This research project is primarily concerned with the impact of
NAFDAC on marketing of Drugs in Enugu state.
The purpose of this research is to know how the
national Agency for food and Drugs Administration and control (NAFDAC ) can
help to solve the problem being encountered in Enugu state in particular
and in this Nation in general, concerning failed counterfeit, substandard,
unwholesome, adulterated and unregistered of safeguarding the public in every
aspect of health affair.
The agency accomplishes this in Enugu state by ensuring that only
the right quality of drugs, food and other regulated products are manufactured,
imported, exported, distributed, advertised, sold and used . NAFDAC as the for
most consumer protection and regulatory was therefore set up by the
government to ensure that wholesome foods As the
for most consumer protection and regulatory agency was therefore set up
by the government to ensure that wholesome foods efficacious medicines and safe
cosmetics are made available to the consumers.
To ensure effectiveness from inception the Agency is structured
into six directorates they are as fellows (1) Registration and regulatory
(6) planning research and statistics and (6) Finance and
Administration. These directorates are always busy competing with each other in
order to ensure that every but of their activities are moving according to
planned proposal to fulfill the government aim in establishing the agency .
This study is based on this issue and the main objective of it to
help in meeting the standard specification in order to protect and promote
public health in the country. To identify ways in which we uplift the standard
of manufacturing, distribution and sales of drugs and other regulatory product
and this improvement can only be obtained through NAFDAC in regulating the drug
1.1background of the
of the study
of the study
and limitation of the study
of terms ( operational definitions)
Review of Related
2.2 Review of Empowering Related NAFDAC regulatory laws
2.3 Review of Empowering Tariff
2.4 Strategic for Eradication of fake Drugs and
strengthening regulatory Activities
2.5 The essence of regulation | Registration of
2.6 The impact of the circulation of take drugs and
Other regulated products.
3.0 Research methodology
3.1 Research design
3.2 Area of the study
3.3 Population of the study
3.4 Sample and sampling procedure
3.5 Instrument for data collection
3.6 Validation of the instrument
3.7 Reliability of research instrument
3.8 Method of administration of the research
4.1 Analysis and presentation of data
5.1 Summary of finding
1.1 BACKGROUND OF THE STUDY
The NAFDAC story is the story of food drugs and other products
regulation in Nigeria. It is a story that began well even before the
creation of the agency. It portrays the ever-evolving nature of drug
regulation and mirrors the prevailing socio-economic environment of the country.
BRIEF HISTORICAL DEVELOPMENT OF FOOD AND DRUG REGULATORY AUTHORITY
Prior to the establishment of NAFDAC, the
Directorate of food and drug Administration and control in the federal ministry
of Health was responsible for the control and regulation of food drugs,
cosmetics and other regulatory products in Nigeria. Under the directorate, the
regulatory structure in Nigeria had most of the necessary components expected
of a regulatory authority.
here were drug laws (with deficiencies no doubt) quality
control laboratories and provision for inspection enforcement and even a fairly
equipped drug – manufacturing laboratory.
However product registration was not in place, and as such
drug importation and manufacturing was a free for all affair . drug information
and adverse drug reaction monitoring processes were not also in place; hence
there were no effective drug recall procedures.
The paucity of enforcement of the existing drug laws can b seen
from the fact that in the twenty years between the enactment of food and drug
decree NO. 35 OF 1974, and the establishment of NAFDAC in 1994, there are no
records of prosecution of offends despite the Ibadan and Jos Incidents in 1989
when over 150 children were reported to have died due to a formulation error.
