NATIONAL AGENCY FOR FOOD AND DRUG

ADMINISTRATION AND CONTROL (NAFDAC)

Director General
Dr Paul Botwev Orhii obtained his degree in Medicine from the Stavropol State Medical
Institute, Russia in 1989 and has a Ph.D in Chrono-Neuropsychopharmacology. He is also a
licensed Attorney and Counselor at Law.

He has worked as a lecturer, teaching pharmacology to medical students at the University

of Jos, Nigeria and, as a Biomedical Scientist, supervising work conducted by graduate
students, research assistants and volunteers at the University of Texas, Health Science
Center at San Antonio, Texas.

He has authored and co-authored several scientific publications and before his
appointment, worked as a Pharmaceutical Litigator. Dr. Orhii was appointed Director-
General of the National Agency for Food and Drug Administration and Control (NAFDAC) on
13th January, 2009. He is currently Vice Chairman of the International Medical Products
Anti-Counterfeiting Task Force (IMPACT).

The achievements of the Agency under the dynamic leadership of Dr. (Mrs.) Dora N. Akunyili (OFR) cannot be
overemphasised and the successor Dr Paul Botwev Orhii during the period under review are outstanding and
encouraging

NAFDAC

The National Agency for Food and Drug Administration and Control (NAFDAC), established by Decree No. 15
of 1993 as amended is a Parastatal of the Federal Ministry of Health, with the mandate to regulate and control
quality standards for Foods, Drugs, Cosmetics, Medical Devices, Chemicals, Detergents and packaged water
imported, manufactured locally and distributed in Nigeria.

The importance of food and drugs to a man and animal is very obvious. They need food in order to grow and
sustain life while life goes on, and because of the inherent disposition to illness, the organs of the body may not
always function properly.

These situations of ill health provide the compelling need for drugs in order to modify the functioning of the body
and restore it to normal. To be acceptable, the drug must not be deleterious to the body but should rather produce
positive effect, which leads to restoration of normal life. In like manner, cosmetics, should have no harmful effect
on the body to which they are applied.

It is the duty of all government to protect the health of the citizens, and in Nigeria this is the responsibility of the
Federal Ministry of Health. Within the Ministry and until 31st December 1992, these responsibilities as regards
foods and drugs devolved on the Department of Food and Drugs Administration and Control, (FDAC)
Department and were inevitably linked with the normal bureaucratic ministerial positions which are manifested
in:
• Slow mobilization of ideas, men and materials for productive work
• Inadequate resource acquisition, utilization and management
• slow disciplinary and poor reward system, and management
• poor funding of activities necessary for effective design and implementation of programs

They are also traceable to a lack of awareness by the public in practical terms of the sensitivity and relevance of
matters concerning control measures on food, drugs, cosmetics, water and chemicals to both preventive and
curative health care. Such control measures when executed successfully provide guaranteed savings of a high
percentage of the expenditure of the government and individuals to cure and relieve illness.

These problems led to the birth of NAFDAC as a parastatal of the Federal Ministry of Health. NAFDAC was thus
established by Decree No. 15 of 1993 to carry out among other things, all the control functions of the former
FDAC while the service functions remain within the ministry.

FUNCTIONS
The name of the Agency reflects its functions very adequately. By the provisions of the enabling decree, (decree
No. 15 of 1993) the Agency is mandated to :
• Regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use
of drugs, cosmetics, medical devices, bottled water and chemicals
• Conducs appropriate test 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 and their raw materials as well as their production processes in factories and other
establishments.
• Undertake appropriate investigation into the production premises and raw materials for food, drugs,
cosmetics, medical devices, bottled water and chemicals and establish relevant quality assurance system,
including certification of the production sites and of the regulated products
 • Undertake inspection of imported food, drugs, cosmetics, medical devices, bottled water and chemicals
and establish relevant quality assurance system, including certification of the production sites and of the
regulated products.
• Compile standard specifications and 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
• Pronounce on the quality and safety of food, drugs, cosmetics, medical devices, bottled water and
chemicals after appropriate analysis
• Undertake measures to ensure that the use of narcotic drugs and psychotropic substances are limited to
medical and scientific purposes
• Grant authorization for the import and export of narcotic drugs and psychotropic substances as well as
other controlled substances
• Collaborate with National Drug Law Enforcement Agency in measures to eradicate drug abuse in Nigeria
• Advise Federal, State and Local Governments, the Private sector and other interested bodies regarding the
quality, safety and regulatory provisions on food, drugs, cosmetics, medical devices, bottled water and
chemicals
• Issue guidelines on, approve and monitor the advertisement of food, drugs, cosmetics, medical devices,
bottled water and chemicals
• Compile and publish relevant data resulting from the performance of the functions of the Agency or from
other sources
• Sponsor such national and international conference as it may consider appropriate
• Liaise with relevant establishments within and outside Nigeria in pursuance of its functions
In discharging the above functions, the agency envisages that its activities will be evident 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.
THE GAINS AND THE IMPACTS OF THE GAINS ON SEVERAL SECTORS OF THE

NIGERIAN SOCIETY

The popular adage that it takes action to turn dreams into realities cannot be more apt in describing the gains
recorded so far by NAFDAC. A brief discussion, of the gains and the impacts of the gains on several sectors of
the Nigerian society, is presented in this chapter.

Enhanced Corporate Culture/Image

The greatest achievement of NAFDAC is the institutionalization of a culture that promotes transparency,
accountability, hard work, and abhors corruption. It brought about behavioural change in the staff. NAFDAC’s
commitment to transform the culture of corruption and prosecute the war against counterfeit and fake drugs was
indeed the oil that lubricated the wheel of our success.
Transparency in the regulatory processes helped in our communication with stakeholders and made it effective
and fruitful. It also contributed to the acceptance of the Agency by an international donor organization as the
executing agency for Gain Fund Project for Vitamin A fortification in Nigeria. NAFDAC’s anticorruption stance
brought support for the Agency and it helped it to achieve effective regulation in Nigeria. Our public
enlightenment campaigns and other strategies bore much fruit because the Government, the Press and the
Nigerian Public unwaveringly supported NAFDAC.
The management style of the Agency in Nigeria is emulated by other government agencies because the
remarkable paradigm shift became an inspiration to others in public service. The Daily Sun publication by Don C.
Adinuba titled, “NAFDAC as a Study in Management” asserts that NAFDAC’s transformation should make a
rewarding study to students of management and leadership.45 To crown it all, the Agency on March 30, 2004,
received an award organized by the Consumer Advocacy Forum of Nigeria (CAFON) as the 1st among the Best
Consumer Sensitive Government Agencies.
2. Growth in the Health and Pharmaceutical Sub-Sector
In the typical formula of reform-agenda, we assume that the private sector is the engine of growth. NAFDAC’S
reform in the pharmaceutical sector has shown that while the private sector is the engine, the public sector indeed
oils this engine without which the former crashes. The credit for the improved profile of NAFDAC can be
attributed to the untiring efforts of NAFDAC staff, the enthusiastic workforce of manufacturers, and pro-active
government policies. These have led to a tremendous increase in production capacities of our local
pharmaceutical industries as reported by individual manufacturers and the Pharmaceutical Manufacturers Group
of Nigeria—PMG-MAN. Nigerian pharmaceutical industries witnessed a 35% increase in turnover drug
production in 2002.

