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Tuesday 5 October 2021

Assessment of the Activities of National Agency for Food and Drug Administration and Control (NAFDAC) in the Control of Fake Drugs

Assessment of the Activities of National Agency for Food and Drug Administration and Control (NAFDAC) in the Control of Fake Drugs

Chapter One

Introduction

1.1 Background to the Study

One of the greatest global threat is faking or counterfeiting of drugs as deliberately and fraudulently produced or mislabeled with respect to its identity or source. This has been a cancer, which has eaten deep into the marrows of societies affecting the state of health of people. The World Health Organization reported that nearly one-third of identified counterfeit drugs contain no active ingredients, while more than 20 percent either have incorrect quantities of active ingredients or contain the wrong ingredients. False packaging and high level of impurities are also commonly found (WHO, 2015). Waver and Whalen (2013), stated that 76 doctors in the United States unknowingly treated cancer patients with a fake version of the drug Avastin. Pharmaceuticals are in high demand, and the punishment for fake pharmaceutical dealing is lower than for narcotics (Sean, 2017). It is no wonder the market for counterfeit pharmaceuticals continues to grow larger than many realize. For example, Interpol's flagship pharmaceutical investigation, Operation Pangea, reports it seized 2.4 million fake and illicit pills in 2011; in 2015, the total number of medications that officials seized jumped to 20.7 million. When hospitals and clinics experience a drug shortage, they often look outside of the regular supply chain, creating opportunities for criminals to push fake pharmaceuticals (Sean, 2017). Drug faking is a public health problem whose effects can be felt from both the manufacturing and the recipient countries although higher in some countries than others causing death, disability and injury to its consumers (WHO, 2008). According to World Health Organization (WHO, 2007), the prevalence of fake medicines is higher in xvi countries with weak regulations, enforcement, and scarcity of supply of basic medicines, unregulated markets and unaffordable prices. Because of these, the quality, safety and efficacy of drug products especially in developing countries cannot be guaranteed. The production of counterfeit drugs is affecting poorer countries and is an important cause of unnecessary mortality and morbidity, loss of public confidence in medicines and health structures, (Segun Akinyadenu, 2013). Drug counterfeiters target medicines that are used in high volume for managing diseases of public health interest such as antimalarial, antibiotics, antihypertensive, anti-diabetic agents and life style drugs (NAFDAC Score Card, 2016). In a 2007 report on counterfeiting and piracy, the Organization for Economic Cooperation and Development (OECD) provided an interesting list with categories of products that are subject to counterfeiting, including pharmaceuticals. This list, without being exhaustive, included medicines used for treating cancer; HIV; malaria; osteoporosis; diabetes; hypertension; cholesterol; cardiovascular disease; obesity; infectious diseases; Alzheimer's disease; prostate disease; erectile dysfunction; asthma and fungal infections; antibiotics; anti- psychotic products; steroids; anti-inflammatory tablets; pain killers; cough medicines; hormones and vitamins; and treatments for hair and weight loss 14 . Literally all kinds of medicines have been or can be counterfeited. (Turin, 2012). Counterfeit medicines pose a very significant challenge to both the economy and public health in Nigeria. In 2009, National Agency for Food and Drug Administration and Control (NAFDAC) officers intercepted a huge consignment of almost 700,000 doses of fake clones of a popular Indian anti-malarial labelled as made in India and on further investigation was found to be made in China. xvii The World's Medical Supply Chain (WMSC) is riddled with counterfeit or fake drugs (Sarah, 2015). In 2012, hundreds of cancer patients took what they thought was Avastin, a monoclonal antibody cancer treatment, only to learn that the drug they obtained lacked the active ingredients. The U.S. Food and Drug Administration (FDA) received reports of fake Botox in clinics all over the country(Sean, 2017). In 2012, the Food and Drug Administration (FDA) warned physicians and medical practices that their supplies of bevaczumab, an expensive drug used in combination with chemotherapy to inhibit tumor growth, might be tainted. It turns out some hospitals were literally giving cancer patients cornstarch instead of anticancer meds: The FDA found that some batches of the counterfeit bevaczumab contained no active pharmaceutical ingredients at all. Before the counterfeit bevacizumab arrived in the United States, investigators found, it traveled through Turkey, Switzerland, Denmark, U.K., and Canada. This global problem of counterfeit or fake drugs affects even legitimate sources, such as hospitals and pharmacies (Susan, 2015). Counterfeit drugs in Nigeria include preparations without active ingredients, toxic preparations, expired drugs that are relabeled, drugs issued without complete manufacturing information and drugs that are unregistered with NAFDAC. Current estimate suggests that 10% of prescription drugs sold worldwide are counterfeits, fake or contaminated, and in parts of Africa and Asia, the figures exceed 50% (Newton et al., 2001; Cockburn, 2002).


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