ABSTRACT

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 Affairs

(2) Inspectorate  (3) laboratory services (4) Narcotics

(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 market.

TABLE OF CONTENTS

CHAPTER ONE

Introduction        

1.1background of the study        

1.2  Statement of problem           

1.3  Objective of the study         

1.4  Formulation of hypothesis    

1.5  Significance of the study      

1.6  Scope and limitation of the study       

1.7  Definition of terms ( operational definitions)   

CHAPTER TWO

Review of Related Literature         

2.1 Introduction            

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

consumer product          

2.6      The impact of the circulation of take drugs and

Other regulated products.         

CHAPTER THREE

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 instruments

CHAPTER FOUR

4.1        Analysis and presentation of data      

CHAPTER FIVE

5.1        Summary of finding         

5.2        Conclusion            

5.3        Recommendation  

5.4        Bibliography         

Appendix              

CHAPTER ONE

1.0 INTRODUCTION

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 IN NIGERIA:

     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;

1.   Registration and Regulatory Affairs

2.   Inspectorate

3.   Laboratory services

4.   Narcotics

5.   planning Research and statistics

6.   finance and Administration

Offices:

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

(III)     Food 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 stakeholders

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 Advert control.

     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 NAFDAC:      

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 following functions:

Analyze and make pronouncement on the quality and safety of regulated products.

Serve as reference laboratory for Nigeria custom service, NDLEA and other government Agencies.

Specialized units in the laboratories include the following:

Drug

Food

Sea food

Organoleptic

Radiation

Water

Pesticide /Biological control

Mycotoxin

Vitamin Analysis

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 regulated products.

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 products.

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)

Routine inspection

Registration

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 of chemicals

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 drugs

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:

Ø    Evasion of registration by importers | manufactures Irregular distribution channels for regulated products.

Ø    Unethical practices by manufactures importers exporters and their agents. Mislabeling of products such as unjustified claims. falsification of documents.

Ø    Marketing of products different from registered ones.

Ø    Dumping 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 manufacturer

(g)         Drugs labeled “for export only”(for whatever

reason).

(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

compliance

-                                              Sanctions such as prosecution and destruction

-                                              Mandatory  registration channel

-                                              Sanitization of the distribution channel

-                                              Strengthened inspectorate activities

        Public Enlightenment 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 parts.

What   are  fake |  counterfeit   Drugs?

  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 traced.

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 motives

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 enforcement agents”.

 

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 drugs.

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 distribution chain.

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 in Nigeria

(iii) Evaluate the factors that have encouraged the

       proliferation of fake | counterfeit drugs in the

        country.

(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 fakers vices.

(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- NAFDAC and

(viii). Evaluate what the Agency hopes intends to achieve in future.

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 national borders.

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)

Ø  NAFDAC 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.

Ø  Cloning is the deceptive and fraudulent manufacturing of a fast moving registered product by a questionable source to rake up profit without associated abilities.

Ø  Expiry 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.

Ø  Drugs food cosmetics etc containing berried substance are only banned when they are substance are found to be harmful.

Ø  A 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.