The Executive Secretary of PMG-MAN attributed improved performance of the sector to 100% import inspection
policy and the new impetus from NAFDAC, which has seriously curtailed dumping.46 GlaxoSmithKline
recorded a 77% growth in sales during the same period. The company’s General Manager for West Africa
attributed this tremendous increase to “NAFDAC living up to its responsibilities of enforcing strict compliance to
product regulation.”47 MAY & BAKER’s profit growth rose by 88% for the first half of 2003. The company was
also optimistic of a better performance in the second half of 2003. Pharma Deko Plc witnessed an increased
demand for its products resulting in a 78.5% increase in turnover in 2002.48 It is noteworthy that the company
had not paid dividends since 1999 due to losses but the company declared dividends in 2003.49 NEIMETH
International Pharmaceuticals Plc recorded 105% increase in its profit before tax at the end of its financial year in
March 31, 2003.50 The Nigerian Association of the Chambers of Commerce, Industry, Mines and Agriculture in
its review of the economic performance of the 2003 fiscal year, said that the government target of achieving 65%
capacity utilization in the economy was not realized. The only exception was the pharmaceutical manufacturing
sector where the vigorous onslaught of NAFDAC on fake and substandard products pushed capacity utilization to
nearly 60%.51 NAFDAC activities, therefore, reinforced the confidence of investors in the pharmaceutical
industry, as evidenced in the continuous upward movement in the share prices of the pharmaceutical companies
quoted in the Nigerian Stock Exchange.
Nigerian stock exchange extolled NAFDAC over the rise in healthcare stocks prices, stating that capacity
utilization of practitioners in the sector had greatly improved through the agency’s sustained fight against faking
and counterfeiting of regulated products. The Exchange’s July monthly stock market review showed capacity in
the industry at 64%, which had risen far above the 54% manufacturing sector average in recent times. This in turn
is believed to have encouraged the standardization of the products, leading to recovery of lost market share. It has
also brought the need to rehabilitate, expand, and modernize the companies’ plants, the possibility of opening new
product lines and diversification to capture new markets. The Exchange noted that the success of the agency in
controlling the importation of regulated products, beefing up surveillance at the ports, clamping down on major
sources of fake products both locally and internationally impacted positively on the healthcare sector. Many
companies have returned to profitability and have become key players in the sector. Chart 3 also shows soaring
share prices of some quoted companies, from the year 2003 to July 2004.

The Agency's reforms have led to other West African countries’ renewed confidence and increased patronage of
pharmaceutical products produced in Nigeria as evidenced by the lifting of the ban on “Made in Nigeria” drugs
by the Ghanaian authorities.
Many Multinational Drug Companies are coming back to Nigeria due to the present regulatory environment. For
example, Glaxo Smith Kline built a new OTC Factory worth one billion Naira. The company now locally
manufactures Septrin Tablets. Their toothpaste brand, Macleans withdrawn from the Market is now locally
produced. Pharmacia left earlier but is now back as a full fledged scientific office. Ciba – Gaeigy and Sandoz left
and are now back jointly as Norvatis. Reckett Benckiser ltd, formerly importing Dettol Antiseptic disinfectant and
soap now manufacturers locally. Tura range of products imported from Tura International England is now being
manufactured locally by Tura International.

3. Increased Public Awareness

The public awareness created regarding NAFDAC's regulatory activities, especially those activities relate to fake
and counterfeit drugs, resulted in the participation of the regulated industries, consumers, and other stakeholders
in the promotion of food and drug regulation in Nigeria. These achievements, among others, have awakened
consciousness that Nigeria is no longer a dumping ground for fake drugs, and other substandard regulated
products. There is an encouraging level of compliance to NAFDAC's ban on the importation of counterfeit and
other substandard products due to the commitment of importers to comply with NAFDAC directives. The
consciousness and alertness of both the consumers and stakeholders were also heightened, particularly the
dangers posed to health by the consumption of fake drugs and other substandard products. In a public opinion poll
conducted by The Guardian newspaper on the activities of NAFDAC, 83% of 1,200 respondents rated
NAFDAC’s performance as “good” or “excellent.”52
Consumers have now formed the habit of scrutinizing their drugs, food, and other regulated products for
genuineness by checking expiry dates and the NAFDAC registration numbers before purchase and use.
Manufacturers and importers are encouraged to bring to the attention of NAFDAC all discovered cases of faking
of their registered products for investigation, publication, and possible prosecution. Manufacturers and importers
of unregistered products are spurred by NAFDAC’s publications of unregistered products to submit their products
for registration, knowing fully well the negative impact such adverse publicity would have on their products and
organizations.
NAFDAC’s staff enjoys high esteem, perception, and goodwill from the Nigerian public and consumers who are
in a better position to appreciate the fact that NAFDAC is focused on the promotion of good health rather than
being a punitive Agency.
The international community is not left out on this increased awareness on the activities of NAFDAC. An excerpt
of a correspondence during the planning of a counterfeit drug conference for African countries in Dakar and Cape
Town reads in part:

----------. “I am pleased to report that in planning for the conference, praise for NAFDAC and Dr. Akunyili has
been universal. Everyone is very impressed with NAFDAC’s efforts and tenacity, and for that reason, we would
like to highlight NAFDAC during the conferences as a model for other countries in Africa which are trying to win
the battle against counterfeit drugs. Therefore, if it would be possible, we would be very appreciative if Dr.
Akunyili could speak and participate in both Dakar and Cape Town version of the conferences”.---------. (Micheal
B.Adlin, Ofice of Enforcement, U.S. Patent and Trademark office, P.O. Box 1450, Alexandria, VA 22313-1450)

4. Improved Output
From April 2001 to September 2005, the Agency carried out over ninety (90) destruction exercises of counterfeit
and substandard products valued at over N10.51 billion (US$75.07 million). This represents a 4,230.8% increase
in the value of products destroyed from 1994 to 1999 which was estimated to be about N204.12M (US$1.512
million).
The gradual upgrading of the Agency’s laboratories to international standards yielded fruits in the form of
international accreditation. Our pesticide residue laboratory, with the support of the IAEA, was upgraded to check
on residues of pesticides used in agricultural processes for raw materials intended for the food industry. On
February 8 2005, we commissioned an ultra modern mycotoxin laboratory to ensure that our food products meet
all sanitary and phytosanitary conditions. This will help improve the reputation of Nigeria as a reliable supplier of
good quality food product to the global market. Our seafood laboratories have European Union (EU) accreditation
for Fish and Shrimp Export, while the Central Vaccine Control Laboratory is recognized by the World Health
Organization (WHO) as the best in the West African Sub-Region. The Pesticide Residue, Pesticide Formulation,
and Mycotoxin Laboratories are affiliated with the International Atomic Energy Agency (IAEA) while the
Vitamin Analysis Laboratory is affiliated with the United Nations Children’s Fund (UNICEF).

THE JOURNEY SO FAR

The thrust of NAFDAC mandate is to safeguard the health of the nation and the only way to actualize this
mandate is to ensure that the people at the grassroot level are adequately covered.The new NAFDAC which was
born in April 2001 promptly established three (3) Special Zonal Offices to fight fake/counterfeit drugs and
unwholesome regulated products in Aba Abia State, Onitsha Anambra State and Kaduna, Kaduna State.

For effective control while positively touching the lives of Nigerians in a special way, the new NAFDAC ensured
that there is presence of NAFDAC in the remaining twelve (12) States not previously covered by NAFDAC
offices
The fight against fake/counterfeit regulated products, has produced rewarding results because the
awareness/enlightenment campaigns and enforcement activities embarked upon by NAFDAC is now touching on
the lives of all in the 36 states of the Federation and FCT Abuja without any exception.

Three special zonal offices established in the high incidence areas of distribution of faking/counterfeiting of
regulated products Onitsha, Aba, and Kaduna in addition to Lagos, have assisted NAFDAC in confiscating and
destroying fake drugs and other regulated products and destroying fake drugs and other regulated products worth
several billions of Naira.

As at now, all the offices of the Agency put together are fully operational for effective accessibility and enhance
efficiency. These office include:

• Corporate Headquarters, Abuja

• Lagos Administrative Office
• 37 Inspectorate Offices
• 3 Special Inspectorate Offices
• 6 Zonal Offices
• 5 Laboratories at Oshodi Lagos, Yaba Lagos, Kaduna and Maiduguri. The Laboratory in Port Harcourts is
currently being refurbished
• 3 Narcotics offices in Abeokuta, Lagos and Port Harcourt.

