1.1 BACKGROUND OF THE STUDY
The national agency for Food and drugs administration and control (NAFDAC) was established by decree No 15 of 1993.
Before NAFDAC was inaugurated the Federal Ministry of health was performing her functions.
NAFDAC came into existence on 31st December, decree to ensure a more effective health system and control of regulated product, so as to reduce our health problems. According to Lucas (2006) in Lagos Organization review magazine he described our health system as “sick needing intensive care, blind, lacking vision, deaf to the cries of the sick and dying, impotent, incapable of responsible”. So with this kind of remarks the agency knew it had to do something to boost our health system by making sure the right quality of drugs, food and other regulated products are given to the Nation.
The mission statement is “Safeguarding the health of the nation” has a great effect on the health of the nation because it is very necessary to safeguard the health of the nation because a healthy nation given room for a healthy economy. The agency has the mandate to regulate and control importation, exportation of products and also conduct appropriate test and ensure compliance of quality products.
Akunyili (2005) remarked that mortality renewed rigorously on manslaughter because fake and adulterated products tarnish the image of the country. So NAFDAC was mandated to ensure that the fake, adulterated and sub-stand and products because this makes exportation of products difficult, it inhabits foreign investment and there is a great lack of confidence in made in Nigerian products and lack of patronage of our products by other countries.
The Nigerian economy is at a high risk because of this illness of fake and substandard drug. As the saying goes “a healthy nation is a wealthy nation” because the menace was really affecting our economy but NAFDAC along with it’s director general have ushered in a new culture of excellence and honesty with NAFDAC they have recorded strings of successes and so has change the pharmaceutical industry in the country, because many Nigerian companies who are distributor or importers of drugs and foods to several countries because they believe that all Nigeria products are fake and substandard and this has lead to bankruptcy or the collapse of some many Nigeria food or pharmaceutical companies which has lead to increase in poverty rate, unemployment and fall in the rate of foreign exchange returns, and this has made so many individuals leave. The pharmaceutical companies and this has lead to decrease in production of our local goods because manufactures do not get the encouragement they need from consumers.
So many Nigerians travel overseas for medical treatment because they believe our health system is below standard but now there is tremendous increase in the performance of the performance of the pharmaceutical sector, the general manager of GlaxoSmithKline attributed or commended this tremendous increase to “NAFDAC, living up to the responsibilities of enforcing strict compliance to products regulation.
NAFDAC’s activities have reinforced the confidence of investors in the pharmaceutical industry, as evidence of the continuous upward movement in the share prices of the pharmaceutical companies quoted in the Nigerian stock exchange and this has lead to improvement in the health and pharmaceutical subsection, improvement of government policies, improvement of infrastructure, upgrading of NAFDAC Laboratories, Computerization of the agency’s regulatory activities, creation of the NAFDAC Website as well as provision of functional utility greatly enhanced transportation of Staff for regulatory assignment and improvement in health indices. According to Achebe (2006), in Lagos organization review magazine said “here is another effort of reform by this administration that touches the life’s of million of Nigerian”.
1. Does NAFDAC policies encourage foreign investors in the economy. Would NAFDAC policies help in eradicating fake and substandard drags and products in Nigeria?
2. Has NAFDAC made any contribution to employment in the Nigeria economy?
3. NAFDAC has a regulatory body, does its has any impact on food importation in Nigerian?
4. Has NAFDAC done anything or taken any measures to project the domestic Industries.
1.2 STATEMENT OF PROBLEM
The issue here is not much is known of the performance of NAFDAC and its impact on the Nigerian economy. There is need for a detailed study of NAFDAC performance and in relation to its contributions to the Nigerian economy.
1.3 OBJECTIVES OF THE STUDY
Since the safeguarding of health can only be done by ensuring that only right quality of drugs and other products.
It has become important for NAFDAC to have a positive impact on fake drug and substandard drugs and also the relevance, function and most especially in the area of its performance and roles in the Nigeria economy’s this study aims at and its impact in the growth of the Nigerian economy.
1. Identifying the impact of NAFDAC in reducing fake and substandard products.
2. To indentify the necessary programs or effort NAFDAC put in place to improve and create confidence and generally acceptance of “MADE IN NIGERIAN PRODUCTS”
3. To highlight the role NAFDAC has played is boosting the Nigeria economy.
4. To identify how effective the policies of NAFDAC have been in the economy.
5. To highlight the role of NAFDAC in facilitating good and quality products.
6. To evaluate NAFDAC contribution in the protection of domestic industries.
1.4 SIGNIFICANCE OF THE STUDY
The essence of this study is to expose the functions and roles of NAFDAC and why we need NAFDAC in the economy. It will show the need for the nation to join hands and co-operate with NAFDAC to ensure that the scourge and menace of adult erated and fake drugs and products coming into the country is curbed. Stake holders such as manufacturers, importers, and distributors and other key player in the economic sector will be aware of the guidelines initiated by NAFDAC and how the evil of fake drugs affect our economy and the damage it has done in our nation. Also to create environment for information and feedback process and also collaboration with NAFDAC in other to renew confidence and increase the buying or purchase the goods products in Nigeria and outside Nigeria.