Despite the fact that Nigeria had a relatively well – developed
regulatory process, civil service bureaucracy’ corruption, political
instability and a host of other lapsed the varted this process. To remove these
bottlenecks and ensure effectiveness, the then honourable minister of Health
Prof. Olikoye Ransome kuti, directed in September 1992 that a blue print be
prepared for the establishment of a food and drug regulatory Agency . in the
words of the pioneer director general of NAFDAC Prof. G.E. Osuide “the excision
of the functions of control and regulation of foods, drug and regulated
products from the main stream of civil service setting was a progressive
decision in tune with what obtain in a number of countries’’ while inaugurating
the pioneer governing council of NAFDAC in September 1992 the Honourable
minister of Health, Prof Olikoye Ransome kuti said that the establishment
of NAFDAC was, “to give a frontal attack to the health problems arising from food,
chemicals, drugs medicines and similar regulated product without the
inhibitions 0f the civil service setting”.
The National Agency for food and Drug Administration and control
(NAFDAC), was therefore established by Decree NO.15 OF 1993 (as
amended), as a parastaltal of the federal ministry of Health, exportation,
distribution, advertisement, shall and use of food, drugs, cosmetics, chemicals
|detergents, medical devices and all drinks including our “pure” water.
The scope of this material puts the responsibility of touches
on the life of every Nigeria, hence the slogan ‘safeguarding the health
of the nation’.
he mission statement of the Agency is to safeguard public
health by ensuring that only right quality of drugs food and other regulated
products are manufactured, imported, exported, distributed, advertised
sold and used NAFDAC as the foremost consumer protection and regulatory
agency was therefore set up by government to ensure that wholesome foods,
efficacious medicines and safe cosmetics are made available to the consumer.
The agency protects and promotes the well being of Nigerians by
ensuring that hazards attendant & food consumption and medicine intake are
totally eliminated. Thereby improving the quality of life “In essence, NAFDAC
is the people Agency”.(Okwuraiwe,P.E)
From inception, the Agency was structured
into the following six directorates;
and Regulatory Affairs
Research and statistics
NAFDAC has its corporate head quarters at not 2032, olusegun
Obasanjo way, wuse zone 7 Abuja.its lagos liaison office is located at the
federal secretariat complese ikoyi lagos while the Agency Inspectorate offices
are in all the state of the federation and Abuja.
It maintains 4 special zonal office 6 zonal office 5 Quality
control functional liberations and 3 Narcotics offices.
Administrative structure of NAFDAC:
The structure of Agency has the chief Executive of NAFDAC who
report to the governing council comprising of appointed member and other heads
of related regulatory bodies. There are presently eight directorates in the
Agency manned by full Directors in the Director General.
Director- General’s office:
(I) Technical services
(II) Special Duties
and Drug information center (FDIC)
(IV) Legal Unit
(V) Public Relation Unit
Directorate of Registration &Regulatory
This is the licensing arm of NAFDAC. Registration and Registration
is responsible for registration of all products regulated by the Agency namely
food drugs which include narcotics and controlled substances, cosmetics medical
devices, detergent and packages water.
The Directorate formulates, un dates and reviews relevant
regulation that the Agency employ in exercising its mandate. The Directorate
ensures that advertisement of regulated products is not exaggerated,
unwarranted , detrimental and deceptive to consumers and other
The Directorate collects samples of the products to be registered
from company representative and forward to appropriate unite the Registration
and Regulatory for further action while sample will be sent to laboratories for
analysis. When all the report are obtained from the various units with their
recommendation, Registration and Regulatory would make appropriate
recommendation to the product Approval committee.
The Directorate is headed by a Director and
each of the four broad divisions headed by Deputy Director is Regulatory
Affairs, Drug Registration, food Registration and consumer Affairs and
Directorate of Laboratory Services.
This directorate is headed by a Director and each of the
Laboratories is headed by Deputy Director.
The following are functional Laboratories of
Central Laboratory complex, Oshodi, Lagos
Central Drug Vaccine Control Laboratory, yaba
Area Laboratory, Kaduna
Area Laboratory, Maiduguri
Area Laboratory, Port Harcourt
Laboratory services Directorate is majorly responsible for the
Analyze and make pronouncement on the quality and safety of
Serve as reference laboratory for Nigeria custom service, NDLEA
and other government Agencies.