Most of our state and zonal offices had no sufficient furniture and equipment. The Agency embarked on
procurement of office furniture and equipment. To date, all our zonal and state offices are equipped with
computers and other communication accessories necessary for good data processing and record keeping. They are
also provided with appropriate vehicles for more effective monitoring and control of regulated products in their
zones and states.

In the same time, communication equipment was procured and installed for our enforcement unit. This has
enhanced the Agency’s activities. It is now easy for field officers to be in constant touch with one another.

Public Enlightenment Campaigns

• Workshop on Packaged Water, Fruit Juices and other Water-Based Drinks
• Workshops for Patent Medicines Dealers
 • Workshops for Drug Importers
• Workshop for National Union of Road Transport Owners and Workers
• Workshop for Licensed Clearing and Freight Forwarders
• Workshops for Herbal Medicine Practitioners of Nigeria
• Workshop for Cosmetics Manufacturers and Ethics Association of Nigeria.

In consonance with the Agency’s new beginning, a National Workshop on packaged water and water-based
drinks was flagged off in Lagos on 21st of June 2001. The target participants are the producers (whether
registered or aspiring to register) of packaged water, juices, yogurt and other water based drinks.

The objectives of the workshop are to inform and enlighten everyone about the health implications of drinking
contaminated water, educate the producers on proper methods for manufacture of good drinking water, to expose
the participant to the right type of equipment used in the production and packaging of water (some of which were
displayed and their functions explained during the course of the workshop), as well as to educate them on the
processes involved in registration and advertisement of their products with NAFDAC, so as to encourage the
producers to come forward and register their products. The workshop has been carried out in almost all the states
of the Federation and Abuja.

This workshop has revealed the ignorance of the vast majority of the manufacturers and the general public on the
health implications of producing packaged potable water without due process. The Agency has now exposed the
manufacturers to modern equipment for production, and has also simplified the registration process without
compromising quality. Other workshops held with various stakeholders dwelt on the dangers of fake drugs,
unwholesome regulated products and new guidelines for drug Importation and ban on unauthorized advert of
herbal medicines by the media and emphasis on registration of herbal preparations.

The Agency currently runs public enlightenment jingles cast in English Language in the network stations of NTA
and FRCN. Similarly, the vernacularversions of the jingles are also being aired in the Kaduna, Enugu and Ibadan
regional stations of FRCN. Plans are afoot to start a new Television and Radio weekly discussion programme.

Billboards have been erected in strategic parts of the country. Several posters and stickers warning against the
health hazards of fake drugs and other substandard products have also been produced and circulated nation-wide.
The Agency also publishes a Bi-annual NAFDAC NEWS magazine and consumers safety Bulletin.

Regular Publication of NAFDAC list of Identified

Fake Products
The insurgence of fake, adulterated and substandard regulated products gave the present leadership of the Agency
sleepless nights. Consequently an articulated and educative periodic publication of identified fake, adulterated and
substandard products was embarked on. This is towards creating a massive awareness that will eventually render
the distribution of such products ineffective.

These days, people scrutinize their medicines, food and other regulated products for genuiness expiry date and
even NAFDAC registration number, where applicable, before purchase and use.

In NAFDAC’s bid to rid the country of fake, adulterated, substandard and unwholesome processed foods, drugs
and other regulated products, manufacturers of NAFDAC regulated products and other stakeholders are
approached to assist in identifying the salient distinguishing features between their genuine products and fake
ones.

The manufacturers of regulated products are equally encouraged to bring to the attention of NAFDAC all
incidences of identified faking for investigation and publication. This is then referred to the enforcement
Directorate for necessary action. This helps to engender and sustain good working relationship between
NAFDAC and these stakeholders.

Importers and manufacturers of unregistered products are spurred by these publications to initiate registration of
their products due to the negative publicity and reduction in sales they get from the publication.

NAFDAC also engages in periodic publication of blacklisted companies, both local and international, who do not
conform to World Health Organization (WHO) certified Good Manufacturing Practice (GMP) or produces
substandard products, to warn importers and consumers so as to shun products from these companies. The list of
identified companies involved in the activity, in India and China, has been forwarded to the Honourable Minister
of Health for further directive.

Creation of Enforcement Directorate

The Task Force(s) on Counterfeit and Fake Drugs were established under Decree No. 17 of 1989, when it became
clear to government that the Food and Drugs Decree No. 35 of 1974 was not adequately addressing the
manufacture, importation and distribution of Fake and Counterfeit Drugs which reached crises stage by the mid
80’s. The Counterfeit and Fake Drugs Decree No. 17 of 1989 was therefore to serve as a deterrent to perpetrators
from importing, manufacturing and distributing or selling fake and counterfeit drugs.
In May 1999, Decree No. 17 of 1989 was repealed and replaced with Decree No. 25 of 1999 which retained most
of the provisions of the former Decree and, also has the inclusion of “Unwholesome processed Foods” and
provided for stiffer penalties including the forfeiture of products once such products have been found to violate
the provisions of the said Decree.

The overall responsibility for enforcing the provisions of this Decree including Decree No. 15 of 1993 which
established NAFDAC, the Drug and Related Products (Registration etc) Decree No. 19 of 1993 as amended, and
other relevant Decrees and Regulations rests on the Federal Task Force on Counterfeit and Fake Drugs, hitherto a
unit under the office of the Director – General.

In enforcing the provisions of these Decrees and Regulations, the Federal Task Force encountered widening and
increasing responsibilities such as:

• Coordinating the state Task Forces by the Federal Task Force as provided by the Law.
• Tracking down the increasing perverseness of spurious products fakers and importers.
• Coping with increasing sophistication of the criminals involved in faking products.

In order to address these problems squarely, the new management decided to create a new directorate to deal with
matters bordering on enforcement in all its ramifications.

In doing this, the new management derived its powers from section (8) paragraph (g) of Decree No. 15 of 1993
setting up the Agency. At present, the Directorate works with a detachment of police officers from Force CID
Alagbon, some officers from NDLEA as well as the normal duty officers of NAFDAC, all under a Director of
Enforcement.

Within the period of its existence, the Enforcement Directorate has been involved in so many enforcement
activities such as prosecution of manufacturers and importers of fake/counterfeit regulated products, destruction
of spurious products including the ones at Onitsha. This has justified the vision of the Director General and her
management team in setting up the Directorate.

Reconstitution of the Legal Unit of NAFDAC

A Legal Unit is a vital component of any corporate organization. The National Agency for Food and Drug
Administration and Control as a responsible and dynamic organization has shown enough responsiveness in not
only embracing this creed but also actualizing it as a corporate entity.It is pertinent to note that prior to the
reconstitution of the legal unit by the current management on 15th August, 2001, the unit was only a concept but
its deliberate efforts to reposition it (the Legal Unit) for effectiveness has started yielding the following dividends:

• Within the period under review, the unit reviewed various laws relevant to the operations and
effectiveness of the Agency. The draft bills have been forwarded to the appropriate government bodies for
necessary action.
• The Legal Unit spearheaded the promulgation of the National Agency for Food and Drug Administration
and Control Tariff Regulations 2001 and ensured its publication in the Federal Republic of Nigeria Extra
Ordinary Official Gazette No. 8 of Vol. 89 of 28 January, 2002.
• The Legal Unit has tremendously enriched the control and regulatory decisions of the Agency. This could
be seen in the outcome of consultative meetings.
• In the present democratic culture, the legal unit has guided the Agency out of legal minefield without
incurring liabilities in the hands of professional litigants and/or mischief-makers.
• The prosecution of violators of the Counterfeit and Fake Drugs and Unwholesome Processed Foods
(miscellaneous provisions) Decree No. 25 of 1999 has been revitalized by the legal unit with its attendant
signal to counterfeiters and merchants of death that the law is not a paper tiger.
• The Legal Unit has safeguarded the Agency’s interest in the conduct of searches of titles, vetting and
drafting of legal documents and handling of civil suits.
• Finally, the unit has evolved a strategy and provided a framework for the preparation and drafting of
regulations, which will provide the requisite legal cum technical details for the protection of the Agency.