Finally, the study will enable the Nigeria economy and government to understand the economy and need to give their support to NAFDAC.
1.5 RESEARCH QUESTIONS
These following basic research questions designed to evaluate the performance of NAFDAC and it’s input of growth in the Nigeria.
1. What is the significant relevance of NAFDAC to the Nigeria economy?
2. Will the guidelines initiated by NAFDAC bring positive changes in the economy?
3. What effective measures have NAFDAC taken to facilitate foreign investment in the economy?
4. What is the significant relevance of NAFDAC in improving the level of confidence and acceptance of made in Nigeria Products?
5. What is the relevance of NAFDAC on the registration and certification of products.
1.6 RESEARCH HYPOTHESIS
The following hypothesis has been drawn from this pieces of work
1. Ho! NAFDAC has no significant Impact on the Nigerian economy.
Hi! NAFDAC has significant on the Nigerian economy.
2. H0! NAFDAC has no significant influence on foreign investment in Nigeria.
Hi! NAFDAC has significant influence on foreign investment in Nigeria.
1.7 SCOPE OF THE STUDY
The role and functions NAFDAC plays in the Nigerian economy today include the mandate to regulate and control the manufactures and their products importation, exportation, distribution, and advertisement sale and use of food, drugs and other products and also creating of laws that will protect this products.
This study will be limited to the “Evaluation of the performance of NAFDAC and its impact of growth in the Nigeria Economy”. Also this study will be limited to the relevance of NAFDAC on improving the level of confidence and acceptance of made in Nigeria products and to determine NAFDAC contribution to the Nigerian economy.
1.8 LIMITATION OF THE STUDY
The limitation faced by the researcher in the course of carrying out this study was the delay in getting data from the various respondents. Most respondents were reluctant in filling questionnaires administered to them due to their busy schedules and nature of their work. Faced with this problem the researcher convened a meeting with the staff of NAFDAC and other respondents during which he addressed them and explained that the research was a normal routine university requirement for student to graduate and had nothing to do with giving information to government or any other body and so the work would remain confidential.
Having thus convinced them that it was not to be used against them they cooperated and gave all the necessary information required.
1.9 DEFINITION OF TERMS
1. Fake products: Products made to appear to be a particular product but is really not that product.
2. Regulated Products: Product controlled by NAFDAC such as food, drugs, cosmetics etc.
3. Substandard Products: Product that are below the normal requirement of a particular goods or products.
4. Stakeholders: people that invest in a particular sector, company, or organization the economy.
REVIEW OF THE LITERATURE
The following literature will be relevance to help us arrived at a better understanding of the mandate given on NAFDAC by the Federal Government and also it performance and input of growth in Nigeria economy.
2.1 HISTORICAL BACKGROUND OF FOOD AND DRUGS REGULATORY AUTHORITY AND THE BIRTH OF NAFDAC
2.1.1 The structure of the agency directorate
2.2 An outline of NAFDAC
2.2.1 Vision and mission statement
2.3 NAFDAC and its structures
2.3.1 Office structures
2.3.2 Administrative structure of NAFDAC
2.4 NAFDAC directorates and unit
2.4.1 Enforcement directorates
2.4.2 Inspectorate directorates
2.4.3 Directorate of administration and finance
2.4.4 Directorate of planning, research and statistics
2.4.5 Directorate of registration and regulatory affairs
2.4.6 Directorate of narcotics and controlled substances
2.4.7 The ports inspection Directorate
2.4.8 Directorate of laboratory services
2.5 NAFDAC and its enforcement activities
2.6 Relevance of products registration as a means of checking fake and adulterated or substandard products
2.7 Regulatory mechanism
2.7.1 Process of registration
2.7.2 NAFDAC of registration
2.7.3 Inspection of GMP in oversea countries by NAFDAC
2.7.4 GMP inspection in oversea countries
2.7.5 The journey so far
2.7.6 Outcome of this journey
2.8 Laboratory directorate
2.9 NAFDAC (FDIC)
2.10 Mandate and functions of NAFDAC
2.1 HISTORICAL BACKGROUND OF FOOD AND DRUGS REGULATORY AUTHORITY AND THE BIRTH OF NAFDAC
The importance of foods and drugs to the man and animal alike is very obvious. The situations of ill health provide the compelling need for drugs in order to modify the functioning of the body and restore it to normal. It is the duty of the government to ensure the protection of the health of its citizens, according to Kumulo (2005) in the NAFDAC bulletin he said, “when the citizen health is impaired as a result of fake regulated products, their productivity drops and the reasons a health ministry was set to check the quality of our health system.
This initially was a responsibility as regards food and drugs was given to the department of foods and drugs administration and control (FDAC).
However, products registration was not in existence and therefore drugs importation and manufacturing was a free affair for all stake holders, failures in enforcement of the existing drug laws which came into law brought about no effective drug monitoring.
