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The National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria is a federal agency 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 is any substance consumed by an organism for nutritional support. Food is usually of plant, animal, or fungal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is inge ...
,
drugs A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via inhalat ...
,
cosmetics Cosmetics are constituted mixtures of chemical compounds derived from either natural sources, or synthetically created ones. Cosmetics have various purposes. Those designed for personal care and skin care can be used to cleanse or protect ...
, medical devices, chemicals and packaged water. The agent is headed by Dr
Monica Eimunjeze
in acting capacity on November 12, 2022, according to an internal memo dated November 17, 2022, signed by Oboli A.U and copied to all Directors at the agency, follows the expiration of Prof
Mojisola Adeyeye Mojisola Christianah Adeyeye is a Nigerian pharmacist and professor. She was appointed the Director-General of National Agency for Food and Drug Administration and Control (NAFDAC) on 3 November 2017 by the President of The Federal Republic of Ni ...
. She was appointed on 12 November 2022 by the President of Federal Republic of
Nigeria Nigeria ( ), , ig, Naìjíríyà, yo, Nàìjíríà, pcm, Naijá , ff, Naajeeriya, kcg, Naijeriya officially the Federal Republic of Nigeria, is a country in West Africa. It is situated between the Sahel to the north and the Gulf o ...
as the acting Director-General of National Agency for Food and Drug Administration and Control (NAFDAC).


Formation

The organization was established to counter illicit and counterfeit products in Nigeria in 1993 under the country's health and safety law.
Adulterated An adulterant is caused by the act of adulteration, a practice of secretly mixing a substance with another. Typical substances that are adulterated include but are not limited to food, cosmetics, pharmaceuticals, fuel, or other chemicals, th ...
and
counterfeit drugs A counterfeit medication or a counterfeit drug is a medication or pharmaceutical item which is produced and sold with the intent to deceptively represent its origin, authenticity, or effectiveness. A counterfeit drug may contain inappropriate qua ...
are a problem in Nigeria. In one 1989 incident, over 150 children died as a result of
paracetamol Paracetamol, also known as acetaminophen, is a medication used to treat fever and mild to moderate pain. Common brand names include Tylenol and Panadol. At a standard dose, paracetamol only slightly decreases body temperature; it is inferior ...
syrup containing
diethylene glycol Diethylene glycol (DEG) is an organic compound with the formula (HOCH2CH2)2O. It is a colorless, practically odorless, and hygroscopic liquid with a sweetish taste. It is a four carbon dimer of ethylene glycol. It is miscible in water, alcohol, ...
. The problem of fake drugs was so severe that neighbouring countries such as
Ghana Ghana (; tw, Gaana, ee, Gana), officially the Republic of Ghana, is a country in West Africa. It abuts the Gulf of Guinea and the Atlantic Ocean to the south, sharing borders with Ivory Coast in the west, Burkina Faso in the north, and To ...
and
Sierra Leone Sierra Leone,)]. officially the Republic of Sierra Leone, is a country on the southwest coast of West Africa. It is bordered by Liberia to the southeast and Guinea surrounds the northern half of the nation. Covering a total area of , Sierra ...
officially banned the sale of drugs, foods and beverages products made in Nigeria. Such problems led to the establishment of NAFDAC, with the goal of eliminating counterfeit pharmaceuticals, foods and beverages products that are not manufactured in Nigeria and ensuring that available medications are safe and effective. The formation of NAFDAC was inspired by a 1988
World Health Assembly The World Health Assembly (WHA) is the forum through which the World Health Organization (WHO) 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. T ...
resolution requesting countries' help in combating the global health threat posed by
counterfeit pharmaceuticals A counterfeit medication or a counterfeit drug is a medication or pharmaceutical item which is produced and sold with the intent to deceptively represent its origin, authenticity, or effectiveness. A counterfeit drug may contain inappropriate qu ...
. In December 1992, NAFDAC's first governing council was formed. The council was chaired by 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 lack of laws, concerning fake drugs.


