BOX 6-1
Classifying Falsified Medicines

One way to classify falsified medicines is to assign categories based on the sophistication of the fake. This is an example of such categorization.

•   Category 1: Completely fraudulent products with unknown contents and therapeutic effects significantly different from the genuine drug.

•   Category 2: Look somewhat similar to the drug being imitated, but the drug composition is not known.

•   Category 3: Look very similar or identical to the genuine product but contain an entirely different drug, if any.

•   Category 4: Look very similar or identical to the actual product but contain an alternative drug or synthetic analogue providing similar therapeutic value to that of the authentic product; intended to create repeat business.

•   Category 5: Visually identical, highly sophisticated copies or synthetic analogues with some therapeutic value that cannot be detected using most field and laboratory methods.

Overview of Detection, Screening, and Analytical Techniques

The main categories of techniques for pharmaceutical analysis can be broken down as follows: visual inspection of product and packaging; tests for physical properties such as disintegration, reflectance spectroscopy, and refractive index; chemical tests including colorimetry and dissolution; chromatography; spectroscopic techniques; and mass spectrometry. Within each of these categories, some technologies are appropriate for use in the field with minimal training, while others require sophisticated lab equipment and a high level of technical expertise.

Visual Inspection and Package Technologies

An expert can identify some drug quality problems by sight. Therefore, visual inspection of a product and its packaging by someone who knows the properties of the authentic drug or is able to compare the sample to the authentic product is the standard first step in any drug quality analysis (Martino et al., 2010). These visual inspections provide qualitative data about drugs’ identities. Differences from the authentic materials in color, size, shape, tablet quality, and packaging indicate a possible falsified or substandard drug. These differences range from subtle to obvious. An educated consumer could probably identify a very-poor-quality fake, such as a pill of entirely the wrong color or shape, if they knew some properties of the authentic product, but even experts struggle to recognize more subtle inconsistencies. The Global Pharma Health Fund’s Minilab toolkit promotes visual inspection as the first step to identifying falsified and substandard drugs but admits that this is challenging even for experts (Jähnke et al., 2008; Sherma, 2007). In recent years, criminals have produced very accurate reproductions of legitimate packaging. And, as Chapter 4 mentions, poor-quality drugs can sometimes be hidden in legitimate packaging (Sherma, 2007).



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