This problem led to the birth of Nations Agency for Food and Drug Administration and Control (NAFDAC), which was thus established by decree No 15 of 1993 to carry out control function. According to Osuide (2003) said “the fucntion of control and regulation of control and regulation of food and drugs and other regulated product form the main stream of civil service setting was a progressive decision in time”
NAFDAC was established so as to curb the menace of fake and adulterated products because according to Johnson (2006) “ the society is wholly affected by fake and adulterated product will become too weak to work as a result, manpower, labour and entrepreneurs are lost and the economy is affected”. If they are disabled they increased the dependent population.
However, this task should not be left to NAFDAC alone, all hands should be on deck for the fight against those unwanted product for the good of our country mean while we must promote our genuine manufacturers, we must do this to increase the capital base of our economy.
We must rise to the challenge of restoring the reputation of our great country Nigeria because according to Mitchell (2005) tourists and investors are equally scared and the country is deprived of much needed foreign exchange earnings and employment opportunities that accompany these ventures” because a lot of our foreign exchange used for importation of these products is wasted as most of these products are eventually destroyed by NAFDAC officers”
Therefore, the late Director General of NAFDAC Dr. (Mrs.) Dora N. Akunyili organized workshops for drug importers to enlighten them on the dangers of importing fake drugs and also consumers are enlighten on the effect of purchasing fake drugs.
According to Akunyili (2005) “The evil of fake drugs is worse than the combined scourge of malaria, HIV/AIDS and armed robbery put together and anyone can be a victim of it” so the right quality of products that are safe to health can only be guaranteed by NAFDAC and for NAFDAC and every individual should the agency.
So that the health of our nations will be safeguarded according to Olikoye Ransom Kuti (2004) said “the establishment of NAFDAC was given frontal attack to health and regulated product without the inhibition of the civil service setting.
This new regulatory body (NAFDAC) which was put in place by law of the decree no 15 of 1993, to take charge and bear the responsibilities of control and policing of manufacturer, importation, exportation, distribution chemicals, mechanical devices and all drinks.
The eight directors have been structured to achieve a positive result in the fight against fake and substandard products according to Akunyili (2003). The weakest point of Nigerian dugs regulation is probably in the area of implementation and enforcement.
2.1.1 THE STRUCTURE OF THE AGENCY DIRECTORATE
1. Administration and Finance
2. Planning research and statistics
3. Narcotics and controlled substances
4. Registration and regulatory affairs
5. Establishment inspection services
6. Pro inspection services
7. Laboratory services
8. Enforcement directorate
2.2 AN OUTLINE OF NAFDAC
The national agency for foods and drugs administration and control was established by decree No 15 of 1993 as amend by the importation, exportation, manufacture, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, detergent chemical and bottled water (all known as regulated products). The main objective of the agencies control activities is to ensure that these regulated products offered for consumption to unsuspecting consumers are of good quality, safe, nutritious. Efficacious and wholesomeness is desired.
These products have a great impact on human health such that this effective control necessary in order to avoid catastrophic consequences on the consumers.
There is also an economic aspect of the control which is to ensure that the unspent earned money in the purchase of fake or adulteries products. Source: (NAFDAC bulletin “the journey so far” 2003-2015).
2.2.1 VISION AND MISSION STATEMENT
To achieve its aims and objectives, the agency formulated a clear “vision” “SAFEGUARDING PUBLIC HEALTH” the vision of the agency usher in the main aim or task of the agency this was further made clear by the MISSION STATEMENT to safeguarding public health by ensuring that only the right quality drugs, food and other regulated products are manufactured, imported and exported, advertised, distributed, sold and used.
(Source: NAFDAC bulletin “its structure”)
2.3 NAFDAC AND ITS STRUCTURES
The National Agency for Food and Drug Administration and Control (NAFDAC) which was set p as a parastal under the control of the defunct twelve-member government council which was formally in a guaranteed on 31st December, 1992 by the then minister of health professor Olikoye Ransom Kuti.
The council had its chairman a high experienced retired public officer and diplomat in the person of Ambassador Tanmu Saulawa.
1. Financial and general purpose committee
2. Establishment and disciplinary
3. Technical, research and constancy
And also NAFDAC like any other or council have its own structures
Directorates and units
2.3.1 OFFICE STRUCTURES
Corporate headquarters which is at plot 2032, olusegun Obasanjo way wuse zone 7 Abuja.
Lagos Liason office located at the Federal Secretariat Complex phrase 2 Ikoyi Lagos
Inspectorate Offices in all the state of the federation and Abuja.
Four special zonal officers.
Five quality control functional laboratories.
Three narcotics offices.
2.3.2 ADMINISTRATIVE STRUCTURE OF NAFDAC
NAFDAC has the chief of the agency who reports to governing council comprising of appointed member and other heads of the related regulatory bodies. The agency also manned full directors report to the directors general and the directors general offices induced.
Public relations unit
Special duties (food, drug information center)
2.4 NAFDAC DIRECTORATES AND UNIT
NAFDAC also has eight directorate or units which include, enforcement, directorate of registration and regulatory. Administration and finance, narcotics and controlled substances, inspectorate services, ports inspection unit, legal units.