Administration

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: *Chairman - Yusuf A. Suleiman (Dan Amar Sokoto) *The Permanent Secretary of the Ministry of Health - Mr. A. M. Abdullahi. *The Director-General of NAFDAC - Mojisola Christianah Adeyeye *Standard Organization of Nigeria (SON) - Barr. Aboloma Osita *National Institute for Pharmaceutical Research and Development (NIPRD) *The chairman of the
Pharmacists Council of Nigeria The Pharmacists Council of Nigeria (PCN) is a Federal Government Agency of Nigeria, established by Decree 91 of 1992 (now Act 91 of 1992)—due to transfer of power from military to civilian in 1999—to regulate and control the practice of pharmac ...
(PCN) - Elijah Mohammed *The chairman of the
National Drug Law Enforcement Agency The National Drug Law Enforcement Agency (NDLEA) is a federal law enforcement agency in Nigeria under the Federal Ministry of Justice charged with eliminating the growing, processing, manufacturing, selling, exporting, and trafficking of hard d ...
(NDLEA) - Muhammad Abdallah *Representative of the Pharmaceutical Manufacturing Group of Manufacturers Association of Nigeria - Okey Akpa *Representative of the Food and Beverage Group of Manufacturers Association of Nigeria - Anegbe Patrick * Tukur S. Fada Tambuwal –    Member * Mufutau Bolaji Yahaya –    Member * Opeyemi Bamidele –    Member Three people from the general public are also represented on the council.About NAFDAC
2005. Retrieved on 2006-03-27
Several units make up NAFDAC which includes: *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, sensitize, 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.


Functions

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, packaged water and chemicals *Conduct appropriate tests, ensure compliance with standard specifications designated and approved by the council for the effective control of quality of food, drugs, cosmetics, medical devices, packaged 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 Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For ...
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 Chief Olusegun Matthew Okikiola Ogunboye Aremu Obasanjo, , ( ; yo, Olúṣẹ́gun Ọbásanjọ́ ; born 5 March 1937) is a Nigerian political and military leader who served as Nigeria's head of state from 1976 to 1979 and later as its pres ...
's administration dissolved the management of NAFDAC in August 2000. In April 2001, a new management team, with
Dora Akunyili Dora Nkem Akunyili (14 July 1954 – 7 June 2014) was the Director-General of National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria from 2001 to 2008. Early life and education Dora Edemobi was born in Makurdi, ...
as director-general, was inaugurated.NAFDAC: Battle against fake drugs
. 2003-03-04. Retrieved on 2006-03-25
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
Calabar Calabar (also referred to as Callabar, Calabari, Calbari and Kalabar) is the capital city of Cross River State, Nigeria. It was originally named Akwa Akpa, in the Efik language. The city is adjacent to the Calabar and Great Kwa rivers and cre ...
and
Apapa Apapa is a Local Government Area in Lagos, located to the west of Lagos Island. Apapa contains a number of ports and terminals operated by the Nigerian Ports Authority (NPA), including the major port of Lagos State and Lagos Port Complex (LPC ...
sea ports,
Murtala Muhammed Murtala Ramat Muhammad (8 November 1938 – 13 February 1976) was a Nigerian general who led the 1966 Nigerian counter-coup in overthrowing the Johnson Aguiyi-Ironsi military regime and featured prominently during the Nigerian Civil War ...
and
Mallam Aminu Kano International Airport Mallam Aminu Kano International Airport is an international airport serving Kano, the capital city of Kano State of Nigeria. It was a Royal Air Force station before the country became independent. It is the main airport serving northern Niger ...
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 “
Dora Akunyili Dora Nkem Akunyili (14 July 1954 – 7 June 2014) was the Director-General of National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria from 2001 to 2008. Early life and education Dora Edemobi was born in Makurdi, ...
approached her job with zeal in order to rid the Nigerian drug market of fake drugs and contaminated water sold as “
pure water Purified water is water that has been mechanically filtered or processed to remove impurities and make it suitable for use. Distilled water was, formerly, the most common form of purified water, but, in recent years, water is more frequently puri ...
.”The Director General: Prof. Dora Nkem Akunyili (OFR) – Biography
. NAFDAC Nigeria. Retrieved on 2007-07-25


