We are a pharmaceutical tablet manufacturer that is increasingly concerned by counterfeit drugs. We have received tablets
that we suspect are counterfeit, but examination of the bulk composition has shown no significant differences. Could surface
analysis techniques be utilized to determine the difference between genuine products and copies?
The answer is yes if the route of manufacture is different. However, before going into specifics we should define counterfeit
drugs, explain the background and why they are such a large problem.
The threat
Counterfeiting was first recognized by the World Health Organization in 1985 and the agency estimates that the sales of fraudulent
drugs will reach $75 billion (€47.9 billion) by 2010.1 Currently, counterfeit pharmaceuticals are believed to account for 10% of the global supply chain and this percentage
rises to 70% in some developing countries. Even in the US, a country renowned for having some of the most stringent regulations
for the pharmaceutical industry, the sale of counterfeit drugs was estimated at $32 billion (€20.4 billion) in 2006. While the direct effect on pharmaceutical company profits is important, the most concerning aspect is the health risks. In
the best case scenario the counterfeit drug performs as the genuine article with no side-effects, in the worst case scenario
the counterfeit drug results in death.
Currently, counterfeit drugs can be split into several categories:
- products without active ingredients
- products with incorrect quantities of active ingredients
- products with the wrong ingredients
- products with the correct quantities of active ingredients but with fake packaging
- products with high levels of impurities and contaminants
- copies of the original product.
Justine Bentley
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Counterfeit drugs with the wrong chemical composition or contaminants can be investigated by a range of techniques such as
nuclear magnetic resonance, near infrared spectrometry, thin layer chromatography, desorption electrostatic ionization, Raman
spectroscopy, X-ray diffraction and liquid chromatography–mass spectrometry. However, those that contain the correct ingredients
in the correct amounts (i.e., copies of the original) are more difficult to identify while potentially being as deadly as
those with the incorrect ingredients.
Regarding the initial question, we need to understand why drugs with the correct ingredients in the correct amounts are a
problem.
At first, these drugs may not appear to have the same health concerns as other types of counterfeit drugs, but it is not just
the profits of pharmaceutical companies that suffer because of the practice of copying originals. Just because a drug contains
the same ingredients as a genuine drug doesn't mean it will react in the same way or, more precisely, have the same effects
on the person taking it. Drugs are specially designed to release APIs at set times if the composition is correct, but if the
distribution of the counterfeit is different then it will produce undesired effects.
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