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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