Counterfeiting of drugs is often undertaken by people and organizations involved in other types of crime, frequently on a large national or even international scale. Measures are needed to prevent the manufacture, supply and distribution of counterfeit drugs. Close cooperation between the various drug control and law enforcement agencies within countries and at the international level is required to ensure that these measures are implemented effectively.

Governments and national DRAs are the organizations with the collective prime responsibility to develop such measures. Legitimate pharmaceutical manufacturers also have a responsibility in the fight against counterfeiting. However, counter-measures are often most effective when they are instituted collaboratively by government and industry.

Experience gained so far has shown that the nature and extent of counterfeiting and the factors facilitating it vary from country to country, and that there is no single or simple way to eliminate the problem. Thus each country has to develop a strategy based on its own situation, taking into account the magnitude of the problem and the available infrastructure, and human and other resources. Even countries with a highly evolved drug regulatory system may not find it easy to design and implement appropriate strategies. Countries with less developed drug regulatory systems and accompanying shortages of trained human resources and funds may have difficulties. It is hoped such countries can be given support and guidance from international organizations, such as WHO, and from selected developed countries with experience in this area.

In the first instance, measures should be directed towards the effective detection of counterfeit drugs in national drug distribution channels, and to preventing them entering these channels. While this may not totally eradicate counterfeit drugs, it should substantially reduce the exposure of the population to the risks associated with these products. Although counterfeit drugs are known to exist in the national drug distribution channels of many countries, their extent and nature are not fully known. An assessment of the current situation is therefore the first step, ensuring that a clear distinction is made between substandard and counterfeit products. Measures should also include procedures to improve drug control systems and cooperation in enforcing existing legislation.