FACT SHEET Counterfeit and Substandard Drugs in Low Income Countries Counterfeit and substandard pharmaceuticals have become increasingly prevalent in almost every nation around the world. Whether a drug is considered counterfeit varies by the classifying country and/or organization.1 Because of varying definitions and methods of classification, the World Health Organization (WHO) has attempted to standardize the classification method, and defines a counterfeit drug as one that is “deliberately and fraudulently mislabeled with respect to identity source or both.â€?2 Governments and organizations have identified a plethora of categories to identify counterfeit drugs, but most fall into the following six groups: • • • • • •
Products missing active ingredients (32.1 percent of counterfeits) Products with incorrect quantities of active ingredients (20.2 percent); Products with wrong ingredients (21.4 percent); Products with correct ingredients and amounts but fake packaging (15.6 percent); Copies of original products (1 percent); And products that contain high levels of containments (8.5 percent).3
www.globalhealth.org
The difference between substandard versus counterfeit pharmaceuticals is that counterfeit drugs are defined as being intentionally mislabeled or improperly made in order to mislead the consumer. Substandard pharmaceuticals, on the other hand, may be genuine products, but have not met the stringent quality specifications set for them. This is usually the result of human error, negligence, or insufficient human capital.4 In addition, a drug that chemically is correct, but the package contains an inadequate or incorrect dosage is considered substandard. Scale of the Problem While a comprehensive study of the global counterfeit drug problem has yet to be undertaken, the WHO has compiled information on the prevalence of certain counterfeit medicines in developing countries. Counterfeit and substandard pharmaceutical have been found in nations around the world, including the United States and Europe. However, the major problem resides in low income countries located in Sub-Saharan Africa and South and Southeast Asia, where drug regulatory systems are weak and availability of essential medicines are scarce and inconsistent. Recent Counterfeit Drug Cases1 &RXQWHUIHLW 0HGLFLQH 0HWDNHOILQ DQWL PDODULD 9LDJUD &LDOLV /LSLWRU $QWL GLDEHWLF 7UDGLWLRQDO &KLQHVH 0HGLFLQH
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