National Agency for Food and Drug Administration and Control
Encyclopedia
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| Established: | 1993 |
| Director General: | Paul Bortwev Orhii |
| Headquarters Headquarters Headquarters denotes the location where most, if not all, of the important functions of an organization are coordinated. In the United States, the corporate headquarters represents the entity at the center or the top of a corporation taking full responsibility managing all business activities... : |
Abuja Abuja Abuja is the capital city of Nigeria. It is located in the centre of Nigeria, within the Federal Capital Territory . Abuja is a planned city, and was built mainly in the 1980s. It officially became Nigeria's capital on 12 December 1991, replacing Lagos... , Nigeria Nigeria Nigeria , officially the Federal Republic of Nigeria, is a federal constitutional republic comprising 36 states and its Federal Capital Territory, Abuja. The country is located in West Africa and shares land borders with the Republic of Benin in the west, Chad and Cameroon in the east, and Niger in... |
The National Agency for Food and Drug Administration and Control (NAFDAC) is a Nigeria
Nigeria
Nigeria , officially the Federal Republic of Nigeria, is a federal constitutional republic comprising 36 states and its Federal Capital Territory, Abuja. The country is located in West Africa and shares land borders with the Republic of Benin in the west, Chad and Cameroon in the east, and Niger in...
n government agency
Government agency
A government or state agency is a permanent or semi-permanent organization in the machinery of government that is responsible for the oversight and administration of specific functions, such as an intelligence agency. There is a notable variety of agency types...
under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food
Food
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals...
, drugs
DRUGS
Destroy Rebuild Until God Shows are an American post-hardcore band formed in 2010. They released their debut self-titled album on February 22, 2011.- Formation :...
, cosmetics
Cosmetics
Cosmetics are substances used to enhance the appearance or odor of the human body. Cosmetics include skin-care creams, lotions, powders, perfumes, lipsticks, fingernail and toe nail polish, eye and facial makeup, towelettes, permanent waves, colored contact lenses, hair colors, hair sprays and...
, medical devices, chemicals and prepackaged water
Water
Water is a chemical substance with the chemical formula H2O. A water molecule contains one oxygen and two hydrogen atoms connected by covalent bonds. Water is a liquid at ambient conditions, but it often co-exists on Earth with its solid state, ice, and gaseous state . Water also exists in a...
.The current Director-General of NAFDAC,Dr Paul Orhii, holds a PhD in medicine. Dr Paul B. Orhii is a Russian trained doctor and he recently acquired a Juris Doctor degree from the Thurgood Marshall School of Law at the Texas Southern University.
He hails from Ushongo Local Government Area of Benue State. Orhii who has a Doctorate Degree in Neuro-Pharmacology took over from Mrs. Dora Akunyili who was recently appointed Minister of Information and Communications. Orhii has over 20 years cumulative working experience in the field of medicine in Nigeria and the United States of America.
History of NAFDAC
The organization was formed to checkmate illicit and counterfeit products in Nigreia in 1993 under the countries health and safety lawAdulterated and counterfeit drugs are a problem in Nigeria. In one 1989 incident, over 150 children died as a result of paracetamol
Paracetamol
Paracetamol INN , or acetaminophen USAN , is a widely used over-the-counter analgesic and antipyretic . It is commonly used for the relief of headaches and other minor aches and pains and is a major ingredient in numerous cold and flu remedies...
syrup containing diethylene glycol
Diethylene glycol
Diethylene glycol is an organic compound with the formula 2O. It is a colorless, practically odorless, poisonous, and hygroscopic liquid with a sweetish taste. It is miscible in water, alcohol, ether, acetone, and ethylene glycol. DEG is a widely used solvent...
. The problem of fake drugs was so severe that neighboring countries such as Ghana
Ghana
Ghana , officially the Republic of Ghana, is a country located in West Africa. It is bordered by Côte d'Ivoire to the west, Burkina Faso to the north, Togo to the east, and the Gulf of Guinea to the south...
and Sierra Leone
Sierra Leone
Sierra Leone , officially the Republic of Sierra Leone, is a country in West Africa. It is bordered by Guinea to the north and east, Liberia to the southeast, and the Atlantic Ocean to the west and southwest. Sierra Leone covers a total area of and has an estimated population between 5.4 and 6.4...
officially banned the sale of drugs foods & beverages products made in aside Nigeria.
