NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL

NAFDAC
Established:	1993
Director General:	Paul Bortwev Orhii
Headquarters:	Abuja, Nigeria

The National Agency for Food and Drug Administration and Control (NAFDAC) is a Nigerian government 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, drugs, cosmetics, medical devices, chemicals and prepackaged water. The current Director-General of NAFDAC, Dr Paul Orhii, holds a PhD in medicine.

History of NAFDAC

The organization was formed to checkmate illicit and counterfeit products in Nigreia in 1993 under the countries health and safety law Adulterated and counterfeit drugs are a problem in Nigeria. In one 1989 incident, over 150 children died as a result of paracetamol syrup containing diethylene glycol. The problem of fake drugs was so severe that neighboring countries such as Ghana and Sierra Leone 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 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.

Structure of NAFDAC

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:

1. The Permanent Secretary of the Ministry of Health
2. The Director-General of NAFDAC
3. Standard Organization of Nigeria (SON)
4. The National Institute for Pharmaceutical Research and Development (NIPRD)
5. The chairman of the Pharmacists’ Council of Nigeria (PCN)
6. The chairman of the National Drug Law Enforcement Agency (NDLEA)
7. 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:

1. 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."
2. 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.
3. Internal Audit provides a means of measuring the effectiveness of the system of internal control and accounting, and carries out special investigations.

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.^[2] 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 and Apapa sea ports, Murtala Muhammed and Mallam Aminu Kano International Airports 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

1. The creation of 6 Zonal and 36 state offices for easier accessibility, which are being equipped to function effectively,
2. 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),
3. Raising awareness not just in Nigeria, also in other countries like India, China, Pakistan, Indonesia, and Egypt,
4. 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,
5. 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,
6. 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.

• 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

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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 Organization (WHO)
• Codex Alimentarius Commission of Food and Agricultural Organization (CACFAO)
• United States Food and Drug Administration (USFDA)
• Environmental and Occupational Health Science Institute (EOHSI).