IMPACT OF NAFDAC ON MARKETING OF DRUGS IN ENUGU STATE
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IMPACT OF NAFDAC ON MARKETING OF DRUGS IN ENUGU STATE
ABSTRACT
The main focus of this study project is how NAFDAC affects drug marketing in the state of Enugu.
The goal of this study is to determine how the National Agency for Food and Drug Administration and Control (NAFDAC) can contribute to the solution of the issues facing this country,
specifically in Enugu State, regarding the failure of counterfeit, substandard, unwholesome, adulterated, and unregistered products to protect the public in all areas of health.
In Enugu state, the agency achieves this by making sure that only food, medications, and other regulated goods are produced, imported, exported, distributed, advertised, sold, and used.
The government established NAFDAC as the primary consumer protection and regulatory body to guarantee that wholesome foods Therefore, the government established the majority of consumer protection and regulatory agencies to guarantee that customers have access to healthful meals, effective medications, and safe cosmetics.
The Agency is divided into six directorates in order to guarantee efficacy from the start. Fellows (1) Regulatory Affairs and Registration
(2) Inspectorate (3) Services for laboratories (4) Drugs of Abuse
(6) finance and administration, and (6) planning, statistics, and research. These directorates are always in competition with one another to make sure that all of their operations proceed as intended in order to achieve the government’s goal for the agency’s establishment.
This study is centred on this problem, and its primary goal is to assist in fulfilling the requirements in order to safeguard and advance the nation’s public health.
To determine how we may enhance the manufacturing, distribution, and sales standards for pharmaceuticals and other regulated products; this improvement can only be attained by reading Chapter One
1.0 INTRODUCTION
1.1 Background of The Study
The history of food medicines and other product regulation in Nigeria is told through NAFDAC. This is a tale that started long before the agency was established. It depicts how drug laws are always changing and reflects the nation’s current socioeconomic climate.
SUMMARY OF THE HISTORICAL DEVELOPMENT OF NIGERIAN FOOD AND DRUG REGULATORY AUTHORITY:
The federal ministry of health’s Directorate of Food and Drug Administration and Control was in charge of policing food pharmaceuticals, cosmetics, and other regulated goods in Nigeria before NAFDAC was founded.
The majority of the elements required for a regulatory authority were present in Nigeria’s regulatory system, which was under the directorate.
There were provisions for inspection enforcement, quality control laboratories, drug legislation (though obviously with flaws), and even a reasonably equipped drug manufacturing laboratory.
Unfortunately, there was no system in place for product registration, therefore the importation and manufacture of drugs was unregulated. There were no efficient drug recall procedures since adverse drug reaction monitoring systems and drug information were not in place.
The fact that there are no records of offences being prosecuted in the twenty years between the adoption of Food and Drug Decree No. 35 OF 1974 and the creation of NAFDAC in 1994—despite the 1989 Ibadan and Jos Incidents, in which over 150 children were reportedly reported to have died as a result of a formulation error—demonstrates the laxity of enforcement of the current drug laws.
Nigeria had a somewhat well-developed regulatory framework, but corruption in the public service bureaucracy, political unrest, and a variety of other issues hindered it. In September 1992,
the then-honorable minister of health, Prof. Olikoye Ransome Kuti, gave the order to draft a blueprint for the creation of a food and drug regulatory agency in order to eliminate these obstacles and guarantee efficacy. ”
The excision of the functions of control and regulation of foods, drugs, 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,” said Prof. G.E. Osuide, the first director general of NAFDAC.
The Honourable Minister of Health, Prof. Olikoye Ransome Kuti, stated that the goal of NAFDAC’s founding was “to give a frontal attack to the health problems arising from food, chemicals, drugs, medicines, and similar regulated product without the inhibitions of the civil service setting” during the council’s first meeting in September 1992.
The National Agency for the Administration of Food and Drugs
Therefore, as a parastal of the federal ministry of health, (NAFDAC) was founded by Decree NO.15 OF 1993 (as amended), governing the exportation, distribution, advertisement, and use of food, medications, cosmetics, chemicals, detergents, medical gadgets, and all beverages, including our “pure” water.