Specialized units in the laboratories include the following:
Pesticide /Biological control
Sea food laboratory is accredited by the European union for fish
and shrimp export.
Pesticide Residue pesticide formulation and mycotoxin laboratories
are affiliated with the international Atomic Energy Agency(IAEA).
The vitamin Analysis laboratory is affiliated with united Nations
children find (UNICEF).
Vaccine control laboratory yaba recognized by
WHO in West African region.
Ports Inspection Directorate:
The directorate take care of regulatory activities at all port of
enter, border posts, airports and inland container terminals.
Functions of this directorate include the following:
Control and regulate importation of regulated products
Under take inspection of importation regulated products
Compile guide line for the importation and exportation of
Control the exportation and issue quality certification of
regulated products intended for export.
The directorate has office in cities with seaports, airport,
inland container terminals and border posts at same and Idiroko borders.
Establishment inspection Directorate (EID): This directorate is
responsible for compiling establishment inventory for production of regulated
The inventory state the name of establishment, its location and
type regulated products it produces. The directorate responsible for the
inspection of establishment for purposes, which include but not limited to
Good manufacturing practices (GMP)
Surveillance e.g survey of bakeries
Investigation e.g follow –up on consumer complaints
Directorate of Narcotics and controlled substances:
The directorate control and documents the importation distribution
And use of narcotics, psychotropic substances and chemicals
It promotes activities geared towards the reduction of demand for
psychoactive drugs as well as rational use of drugs in general.
It also ensures effective control on importation and distribution
It ensures Nigeria’s obligation under the international Drug
treaties with respect to licit transactions in Narcotic’s, drug and
psychotropic substances are fulfilled.
Directorate of enforcement:
This directorate was recently created to deal with all meters
bordering on enforcement in all its ramifications. It is involved in the
projection of manufactures and importers of take products. The directorate of
enforcement co-ordinates all states task force on fake and counterfeit drugs
and also serve as chairman of the federal task force on fake and counterfeit
Directorate of planning, research and statistics:
This is a services directorate that is responsible for planning,
researching and collating of statistical data, as well as co-ordinating and
documenting the activities of all the other directorate for the efficient
achievement of the goals of the agency.
(i) The directorate is responsible for complication
and production of NAFDAC’S Annual Reports.
(ii) It ensures the development and establishment of
strategies for the effective implementation of the mandates of NAFDAC.
(iii) It coordinates staff trainings at all levels.
Directorate of Administration and Finance:
The directorate is involved in the day- to –day administration of
the agency such as employment, promotion and discipline, pension and gravity,
movement of officers and other establishment functions. The directorate is also
responsible for management funds.
Challenges of NAFDAC As A Regulatory Body:
of registration by importers | manufactures Irregular distribution channels for
practices by manufactures importers exporters and their agents. Mislabeling of
products such as unjustified claims. falsification of documents.
of products different from registered ones.
and circulation of take and counterfeit products in Nigeria .
Types of fake and Counterfeit Drugs:
Fake and counterfeit drugs as stipulated by National Agency for
food and Drugs Administration and control (NAFDAC) are:
(a) copy | clone of genuine Drugs.
(b) Drugs with insufficient or no active ingredients.
(c) Drugs with active ingredient (s) different
from what is stated on the package e.g paracetamol tablets packaged and labeled
as “Fansider” as sulphadoxine | pyrimethamine combination.
(d) Expired or about to expire drugs
(e) Herbal preparation that are toxic or harmful or
ineffective or mixed with orthodox medicine.
(f) Drugs without full name and address of the
(g) Drugs labeled “for export only”(for whatever
(h) Drugs not certified and registered by NAFDAC
Other forms of
substandard | unwholesome products identified by NAFDAC include:-
(i) Non – iodized or insufficiently iodized salt.
(ii) Improperly processed and unregistered sachet water (properly
called pure water).
(iii) Designer perfumes whose packets and bottles are imported
into Nigeria and Filled locally with diluted concentrates.