Such problems led to the establishment of NAFDAC, with the goal of eliminating counterfeit pharmaceuticals, foods & beverages products that are not manufacturer in Nigeria and ensuring that available medications are safe and effective.
The formation of NAFDAC was inspired by a 1988 World Health Assembly
World Health Assembly
The World Health Assembly is the forum through which the World Health Organization is governed by its 194 member states. It is the world's highest health policy setting body and is composed of health ministers from member states....
resolution requesting countries' help in combating the global health threat posed by counterfeit pharmaceuticals.
In December 1992, NAFDAC's first governing council was formed. The council was chaired by Ambassador Tanimu Saulawa. In January 1993, supporting legislation was approved as legislative Decree No. 15 of 1993. On January 1, 1994 NAFDAC was officially established as a “parastatal of the Federal Ministry of Health”.
NAFDAC replaced an earlier Federal Ministry of Health body, the Directorate of Food and Drug Administration and Control, which had been deemed ineffective, partially because of a lack of laws concerning fake drugs.
Chairman and council
“(NAFDAC) is headed by a chairman who presides over a governing council appointed by the president on the recommendation of the Minister of Health.”Other council members are:- The Permanent Secretary of the Ministry of Health
- The Director-General of NAFDAC
- Standard Organization of Nigeria (SON)
- The National Institute for Pharmaceutical Research and Development (NIPRD)
- The chairman of the Pharmacists’ Council of Nigeria (PCN)
- The chairman of the National Drug Law Enforcement AgencyNational Drug Law Enforcement AgencyThe National Drug Law Enforcement Agency is a Federal agency in Nigeria charged with eliminating the growing, processing, manufacturing, selling, exporting, and trafficking of hard drugs. The agency was established by Decree Number 48 of January l990. The NDLEA is present in international...
(NDLEA) - A representative each of the Pharmaceutical Group and the Food and Beverages Group of the Manufacturers’ Association of Nigeria.
Three people from the general public are also represented on the council.
Several units make up NAFDAC:
- The Legal Unit is charged with offering legal advice on “law arising from Employee-Employer relationship and is the custodian of legal documents and all agreements relating to the Agency."
- The Public Relations Unit is headed by the Director-General’s office. Its main function is to inform, sensitivize, enlighten and create awareness concerning the role of the Agency. The agency is divided into eight directorates with the last two newly added.
- Internal Audit provides a means of measuring the effectiveness of the system of internal control and accounting, and carries out special investigations.
E-mail: - nafdac.lagos@nafdac-ng.com or legal@nafdac-ng.com & info@nafdac-ng.com
Functions of NAFDAC
NAFDAC has various basic functions. According to the requirements of its enabling decree, the Agency was authorized to:- Regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of drugs, cosmetics, medical devices, bottled water and chemicals
- Conduct appropriate tests and ensure compliance with standard specifications designated and approved by the council for the effective control of quality of food, drugs, cosmetics, medical devices, bottled water, and chemicals.
- Undertake appropriate investigation into the production premises and raw materials for food, drugs, cosmetics, medical devices, bottled water and chemicals and establish a relevant quality assurance system, including certification of the production sites and of the regulated products
- Undertake inspection of imported foods, drugs, cosmetics, medical devices, bottled water, and chemicals and establish a relevant quality assurance system, including certification of the production sites and of the regulated products.
- Compile standard specifications, regulations, and guidelines for the production, importation, exportation, sale and distribution of food, drugs, cosmetics, medical devices, bottled water, and chemicals
- Undertake the registration of food, drugs, medical devices, bottled water and chemicals
- Control the exportation and issue quality certification of food, drugs, medical devices, bottled water and chemicals intended for export
- Establish and maintain relevant laboratories or other institutions in strategic areas of Nigeria as may be necessary for the performance of its functions.
NAFDAC envisions that by making these functions known, that its actions will be apparent “in all sectors that deal with food, cosmetics, medical devices, bottled water, and chemicals to the extent of instilling extra need for caution and compulsion to respect and obey existing regulations both for healthy, living and knowledge of certain sanctions or default.". Despite the establishment of NAFDAC, the sale and use of fake drugs did not end.