2.4.1 ENFORCEMENT DIRECTORATES
The enforcement directorates was created in 2001 by the former management of NAFDAC headed by late Dr. Dora Akunyili as a strategy to cope with the widening enforcement responsibilities of the agency. It is the directorate used by the agency to enforce violations of laws and regulations pertaining to the agency’s mandate. Within the period of its existence, been involved in so many enforcement activities such as prosecution of manufacturers and imports of fake drugs, counterfeit regulated products destruction of spooled products including the one at Onitsha and Lagos worth of several millions e.t.c. thus justify the visions of the director general and the management team.
Prior to the establishment of the enforcement directorate by the former administration of NAFDAC headed by late Dr. Dora N. Akunyili (OFR), the federal task force on counterfeit and fake drugs was established under decree no 17 of 1989 to address the manufacturing, importation and distribution of counterfeit and fake drugs in Nigeria.
i. Collection of information and intelligence
iii. Inspection operation and raids
v. Sampling and packaging samples for analysis and exhibits compilation of case for prosecution
Source: NAFDAC bulletin (its directorates and their function)
2.4.2 INSPECTORATE DIRECTORATES
The inspectorate directorate aim of the agency can be described as the agency can be described as the pivot on which the activities of the other directorate resolve. It is usually called “the eye and ear of the agency”. The inspectorate shall however cover only the establishment inspector offices in all states of the federation and even the federal capital Abuja. The state and the federal capital territory offices are grouped into seven zone.
A director based at the agencies corporate head office. Abuja takes charge and co-ordinates activities nationwide. The directorate is responsible for the inspections of overseas establishment whole regulated products are to be imported in Nigeria. The aim of this inspection is to ensure that products that are to be imported in Nigeria. The aim of this inspection is to ensure that products are manufactured practice (GMP).
Directorate also carried out to evaluate processes, facilities, documentary, evidence control as well as the environment impact in the manufacturing, storage and distribution of the products.
Furthermore, the directorate of the directorate engages in investigating the consumer complaining and alert natives and complements, so as to carry out the enforcement aim of the agency through its function activities. Sanction are applied on products and establishment for non-compliance to quality standard and GMP respectively.
Finally, the directorate is also with responsibility to draw samples f regulated products for purposes of laboratory assessment, explains for prosecution, shelf life studies etc.
THE ROLE OF NAFDAC INSPECTORATE
The power exercised by the inspecting officers while carrying out inspection activities are provided from the foods and drugs decree No 35 of 1974 sections 10,12 and 13 as amended by decree No. 12 of 1999. The power are reemphasized in part ii, section 5c, d and g as amended by decree No 19 of 1999.
The inspectorate directorate of NAFDAC its inspecting officer plays roles such as
i. Routine inspection
ii. Pre-production inspection (drugs)
iii. Production inspection of establishment (food, water, cosmetics, detergent, etc)
iv. Pre-registration inspection (all regulated products)
v. Surveillance inspection (all regulated products)
vi. Sanction activities
vii. Sampling of regulated products for laboratory analysis
viii. Follow-up inspection
(Source: NAFDAC bulletin “its directorates and their functions”)
2.4.3 DIRECTORATE OF ADMINISTRATION AND FINANCE
This directorate is made up to two division administration and finance. The overall function of the directorate is to direct and co-ordinate the agency through effective and efficient management of its human and material reason it is involved in the day administration of the agency such as employment, promotion disciples, pension and gratuity, movement of officers and other establishment function. It is also responsible for management of fund.
FUNCTION OF ADMINISTRATION
i. The administration co-ordinate create a linkage with in all other directorate of the agency develop strategies makes for casts sets goals and targets for the achievement of the corporate goals for the agency council.
ii. It also prepares and analysis activities to be carried out, putting place the decision now it will be carried out and also creating the basic relationship needed to be able to achieve the job destined.
iii. It helps to classify the activities into manageable activities and tasks.
iv. The administrative division facilities the determination of the main power needs of the agency at any point in time.
v. It recruits suitable staff using all civil service produce as well as all other scientific processes in filling vacant positions.
However, relationship between management and labour in the agency is cordid. The administration division is also segmented into various units performing different functions. This unit includes;
i. Staff welfare and security units
ii. Promotion and discipline units
iii. Establishment unit.
iv. Council matters unit
v. Record and registry unit
vi. Pension unit
vii. Appointment and training
The finance division deals with financial issues and how the agency generates funds and how they utilize the fund systematically.
FUNCTIONS OF FINANCE DIVISION
i. The department keeps records of all funds of the agency. It collects and lodges in banks all funds due to the agency.
ii. It appears, defends and analysis the yearly budget of the agency.
iii. It also defrays all claims against the agency. These payments are affected 3 days of DG (NAFDAC) approved.
iv. It provides information as advises in the management on scientific ways of utilizing her funds.
v. It also keeps daily records of all financial transactions that takes place in the agency.