Staff Welfare/Working Environment

The welfare of staff has been one of the Director-General’s top priorities, since she assumed duty. This she did in
several ways e.g.

• At the time she assumed duty, the morale of NAFDAC staff was very low. Her coming and meeting with
staff re-assured the workers.
• She actualized her promises by providing more conducive working environment. These include
generators, computers, air conditioners etc.
• Staff buses and utility vehicles were repaired, while new vehicles were purchased.
• Car re-furbishing loan has been resuscitated.
• Two clinics in addition to Government hospitals were approved.
• Harmonized the banking system to the advantage of staff. We now enjoy fast track bank services
anywhere in the country.
• Assistance is now being given to staff involved in functions such as burials, wedding etc
Advocacy meetings with Law Enforcement Organizations

Inspector-General of Police

The Director-General paid an advocacy visit to the Inspector-General of Police, soliciting his cooperation and
assistance in the following areas:

• Eradication of fake, adulterated, and substandard drugs in the country.

• Dismantling of open drug markets that have constituted a menace to public health.
• Crackdown on illegal premises of drug distribution.
• Eradication of illegal manufacturing outfits of foods, drugs, fruit juices, and cosmetics.
• Checking the growing number of unregistered packaged water products in the market.
• Checking the nefarious activities of importers of substandard regulated products.
• Furthermore, they agreed that the Police would provide NAFDAC with Policemen to assist in its
regulatory activities, especially in arresting, and prosecuting of offenders; as well as, protecting its
facilities.

Chairman, National Drug Law Enforcement Agency (NDLEA)

The Director-General paid a courtesy call and advocacy visit to the Chairman of NDLEA to find ways of working
together with the counter-narcotics body. The two sister Agencies agreed to collaborate in their operations.

• The NDLEA boss promised to provide:

• Security back-up for NAFDAC’s enforcement activities.
• Technical assistance in training of NAFDAC’s enforcement unit.
• Cooperation in information exchange.
• Use of NDLEA’s anti-drug facilities at the zones.

Comptroller-General of Customs

The Director-General also paid courtesy call to the Comptroller General of Customs and sought his assistance and
cooperation in checking the nefarious activities of importers of fake, adulterated and/or substandard regulated
products into the country. The Comptroller agreed to:

• Ensure that Customs Service Officers avail and/or present importation/shipping documents e.g. bill of
entry/lading, etc to NAFDAC inspectors to enable close examination, with a view to identifying those
containing regulated products for inspection.
 • Ensure that Customs Service Officers routinely invite NAFDAC inspectors for the joint examination of
regulated products, and to physically examine their contents and remove official samples intended for
laboratory analysis.
• Collaborate in ensuring that stop and seizure notices issued by NAFDAC inspectors for violating products
are honoured.

Honourable Minister of Aviation

The Director-General also held top level meeting with Hon. Minister of Aviation, Dr. Kema Chikwe, Managing
Director of Federal Airport Authority of Nigeria (FAAN) and Airline officials over the airlifting of fake drugs and
substandard regulated products by Ethiopian Airline, KLM and some courier companies.

A major fall out of the meeting was the new standing policy that any airline carrying fake regulated products will
be prosecuted by NAFDAC apart from having their aircrafts grounded. This is a practical approach towards
tackling the latest dimension of using airports as route for importing fake drugs into the country.

Review of NAFDAC operational guidelines

The Decree setting up NAFDAC mandated it to regulate and control the importation, exportation, manufacture,
advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, bottled water and chemicals.
This implies that any person wishing to engage in any of the above activities must require the Agency’s approval.
In order to actualize this mandate, the Agency developed guidelines for its operations.

The stakeholders viewed the guidelines, which are systematic instructions of the procedures, to be grossly
inadequate. The Director-General then set as one of her major agenda, the review of the guidelines of NAFDAC
operations.

A committee comprising of expert consultants and NAFDAC staff was set up, which not only reviewed the
existing guidelines but also prepared Standard Operating Procedures (SOP) for all the divisions of various
Directorates with special emphasis on Registration and Regulatory Affairs, Inspectorate, Laboratory Services and
Narcotics and Control Substances Directorates.

The guidelines cover:

• Registration of locally manufactured food, drugs, cosmetics, medical devices, water, detergent and
chemicals.
• Registration of imported food, drugs, cosmetics, medical devices, water, detergent and chemicals.
• Exportation of locally manufactured regulated products.
 • Importation of regulated products.
• Issuance of Narcotics and Controlled Substances permit.
• Registration of vaccines and biologicals, etc.

The new guidelines are quite comprehensive and will improve communication between the stakeholders and the
Agency while the SOP will reduce decision-making time in registration procedures thereby eliminating
unnecessary bottlenecks that existed in the past.
Return of NAFDAC to the Ports

In 1996, the Federal Military Government by its Port Reform Decree, banned some Government Agencies from
being in the ports. NAFDAC was affected by this decree, as the decree, provided that the Agency should perform
its statutory functions in the ports only on invitation by the Nigeria Customs Service.

The Agency had to depend solely on the discretion of the Nigerian Customs for inspection and release of
regulated products. This resulted in proliferation of fake and substandard regulated products as they moved freely
through the ports, unchecked by the Nation’s health authority.In recognition of the seriousness of this problem,
the Director – General NAFDAC of worked tirelessly towards convincing the government on the need for
NAFDAC not only to be returned to the ports but to also strengthen its port operations.

The return of NAFDAC has been achieved with the support of the President and Commander-in-Chief of the
Armed Forces Chief Olusegun Obasanjo (GCFR) who granted the approval after the courtesy call by the
Director-General of NAFDAC.The return of NAFDAC to the ports has resulted in several seizures of
consignments of fake and substandard products. Also a lot of unregistered regulated products have been
intercepted at the ports.

The Director-General of NAFDAC has also consulted with the Comptroller-General of Customs to seek the co-
operation of the Customs in the war against fake and substandard regulated product. This has also made a
significant contribution to the efforts of NAFDAC as more and more Custom Officers are becoming aware of
dangers of releasing regulated products without NAFDAC clearance.The Comptroller-General of Customs has
recently directed that any Customs officer who aids and abets the clearing of regulated products without
NAFDAC approval runs the risk of instant dismissal from service. Arising from NAFDAC return to the ports,
there has been increased surveillance and sanction activities which has led to several successful prosecutions of
erring companies and individuals.

Creation of Port Inspection Directorate

Following the approval granted to NAFDAC by Mr. President, Chief Olusegun Obasanjo (GCFR) to return to the
ports; and to ensure more effective control of regulated products coming into the country through our ports of
entry, the Agency using the provisions of section (8) paragraph (g) created Ports Inspection Directorate in June,
2002. The Directorate is in charge of all Seaports, Murtala Muhammed International Airport Lagos, Kano
Airport, Land border posts (Seme, Idiroko) in the country.

The functions of the Directorate are to:

• Control and Regulate the Importation of Food, Drugs, Cosmetics, Medical Devices, Chemicals and Bottle
Water.
• Undertake the inspection of regulated products at the ports.
• Compile guidelines for the importation and exportation of regulated products.
• Control the exportation and issue quality certificates of Food Drugs, Cosmetics, Medical Devices, Bottled
Water and Chemicals intended for export.

The Agency officials with the assistance of the Minister of Aviation, Dr. Mrs. Kema Chikwe in August, 2002
were issued with On Duty Cards (ODC) which gave them access to the Tarmac, baggage halls of the Murtala
Muhammed International Airport (MMIA), Lagos. Letters were sent to some airlines which were implicated in
the dumping of fake drugs and substandard regulated products in Nigeria to desist from this act or have their
planes grounded. Similar letters are to be forwarded to Shipping Agencies soon.

The return of the Agency to ports coupled with the access to the Tarmac, baggage Halls of MMIA has led to an
increase in the surveillance activities of the Directorate. The Directorate from time to time holds meetings with
representatives of Nigeria Ports Authority, Nigeria Customs Service, Clearing Agents, Freight Forwarders and
other relevant Government Agencies to solicit their co-operation in its war against the importation of fake,
substandard and unwholesome products.