Controversies

The activities of NAFDAC have been the subject of considerable scrutiny in recent years. The agency has drawn fire for being susceptible to overt government interference, subject to bribery, internal feuding and constant rumours and or allegations abound concerning misappropriation of funds. In one high-profile (and typical) case, the former NAFDAC director of finance and accounts, Andrew Ademola Mogbojuri, alleged mass fraud in 2015 against the agency's director-general, Paul Orhii. The agency claimed sour grapes was behind the allegation and labelled Mogbojuri's claim "misleading and cheap blackmail". Orhii was also the subject of a sweeping fraud allegation by NAFDAC
whistleblowers A whistleblower (also written as whistle-blower or whistle blower) is a person, often an employee, who reveals information about activity within a private or public organization that is deemed illegal, immoral, illicit, unsafe or fraudulent. Whi ...
earlier in 2015. A petition was sent to Nigerian President
Muhammadu Buhari Muhammadu Buhari (born 17 December 1942) is a Nigerian politician and current president of Nigeria since 2015. Buhari is a retired Nigerian Army major general who served as the country's military head of state from 31 December 1983 to 27 Au ...
, alleging frivolous contract awards and supplies, manipulated publicity efforts, donations and international air travel
racketeering Racketeering is a type of organized crime in which the perpetrators set up a coercive, fraudulent, extortionary, or otherwise illegal coordinated scheme or operation (a "racket") to repeatedly or consistently collect a profit. Originally and of ...
. Some of the world's largest brewers have been caught up in NAFDAC scandals as well. From a 2013 report alleging bribery conducted by
Guinness Guinness () is an Irish dry stout that originated in the brewery of Arthur Guinness at St. James's Gate, Dublin, Ireland, in 1759. It is one of the most successful alcohol brands worldwide, brewed in almost 50 countries, and available in ove ...
and
Heineken Heineken Lager Beer ( nl, Heineken Pilsener), or simply Heineken () is a pale lager beer with 5% alcohol by volume produced by the Dutch brewing company Heineken N.V. Heineken beer is sold in a green bottle with a red star. History On 15 Febr ...
:
''Two multinational beer companies (Guinness and Heineken) have decided to do it the illegal way, which insiders alleged is to bribe officials of National Agency for Food and Drugs Administration Control (NAFDAC) to deny the manufacturers of local herbal gin accreditation, knowing that Nigerians who had been patronizing them will desist once they are not accredited by the agency. The bribes amount to millions of Naira.
Guinness was back in the NAFDAC glare in 2016. Having been fined about ₦1 billion in November 2015for allegedly re-validating and using expired raw materials without prior approval, the multinational brewer responded with a lawsuit, which was quietly dropped in March 2016.
/blockquote>


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.Stakeholders. (2005). Retrieved on April 10, 2006 from http://www.nafdacnigeria.org/stakeholders.html *Consumer Protection Council of Nigeria(CPC) *Standards Organisation of Nigeria (SON) *National Drug Law Enforcement Agency (NDLEA) *National Institute for Pharmaceutical Research and Development (NIPRD) *Pharmacists Council of Nigeria (PCN) *Pharmaceutical Manufacturers Group of Manufactures Association of Nigeria (PMG-MAN) *Consumer Association of Nigeria *Institute of Public Analysts of Nigeria (IPAN) *
Pharmaceutical Society of Nigeria Pharmaceutical Society of Nigeria (PSN) is a professional body for practicing pharmacists in Nigeria and was established in to instill discipline and maintaining professional ethics among members of the organization. The first president of the asso ...
(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 The United Nations Office on Drugs and Crime (UNODC; French: ''Office des Nations unies contre la drogue et le crime'') is a United Nations office that was established in 1997 as the Office for Drug Control and Crime Prevention by combining the ...
(UNDCP) *
World Health Organization The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...
(WHO) *
Codex Alimentarius The Codex Alimentarius () is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations published by the Food and Agriculture Organization of the United Nations relating to food, food production ...
Commission of Food and Agriculture Organization (CACFAO) *
United States Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
(USFDA) *
Environmental and Occupational Health Science Institute A biophysical environment is a biotic and abiotic surrounding of an organism or population, and consequently includes the factors that have an influence in their survival, development, and evolution. A biophysical environment can vary in scale f ...
(EOHSI).


See also

*
Dora Akunyili Dora Nkem Akunyili (14 July 1954 – 7 June 2014) was the Director-General of National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria from 2001 to 2008. Early life and education Dora Edemobi was born in Makurdi, ...
*
Mojisola Adeyeye Mojisola Christianah Adeyeye is a Nigerian pharmacist and professor. She was appointed the Director-General of National Agency for Food and Drug Administration and Control (NAFDAC) on 3 November 2017 by the President of The Federal Republic of Ni ...

RxNigeria.com
- An online database of pharmaceuticals and allied products approved for use in Nigeria by NAFDAC.


External links


NAFDAC Official websiteFAAN Carrier Portal


References

{{Authority control Food safety organizations National agencies for drug regulation (Nigeria) Medical and health organizations based in Nigeria Nigeria articles needing expert attention Food safety in Nigeria Regulation in Nigeria