Counterfeiting of commercial products is an activity that has existed for a very long time. However, the counterfeiting of drugs is a recent event. The presence of counterfeit drugs is reported in both developed and developing countries, but is encountered particularly in countries where enforcement action may be weak, regulatory controls poor and patent rights and trademarks unprotected. The extent of distribution of counterfeit drugs in any country is unknown, despite the estimates sometimes flaunted. Studies have been conducted in various countries on the quality of available pharmaceutical products. However, most of these studies were not specifically oriented towards the problem of counterfeit drugs and information on the nature and extent of counterfeits is therefore scarce.

Country studies

A report carried out by the Drug Quality Control Centre (DQCC) of the Lao people's Democratic Republic between 1990 and 1992 indicated that out of 502 samples tested 87 (17.8%) proved to be substandard. A similar study carried out in 1995 showed that out of 52 samples, 30% contained less than half of the labelled amount of active ingredient(s).

Similarly, in Viet Nam, counterfeit drags are reported to be found throughout the country, and even in rural areas. Counterfeits have been reported of antibiotics, vitamins, antimalarials and hormones. Many categories of fake drugs are reported to exist including those with no active ingredient and those containing active ingredients different from the legitimate product. For instance, out of 31 123 samples subjected to laboratory analysis in 1995, 1703 (5.5%) samples failed to comply with pharmacopoeial standards. Of these, 1537 were substandard and 166 (0.5%) contained the wrong ingredient or no active ingredient.

During 1992 and 1993, a study was carried out in Africa by ReMeD (Réseau Médicament et Développement) of France with financial and technical support from WHO, to assess the quality of drugs on African markets. The study involved collection of samples of selected pharmaceutical preparations from 3 countries, the Cameroon, Chad and Madagascar. Samples were collected from private and public sector sources as well as from illegal markets, and included branded and generic products. The results obtained were as follows:

The above-mentioned studies were based on laboratory tests of identity, purity, and strength alone. No investigative work was carried out to establish whether the products have been mislabelled deliberately and fraudulently, a condition which needs to be verified in order to establish that a given product is counterfeit.

The World Health Organization (WHO) has also begun a study on counterfeit drugs in order to assess the situation and propose preventive measures for use by Member States in combating pharmaceutical counterfeiting. The objective of the WHO study is to provide independent information on a specific situation in a selected country using methodology which can be applied where ever a problem of counterfeit drugs exists. Countries for inclusion in the study were selected from those susceptible to counterfeiting and willing to participate. These included Cambodia, Lao People's Democratic Republic, Myanmar and Viet Nam. Two studies were initially proposed for Myanmar and Viet Nam.

The first country study was conducted in Viet Nam. An international team leader was sent to work with local regulatory personnel. Pharmaceuticals targeted for the study were amoxicillin capsules, ampicillin capsules and paediatric syrup, chloramphenicol capsules and powder for injection, chloroquine tablets, metronidazole tablets, paracetamol tablets, rifampicin alone or a combination of products containing rifampicin, salbutamol tablets and tetracycline capsules.

As a first step, information on the national drug supply system was compiled as well as data on the regulatory capacity of the country. Secondly, problems related to counterfeit drugs were sought through use of a questionnaire and samples were collected from selected areas. Testing of samples was carried out by a WHO Collaborating Laboratory. A total of 288 samples of drug products, imported as well as locally-produced, were collected from three geographical areas covering both public and private drug outlets selected randomly. The operation was carried out anonymously by recruiting local people. The study is not yet complete. However, preliminary findings indicate that out of the 288 samples investigated 161 were locally manufactured and the remaining 127 imported. Seventy-six of the 127 imported products were not registered by the Ministry of Health of Viet Nam, whereas all the local products were registered. Five of the 288 samples were found to have similarities in their colour, packaging, and imprints and all were found to be registered in Viet Nam. Preliminary results of laboratory testing indicated that 32 products did not comply with pharmacopoeial specifications.

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