Finally, the division also prepares annual financial reports which are audited upon and subsequently presented to the present ministry and other stack-holders. The division is also made up of anagram of several units which includes:
i. Advance unit
ii. Expenditure unit
iii. Revenue unit
iv. Store unit
v. Wages and salary unit
vi. Finance, planning and budgeting.
(source: NAFDAC bulletin “its directory and their functions)
2.4.4 DIRECTORATE OF PLANNING, RESEARCH AND STATISTICS
The planning research and statistics (PRS) directorate is one of the agencies with the responsibility of planning, research collecting statistical data as well as co-ordination and documenting the various directorate’s activities and achievements.
Presently the directorate of planning research and statistical (PRS), it has two main divisions which include:
i. Planning monitoring and training
ii. Research and statistics.
FUNCTIONS OF PLANNING, RESEARCH AND STATISTICS
i. Manpower training and development including workshops, conference and seminars.
ii. Liaison function with relevant bodies outside the agency
iii. Conducting research into the internal organizational, operation and conducting research into the sectors over which regulatory bodies have jurisdiction in collaboration with other organization and agencies institution and parasatals.
iv. Providing secretariat to all policy bodies within the regulatory sector including the sector and top management committee (TMC) of the agency.
v. Development of plans of the agency.
Source: NAFDAC bulletin “its directories and their functions.
2.4.5 DIRECTORATE OF REGISTRATION AND REGULATORY AFFAIRS
National agency for food and drug administration and control (NAFDAC) one of its major functions is to register and regulate products.
The desire No 15 of 1993 that established the agency gave it, the function of regulating and setting safety and quality standard for food, drug, cosmetics medical services, packaged water and chemicals. The decree also charges the agency with the regulation and control of the importation, exportation, manufacture, distribution, advertisement, sale and use of these regulation products.
The major strategy used by the agency to carry out that function in the registration of regulated products. The directorate of registration and regulatory affairs is headed by a director and is composed of four divisions
i. Drug, cosmetics and medical device
ii. Food, beverages and bottle water division
iii. Advert control and consumer affair division
iv. Regulating affairs.
FUNCTIONS OF THE DIRECTORATE OF REGISTRATION AND REGULATING AFFAIRS
i. Receiving and investigating consumer and carrying out market surveys to ensure post registered products on the market.
ii. Registration of foods, drugs, cosmetics medical devices, packaged water, detergents and chemicals.
iii. The directorate formulators periodic review of relevant regulation to control the products registered by the agency.
iv. Control of advertisement of regulated products to ensure that the advertisements are not exaggerated, deceptive or detonating to the consumer.
v. Documentation of registered products
(Source: NAFDAC bulletin “its directories and their functions”)
2.4.6 DIRECTORATE OF NARCOTICS AND CONTROLLED SUBSTANCES
According to the context of international drug, narcotic. Drug means any drug that is used designated in the UN 1961 convention e.g. includes cannabis, morphine etc. the directorate of narcotics and controlled substances are mandated to control and documents the importation, distribution and use of narcotics, psychotropic substances and chemicals.
It also 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 an importation and distribution chemicals.
The directorate also ensures Nigeria obligation under the international drug treaties with respect to illicit transactions in narcotics, drug and psychotropic substances are fulfilled.
And they are three divisions in the directorate which include
i. Narcotics control division
ii. Drug abuse control division
iii. Chemical division (comprising chemical monitoring and chemical import control units)
FUNCTIONS OF THE DIRECTORATE OF NARCOTICS & CONTROLLED SUBSTANCES
i. The directorate controls the importation of narcotic drugs, psychotropic substance & controlled chemicals/precursors through its narcotic control division.
ii. Destruction exercises for expired controlled drugs, substances and chemicals.
iii. Drugs abuse campaign in schools.
iv. Assisting students of tertiary institutions in their projects related to drugs abusers/misuse.
v. Inspections of warehouse to ascertain adequacy of storage space and handling of chemicals and scruiting of safety data sheets and monitoring and marketing, distribution, storage and disposal of chemicals. (Source: NAFDAC bulletin “its directories and their functions)
2.4.7 THE PORTS INSPECTION DIRECTORATE
The directorate of ports inspection are charged with the responsibility of regulating activities at all ports of entry borders, posits, curport and in a land container terminals.
The directorate has its offices in cities with seaports, airports, terminals and border ports. The directorate has well developed standard operating procedures for its activities in the port offices and at the posts of entry.
FUNCTIONS OF THE PORT INSPECTION DIRECTORATE
The functions of the directorate are as specified by section 5, subsection a, d, e and g of degree 15 of 1993 as follows.
a. To control and regulate the importation of foods, drugs, cosmetics, medical devices, chemical and bottled water.
b. Undertake the inspection of the importation of food, drugs, cosmetics, medical devices, establish relevant quality assurance systems including certification of the regulated products.
c. Complete guideline for the importation and exportation of foods, drugs, cosmetics, medical devices, bottled water and chemical.
d. Control the exportation and issue quality certification of import documents and food, drugs, cosmetics, medical devices, bottled water and chemicals intended for export.
e. Screening of import documents before the issuance pre-release stamps applying administrative penalties when and where necessary e.g. importation of chemical without permits, non renewal of expired registration licenses after six months e.t.c.