(iv) Deceptively labeled juices. Example of such
labeling include “100% fruits juices” no sugar added” “no added sivectener’’
“no preservative”, etc. yet juices from fruits that are not naturally very
sweet like orange and guava are as sweet .
(v) Bread enhanced with potassium Bromate, which was
banned since the early 1990’s for
its implication in cancer, kidney failure loss of hearing and breakdown of
vitamins strategies of NAFDAC in Eradication of fake product by the Agency
include the following.
- public Enlightenment
- Education of stakeholders to elicit voluntary
- Sanctions such as prosecution and destruction
- Mandatory registration channel
- Sanitization of the distribution channel
- Strengthened inspectorate activities
campaign activities of
NAFDAC News, Guidelines, stickers, posters etc
(f) Bimonthly publication of identified take counterfeit
substandard, unwholesome and unregistered product and their genuine counter
What are fake | counterfeit
The world Health organization (WHO) defines counterfeit
medicine as “one which is deliberately and frequently mislabeled with respect
to identity and | or source. Counterfeiting can apply to both branded and
generic products and counterfeit products may include products with the correct
ingredients or with the wrong ingredient without active ingredients, with wrong
ingredient without active ingredients, with insufficient active ingredients or
with fake packaging”.
According to WHO definition, what makes a drugs medicine
counterfeit is “the deliberate or intentional nature of the mislabeling of a
product with the intention to deceive the consumer”(Akunyili N.O.2003). A
genuine the drug manufacture said Akunyili, will never hide his |her address.
It is only cloners , fakers and counterfeiters that hide their addresses so
that they cannot be traced. Cloning as put by Akunyih, is that they cannot be
Cloning as put by Akunyih, is that eleceptive and fraudulent
manufacturing of a fast moving registered product by a questionable source to
rake up profit without associated liabilities it is solely driven by financial
1.2 STATEMENT OF PROBLEM:
1) The problem of
proliferation of fake drug in Nigeria has been a long-standing problem. In the
words of abanum, p.s, a pharmacist, “it is a problem that has resulted from the
strong drive to make money fast usually referred to as the “get rich quick
syndrome” and worsened in the 80’s and
90’s by inefficient regulatory control and high level of corruption by law
2) According to
Akunyili, N.D; the prevalence of fake |counterfeit drugs vis-avis products in
the country arose from several years of dumping of these product without
effective control she maintained that human lives were lost daily while others
have been maimed for life through the use and administration of unwholesome
Several products have fallen victim to faking by unscrupulous
businessmen. Virtually all drugs regulated by NAFDAC are involved. These
are food products, drugs and medicaments for human consumption, veterinary
products, cosmetic products, cosmetic products, chemicals detergents,
mechanical devices and all types of drives including water. In addition to the
above products different types of spare parts are also fake widely. It is
therefore difficult to embark on any discussion on strategies for the
eradication of fake product with varying degrees of regulation and control.
As we try to look at the strategies for the eradication of take
drugs in Nigeria it is important to understand what constitute take drugs, the
genesis and circulation of these drugs, the impact of their circulation on the
populace and the factors that encourage their proliferation. Abamum, P.S
defined a fake drug as “a product that is purported to be what it is not”. To
him, “it may or may not contain the active substance it is not produced by the
owners of the trademark it carries on the packaging”.
The prevalence of fake | counterfeit drugs in the country arose
from several years of dumping of these products without effective control. It
is a fallout of the chaos that have existed in drug distribution for over two
decades. Today very large number of illegal operation exists at level in the
3) Most of these
infiltrators were drafted into the drug business as it was result of
haphazard manner import licenses on drugs were issued to all corners in the
80’s by the then politicians and military leaders in outright disregard to the
eventual public health implications of their actions. As put by Abanum, “some
of these beneficiaries of import licenses on drugs suddenly found out that a
lot of money could be made from business on drugs and so became emergency
importers of drugs”. He contained that in the face of inactive regulation,
their numbers increased and competition some of them looked at the option of
importing fake products to have an edge over their competitors fundamentally
out of ignorance of the input of their actions on the consuming public.
