Counterfeit drugs and medical devices in developing countries

Abstract

The World Health Organization has reported that counterfeit medicines potentially make up more than 50% of the global drug market, with a significant proportion of these fake products being encountered in developing countries. This occurrence is attributed to a lack of effective regulation and a weak enforcement capacity existing in these countries, with an increase in this trade resulting from the growing size and sophistication of drug counterfeiters. In addition, due to both cost and lack of availability of medicines, consumers in developing countries are more likely to seek out these inexpensive options. The World Health Organization is mindful of the impact of counterfeit drugs on consumer confidence in health care systems, health professionals, the supply chain, and genuine suppliers of medicines and medical devices. Antibiotics, antituberculosis drugs, and antimalarial and antiretroviral drugs are frequently targeted, with reports of 60% of the anti-infective drugs in Asia and Africa containing active pharmaceutical ingredients outside their pharmacopoeial limits. This has obvious public health implications of increasing drug resistance and negating all the efforts that have already gone into the provision of medicines to treat these life threatening conditions in the developing world. This review, while focusing on counterfeit medicines and medical devices in developing countries, will present information on their impact and how these issues can be addressed by regulation and control of the supply chain using technology appropriate to the developing world. The complexity of the problem will also be highlighted in terms of the definition of counterfeit and substandard medicines, including gray pharmaceuticals. Although this issue presents as a global public health problem, outcomes in developing countries where counterfeit drugs to treat malaria, tuberculosis, and human immunodeficiency virus/acquired immunodeficiency syndrome not only result in drug resistance, but a number of deaths from the untreated disease, is in stark contrast with the developed world, where lifestyle drugs such as sildenafil (Viagra ®) are most commonly counterfeited.

Public Awareness and Identification of Counterfeit Drugs in Tanzania: A View on Antimalarial Drugs

“…Currently, it is estimated that 10-15% of the global drugs supplied are counterfeit [3,5]. The prevalence is higher in developing countries in Africa and in parts of Asia and Latin America where up to 30-60% of drugs on the market are counterfeit [3,[5][6][7][8][9]. India is a major supplier of poor quality drugs whereby 35-75% of fake/counterfeit drugs globally originate from India [10,11].…”

“…The most affected people with counterfeit drugs are the poor living in developing countries [8,[12][13][14][15] where selfmedication is common and in a few of these countries in Africa drugs are sold through the informal economy in openair markets together with vegetables and fruits or by hawkers alongside newspaper vendors [16,17]. Counterfeit drugs are a major cause of therapeutic failure, serious adverse events, deaths, economic burden, drug resistance, and loss of public confidence in drugs and health services [7,8,12,14,[18][19][20][21][22][23].…”

Fluoroquinolone-resistant tuberculosis: implications in settings with weak healthcare systems

“…50 Both counterfeit as well as substandard FQ preparations are rife in many developing countries. 80 The use of counterfeit antibiotics has been reported from Nigeria, India, Bangladesh, Burma, Cameroon, Vietnam, Cote d'Ivoire, and several other countries. 81 Factors contributing to the easy availability of substandard preparations include inadequate approval and regulatory policies and improper manufacturing practices and quality assurance in manufacturing.…”

Investigation of the Quality of Antibiotics-Based Amoxicillin for Monitoring of Some Different Medicine Markets of Democratic Republic of Congo

“…From the point of view of falsification, the problem of medicines of low quality is an economic crime that discredits the pharmaceutical industry and the threat of bankrupt. The impact of poor quality medicines is a real, worldwide and multifaceted threat to public health [11]. According to the World Health Organization (WHO), more than 30% of medicines are counterfeit in some areas of Latin America, South East Asia and Sub-Saharan Africa.…”