Counterfeiting of commercial products is an age-old practice which flourishes in many countries and is motivated mainly by the huge profits to be made. Trade in counterfeit drugs appears to be widespread internationally and affects both developing and developed countries. Over the last decade or so, it has been brought to the attention of governments and the public as never before. The spread of counterfeit drugs is generally more pronounced in those countries where the manufacture, importation, distribution, supply and sale of drugs are less regulated and enforcement may be weak. Current information indicates that drug counterfeiting is becoming more and more sophisticated, and thus the responsible authorities in Member States are advised to keep this issue under constant review.

Counterfeit drugs are not necessarily of the quality they purport to be and may be mislabelled with respect to identity and/or source. They can be imported, smuggled or manufactured locally by large consortia in large factories and establishments equipped with the most modem equipment, or by small-time operators in smaller, often poorly equipped facilities. Some examples of types of counterfeit drugs include:

- products which do not contain any of the specified active ingredients despite such declarations on the labels

- products which contain active ingredients other than those specified on their labels

- products which contain the correct strength of the specified active ingredients but whose source is different to the one declared

- products which contain the specified active ingredients but in strengths different to those declared; they may also contain different or different quantities of impurities.

National drug distribution channels have been established by law in a number of countries to ensure that the nation's drugs are of the correct quality, efficacy and safety. Unfortunately, these channels are sometimes undermined and infiltrated so that counterfeit products have been found alongside genuine drugs in legitimate channels, as well as in the illegitimate markets that exist in many developing countries. In every case, there is fraudulent intent to deliberately and knowingly manufacture, distribute, supply or sell these products for unlawful gain.

New global trade arrangements, free trade agreements and deregulation measures are dramatically changing the pharmaceutical market worldwide; they are also resulting in a proliferation of pharmaceutical products. This may set a scene which favours an increase in counterfeiting activities. Factors such as inequitable income and wealth distribution, and variable social and economic development also contribute to the increasing incidence of counterfeit.

The precise extent of the occurrence and distribution of counterfeit drugs is unknown, even though estimates derived from country studies are widely cited. Since 1982, WHO has been collecting data on counterfeit drugs. The majority of cases involved tablet and capsule dosage forms. However, there is a shortage of validated information and thus the acquisition of accurate data is a priority.

Awareness of the harmful effects of counterfeit drugs is growing in all sectors at national and international levels. Yet greater cooperation and collaboration are required between governments and relevant organizations if there is to be significant progress in the fight against counterfeit drugs.