As the market grew, sections of were development and set out for
the sale of drugs both good and fake. Like all other traders in the markets
they also formed themselves into associations to products themselves and
negotiate with law enforcement agents when the need arose. According to Abanum,
they become impregnable to the regulatory authorities. Several of the merchants
who could not indulge or perfect the illicit business went under. Gradually, the
markets become a veritable environment for “safe” sale of these fake products.
1.3 OBJECTIVE OF THE STUDY:
The broad objective of the study is NAFDAC on marketing of drug.
Specially, the objectives will include to:-
i. Ascertain the impact of the circulation of fake and
counterfeit drug on the innocent consumers.
(ii) Determine the strategies of NAFDAC for the
eradication of fake | counterfeit drugs
(iii) Evaluate the factors that have encouraged the
proliferation of fake |
counterfeit drugs in the
(iv) Find out to what extent NAFDAC intervention in the
manufacture distribution and sale of fake counterfeit drugs
protects the survival of genuine manufactures and marketers in the face to
(vi) Know the incidence and level of fake |
counterfeit drug in Nigeria and efforts being made to enforce compliance to
NAFDAC regulatory directives and control.
(vii) Determine the efforts made by the Agency to
ensure that regulated product conform to international standard requirement on
the manufacture distribution and sale of the relevant drug product.
(vii ) Ascertain the duties, power, jurisdiction, and area of
operation of national Agency for food and drug Administration and control-
(viii). Evaluate what the Agency hopes intends to achieve in
1.4 FORMULATION OF HYPOTHESES:
H0 : There is no significant impact of NAFDAC intervention on the
manufacture, distribution sale vis – a- vis marketing of regulated drug
Hiii : NAFDAC has not achieved the desired control on fake |
counterfeit drugs in Enugu state due to high level of corruption induced by
financial motive and economic tendencies of the fakers.
Hiv: Effective control cannot be maintained in Enugu state because
those who ought to fight taking and counterfeiting rather support the trend.
Products between the pre and post- establishment of the Agency
(Hii) There is significant impact of NAFDAC intervention on the
manufacture, sale vis – a – vis marketing of regulated consumer products
between the pre and post- establishment of the Agency.
1.5 Significance of the STUDY:
Specifically, the researcher’s area of struck adherence will be
formed from the operation of national Agency for food and Drug Administration
and control –NAFDAC and the result of the intervention on fake counterfeit
adulterated, substandard and unwholesome Drug in various bulletins, newsprints
and literature. The study will therefore enable the student to ascertain facts
surrounding the duties powers and jurisdiction entrusted on NAFDAC and the
attendant effect on regulated drug products marketing. The research will also
elicit the efforts made by the Agency to stem the ugly tide in redeeming
regulatory directives to save the lives of patient within and outside our
Moreso further research findings will draw reference from this
study. Therefore, the study will be of immense help and value to failure
students and researchers in particular. The findings of this study will also be
of great assistance to the society and government at large.
It is therefore justifiable to asses the effect| impact of
NAFDAC on marketing of Drug products.
1.7 Definition of terms (operational Definitions)
means National Agency for food and Administration and control
Ø Fake |
counterfeit product is the deliberate or intention nature of the mislabeling of
a product with the intention to deceive the consumer.
is the deceptive and fraudulent manufacturing of a fast moving registered
product by a questionable source to rake up profit without associated abilities.
date is a date scientifically affixed on a product after which the manufacturer
is n longer liable for any harmful effect of that product and after which it is
no longer safe to use the product.
food cosmetics etc containing berried substance are only banned when they are
substance are found to be harmful.
consumer is someone who uses articles or products made by another, the
opposites of which are a producer.
Ø G M P
Stands for good manufacturing practice
Ø TQM means
Total Quality management.
TERMS AND CONDITIONS APPLY
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