2.4.8 DIRECTORATE OF LABORATORY SERVICES
This directorate is headed by a director and each of the laboratories is headed by (Directorate director). The following are functional laboratories of NAFDAC.
i. Central laboratory complex, Oshodi Lagos.
ii. Central drug and vaccine control laboratory Yaba
iii. Area laboratory Kaduna
iv. Area laboratory Maiduguri
v. Area laboratory Port-Harcourt
FUNCTIONS OF THE DIRECTORATE OF LAB SCIENCE
Laboratory services are majority responsible for the following functions analyze and safety of regulated products. Serve as reference laboratory for Nigerian custom service, NDLEA and other governmental agencies specialized units in the laboratories include the following:-
ix. Vitamin analysis
Laboratories which are approved and recognized as having human and material resources and procedures which meet nationally and internally established standards.
i. Seafood laboratory is accredited by the European Union for fish and shrimp export.
ii. Pesticide residue- pesticide formulation and mycotoxic laboratories are afflicted with the international atomic energy agency (IAEA).
iii. The vitamin analysis laboratory is affiliated with united nations children’s fund (UNICEF)
iv. Vaccine control laboratory Yaba recognized by WHO in West African sub-region.
2.5 NAFDAC AND ITS ENFORCEMENT ACTIVITIES
Since the establishment of the enforcement directorate which came into existence in 2001.
The former director general late Professor Dora Akunyili OFR, who became the defining statement of the director of the storm like which she was over taking Nigeria. She had maintained that the need for the enforcement directorate was because of the widening volume of enforcement responsibilities.
The suitable acceptance or particular circumstance can be easily appreciated by the available statistics in enforcement by the agency that is been document in NAFDAC 1999 and 2000 annual report when late Professor Dora Akunyili came on board as a chief executive. A total of sixty-eight (68) investigations were carried throughout the country. But between the year interval from January to December 2002, a total of two hundred and nine (209) cases were investigated.
In January 2003, a total of forty four (44) cases was investigated form part of the country, this investigation and action by NAFDAC has increased the confidence of the public in NAFDAC. Also in the course of enforcement activities, seizures or confiscations of fake, counterfeit, substandard and exported drugs are made in this end, the directorate has seized and destroyed fake, wholesome and superiors products like about 15.68 billion like year 2001 to October 2012. The two (2) factors that plays crucial roles in enforcement activities are surveillance and promptness of response manifested in the burst and seizure operation at
a. Abule-Oshun, Badagry expressing warehouse
b. Ojo Millary cantonment
So this directorate is created to deal will all matters burdening on enforcement in all its ramifications. It is involved in the prosecution of manufactures and importers of fake product. The director of enforcement co-ordinates all states task forces on fake and counterfeit drugs and also serve as chairman of the federal task force on fake and counterfeit drugs.
The level of enforcement activities which increasing and the decisions of dealing with the case and the enthusiasm of Nigeria as evidence by this rate at which complaints are forwarded (e.g. 44 in January 2003). Is an indication that there is no hiding place for violators of NAFDAC related laws and regulations.
(Source: consumer bulletin 2014)
2.6 RELEVANCE OF PRODUCTS REGISTRATION AS A MEANS OF CHECKING FAKE AND ADULTERATED OR SUBSTANDARD PRODUCTS
Product registration is a valuable means through which the government attempts o control the way products are imported, manufacturer and offered for sale in Nigeria.
The whole exercise of products registration is an essential tool in limiting the number and types of regulated products imported or manufactured in the country. It aids in the country and aids in the introduction of new products and the remand of unsuitable products from the market.
Products registration is not a simple administration but it is the very climax of all in built processes designed to ensure that drags and other regulated products, imported into the country are sale efficacious and of good quality.
These mechanisms of registration also ensure that food products that are imported are wholesome, that those manufactured locally are carried out under hygienic and sanitary conditions.
2.7 REGULATORY MECHANISM
The control and regulation are carried out through the mechanisms of inspection monitoring of the facilities where regulated product are manufactured as well as through laboratory evaluation.
After the promulgation of decree 15 of 1993, the National Agency for Food and Drugs Administration and Control (NAFDAC) was charged the responsibilities to regulate food, drugs, cosmetics, medical devices, chemicals detergent and packaged water. To further strengthen the hands of NAFDAC government also promulgated decree No 19 of 1993 known as drug and regulate products, registration decree e.t.c. This decree prohibites the importation and manufacturing distribution, advertisement sale and use of any of the regulated product that has not been registered like (NAFDAC) contravention of this decree attracts fine and imprisonment and the forfeiture of the seized products.