The motto “safeguarding the health of the nation” comes from the material’s scope, which places responsibility for touches on every Nigerian’s life.
The Agency’s objective is to protect public health by guaranteeing that only food, medicines, and other regulated goods of the proper quality are produced, imported, exported, distributed, advertised, sold, and utilised.
Therefore, the government established NAFDAC as the premier consumer protection and regulatory organisation to guarantee that consumers have access to healthful foods, effective medications, and safe cosmetics.
The organisation works to safeguard and advance the health of Nigerians by making sure that any associated risks with food and medication usage are completely removed. enhancing life quality as a result. NAFDAC is essentially the people agency.(P.E. Okwuraiwe)
The Agency was initially organised into the six directorates listed below:
1. Regulatory Affairs and Registration
2. The Inspector General
3. Services for laboratories
4. Drugs of abuse
5. organising Statistics and research
6. Administration and Finance
Offices:
The corporate headquarters of NAFDAC are located in Wuse Zone 7 Abuja at Not 2032, Olusegun Obasanjo Way.While the Agency Inspectorate offices are spread throughout every state in the federation as well as Abuja, its Lagos liaison office is housed at the Federal Secretariat Complex in Ikoyi, Lagos.
It keeps three narcotics offices, six zonal offices, five quality control functional liberations, and four special zonal offices.
The NAFDAC’s administrative structure:
The head of NAFDAC, as well as other heads of associated regulatory entities, make up the Agency’s governing council, to which the chief executive of NAFDAC reports. At the moment, the Agency has eight directorates, each headed by a full Director under the Director General.
Office of the Director-General:
(I) Technical support services
(II) Unique Responsibilities
III) The Food and Drug Administration (FDIC)
(IV) Lawful Division
(V) Unit of Public Relations
Regulatory and Registration Directorate
This is NAFDAC’s licencing division. Registration & Registration is in charge of registering all goods that the Agency regulates, including food, medications (including opioids and other prohibited substances), cosmetics, water packages, medical devices, and detergent.
The Directorate drafts, publishes, and examines pertinent regulations that the Agency uses to carry out its duties. The Directorate makes ensuring that advertisements for regulated products are not overdone, unnecessary, harmful, or misleading to stakeholders and consumers.
Samples of the items that need to be registered are obtained from firm representatives by the Directorate, who then sends them to the relevant unit for registration and regulatory action.
The samples are also submitted to labs for analysis. Following receipt of all reports from the various units along with their recommendations, Registration and Regulatory would present the relevant recommendations to the committee for product approval.
The four main sections of the Directorate—Regulatory Affairs, Drug Registration, Food Registration, Consumer Affairs, and Advert Control—are each led by a Deputy Director. The Directorate is overseen by a Director.
Laboratory Services Directorate.
A Director oversees this directorate, while a Deputy Director is in charge of each Laboratory.
The NAFDAC’s operational laboratories are as follows:
Oshodi, Lagos’s Central Laboratory Complex
Vaccine Control Laboratory for Central Drugs, Yaba
Kaduna’s Area Laboratory
Local Research Centre, Maiduguri
Port Harcourt’s Area Laboratory
The following are the primary responsibilities of the Laboratory Services Directorate:
Examine and comment on the safety and quality of products that are subject to regulations.
act as the NDLEA, the Nigerian Customs Service, and other government agencies’ reference lab.
The following are some of the laboratory’s specialised units:
Medicine
Food
seafood
Organoleptic
rays
Water
Biological control and pesticides
Mycotoxin
Analysis of Vitamins
The European Union has authorised Sea Food Laboratory for the export of fish and prawns.
The International Atomic Energy Agency is associated with the Pesticide Residue, Pesticide Formulation, and Mycotoxin Laboratories (IAEA).
The United Nations Children’s Fund (UNICEF) is associated with the Vitamin Analysis Laboratory.
