Counterfeit pharmaceutical products present a new and serious threat to health care delivery. The alert was first given during the Conference of Experts on the Rational Use of Drugs, held in Nairobi in November 1985. In 1988, the Forty-first World Health Assembly adopted a resolution (WHA41.16) requesting governments and pharmaceutical manufacturers “to cooperate in the detection and prevention of the increasing incidence of the export or smuggling of falsely labelled, spurious, counterfeited or substandard pharmaceutical preparations” and requesting the Director-General “to initiate programmes for the prevention and detection of the export, import and smuggling of falsely labelled, spurious, counterfeited or substandard pharmaceutical preparations, and to cooperate with the Secretary-General of the United Nations in cases when the provisions of the international drug treaties are violated”. A joint WHO/International Federation of Pharmaceutical Manufacturers Associations workshop on counterfeit drugs was organized in Geneva in April 1992. The observations and recommendations published in the report of the workshop are contained in Chapter 8. Apart from the need for coordination and exchange of information between all interested parties, the recommendations stress the need for overall regulatory control through the setting up and strengthening of national drug regulatory and control authorities.

In 1995 a project was started to develop means to combat counterfeit drugs. Guidelines on drug inspection and the analysis of suspect samples have been prepared and a model training course on the application of these guidelines has been developed. A global workshop will be held at the end of 1997 to consider progress made and plan further activities.