Since the Nairobi meeting, public awareness of the problem of counterfeit medicines has been growing. Both government authorities and manufacturers have been giving attention to its prevention, and WHO has been receiving reports related to counterfeit drugs. According to this database, the problem of counterfeit drugs is known to involve both developed and developing countries. For instance, between 1982 and April 1999, 771 confidential and public reports relating to such drugs were received by WHO.¹² The geographical origin of these reports is shown in Figure 1.

Figure 1: Geographical origin of cases (1982 - April 1999; total: 771)*

* Countries classified according to WHO Regional Offices:

The public reports received include some anecdotal accounts which were published in journals. The confidential reports were received from national authorities for regulatory information purposes. Although most of the reports are not confirmed, and bias is likely, they provide some insight into the problem.

The pharmaco-therapeutic classes of the cases reported are shown in Figure 2, which indicates that the majority of detected counterfeit products in the database are the “life-saving” drugs, i.e. antibiotics.

Figure 2: Pharmaco-therapeutic classes of cases reported (1982 - April 1999; total: 771)

In developing countries, the two top-ranking classes of medicines reported to be counterfeited are anti-infectives and anti-parasites, whereas in industrialized countries anabolic steroids and dermatological products accounted for the majority of counterfeit products.

Out of the 771 cases reported, indications about the quality of the active ingredients contained were supplied only for 325 cases. Of these, about 59% contained no active ingredients, 7% contained the correct amount of active ingredients, 17% contained the incorrect amount of active ingredients and 16% contained different active ingredients. No indication was given about the quality of the active ingredients of the remaining 58% of the case reports.¹³

To further supplement the database, in May 1996 the WHO Division of Drug Management and Policies (DMP) sent a questionnaire to the information officers^* of Member States, the six WHO regional offices and other organizations to obtain information on counterfeit drugs. Of the 46 countries that had responded to the questionnaire as of March 1997, 41% recognized the existence of problems of counterfeit drugs in their domain.¹⁴

* These are information officers nominated in accordance with resolution WHA15.41 for the regular exchange of information on the safety and efficacy of pharmaceutical preparations as well as on drug regulatory decisions taken in Member States.