United Nations Public Service Awards Case Studies

Prior to the assumption of office by Prof. Dora Akunyili as Director General of NAFDAC in April 2001, Nigeria was faced with the challenge of revitalizing a failed food and drug regulatory environment of about three decades, which resulted in a crises situation characterized by massive copying of original brands of most regulated products. Various forms of fake drugs, unwholesome food, substandard cosmetics, chemicals and related products were dumped in Nigeria. For example;

• There was high prevalence of expired products, products without expiry or best before date, or those re-labeled with the intention of extending their shelf-life.
• Improperly processed and unregistered packaged water popularly called “pure water”.
• Deceptively labeled juices became the fashion. Examples of such labeling include: 100% fruit juice, no sugar added, no added sweetener, no preservative; yet, juices from fruits that are not naturally very sweet such as orange and guava were as sweet as honey. These juices were actually regarded as classic drinks.
• Non-iodized salt and high rate of goiter.
• Over 95% of Nigerian bakers continued to use potassium bromate as a bread enhancer despite its being banned since the early 90s, for its implication in cancer, kidney failure, loss of hearing and breakdown of vitamins.
• Body creams containing bleaching agents like mercury, hydroquinone etc. which damage the skin and other organs, especially the kidney.

However, the counterfeiting of pharmaceutical products presented a greater problem with far reaching public health consequences.

• The average incidence of counterfeit medicines in Nigeria was over 41% from various studies done before 2001.
- Poole (1989) reported that 25% of drug samples studied were fake, 25%
genuine and 50% inconclusive.
– Adeoye Lambo (1990) reported that 54% of drugs in Lagos were fake and that the figure would rise to 80% the following year.
– Ochekpe et al (1993) reported a failure rate of 41.4% out of 379 drugs tested for percentage content of active ingredients in reference to British Pharmacopoeia (BP) 1988 specifications.5
– Taylor et al (2001) reported that 48% of drugs tested were substandard.6

• NAFDAC’s study in 2002 showed that 68% of drugs in Nigeria were unregistered.
• Almost all drugs have been counterfeited, and counterfeiters target cost and volume.
• Antimalarials, antibiotics and vitamins are among the most used drugs in Nigeria. Out of the three, antimalarials as a group had the least proportion of products with standard active ingredients.

This situation adversely affected all classes of the Nigerian society.

What is the initiative about? (the solution)
This initiative put in place by Prof. Dora Akunyili has helped in revitalizing the food, drugs, cosmetics and other regulated products industries in Nigeria. A base line survey sponsored by the WHO and DFID revealed that counterfeit drugs in circulation have dropped from an average of over 41% in 2001 to 16.7% in 2006 and drugs unregistered by NAFDAC stand at 19% in 2006 as against 68% recorded in 2001. There is immense public awareness which has resulted in the participation of all stakeholders – Manufacturers Association of Nigeria (MAN), Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria (PMGMAN), Pharmacists Council of Nigeria (PCN), Medical and Dental Council of Nigeria (MDCN), Standards Organization of Nigeria (SON), the Nigerian Customs Services, etc - in the regulatory processes, and this has awakened international consciousness that Nigeria is no longer a dumping ground for fake products. Furthermore, there has been an increase in the production capacities of our local pharmaceutical industries and their number has risen from 70 to 150 in the last 6 years. They can now produce over 40% of our local drug need as against less than 25% in 2001. Share prices of the pharmaceutical companies quoted in the Nigerian Stock Exchange have witnessed a tremendous rise in the past few years and many multinational pharmaceutical companies are coming back to Nigeria as a result of the improved regulatory environment. Ban on ‘made-in-Nigeria’ drugs has been lifted by other West African countries. In fact there is so much confidence in ‘made-in-Nigeria’ drugs that our drugs are now marketed in many African countries. For instance, NAFDAC officials intercepted drugs made in India but labeled ‘made-in-Nigeria’. In the last 6 years, NAFDAC has carried out 115 destruction exercises of counterfeit and substandard products valued at over 20 Billion naira. Old food and cosmetics industries are expanding their production capacities while new ones are springing up. NAFDAC has sanitization packaged water production and this is seen from the decreasing cases of cholera and other water-borne disease outbreaks, which used to be rampant in the country. NAFDAC monitors salt iodization, and UNICEF rated Nigeria as the first country in Africa to achieve universal salt iodization. NAFDAC is currently working to achieve the same feat with vitamin A fortification. The use of bromate by Nigerian bakers has dropped from over 95% in 2001 to less than 0.01% as reported in various surveys in 2006. The generality of the Nigerian people have benefited immensely from this initiative. It has created a reasonably well regulated environment that have saved the lives of millions of Nigerians, and indeed millions of Africans and boosted our economy by encouraging local industries and foreign investors