WHO-recognized vaccination control laboratory yaba in the West African region.
Directorate of Port Inspection:
The directorate is in charge of all regulatory operations at airports, border crossings, ports of entry, and inland container terminals.
This directorate’s duties consist of the following:
Regulating and controlling the import of products under control
inspect items that are subject to import regulations
Create guidelines for the import and export of goods that are subject to regulations.
Regulated products meant for export are subject to quality certification and exportation controls.
The directorate maintains offices in cities with border posts at the same and Idiroko borders, as well as seaports, airports, and inland container terminals.
Establishment inventory compilation for the manufacture of regulated items is the duty of the Establishment Inspection Directorate (EID).
The inventory lists the name of the company, its address, and the kinds of regulated goods it manufactures. The directorate in charge of inspecting the establishment for the following purposes, among others,
GMPs, or good manufacturing practices
regular examination
Signing up
surveillance, such as a bakery survey
Research, such as a follow-up on complaints from customers
Directorate of Controlled Substances and Narcotics:
The distribution of imports is overseen and recorded by the directorate.
With the use of chemicals, psychotropic drugs, and narcotics
It encourages initiatives targeted at decreasing the market for psychoactive substances and encouraging the responsible use of drugs overall.
Additionally, it guarantees efficient regulation of chemical imports and distribution.
It guarantees that Nigeria complies with its obligations under international drug treaties regarding the lawful trade in narcotics, drugs, and psychotropic substances.
Enforcement Directorate:
This division was recently established to handle any metres that have implications for enforcement. It is associated with the projection of producers and importers of consumer goods.
The directorate of enforcement chairs the federal task force on fake and counterfeit drugs and oversees the coordination of the state task forces on the subject.
Planning, Research, and Statistics Directorate:
This directorate of services is in charge of organising, gathering, and analysing statistical data in addition to supervising and recording the work of every other directorate to ensure the effective accomplishment of the agency’s objectives.
The directorate bears the responsibility of producing and making NAFDAC’s annual reports more complex.
(ii) It guarantees the formulation and establishment of plans for the successful execution of NAFDAC’s missions.
(iii) It arranges for employee trainings at every level.
The Finance and Administration Directorate:
The directorate is in charge of managing the agency’s daily operations, including hiring, disciplining and promoting employees, managing pensions and benefits, relocating officials, and other establishment duties. The handling of money falls under the purview of the directorate.
NAFDAC’s Obstacles in Acting as a Regulator:
Importers that build irregular distribution channels for controlled products are evading registration.
Importers, exporters, manufacturers, and their representatives engaging in unethical operations. product mislabeling, including making irrational promises. fabrication of records.
Ø Product marketing that differs from registered products.
The act of disposing and distributing fake goods in Nigeria.
Drugs that are counterfeit or phoney include:
According to the National Agency for Food and Drug Administration and Control (NAFDAC), fake and counterfeit medications include:
(a) A duplicate or clone of real medications.
(b) Medication containing little or no active components.
(c) Medications whose active ingredient(s) differ from what is listed on the label; for example, paracetamol pills packed and labelled as “Fansider” but really contain a mixture of pyrimethamine and sulphadoxine.
(c) Drugs that have expired or are likely to expire
(e) Herbal preparations that are dangerous, poisonous, ineffectual, or combined with conventional medication.
(f) Medicines that don’t have the manufacturer’s complete name and address
(g) Medications marked “for export only” (for whatever reason
cause).
(h) Substances that NAFDAC has not certified or registered
Additional subpar and unhealthy product categories that NAFDAC has identified are:
(i) Salt that has not been sufficiently or not at all iodized.
(ii) Sachet water that was improperly prepared and unregistered (normally labelled pure water).
(iii) Designer fragrances filled locally with diluted concentrates in bottles and packets that are imported into Nigeria.
Juices with misleading labelling (iv). Such labelling examples include “100% fruits juices” and “no added sugar” or “no added stabiliser”; NAFDAC regulates the medication industry.
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