Pre-approval inspections to assess overseas plants

Inspection and licensing of pharmaceutical manufacturing facilities on the basis of compliance with Good
Manufacturing Practice (GMP) standard is a vital component of drug control.The inspection activity is a process
of sequential examination of production and control activities on the basis of the GMP guidelines issued by
WHO.

A National Drug Control Authority is expected to inspect manufacturing and quality control facilities prior to
granting marketing authorization. This is to verify that production and quality control procedures employed in the
manufacture of regulated products are performed correctly in accordance with data supplied in the relevant
licensing applications.Prior to the inception of the present management, NAFDAC as a drug control authority, has
not been undertaking this important requirement for GMP assessment of oversea plants that export their products
to Nigeria.

The Director-General (NAFDAC) in realization of the health implications of this lapse, initiated the process of
oversea visits to assess plants. This is to ensure that marketing authorization is not granted to products produced
under unsatisfactory Good Manufacturing Practice (GMP).Currently, a number of factories have been inspected
in India, China, Germany, Netherlands, Italy, Indonesia, Malaysia etc. and the process is continuous.

Registration of regulated products

Arising from the deluge of complaints on the time frame for registration of regulated products which in the past
ranged from 7 months to 2 years, the DG (NAFDAC) set up a committee which considered the various stages in
processing registration of products. At the end of the exercise, a 2 months time frame was approved by the
management.

This decision has resulted in the 100% increase in the number of registered products as reflected in the table
below

The above representation shows that a total number of five thousand, seven hundred and thirty five (5,735)
products were registered by NAFDAC in seven years while three thousand six hundred and thirty (3,630)
products were registered just in a year and four months. The Agency will continue to strive to evolve new policies
that will ease the registration processes and procedures in order to reduce the difficulties experienced by
companies in this area.

Some Administrative Guidelines

• A factory must be WHO certified before they can export drugs to Nigeria.
• NAFDAC officials must inspect factories anywhere in the world before we register or renew registration
for their drugs, food, juices etc. This is at no cost to the importer.
• NAFDAC has appointed analysts in India who now certify any drug before it leaves the shores of India to
Nigeria.
• For imported products from all countries, India inclusive, NAFDAC now requires mandatory pre-
shipment information to be provided by all importers before the arrival of the products at our ports.
 • Renewal of registration of any drug or any other regulated product is done every five years. One of our
new guidelines is that if there is no evidence of commencement of product renewal three months after the
expiration of the product registration, the registration of the product will be automatically cancelled, and
when this is done, it will not be revisited for any reason.
• Importers must insist that their foreign partners affix NAFDAC registration number on the packaging of
their products to be imported into Nigeria.
• Confiscation and subsequent destruction of the drugs of any drug seller who fails to provide a proper
invoice of purchase with full name and address. This is to enable us trace the big time importers and
distributors.
• Faced by frustrations of evacuating many lorry loads of fake drugs on tip off without anybody accepting
ownership of the evacuated drugs, NAFDAC has notified the public that whenever the importer cannot be
traced, the landlord of the premises used for the storage of fake drugs will be arrested, with a view to
tracing the fake drug importer for necessary sanctions.

Some other actions taken to eradicate fake products, and to create a strong regulatory environment are as follows:

• Reorganization of the Agency for better effectiveness.

• We had to work hard for total reorientation of staff. This Cultural Revolution is paramount, in view of the
fact that for a regulatory Agency like NAFDAC, honest, dedicated and hardworking staff is more
important than sophisticated equipment.
• As earlier stated, NAFDAC has created two new Directorates; Ports Inspection and Enforcement
Directorates for more effective surveillance at all ports of entry and better enforcement activities
respectively. This has resulted in increased seizures of fake and counterfeit drugs at the ports, sealing of
supermarkets for sale of unregistered and expired items, sealing of food and drug manufacturing factories
whose GMP status were found to be unsatisfactory, and the closure of Ariaria drug market in Aba among
others.
• We have embarked on planned, systematic, continuous and sustained surveillance at all our entry points
and in all markets and shops as opposed to sporadic raids.
• Advocacy by the Agency resulting in better relationship and co-operation with International Agencies and
National Regulatory Authorities. e.g. NDLEA, Customs, Regulatory Authorities in India, China, etc.
• NAFDAC in recognition of long usage of herbal products by our people, and in line with WHO
recommendation of accepting herbal products based on
• long history of safe use in a locality, decided to use acute toxicity test as a safety parameter for herbal
preparations while reserving efficacy tests, detailed analysis and clinical trials for more complex products
 such as those claimed to be HIV/AIDS herbal preparations. We also recognize the positive effect of some
placebo on certain patients, this is why we emphasize more on quality and safety.
• To further enhance the effectiveness of these activities, NAFDAC undertook public enlightenment
activities for herbal medicines practitioners. Out of the multitude of herbal medicines in circulation, only
about 20 are registered, of which most are imported.
• The Agency has solicited the assistance of media practitioners in ensuring that only adverts with
NAFDAC Advert-Permit are carried by our print and electronic media.

PROBLEMS FACING NATIONAL AGENCY FOR FOOD AND

DRUG ADMINISTRATION AND CONTROL (NAFDAC)

Counterfeiting is a global problem. Many goods moving through international commerce are counterfeited.
Industry data show that 5-7% of world trade, valued at about US$280 billion is lost to counterfeiting. It is
estimated that about US$20 billion worth of products in the Information Technology (IT) sector move through
unauthorized channels annually. The pharmaceutical industry and the personal care products industry are also
riddled with counterfeits. Millions of dollars of counterfeit pharmaceuticals and personal care products are
reported to move through various authorized and unauthorized channels. These channels make it possible for
counterfeits, expired, repackaged and relabelled products to be shipped internationally.

Several criminal networks involved in drug faking and counterfeiting have evolved over the years. They include
manufacturers, importers, distributors and retailers. Other collaborators are inspection agents, shipping and
clearing agents and corrupt government officials of drug regulatory agencies, customs and police. Drug
counterfeiting was highlighted at the World Health Organization’s Conference of Experts on the Rational Use of
Drugs, held in Nairobi in 1985.At the World Health Assembly (WHA) in May 1988, a number of countries
expressed concern over counterfeit drugs that were circulating in their markets. The Assembly adopted resolution
WHA 41.16,12 which requested governments and pharmaceutical manufacturers to cooperate in the detection and
prevention of the increasing incidence of the export or smuggling of falsely labelled, spurious, counterfeited or
substandard pharmaceutical preparations.

The World Health Organization (WHO), since 1984, has been collaborating and collating data related to
counterfeit drugs. This has enabled the organization to develop a database on counterfeit drugs. The World Health
Organization received 771 reports of counterfeit drugs from different countries between 1984 and 1999. Twenty-
two percent of these reports came from industrialized countries, while the rest came from developing countries.13
Forty six confidential reports of counterfeit drugs were received by WHO from 20 countries from January 1999 to
October 2000. About 60% of these reports came from developing countries while the remaining 40% were
reported by developed countries.14 However, most of these reports, according to WHO, were not independently
verified and might not be useful for quantitative purposes. The data also shows that only a few countries were
willing to provide information about cases detected. This silence is one of the major driving forces for
counterfeiting.

