection and prevention market, counterfeit pharmaceuticals pose another, far-more-extensive worldwide challenge..
The World Health Organization (WHO), Geneva, Switzerland, estimates that globally 10% of medication is counterfeit. Criminal trade in counterfeit medication is more prevalent in developing countries with weak drug regulation, control and enforcement, and where basic medicines are scarce or irregularly supplied and unaffordable. It’s endemic in southeast Asia and Africa, where the amount of counterfeit pharmaceuticals in circulation is more than 50% in some countries.
The most counterfeited drugs in developing countries are designed to fight malaria, tuberculosis and HIV/AIDS. In developed countries, hormones, corticosteroids, cancer drugs and retrovirals are common targets — along with lifestyle drugs which treat conditions such as sexual impotence, baldness and obesity, according to WHO. Now, the U. S. Food and Drug Administration (FDA) has taken a big step forward in its battle against counterfeit drugs.
“Drug counterfeiting is a serious public health concern,” says Margaret Hamburg, FDA commissioner of food and drugs. “We look forward to working with industry to help ensure that consumers are not exposed to products containing unknown, ineffective or harmful ingredients.”
The document aims to provide guidance to industry about use of PCIDs in solid oral dosage forms, which include pills and capsules, for anti-counterfeiting.
A PCID is a substance or combination of substances possessing a unique physical or chemical property used to identify and authenticate a drug product or dosage. In addition to inks, pigments and flavors, specific chemicals may be used as molecular tags in a PCID.
There are various available means for PCID presentation and detection, such as photolithography, holography, laser scanning devices and excitation/fluorescence detection. Many identifying characteristics, such as pigments or flavors, could be easily observed by patients, healthcare practitioners and pharmacies, says the FDA. Some might require instrumental detection, for example a scanner or photometric detector.
The FDA anticipates many potential PCID ingredients are already used as food additives, colorants or other types of inactive ingredients with established safety profiles. However, recent advances in X-ray diffraction (XRD) mean that it’s now possible to use the technique as a basis for phase identification and quantification of counterfeit pharmaceuticals.
One company leading the way is inXitu, Mountain View, Calif. Its portable field XRD analyzer TERRA, which took the Editors’ Choice Gold Prize at Pittcon in March, has been tailored for completely contained operation in remote environments and at all points in the global pharmaceutical supply chain. It can achieve qualitative and quantitative validations within two minutes.
The company’s Web site (www.inxitu.com/index.html) shows an example of such an analysis where a suspect batch of Viagra was found to consist of three mineral fillers: gypsum, bassinite and dolomite.