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.

1. 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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