New Amendments since 2001
Dissatisfied with progress in combating fake drugs, President Olusegun Obasanjo's administration dissolved the management of NAFDAC in August 2000. In April 2001, a new management team, with Dr. Dora Akunyili as Director-General, was inaugurated. The team re-organized the agency, which has been successful in the recent past due to three new federal policies:- The outright ban on the importation of drugs and other regulated products through land borders.
- The designation of CalabarCalabarCalabar is a city in Cross River State, southeastern Nigeria. The original name for Calabar was Atakpa, from the Jukun language....
and ApapaApapaApapa is the major port of the city of Lagos, Nigeria, and is located to the west of Lagos Island, across Lagos Harbour. It is also one of Nigeria's 774 Local Government Areas.- Overview :...
sea ports, Murtala MuhammedMurtala Mohammed International AirportMurtala Muhammed International Airport is an international airport located in Ikeja, Lagos State, Nigeria, and is the major airport serving the city of Lagos, southwestern Nigeria and the entire nation. Originally known as Lagos International Airport, it was renamed midway during construction...
and Mallam Aminu Kano International AirportMallam Aminu Kano International AirportMallam Aminu Kano International Airport is located in Kano, a city in the Kano State of Nigeria. It is the main airport serving northern Nigeria and was named after Nigerian politician Aminu Kano. The airport consists of an international and a domestic terminal. Both terminals share the same...
s as exclusive ports of entry for the importation of drugs and pharmaceutical raw materials. - Release of shipping and cargo manifests by the Nigerian Ports Authority, shipping lines and airlines to NAFDAC inspectors. For several years, Nigeria was drowned in an ocean of fake drugs. Then “Dr. Dora Akunyili approached her job with zeal…, to preserve in ridding the Nigerian market of fake drugs and contaminated water sold as “pure water.”
Achievements
NAFDAC has made several achievements over the years, including- The creation of 6 Zonal and 36 state offices for easier accessibility, which are being equipped to function effectively,
- Organization of workshops to enlighten various stakeholders, such as (a) pure water producers (b) the Patent and Proprietary Medicine Dealers Association (PPMDA), and (c) the National Union of Road Transport Workers and National Association of Road Transport Owners (NURTW & NARTO),
- Raising awareness not just in Nigeria, also in other countries like IndiaIndiaIndia , officially the Republic of India , is a country in South Asia. It is the seventh-largest country by geographical area, the second-most populous country with over 1.2 billion people, and the most populous democracy in the world...
, ChinaChinaChinese civilization may refer to:* China for more general discussion of the country.* Chinese culture* Greater China, the transnational community of ethnic Chinese.* History of China* Sinosphere, the area historically affected by Chinese culture...
, PakistanPakistanPakistan , officially the Islamic Republic of Pakistan is a sovereign state in South Asia. It has a coastline along the Arabian Sea and the Gulf of Oman in the south and is bordered by Afghanistan and Iran in the west, India in the east and China in the far northeast. In the north, Tajikistan...
, IndonesiaIndonesiaIndonesia , officially the Republic of Indonesia , is a country in Southeast Asia and Oceania. Indonesia is an archipelago comprising approximately 13,000 islands. It has 33 provinces with over 238 million people, and is the world's fourth most populous country. Indonesia is a republic, with an...
, and EgyptEgyptEgypt , officially the Arab Republic of Egypt, Arabic: , is a country mainly in North Africa, with the Sinai Peninsula forming a land bridge in Southwest Asia. Egypt is thus a transcontinental country, and a major power in Africa, the Mediterranean Basin, the Middle East and the Muslim world...
, - Holding meetings, in concert with the Chairman, House Committee on Health and his members, with Ambassadors of countries identified with exporting fake drugs into Nigeria and solicited their support to stop the trend,
- Achieving excellent results in the fight against counterfeit drugs, as evidenced by the public destruction of about 2 billion Naira worth of drugs from four sources, namely those handed over by repentant traders, those found in secret warehouses on tip off by the drug sellers and the public, and those seized by the drug sellers' internal task forces and NAFDAC task forces,
- Launch of anti-counterfeiting technologies by the Nigerian presidency see NOTE below:
Although the project has been launched, there are serious concerns of complicity, compromise and lack of professionalism in the delivery of the project; it does not however appear that the Presidency is aware of this. The above is buttressed by the following:
- 1. The fact that there are many unanswered questions about the intrigues behind the final emergence of SPROXIL as the technology provider amidst multiple claims and duly communicated evidences of technology theft. It is believed that the DG may have inadvertently (or otherwise) provided the platform that facilitated the theft.
