e-sRC

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
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 antimalerials, antibiotics, antihypertensives, 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.
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
chemotheraphy 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).
Counterfeit pharmaceuticals remain one of the world‟s fastest growing industries. Recent
trends suggest an increase in counterfeit drug sale to over $70 billion in 2010, an
increase of over 90% from 2005 (Finlay, 2011). A report by Pfizer, a global
pharmaceutical firm, on counterfeit drugs states that profits from counterfeiting today
surpasses gains made from heroin and cocaine (PGS, 2007). While the issue of
counterfeit drugs has long been treated as an illicit case of intellectual property
infringement, the view has often masked what is in fact a public health crisis.
In 1989, over 150 children died in Nigeria as a result of paracetamol syrup containing
diethlene glycol (Gbenenee, 2016). It was so severe that neighboring countries like
Ghana and Sierra Leone officially banned the sale of drugs, foods and beverages
products made in Nigeria.
In an attempt to control fake drugs in Nigeria, the food and drug Act was enacted in
1974 in the form of decree which was later renamed an Act with virtually the same
provisions by the civilian administrations 1979 –1983. This Act provides a large
measure of protection to consumers of drug and food products. It is made up of three
main parts: The first section deals with the prohibition of sale of certain food and drug
items, the second forbid the sale and advertising of certain drugs as treatment for disease
and the last section forbids the importation and the last section forbids the importation,
exportation and distribution of some specific food and drug items.
Therefore, NAFDAC was established with the goal of eliminating counterfeit
pharmaceuticals, foods and beverages products that are not manufactured in Nigeria and
ensuring that available medications are safe and effective. The formation of NAFDAC
was also inspired by 1986 World Health Assembly resolution requesting countries‟ help
in combating the global health threat posed by fake or counterfeit pharmaceuticals. Thus,
the mandate of NAFDAC, as established by Decree No. 15 of 1993 (as amended), is to
control and regulate the manufacture, importation, exportation, distribution,
advertisement, sale and use of food, drugs, cosmetics, medical devices and packaged
water including all drinks (referred to as regulated products).
In December 1992, NAFDACS‟s first governing council was formed as chaired by
Tanimu Saulawa. In January 1993, supporting legislation was approved as legislative
Decree No. 15 of 1993 and officially established on 1, January 1994 as a parastatal of the
Federal Ministry of Health though replaced an earlier Federal Ministry of Health body,
the Directorate of Food and Drug Administration and Control which had been deemed
ineffective, partially because of lack of laws concerning fake drugs in Nigeria
(NAFDAC, 2005).
The total number of impounded fake drugs in Nigeria in 2013 is worth over 886, 000,
000 million naira, 120, 000, 000 million naira worth of impounded fake drugs in 2014
and 484, 200. 420 million naira worth of impounded fake drugs in 2015 (Food and Drug
Administration and Control Statistics, 2015). This means that, there is a slight increase
of these fake or counterfeit drugs in the country.
According to studies conducted by NAFDAC from 2001-2012, there is a positive trend
which shows a progressive decrease in the incidence of counterfeit medicines in Nigeria.
This study (NAFDAC/WHO/DFID) shows that, in 2001, counterfeit stood at 40% as
against 16.7% in 2005. National Survey on Quality of Medicines using Truscan shows
that, counterfeits stood at 6.4% in 2012. Therefore, the need to studying the activities of
NAFDAC in the control of fake drugs after the first administrative era in NAFDAC
becomes necessary.
1.2 Statement of the Research Problem
The production of counterfeit drugs has and is still affecting states across Nigeria and
Kaduna state is one among these states. Counterfeit drug is an important cause of
unnecessary mortality and morbidity, loss of public confidence in medicines and health
structures, (Akinyadenu, 2013). A disturbing aspect of the counterfeit drug menace is
that the effects of consuming such drugs go unnoticed most of the times except in such
cases where it results in mass deaths (Erhun, 2001).
In 1947 in Nigeria, 14 children were reported dead after being administered chloroquine
phosphate injections and in 1990, 109 children died after being administered fake
paracetamol syrup containing diethylene glycol (Aluko, 1994). Some people still prefer
self-medication when they are ill and often times, the drugs are bought from unlicensed
drug vendors, whose drug quality is not sure.
Olike (2008), stated that the government have failed as there is political setbacks in
ensuring compliance with standard specification, giving adequate penal sanctions to
offenders as stipulated in the drug laws. The WHO (2007) stated that, the prevalence of
these fake drug is higher in countries with weak legislations and enforcement of
standards as specified by the law. This has given rise to manufacturers producing drugs
with insufficient active ingredients to continue to exist abusing the existing laws guiding
the production of drugs.
NAFDAC ensures that drugs are registered before licenced for sale. This time for
registration of drugs sometimes varies especially for drugs whose substances are
relatively poor and thisslows down registration process of drugs because of the need to
further inspect manufacturers of such drugs. Because of the strict evaluation and
assessment process of drugs, makes producers of drugs with inactive or insufficient
active ingredients not want to pass through the registration process as their drugs will be
faulted by NAFDAC. Furthermore, if a small Drug Regulatory Authority (DRA) is
registering large number of generic products rapidly, the quality of the evaluation and
assessment of the product may well be compromised (Hill and Johnson, 2004).
