Key Findings and Conclusions
• As criminals become more sophisticated, there will be an increased need for expensive technologies to detect falsified medicines.
• There are several categories of techniques to analyze pharmaceuticals. They include 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.
• Novel technologies are constantly being developed to detect falsified and substandard medicines.
A full evaluation of drug quality requires a range of qualitative and quantitative testing to verify the identities and amounts of active ingredients, check for impurities, and ensure acceptable disintegration, dissolution, stability over time, and sterility (USP, 2007). Identifying falsified and substandard drugs does not always follow the same process as a rigorous quality evaluation. A few simple tests can identify a product with no active ingredient or one made under gross manufacturing negligence. More sophisticated fakes resist easy detection. Appearance, content, and therapeutic effect can all be considered in classifying falsified drugs. Box 6-1 outlines one method for making categories.
Criminals in the business of making falsified drugs can buy crude active ingredients, chemicals that have not undergone the appropriate purification steps required to meet pharmacopeial standards or manufacturer’s dossier requirements, for example. The drugs made from such chemicals would pass most tests. Only highly sophisticated and expensive assays could detect trace contaminates. Figure 6-1 gives an overview of the different levels of technology needed to catch progressively more complex falsified drugs.