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Definition of a counterfeit medicines


In its 2003 FIP Statement on counterfeit medicines, FIP adopted the 1992 WHO definition of a counterfeit medicine, that is to say: “The deliberate and fraudulent mislabelling with respect to the identity, composition and/or source of a finished medicinal product, or ingredient for the preparation of a medicinal product. Counterfeiting can apply to both branded and generic products and to traditional remedies. Counterfeit products may include products with the correct ingredients, wrong ingredients, without active ingredients, with insufficient quantity of active ingredient or with false or misleading packing; they may also contain different, or different quantities of, impurities both harmless and toxic”.


This WHO definition was officially endorsed in a meeting, convened in Geneva, 1-3 April 1992, which 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, IFPMA, International Organization of Consumer Unions, and the International Pharmaceutical Federation (FIP).


Global view of the problem including reference to WHO data


Counterfeit medicine is a global issue. According to the latest WHO estimates:


  • Most developed countries with effective regulatory systems and market control (e.g. USA, EU, Australia, Canada, Japan, New Zealand) currently have a very low proportion, i.e. less than 1% of market value. However, we must keep in mind that indications point to an increase in the prevalence of counterfeit medicines even in developed countries;

  • Many developing countries of Africa, parts of Asia, and parts of Latin America have areas where more than 30% of the medicines on sale can be counterfeit. Other developing markets, however, have less than 10%; overall, a reasonable estimate is between 10% and 30%;

  • Many of the former Soviet republics have a proportion of counterfeit medicines which is above 20% of market value -this falls into the developing country range;

  • Medicines purchased over the Internet from sites that conceal their actual physical address are counterfeit in over 50% of cases.


In fact, all markets have gradually become overrun with counterfeit medicines.


Developing countries (in Africa, Asia and Latin America) are the first victims and it is there that the more dreadful consequences have been reported:


  • In 1995, in Niger, fake vaccines have been used during a meningitis outbreak (2,500 children died from meningitis due to the lack of vaccine protection).

  • In 2006, more than 100 people (mostly children) died after having taken counterfeit syrup containing di-etylen glycol in Panama.


Such a global issue needs a joint and strong answer from all relevant stakeholders.This is why SEARPharm Forum has been involved in the fight against counterfeit medicines to protect patients for the related danger in SEA region.


Regular data on such incidents has been compiled by SEARPharm to keep a tab on this problem. Such reports can be found at Publication page.

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