Detectives in the lab

Real or fake? Even experts can't tell with the naked eye whether these tablets are originals or criminal counterfeits. That’s why Carolin Möltgen, who works in a process analysis lab at Merck in Darmstadt, Germany, has placed the suspect pharmaceuticals under a near-infrared chemical imaging (NIR-CI) spectroscope. The powerful analytical machine calculates the distribution of various ingredients in the sample on the basis of about 82,000 spectra per measurement. And the result is clear: "These are definitely counterfeits," says the pharmacist, who is pursuing a doctorate at the University of Heidelberg.
 
Counterfeit and imitation medicines are a global problem. According to estimates, up to ten percent of certain lifestyle drugs used in Europe are counterfeits; in developing countries, up to 25 percent of all pharmaceuticals could be affected. It is difficult to make precise statements, however. One reason for this is that the access to drugs via the Internet has made it much easier for counterfeits to enter the market.

At the same time, the imitations are becoming more and more difficult to distinguish from their archetypes: "In terms of their outward appearance, counterfeit drugs are becoming more and more like the original," says Andreas Maack, Head of Corporate Security at Merck. Many of these imitations are no longer created in some dirty backstreet lab. The counterfeits are instead produced in factories run by organized crime cartels. The results are copies that the layman can hardly distinguish from the original, says the security expert.

But no matter how genuine the tablet or ampoules and their packaging and package inserts appear, the risks that counterfeits pose to patients remains unchanged. That is because the doses of active ingredients are usually either too small or too large. Often, they are not present at all, they have been replaced by other substances, or their expiration date has passed. All of these factors represent a considerable risk for the person who uses these pharmaceuticals.

The Merck Anti-Counterfeiting Operational Network, or MACON for short, is a response to this problem. In the MACON network, which was established in 2008, Merck pooled the expertise from various parts of the company to implement a strategy that takes full account of both preventive and investigative components, says Maack. In the context of how it handles individual cases internally and analyzes risks, one key element of MACON is highly specialized analytical chemistry.

This is where Jens Schewitz and his co-workers come into play. They step in and help out as a task force for MACON when a suspicious drug has to be checked right away. Schewitz, who holds a doctorate in chemistry, actually works in the quality assurance section of Merck, where he monitors the pharmaceuticals being produced in order to ensure a consistently high level of quality. "And who could be in a better position to establish the authenticity of a drug than the person who watches over the production process?" asks Schewitz.