Counterfeit pharmaceutical products were previously thought to be a substantial and increasing problem of low-
income countries, most of the time caused by weak administrative systems. At the global forum on
pharmaceutical anti-counterfeiting held in Geneva, in September 2002, many participants brought to light the
counterfeiting problems that existed in their various countries. There have been cases of court actions resulting
from patients treated with fake or counterfeit drugs in United States; the U.S. has one of the most regulated and
policed pharmaceutical markets. Counterfeit medicines had been detected through referrals from public and
professional bodies, whistle blowers and covert test purchases, according to a report presented by the Medical
Control Agency (MCA) of the United Kingdom. It is noteworthy that the types of counterfeit pharmaceuticals
found in the UK are similar to those found in other countries, include look-a-likes, identical copies, relabelled
products, expired authentic and rejected authentic products that found their way back to the markets. Some
examples of counterfeit pharmaceuticals found in the UK include Nubian (Nalbuphine HCl) injection, multi-dose
presentations not licensed in UK and Viagra (Sildenafil Citrate) with contents varying between 40-100% of claim

Reports from Russia showed that 12% of drugs in circulation are counterfeit and that there is a growing problem
of look-a-like drugs. This prsoblem could be attributed to a lack of enforcement of prescriptions and qualified
medical personnel to handle the healthcare environment. The distribution of drugs also poses a problem, as there
are about 40,000 small outlets and kiosks selling drugs. New pharmacies on wheels have also joined in this
business of distributing drugs and causing further chaos.

Interest in the problem of counterfeiting is relatively new for transitional economies, such as Ukraine. It is
estimated that the amount of counterfeit drugs found in some countries of the former USSR is up to 30%. In
Ukraine, this figure goes up to 40% and as high as 80% for certain pharmaceutical products. This is because there
is no control of import and distribution of pharmaceutical products despite a national legislation for the control of
the pharmaceutical market
Counterfeiting of drugs, especially anti-malaria drugs, has been in existence in Asia from as early as the
seventeenth century when cinchona bark from which quinine is derived was faked.19 A WHO report indicates
that counterfeit drugs are prevalent in Vietnam.20 Reports indicate that Asia is the centre of a complex global
network that manufactures and distribute fake medicines all over the world.
It is believed that in some extreme cases within Asia, companies may be producing legitimate goods at one end of
the factory and counterfeits at the other. Another WHO report indicated that India is responsible for about 35% of
the World’s fake drugs, which is worth US$200 million annually, representing 20% of the World’s total drugs
market. Recognizing the dangerous trend in spurious drug trade, the Indian Government established the
Mashelkar Committee which recommended stringent punitive system for spurious drug makers, including death
penalty for those who cause “grievous body harm or loss of life. Offences related to spurious drugs would also be
made cognizable and non-bailable.

Studies carried out on seven hundred samples by the Pharmaceutical Security Institute in the Philippines showed
that 7% of products marketed were definitely counterfeit.In Lebanon in 1982, factories around Beirut were
reported to be faking about 57 Western drugs due to the civil war and Israeli invasion. The Lebanese government
did nothing to stop these companies or alert the public of the problem. These drugs were still killing people long
after the guns had stopped.

It appears that drug piracy was officially allowed to thrive in countries, such as Lebanon and Thailand, since the
governments failed to address the counterfeiting problem in their countries. Even in Britain, with its wealth of
copyright and drug laws, this silence prevails. The official reason for the silence is that patients run greater risks if
the fear of fakes put them off taking the real product. However, a spokesman for the Association of the British
Pharmaceutical Industry (ABPI) was reported to have stated the real reason for the silence. “It is difficult to
declare a problem without damaging legitimate business. In other words, they believed there was more money to
be made by keeping silent."

In African countries, the incidence of fake and counterfeit drugs is difficult to estimate because of poor
communication, the non-existence or ineffectiveness of drug regulatory authorities, poor drug procurement
practices, low literacy levels, low awareness of the existence of fake and counterfeit drugs, political instability,
and high level of smuggling of pharmaceutical products in the region.
The Essential Drug Monitor (EDM) report on transforming drug supply in Dar es Salaam, Tanzania sums up the
picture in most African countries: “There was chronic shortage of drugs at health facilities, supplies were erratic
as was government funding, resulting in poor drug supply management and irrational use of drugs. Drug quality
was questionable and pharmacy premises were often unsuitable, hot, humid, and cluttered with piles of drugs,
some of which had expired. Pharmacists had low professional visibility.” This clearly mirrors the situation in
many African countries with the exception of a few countries such as South Africa, Nigeria, Ghana, Gambia and
Egypt, which have some level of systematic drug regulation and drug distribution. In a survey of 519 drugs in
three African countries between 1991 and 1993, 77 drugs (18%) were found to be substandard.
Within the West African sub-region, there are very high activities in inter-boundary trade on pharmaceuticals.
Many West African countries, such as Togo, Benin, Chad, Niger, Ghana and Cameroon buy their drugs from
Nigeria because Nigeria has the biggest drug market in the sub-region. In the Republic of Benin, for instance, this
inter-boundary trade is known as the “parallel market.” An EDM report quotes the Beninoise National Office of
Health Protection as estimating patronage of this parallel market to be around 85% of the population. These
counterfeit drugs were generally reported to come from Gabon, Nigeria, and from Asia, Europe and North
America. This market is often controlled by travelling sales persons who have no training and lack all necessary
skills to dispense drugs.28 In view of this trade on pharmaceutical products between Nigeria and other
neighbouring countries, the situation in Nigeria naturally reflects that of the other countries in the sub-region.
Even though the counterfeiting of pharmaceutical products is a global phenomenon, some countries, including
Nigeria, are more affected than others. Fake and counterfeit drugs were first noticed in Nigeria in 1968, when the
Crown Agents divested as the sole distributors of pharmaceuticals in Nigeria. The problem assumed greater
proportions during the import license era of the early 1980s and worsened with the adverse economic effects of
the Structural Adjustment Programme (SAP) introduced in mid 1980’s. The situation got progressively worse
with time until 2001 when NAFDAC started an aggressive war against fake drugs.

A 1989 study conducted by Denham Pole in Nigeria indicated that 25% of samples studied were fake, 25%
genuine and 50% inconclusive (See chart 1).A study conducted in Nigeria in 1990 by the former Deputy Director
General of WHO, Adeoye Lambo, for a pharmaceutical firm in Lagos showed that 54% of drugs in every major
pharmacy shop were fake, a figure that had risen to about 80% in the subsequent years.30 In another study of 581
samples of 27 different drugs from 35 pharmacies in Lagos and Abuja (Nigeria), 279 (48%) of the samples did
not comply with set pharmacopoeia limits and the proportion was uniform for the various types of drugs tested.

The first phase of the study in six major “drug markets” across the country by NAFDAC in 2002, to measure the
level of compliance to drug registration revealed that 67.95% were unregistered by the Agency. A repeat of this
study in 2003 revealed an 80% reduction. The second phase of the study to be conducted in collaboration with
WHO and DFID includes laboratory testing and further investigations of the surveyed drug products will reveal
the level of fake and substandard drugs in the country.

Counterfeit Drugs

The World Health Organization (WHO) defined counterfeit drugs as “medicine which is deliberately and
fraudulently mislabelled with respect to identity and/or source.” According to WHO, counterfeiting can apply to
“both branded and generic products and counterfeit products may include products with the correct ingredients or
with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake
packaging.”6 According to this definition, what makes a drug or medicine counterfeit is the deliberate or
intentional mislabeling of the product.
In 1992, the International Pharmaceutical Federation (FIP) jointly carried out a survey with the Commonwealth
Pharmaceutical Association on the incidence and control of counterfeit drugs. To ensure that all respondents
based their response on the same interpretation of counterfeit medicines, they defined counterfeit medicines as
medicinal products which have been deliberately or fraudulently mislabelled with respect to identity and/or
source. These included those products with the correct ingredients, wrong ingredients, no active ingredient, or
fake packaging. They excluded substandard products, which were correctly labeled.
The U. S. Federal Food, Drug and Cosmetic Act defines a counterfeit drug as “a drug which, or the containers or
labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or
any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons
who in fact manufactured, processed, packed, or distributed such drugs, and which, thereby, falsely purports or is
represented to be the product of, or to have been packed or distributed by, such other drug manufacturer,
processor, packer, or distributor.”
According to Pakistan’s Manual of Drug Laws, a counterfeit drug is “a drug, the label or outer packing of which
is an imitation of, resembles or so resembles as to be calculated to deceive, the label or outer packing of a drug
manufacturer.”

