Essential medicines and health products

What are counterfeit medicines?

Counterfeit medicines are defined differently in different countries. The definitions used in the various WHO Member States show that the nature of the problem of counterfeit medicines varies from country to country.

The first international meeting on counterfeit medicines was held from 1 to 3 April 1992 at WHO in Geneva and gathered experts from governmental institutions of WHO member states, INTERPOL, World Customs Organization (at the time known as Customs Cooperation Council), International Narcotics Control Board, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), International Organization of Consumer Unions, and the International Pharmaceutical Federation (FIP) in response to a World Health Assembly resolution (WHA41.16). The participants agreed on the following definition:

A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient (inadequate quantities of) active ingredient(s) or with fake packaging. (Ref: Guidelines to develop measures to combat counterfeit drugs,)