Field Technologies for Testing Poor Quality Medicines

As with disease pandemics, the globalization of the pharmaceutical trade has the potential to rapidly spread poor-quality medicines worldwide before adequate detection and intervention are possible. There are three main categories of poor quality medicines; degraded, substandard and falsified (counterfeit). Substandard products arise as a result of lack of expertise, poor manufacturing practices, or insufficient infrastructure whilst those falsified are the ‘products’ of criminals. Degraded medicines arise from poor storage conditions. Falsified drugs may not contain the active ingredient, may contain the wrong ingredients or may even contain toxic compounds. Distinguishing between these three classes requires simultaneously identifying and quantifying the expected (or wrong) APIs. In this presentation, we will describe tiered analytical strategies that we have employed in the investigation of counterfeit anti-infectives and contraceptives in developing countries as part of the Counterfeit Drug Forensic Investigation Network (CODFIN). CODFIN facilitates the forensic chemical and biological analysis of suspected poor quality drugs and the dissemination of this information. The chemical and biological results are returned to the organization submitting the samples as soon as possible.