Substandard Drugs

Substandard drugs are genuine drug products which do not meet quality specifications set for them. The term
substandard is used to describe the quality status of genuine drugs produced by legitimate manufacturers.
Normally, manufacturers use specifications laid down by official Pharmacopoeias, such as British Pharmacopoeia
(BP), United States Pharmacopoeia (USP), and European Pharmacopoeia (EP) for each drug that they produce. If
a drug fails to meet the pharmacopoeia specifications used for its formulation, the drug is classified as
substandard.

Nigerian Definition
Individual countries are left to further specify what will constitute mislabeling, misbranding, faking, adulteration
or substandard, within the context of the interpretations of fake and counterfeit products in their laws and
regulations. The Nigerian definition combines the provisions of two decrees: The Counterfeit and Fake Drugs and
Unwholesome Processed Foods (Miscellaneous Provisions) Decree No. 25 of 19999 and Drugs and Related
Products (Registration, etc) Decree No. 19 of 1993.

Adulterated Drugs

A drug or drug product is regarded as adulterated if:

(a) The methods used in, or the facilities or controls used for its manufacture, processing, packing, or holding do
not conform to or are not operated or administered in conformity with current Good Manufacturing Practice
(GMP) to assure that such drugs meet the requirements of the Food and Drugs Act as to the safety, and has the
identity and strength, and meets the quality and purity characteristics which it purports or is represented to
possess.
(b) It purports to be or is represented as a drug, the name of which is recognized in an official compendium, has
its strength differing from, or its quality or purity falling below the standard set forth in such compendium.
(c) Consists in whole or in part any filthy, putrid or decomposed substance, or has been prepared, packaged or
stored under unsanitary conditions where it may have been contaminated with filth or whereby it may have been
rendered injurious to health, or is packed in a container which is composed in whole or in part of any injurious or
deleterious substance which may render the content injurious to health, or bears or contains for the purposes of
colouring any colour other than one which is prescribed, or contains any harmful or toxic substance which may
render it injurious to health, or has been mixed with some other substance so as to reduce its quality or strength.

Fake Drugs
A fake drug is defined as:
(a) any drug or drug product, which is not what it purports to be.
(b) any drug or drug product, which is so coloured, coated, powdered or polished that the damage is concealed, or
which is made to appear to be better or of greater therapeutic value than it really is, or which is not labeled in the
prescribed manner, or which label or container or anything accompanying the drug bears any statement, design or
device which makes a false claim for the drug or which is false or misleading.
(c) any drug or drug product whose container is so made, formed or filled as to be misleading.
(d) any drug or drug product whose label does not bear adequate directions for use and such adequate warning for
use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe
dosage or methods or duration of use; any drug or drug product, which is not registered by NAFDAC in
accordance with the provisions of the Food, Drugs and Related Products (Registration) Decree.

Unwholesome Food
Unwholesome processed food product is any food product which consists in whole or in part of any filthy, putrid
or decomposed substance or has been prepared, packaged or stored under unsanitary conditions where it may
have been contaminated with filth or whereby it may have been rendered injurious to health; or is packed in a
container composed in whole or in part of any injurious or deleterious substance which may render the content
injurious to health. Others are food products that bear or contains for the purposes of colouring any colour other
than one which is prescribed; or contains any harmful or toxic substance which may render it injurious to health
or has been mixed with some other substance so as to reduce its quality or strength.

Fake Drugs and Substandard Regulated Products as Identified by NAFDAC

NAFDAC has identified various forms of fake/counterfeit drugs and other unwholesome regulated products in
Nigeria. These include drugs with no active ingredient(s) or drugs containing only lactose or even chalk in tablets
or olive oil in capsules. Others are drugs with insufficient active ingredients such as Chloroquine tablets
containing 41mg of the active ingredient instead of 200mg, or 50mg of active ingredient in Ampicillin instead of
250mg. Others are drugs with active ingredient(s) that are different from what is stated on the package such as
Paracetamol tablets packaged and labeled as Fansidar (sulphadoxine and pyrimethamine combination).

There are also cloned drugs with the same quantity of active ingredients as the original drug. Cloning is hiding
behind a fast moving registered product to rake up profits without the associated liabilities and it is solely driven
by financial motives. Examples include Panadol by GSK containing 500mg of Paracetamol powder cloned by
some criminals to contain the same 500mg Paracetamol powder as the original. What these fraudsters fail to
understand is that minimal effective blood concentration, which determines the efficacy of the drug, is not only
dependent on the quantity of active ingredient, but also on the quality, excipients, and formulation techniques.
The big question, however, is: who takes responsibility when there are adverse effects of a cloned drug? Fast
moving cosmetics, food and drinks are also massively cloned.
Others are drugs without the full name and address of the manufacturer, expired drugs or drugs without expiry
dates, toxic herbal preparations mixed with orthodox medicine, and contaminated infusions and injectables. Other
forms of substandard/unwholesome products include syringes with poor calibrations or blunt to semi-blunt tips,
contaminated and/or pyrogenic syringes, needles, surgical blades, blood bags and infusion sets, non-sterile gloves,
sutures and condoms, expired products and those products without expiry dates or best before dates, or relabeled
with the intention of extending their shelf life, and contaminated chemicals.

Still others include food and drinks contaminated with bacteria, heavy metals, trace metals, radioactive materials,
and banned chemicals, or those containing unapproved sweeteners, colours, flavours and other additives, or others
with poor quality or internationally unacceptable packaging. There are also cosmetics containing harmful and
banned or restricted chemicals like hydroquinone (more than 2%), mercuric compounds and hexachlorophene,
packets and bottles of designer perfumes imported into Nigeria, and filled locally with diluted concentrates. Other
such products are alcoholic drinks without stated alcohol content, regulated product not registered by NAFDAC
and products marked, "for export only." NAFDAC has used every opportunity at its disposal to inform the
International community that products labeled “for export only,” for whatever reason, are totally unacceptable to
Nigerians. Drugs, food, or other regulated products that cannot be used in the country of manufacture should
never be imported into Nigeria.

FUTURE PLANS

In determining our future plans, we shall be guided by the need to consolidate on our present gains, remove
disabling constraints, improve our administrative and operational capacities, and explore new approaches and
ways to enhance our efficiency and effectiveness. To this end, we intend to embark on the development of a
functional and effective management information system to better coordinate the activities of the Agency.

We plan to establish mini laboratories at the designated ports of entry (Apapa, Calabar, Kano, and Lagos), for on-
the-spot detection of fake drugs and other substandard regulated products, and to reduce the delays inherent in
sending samples from the ports to the various laboratories. Thus, only products or raw materials that require
further testing would be delayed, while those that pass the on-the-spot quality check would be approved for
release into the country.
Other plans include the establishment of laboratory facilities in all the geopolitical zones of the country and their
continuous upgrade to international standards; we also plan to establish new specialized laboratories, such as a
Biochemical Laboratory, to enable the Agency to collaborate with the United Nations Office of Drugs and Crime.
We have plans to develop expertise in the detection of Genetically Modified Food (GMO foods), regulation of the
irradiation of food and expansion of facilities for detection and quantitation, bacteriological typing (such as
Listeria E. coli 0157), BSE (Mad Cow Disease) detection and control, Dioxins, and PCB detection, and Immuno
Assay Techniques.
It is proposed that NAFDAC’s laboratories will serve as reference laboratories in the West African sub region, in
collaboration with IAEA, WHO, FAO, and other relevant international organizations. Currently, a project has
been proposed to IAEA for collaboration in the area of quality assurance systems in NAFDAC’s laboratories that
will lead to the accreditation of NAFDAC’s laboratories.