2.7.1 PROCESS OF REGISTRATION
It is during the process of registration that mechanisms which check the taking and adulteration of products are put in place. Made of application for regulated products.
i. Power of attorney
ii. Certificate of manufacture and free sale.
iii. Certificate of registration of brand name like the trademark registry in the ministry of commission in Nigeria.
iv. Certificate of pharmaceutical products (COPP).
v. Certificate of incorruption of brand names like trademark.
vi. Super intendment pharmacists licence to practice issued by the Nigerian Pharmacist council in Nigeria.
vii. Pharmaceutical premises also issued by the Pharmacist council of Nigeria.
viii. Application letter for import permits by the local representative.
ix. A letter of invitation for inspection of factory abroad.
2.7.2 NAFDAC OF REGISTRATION
All products registered like NAFDAC are issued a number. This number differentiates a NAFDAC registered product and all manufacturers and importers have been advised to have the NAFDAC number printed on the package. They also have been informed that like effect from January 2003 any regulated products without NAFDAC number will be seized and the owner sanctioned.
The product registration licence is valid for 5 years. However, NAFDAC reserves the right to revoke, withdraw or suspend such registration states during the validity period if:-
i. The information that forms the basis of its registration were later found to be false or incomplete.
ii. The circumstance under which the product was registered no longer exist and/or
iii. Condition under which the product was registered has been contravened.
As a developing country, like a high poverty level is prone to dumping fully aware of the health implications, the current NAFDAC management is quite determined t glue the penetrations of the crime the worse fight of their lives. The Nigerian consumer deserves t get value for his money. The citizens deserves to have their lives protected and promote by government.
If these beliefs are accepted then the need for product registration like NAFDAC can never be over emphasized as it is the veritable mechanism that ensures that product reaching the consumer are safe and wholesome.
All manufacturer, importers, dealers are enjoined by NAFDAC to harken the call from NAFDAC to register their product as it is only through this means that their product will have credibility.
2.7.3 INSPECTION OF G.M.P. IN OVERSEA COUNTRIES BY NAFDAC
In order to keep pace like the current scientific demand ensure operations effectiveness and efficiency and to also confirm to international standard as our mandate to protect public health. It became necessary for the agency (NAFDAC) to expand her vision to include overseas inspection.
2.7.4 G.M.P. INSPECTION IN OVERSEA COUNTRIES
G.M.P. means “good manufacturing practice” which is considered as that part of quality assurance which ensures that products are consistently produced and controlled t the quality standard appropriate to the inherent and product that cannot be prevented completely through testing of the final product.
Under G.M.P. all manufacturing processes are clearly define systematically review and should demonstrate ability to consistency in manufacturing good quality products. The principle behind G.M.P. is that quality is built into a product and not just tested for the finished product.
However, importation of fake and substandard regulated product into Nigeria bought about the need to check manufacturing facilities abroad in order to identify credit source of these products. If our local manufacturers can be subjected to routine G.M.P. checking, then it will not be considered out of place to make then sale manufacturers of the consumer products that are manufactured. (Source: An overview of NAFDAC 2014).
2.7.5 THE JOURNEY SO FAR
The first terms on this exercise left for India in March 2002 to check the G.M.P. of pharmaceutical industries since then NAFDAC term have been dispatched to far and near countries which includes China, Indonesia, Malaysia, Brazil, U.S.A., United Kingdom. Belgium, Northland, Germany, South Africa, France, Turkey and Italy in all over 200 factories have been inspected.
2.7.6 OUTCOME OF THIS JOURNEY
The reports from these trips have open up our eyes or given us awareness a great deal today about NAFDAC. NAFDAC has built confidence on the source of products coming into Nigeria. NAFDAC has identified world class factories and those like unsatisfactory G.M.P.
We have also been exposed to the state of the art in manufacturing process and instrumentation altogether NAFDAC
Streamlined the source of regulated products that come into Nigeria.
For companies like poor G.M.P, their products are not allowed into the country and this development has greatly reduced the inflow of sub-standard products. (Source: NAFDAC at a glance)
2.7.7 ACHIEVEMENTS OF THE VARIOUS DIRECTORATES
NAFDAC has achieved a lot through the use of this different directorate some of this achievement is.
1. Enforcement directorate: the newly created enforcement directorate has within the period of its existence, been involved in so many enforcement activities such as prosecution of manufacturers and importers of fake and counterfeit and regulated products inducing the one’s at Onitsha, Kano, and Lagos, worth several millions of naira. Thus justifying the vision of the director general and the management team.
Details of the achievement of this directorate are as follows.
i Investigation of 30 case of fake and counterfeit, expired and sub-standard product.
ii Destruction of 20 metric tones of expired sugar imported by EDXF manufactures Nigeria limited.
iii Destruction of 300 cartoons of expired penicillin-v tablets belonging to embassy pharmacy and chemicals limited Lagos.
iv. Destruction of 1,920 cartoons of expired ever UHT milk products belonging to SCOA Nigeria Limited.
Initiation of NAFDAC by the chemical weapon convention to document the importation and usage of chemicals.
i DRUG ABUSE CONTROL: Preventive drug abuse education was carried out-in a total of twenty-seven school as against twenty-two carried out in 2012.
ii Monitoring of compliance in move and luxury buses arising from the consultative meeting between 14th -15th November 2001 by NAFDAC and the road transport owners and transport worker aimed at stopped hawking of drugs and other regulated products in vehicles.
iii Carried out preventive drug education in market places in three (3) local government area councils in Lagos State. (Source: NAFDAC bulletin its directorates and their functions).
