PROJECT TOPIC :THE IMPACT OF NAFDAC ON MARKETING OF DRUGS
CHAPTERS: Chapter 1 – 5
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Keywords: THE IMPACT OF NAFDAC ON MARKETING OF DRUGS
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
(3) laboratory services
(5) 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
1.1 Background 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)
Review of Related Literature
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.
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
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 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;
- Registration and Regulatory Affairs
- Laboratory services
- planning Research and statistics
- finance and Administration
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)
- Routine inspection
- 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.
- The directorate is responsible for complication and production of NAFDAC’S Annual Reports.
- It ensures the development and establishment of strategies for the effective implementation of the mandates of NAFDAC.
- 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:
- Evasion of registration by importers | manufactures Irregular distribution channels for regulated products.
- Unethical practices by manufactures importers exporters and their agents. Mislabeling of products such as unjustified claims. falsification of documents.
- Marketing of products different from registered ones.
- 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.
Keywords: THE IMPACT OF NAFDAC ON MARKETING OF DRUGS