Our plans also include computerization and streamlining of registration and other processes to further reduce the
turn-around time to the barest minimum. Specifically, we shall implement of SIAMED computer network
programme for drug registration by WHO; reduce unregistered products in circulation through enhanced
surveillance, monitoring and enforcement; and provide improved guidelines for effective regulation and control
of storage, distribution, sale and use of drugs, and other regulated products. To this end, we intend to develop
reliable databases for drug storage, distribution, sale and use.
We plan to complete the Networking of NAFDAC operations in the states, zones and headquarters to ensure a
free flow of timely information and access to databases on NAFDAC activities and operations. We shall establish
functional and state of the art data banks and documentation centre, and establish a self-funding food and drug
training institute, with the initial funding to be borne by NAFDAC. The institute would train NAFDAC staff,
State Government Inspectors, and Analysts. It could also serve as a training centre for all food and drug
regulatory agencies in West Africa.
We hope to strengthen our national and international collaboration with other regulatory and similar agencies for
enhanced effectiveness; expand NAFDAC operations to all the local government areas in the country for better
connection to the grass roots; establish NAFDAC offices in the port towns of Burutu, Koko and Bomadi and at
the land borders of Mfun in Cross River State and Jibiya in Katsina State; expand the Export section of the Ports
Inspection Directorate; provide additional office space and storage space for seized goods and equipment; and
sustain employee commitment and transparency through staff motivation and appropriate incentives, such as the
enhanced salary scale and welfare packages; and the hiring of additional staff in all directorates.

Other goals include:

• Strengthening of staff capacity building through training and re-training of staff in regulatory control and
management functions, in keeping with the high premium which the Agency places on its staff
development.
• Continuous update of NAFDAC laboratories.
• Provision of incinerators to prevent the problems encountered currently during destruction exercises, such
as scavenging, pollution of the environment and poorly managed dumpsites. We will need to acquire
incinerators for our destruction exercises, one each in Lagos, Enugu and Kano.
• Job rotation techniques whereby technical directorate staff will be reshuffled once every three or four
years to eliminate monotony on the job. This presents staff with new challenges, which is expected to
enhance productivity.
• Training in security and self-defense, which will expose the staff of the Enforcement Directorate to
security related courses. This will decrease their apparent vulnerability, and dependence on the police to
provide security for effectiveness in enforcement activities.
• Strengthening of effective post release surveillance activities to guarantee the sale of only genuine
registered regulated products in Nigeria.
• Review of the current Standard Operating Procedures (SOPs) to incorporate new ideas that would improve
communication between NAFDAC and its clients and amongst NAFDAC staff themselves.
• Strengthening of the Food and Drug Information Centres, and establishment of Zonal or State Centres.
• Development of tamper-proof security systems for the protection of NAFDAC’s regulatory instruments,
such as registration numbers, receipts, certificates, I.D. cards and permits. We are exploring various
product security options, including the use of Tamper Evident Holograms for regulated products.
• Extension of drug abuse seminars and enlightenment campaigns conducted in schools to work places, for
civil servants, local government staff and factory workers.
• Harmonization of the control of chemicals with other agencies, such as the Federal Ministry of
Environment and the Federal Ministry of Agriculture.
• Effective monitoring of importation, distribution, storage, sale and utilization of narcotics, psychotropic
and precursor chemical and solvents nationwide.Change of the format of narcotics authorization and
clearance so as to replace the existing obsolete system.

 Provision of a list of all chemical marketers nationwide, including their products and locations.
 Sustainance of NAFDAC enlightenment campaigns at secondary schools.
 Ensuring the enactment and amendment of various draft bills forwarded to the National Assembly in the
shortest possible time.

 Inclusion of members of the Legal unit in the Codex Alimentarius and World Trade Organization.
Our dream is the reduction of fake drugs and counterfeit products to the barest minimum. Our ultimate goal is
to eradicate fake drugs and other substandard regulated products from Nigeria and for NAFDAC to be a
model regulatory Agency in Africa. To this end, we shall continue to consolidate our present strategies, which
have proved very effective. We also intend to follow and keep pace with the global dynamics in drugs and
other regulated products’ regulation and control. We will continue to involve our stakeholders and consumers
in the formulation of our future strategies. We are determined to borrow the best practices from around the
world and to combine them with our own ideas in order to fashion out the most suitable regulatory system in
 Nigeria for Nigerians. We hope to realize our goals in such a manner that would make our slogan,
“NAFDAC; Safeguarding the Health of the Nation,” ring true.

Conclusion
The achievements of the Agency under the dynamic leadership of Dr. (Mrs.) Dora N. Akunyili (OFR) and the
successor Dr Paul Botwev Orhii during the period under review are outstanding and encouraging.

NAFDAC is now a household name as her aggressive crusade against fake and counterfeit drugs and
unwholesome processed food has reached the grassroots through the creation of awareness and enlightenment
programmes.The populace now scrutinize regulated products for the manufacture and expiry dates and NAFDAC
registration number. Importers and manufacturers of regulated products are now aware of the need to have their
products registered before distribution.

This new desire for registration of products is as a result of motivation arising from considerable reduction in the
registration period. Exporters of regulated products are also taking advantage of the conducive atmosphere now
prevailing at NAFDAC.With sustained tempo of the present activities embarked upon by the Director-General the
incidence of faking and counterfeiting of regulated products would be reduced to the barest minimum and
gradually eradicated.

Structure
The agency was set up as a parastatal under the control of the defunct twelve- member Government Council
which was formally inaugurated on 31st December, 1992 by the then Minister of Health, Professor Olikoye
Ransome Kuti. The then council had its chairman, a highly experienced Retired Public Officer and Diplomat in
the person of Ambassador Tanimu Saulawa. When the council was in place, activities of the Agency were
overseen through its three main committees namely:

• Financial and General Purpose Committee

• Establishment and Disciplinary Committee
• Technical, Research and Consultancy Committee

Directorates
• Administration & Finance
• Planning, Research & Statistics
• Narcotics & Controlled Substances
• Regulatory & Registration
• Inspectorate
 • Laboratory Services
• Enforcement
• Ports Inspection
Units
Legal Unit - The unit proffers legal advice on issues of law arising from Employee-Employer relationship and is
the custodian of legal documents and all agreements relating to the Agency. Its functions include the following:

• Ensuring that the rights and interest of the Agency are well protected under the various legal documents
that bind it;
• Drafting regulations, agreements and rendering legal opinions to the Director General. NAFDAC and the
various Directorate.
• Facilities Prosecution of offenders at the Tribunals and Courts.

Public Relations Unit - The Public Relations Unit under the Director Generals office has the primary
responsibility of informing, sensitizing, enlightening and creating awareness on the role of the Agency. In
carrying out these functions the PR unit employed the services of mass media and the information channels of
communication as effective tools in the discharge of its duties.

The unit is solely responsible for the publication, of a Quarterly News Magazine and other publications
Information Brochure and Handbills of the Agency. It also co-ordinates the Information, Education and
Communication (I.E.C) programs of the Agency in the Televisions and Radios as well as other enlightenment,
campaigns. In active collaboration with the Planning Research and Statistics Directorate, the Unit also facilitates
NAFDAC's participation at several international and domestic Trade Fairs and Exhibition.

Internal Audit - Fundamental functions of Internal audit are as follows:

• Provides a means of measuring the effectiveness of the system of internal control and accounting.
• Tests on the accounting purpose of ensuring that they provide reliable basis for the preparation of the
Agency's financial statements.
• Draws attention of top management to areas of inefficiencies, deficiencies and all departures from
established procedures.
• Making of appropriate recommendations for improvements in the bookkeeping and accounting system of
the Agency.
• Carrying out special investigations.
REFERENCE

• http://www.nafdac.gov.ng/index.php?option=com_content&view=article&id=74&Itemid=114
• http://www.nafdacnigeria.org/about.html
• http://en.wikipedia.org/wiki/National_Agency_for_Food_and_Drug_Administration_and_Control
• http://www.suite101.com/content/nafdac-in-nigeria---registration-of-products-a299712
• http://www.nafdac.gov.ng/
• http://www.nafdacnigeria.org/journey.html
• http://www.nafdacnigeria.org/globaltrends.htm
• http://www.nafdacnigeria.org/gains.html

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