2.8 LABORATORY DIRECTORATE
i Immediate report and servicing of most equipment that had broken down, purchase of laboratory equipment and new generators to complement old ones.
ii Signing of an agreement like BDK for supply of chemical, which has resulted in abundant supply of analytical grade chemicals, regents and reference standards, thus ensuring continuous operation and increased productivity/efficiency.
iii Training of staff locally and internationally strengthening of bilateral relations between NAFDAC and international atomic energy agency (IAEA) by the visit of the technical co-operation project co-ordination Dr. Vincent Nkong-Njock from Vienna, Austria.
LEGAL UNIT: they drafted the now gazette NAFDAC tariff regulations 2002 that came into operation on 1st January 2002 successfully concluded 15 cases.
2.8.1 PROFESSIONAL LIASON UNIT
The professional liaison unit (PLU) was set up to facilitate effective communication between NAFDAC and various professional groups that relate to the agency.
The unit took of like brief to over (30) professional bodies and organization nationally and internationally.
Meeting have been held like Kano State pharmaceutical society of NIGERIA (PSN) technical group. (Source: NAFDAC bulletin “its directorates and their functions).
2.9 NAFDAC (FDIC)
NAFDAC as an agency established by law to promote and protect public health in an effort to fulfill one of its statutory mandate established the national food and drug information on the effective use of medicines, cosmetics as well as proper and adequate nutrition. The provision of update timely, duly processed, pertinent and evaluated scientific technical information to ensure rational use of medicines as well as for the consumption of adequate and proper nutrition is highly important such information made available directly to health and food professional policy makers and the public at large.
The (FDIC) established in the national agency for food and drugs administration and control (NAFDAC). FDIC has two primary objectives.
i To promote the rational use of medicines and nutritious and safe food the provision of objectives regularly updated and evaluated scientific and technical information.
ii To develop a nations database and an information network to meet the purpose outlined for the center.
2.9.1 FUNCTIONS OF FDIC
The main functions of the center induces the under listed.
1. To source collect, preserve, retire and disseminate drug information like the aim of releasing the goal of Nigerian NAFDAC policy, national food and nutrition policy etc.
2. To promote rational use of drug and adequate and proper nutrition by
i Providing objective food, drug and toxicological information and making available relevant guidelines and materials.
ii Education stakeholder viz organizations individuals and informing all concerned organizational as well as individuals on food and drug matters.
iii Maintenance of the food and drug network on drug utilization and food and drug network (FADNET)
iv To promote and support research works on drug utilization and food composition data.
v To maintain the food and drug network on drug utilization and food composition and data (Source: NAFDAC, the journey so far)
2.10 MANDATE AND FUNCTIONS OF NAFDAC
The mandate is as specified in section five (5) of the decree establishing it with relevant amendments as follows.
i To regulate and control the importation exportation, manufacture, advertisement, distribution, sale and use of food, drugs, cosmetic, medical device, bottle water, detergents and chemicals.
ii To conduct appropriate test and ensure compliance with standard specifications designated and approved by the council for the effective control of the quality of food, drugs, cosmetics, medical devices, bottled water, detergents and chemicals and their raw materials as well as their production processes in factories and other establishments.
iii Undertake investigation into the production premises and raw materials for food, drugs cosmetics, medical devices, bottled water, detergents including certification of the productions sites and of the regulated products.
iv Undertake inspection of imported foods, drugs, cosmetics, medical devices, bottled water, detergents including certification of the production sits and of the regulated products.
v Compile standard specifications and guidelines for the production, importation, sale and distribution of food, drugs, cosmetics, medical devices bottled water, detergent etc.
vi Undertake the registration of food, drugs cosmetics, medical devices, bottled water, detergents and chemicals.
vii Control the exportation and issue quality certification of food, drugs, cosmetics medical devices bottled water, detergents, and chemicals intended for export.
viii Establish and maintain relevant laboratories or other institutions in strategic areas in Nigeria as may be necessary for the pretence of its functions under this decree.
ix Pronounce on the quality and safety of foods, drugs, cosmetics, medical devices, bottled water, detergents, and chemicals after appropriate analysis.
x Undertake measures to ensure that use of narcotic drugs and psychotropic substances are limited to medical and scientific purposes.
xi Collaborate like the national law enforcement agency in measures to eradicate drug abuse in Nigeria.
xii Advise Federal, State and local governments, private sector and other interested bodies regarding the quality, safety and regulatory provisions of food, drugs, cosmetics, medical devices, bottled water, detergents and chemicals.
Finally amongst others, NAFDAC has been mandated to enforce the decree 15 of 1993 and impose sanctions to violators of the decree and the regulations under it all these above mentioned mandates of NAFDAC tries to achieve the goal of safeguarding the health of the nation.
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