AN ASSESSMENT OF THE CRITICAL ROLE OF NAFDAC ON MARKETING OF DRUGS

CHAPTER ONE

INTRODUCTION

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 offices, 6 zonal offices, 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 and 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.

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)

1. Routine inspection

2. Registration

3. Surveillance e.g survey of bakeries

4. 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.

1. The directorate is responsible for complication and production of NAFDAC’S Annual Reports.

2. It ensures the development and establishment of strategies for the effective implementation of the mandates of NAFDAC.

3. 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:

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

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

3. Marketing of products different from registered ones.

4. 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:

1. Ascertain the impact of the circulation of fake and counterfeit drug on the innocent consumers.

2. Evaluate the factors that have encouraged the proliferation of fake | counterfeit drugs in the country.

3. 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.

4. To determine if NAFDAC has been successful in curbing the marketing of fake drugs.

1.4 Research questions:

1. What are the impact of the circulation of fake and counterfeit drug on the innocent consumers?

2. What are the factors that have encouraged the proliferation of fake | counterfeit drugs in the country?

3. To what extent has 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?

4. has NAFDAC achieved in curbing the marketing of fake drugs?

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.