Measures have been taken to reduce the presence of fake drugs in the country such as
restricting pharmaceutical imports to just two airports and two seaports, each staffed by
NAFDAC officials. NAFDAC discovered several Indian and Chinese drug
manufacturers suspected of producing and exporting fake drugs in Nigeria and banned
the import of those products (Akunyili, 2005).
NAFDAC also established independent contacts with authorities in the two countries to
regulate their exports to Nigeria. The rigorous work that has been undertaken since 2001,
including meticulous borders controls; drafting of prohibition lists regarding substances‟
import; accompanying certification documents for imported drugs; raids to assess the
quality of the medicines produced and distributed; and the boost of the national
pharmaceutical industry, are strategies put in place by NAFDAC to control the
proliferation of fake drugs in Nigeria. Furthermore, all medicines produced and
circulated within the country started carrying a registration number to check their
authenticity. NAFDAC began to wield controls to domestic pharmaceutical producers in
order to make them comply with good manufacturing practices and to ensure the respect
of national rules and directives. (United States Pharmacopeia, 2011).
NAFDAC have adopted other strategies to control fake drugs in Kaduna state and
Nigeria and some of these strategies ranges from licensing of premises and persons,
inspection of manufacturers and distributors, product registration and assessment, public
awareness, etc. Also, an important short-term strategy for fighting counterfeit drugs is
the development of better technologies for protecting the identity of genuine drugs such
as use of Truscan, Mobile Authentication Service (MAS), etc (Inventa International,
2017).
In 2004, three Nigerian hospitals reported cases of adverse reactions from the use of
contaminated infusions produced by four Nigerian companies. Consequently, infusions
and water for injection from all over the country was sampled. The results confirmed
that some batches of infusions produced by the indicted companies were heavily
contaminated with microorganisms. 147 of the 149 brands of water for injection
screened were also not sterile (Dora Akunyili, 2005).
Counterfeit products, (drugs, food, cosmetics, medical devices, chemicals, and water
including all drinks but mostly pharmaceuticals) valued at over N8.0b (US$60 million)
were seized and destroyed in Nigeria by the National Agency for Food and Drug
Administration and Control (NAFDAC) between April 2001 and December 2004.Also,
counterfeit or fake drugs valued at over N29 billion were seized in 3 years (Frost and
Sullivan, 2012) and N12 billion worth of fake drugs in 2016.These problems though
dwindled especially during the period of service of prof. Mrs. Dora (Late), and studies as
conducted by NAFDAC from 2001-1012, shows that in 2001, counterfeit stood at 40%as
against 16.7% in 2005. Also, using Truscan shows that counterfeits stood at 6.4%in 2012
(NSQM Survey, 2012) but yet, has not solved the problem of fake or counterfeit drugs
across the states.
The drug distribution network in Kaduna State, is in a state of chaos because it consists
of open markets, patent medicine stores, community pharmacies, private and public
hospitals, wholesalers/importers and pharmaceutical manufacturers. It is a common
scene in Nigeria, to see petty traders who sell kola nuts, cigarettes, and oranges, among
other items, in market kiosks, motor parks, and road sides hawking drugs that range from
over-the-counter items to antibiotics popularly called “capsules” (Adelusi and Adeluyi,
2000). This is a typical reflection of what is happening in Kaduna state today posing a
threat to public health in the state. The medicines are usually left under the sun in such
conditions that could facilitate the deterioration of the active ingredients while other are
fake which are even more harmful to human health.
The activities of local factories in Nigeria have been controlled by NAFDAC besides
being inspected at the time of product registration. Despite the fact that NAFDAC carry
out inspections once in three months without prior notice, the proliferation of drugs still
becomes eminent. These inspections carried out are to ensure that they are consistent
with current GMP and have not deviated from the conditions under which the product
was registered.It is also important to note that products from factories with poor GMP
are not allowed into the country. However, the effectiveness of these inspection activities
being carried out by NAFDAC remains a big question (Pharmapproach, 2019).
In Kaduna state, there are a lot of drug centres known as “Chemist‟s” other than
Community pharmacies who are statutorily registered with the Pharmacists Council of
Nigeria. With these community pharmacies, there should not be any serious problem of
the sale of fake drugs but unfortunately, there are many unregistered “pharmacies”
thriving. And in such premises drugs are purchased from doubtful sources with its
attendant danger to the health of the public (Erhun and Adeola, 1995).
Recently, it was recorded that NAFDAC seizes N10 million worth of fake drugs in
Kaduna state (Vanguard, 2016). It also, nabbed fake drugs manufacturer in Kaduna state
(www.africaprimenews.com/2016). Also, a man was arraigned over fake drugs and was
charged to court for selling fake drugs in his shop in Zaria, Kaduna state
(sundiatapost.com/2016).
Therefore, all these problems mentioned, shows that efforts have been made by
NAFDAC and empirical data shows that the problem of faking or counterfeiting of drugs
is far from being addressed, fallen short of expectations as fake drugs are still being
manufactured and sold to Nigerians.
It is however against this background that the researcher assess the activities of
NAFDAC in the control of fake drugs in Kaduna State so as to ascertain the extent,
control and success or otherwise to the NAFDAC operation in Kaduna State.
1.3 Research Questions
The following research questions are asked to guide this research study:
i. How has standard specification by NAFDAC affected the control of fake
drugs in Kaduna State?
ii. How has the process of registration of drugs by NAFDAC affected the
control of fake drugs in Kaduna State?
iii. How has the inspection of imported regulated products by NAFDAC
affected the control of fake drugs in Kaduna State?