- What was most surprising to observers is how the DG ignored and blocked all efforts to bring this to his knowledge. Ordinarily, it is expected that the NAFDAC DG at his level of education and exposure should have shown respect for intellectual property rights. Observers are still studying to understand the real cause of this leadership failure: if it is purely a factor of ignorance, or overzealousness in his attempt to record 'some kind of achievements' as a match for the lofty standards set by his predecessor’s (Prof. Dora Akunyili), or if it is to do with any personal interest. Please SEE comments on this page:http://www.thenationonlineng.net/2011/index.php/news/21658-%E2%80%98our-battle-against-fake-drugs%E2%80%99.html
- 2. The fact that there are also unanswered questions of management irresponsibility, lack of prudency and respect for institutional contractual obligations by Dr. Paul Orhii in his administration of the Project. Dr. Paul Orhii officially awarded multiple contracts on the same project to different organizations; he encouraged each party to invest their resource and refused honoring his contractually obligations or providing the parties with official termination of the contract or explanations. People have questioned the rationale behind this act given his backgrounds in Law; could it be that he is just careless, intoxicated by the power that his position is accorded with, or is he taking undue advantage of the weakness of the law in his host environment. All these are subjects of research by keen followers of events and developments in African leaders.
- Observers’ concerns are based on the fact that this act has raised litigations against NAFDAC which will usually end up in the organization paying out huge sum of money in legal fees and penalties for breach of contracts by the time the cases are disposed of. In many scenarios such cases are usually not finished during the tenor of the officer in question and the defaulting officers are often not brought back to account for their leadership failure.
- Ensuring the formation of a wholesale Drug Mart as the bedrock of the sanitization exercise,
- Making NAFDAC activities more efficient to reduce delays in, for example, registration and inspection,
- Holding consultations with national and international stakeholders leading to various areas of assistance, including, in the areas of staff training, equipment donations and information sharing from United States Food and Drug Agency (USFDA), Environmental and Occupational Health Science Institute (EOHSI), South African Medicines and Medical Devices regulatory Agency (SAMMDRA),
- Sending proposals for reviewing obsolete laws to the National Assembly, and
- Putting new guidelines and standard operating procedures (SOP) in place for all regulatory processes.
Stakeholders
NAFDAC ensures it maintains very close contact with a number of national and international organizations whose activities relate to the functions of NAFDAC. Such Organizations include the following.- Consumer Protection Council of Nigeria(CPC)
- The Standard Organizations of Nigeria (SON)
- The National Drug Law Enforcement Agency (NDLEA)
- The National Institute for Pharmaceutical Research and Development (NIPRD)
- The Pharmacists Council of Nigeria (PCN)
- The Pharmaceutical Manufacturers Group of Manufactures Association of Nigeria (PMG-MAN)
- The Consumer Association of Nigeria
- The Federal Environmental Protection Agency (FEPA)
- Institute of Public Analysts of Nigeria (IPAN)
- Pharmaceutical Society of Nigeria (PSN)
- Association of Food, Beverage and Tobacco Employees of Nigeria (AFBTE)
- National Association of Government Approved Freight Forwarders (NAGAFF)
- Association of Nigeria Custom Licensed Agents (ANCLA)
- Patent and Proprietary Medicine Dealers Association (PPMDA)
- National Union of Road Transport Workers (NURTW)
- National Association of Road Transport Owners (NARTO)
In order to keep in touch with the international scene for information, training, co-operation assistance, aid and for financing of specific projects, especially in these days of global and national austerity, the agency maintains close relationship with a number of International Agencies some of which include:
- United Nations International Drug Control Programme (UNDCP)
- World Health OrganizationWorld Health OrganizationThe World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...
(WHO) - Codex AlimentariusCodex AlimentariusThe Codex Alimentarius is a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety. Its name derives from the Codex Alimentarius Austriacus...
Commission of Food and Agricultural Organization (CACFAO) - United States Food and Drug AdministrationFood and Drug AdministrationThe Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(USFDA) - Environmental and Occupational Health Science Institute (EOHSI).