Counterfeit medicines can result in treatment failure

Counterfeit medicines are medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source. According to the World Health Organization (WHO), use of counterfeit medicines can result in treatment failure or even death. Public confidence in health-delivery systems may be eroded following use and/or detection of counterfeit medicines. Both branded and generic products are subject to counterfeiting, says the WHO. Read more

All kinds of medicines have been counterfeited, from medicines for the treatment of life-threatening conditions to inexpensive generic versions of painkillers and antihistamines. Counterfeit medicines may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient or too much active ingredient, or with fake packaging, adds WHO.

Walk down the old signature-market of Lucknow, Ameenabad, shows us an open and very busy market for pharmaceutical products. These are possibly not counterfeit, but surely, easy and open availability of medicines and other pharmaceutical products, is a big cause of worry - particularly because of rising drug resistance in India. So this market may not qualify at all as an example of counterfeit medicines, but may be closer to factors that are propelling irrational use of drugs.

According to the WHO, counterfeit medicines are found everywhere in the world. They range from random mixtures of harmful toxic substances to inactive, ineffective preparations. Some contain a declared, active ingredient and look so similar to the genuine product that they deceive health professionals as well as patients. But in every case, the source of a counterfeit medicine is unknown and its content unreliable. Counterfeit medicines are always illegal. They can result in treatment failure or even death. Eliminating them is a considerable public health challenge.

WHO states that studies can only give snapshots of the immediate situation. Counterfeiters are extremely flexible in the methods they use to mimic products and prevent their detection. They can change these methods from day to day, so when the results of a study are released, they may already be outdated. Finally, information about a case under legal investigation is sometimes only made public after the investigation has been concluded.

Counterfeiting is greatest in regions where regulatory and enforcement systems for medicines are weakest, adds WHO. In most industrialized countries with effective regulatory systems and market control (i.e. Australia, Canada, Japan, New Zealand, most of the European Union and the United States of America), incidence of counterfeit medicines is extremely low – less than 1% of market value according to the estimates of the countries concerned. But in many African countries, and in parts of Asia, Latin America, and countries in transition, a much higher percentage of the medicines on sale may be counterfeit.

Not only is there a huge variation between geographic regions in terms of incidence of counterfeit medicines, variation can also be significant within countries: for example, between urban and rural areas, and between cities, says WHO.

All kinds of medicines have been counterfeited – branded and generic – ranging from medicines for the treatment of life-threatening conditions to inexpensive generic versions of painkillers and antihistamines, states WHO.

Counterfeit medicines pose a public health risk because their content can be dangerous or they can lack active ingredients, says WHO. Their use can result in treatment failure (and contribute to increased resistance in the case of antimalarials that contain insufficient active ingredient) or even death. Unlike substandard medicines where there are problems with the manufacturing process by a known manufacturer, counterfeit medicines are made by people with the intent to mislead.

The extreme difficulty in tracing the manufacturing and distribution channels of counterfeit medicines makes their circulation on markets difficult to stop. Even a single case of a counterfeit medicine is unacceptable since it indicates that the pharmaceutical supply system in which it was detected is vulnerable. Worse, it undermines the credibility of national health and enforcement authorities.

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