Who proposed the solution, who implemented it and who were the stakeholders?
The solutions to the drugs and other regulated products counterfeiting in Nigeria was proposed by Prof. Dora N. Akunyili. Through her inspirational and exceptional leadership style, the solution was implemented by the dedicated and hardworking NAFDAC staff with the support of various stakeholders which include the good people of Nigeria, the ever vibrant Nigerian Press, the Federal Ministry of Health (Supervising Ministry), the Nigerian Customs Services, Export Promotion Council, Federal Ministry of Agriculture, Manufacturers Association of Nigeria (MAN), Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria (PMGMAN), Pharmacists Council of Nigeria (PCN), Medical and Dental Council of Nigeria (MDCN), Standards Organization of Nigeria (SON), Association of Food, Beverages and Tobacco Employers (AFBTE), Safe Water for Africa Foundation, Society for Family Health, Action Aid, Family Health International, Partnership for Transforming Health Systems (PATHS), UNICEF, WHO, DFID, Crown Agents, etc. These have all contributed immensely to the success of NAFDAC.

Describe how and when the initiative was implemented by answering these questions
a. What were the strategies used to implement the initiative? In no more than 500 words, provide a summary of the main objectives and strategies of the initiative, how they were established and by whom.
The main objective of the initiative put in place by Prof. Dora Akunyili is to reduce the incidence of fake drugs and other substandard and unwholesome regulated products to the barest minimum in Nigeria within the shortest possible time frame. The strategies employed include;  Staff Re-Orientation, Reorganization and Motivation • We embarked on staff training and re-training, locally and internationally. • Various welfare packages including thirteenth month salary was initiated and is being sustained. • Corruption is severely sanctioned through outright dismissal.  Restructuring And Modernizing The Regulatory Processes NAFDAC was reorganized into eight functional Directorates as against the previous six. New State Offices were established to cover the thirty-six States of Nigeria and the Federal Capital Territory, Abuja. Six Zonal Offices and four special inspectorate offices were also established in towns with big drug markets. Five old laboratories were upgraded, three new ones are almost completed while warehouses and land border offices were also constructed.  Public Enlightenment Campaigns Enlightenment campaign remains one of our most effective strategies in combating product counterfeiting and creating effective regulation. This involves dialogue, education and persuasion because it addresses the fundamental issue of BEHAVIOURAL CHANGE. These campaigns are sustained by using: - Print and electronic media, jingles, alert notices, billboards and publication of the differences between identified fake and genuine products. - Mobilization campaigns for rural dwellers are on-going. - In 2002, NAFDAC instituted an annual essay competition for Nigerian High School and also established Consumer Safety Clubs in these schools. - In May 2007, NAFDAC Green Pages, a comprehensive multi-media publication that contains particulars of all NAFDAC registered products was launched.  Beefing Up Of Surveillance At All Ports Of Entry  Stopping the Importation of Fake Drugs and Other Substandard Regulated Products to Nigeria at Source i.e. Countries of Production  Mopping Up Fake Drugs and Other Substandard Regulated Products Already In Circulation  Regular GMP Monitoring Of Local Manufacturers  Streamlining And Strict Enforcement Of Our Registration Guidelines

b. What were the key development and implementation steps and the chronology? No more than 500 words
OTHER INTERVENTIONS • Enforcing and monitoring sale prescription drugs strictly on prescription. • NAFDAC established a National Pharmacovigilance Centre in September 2004 and got admitted as the 74th member of the WHO Drug Safety Monitoring Programme. • In 2002, NAFDAC proposed the establishment of an international convention on counterfeiting of pharmaceuticals at the International Conference of Drug Regulatory Authorities (ICDRA) meeting in Hong Kong. At the WHO - sponsored meeting on drug counterfeiting in Rome in February 2006, the International Medicine Products Anti-counterfeiting Taskforce (IMPACT) was proposed, and subsequently established. • NAFDAC initiated and is currently heading the West African Drug Regulatory Authorities Network (WADRAN) which is a forum where heads of drug regulatory authorities in West Africa can share strategies and experiences and carry one another along in the fight against drug counterfeiters. • NAFDAC will commence the use of specialized hologram to safeguard NAFDAC registration numbers on registered products to prevent counterfeiters from copying and faking NAFDAC numbers.

c. What were the main obstacles encountered? How were they overcome? No more than 500 words
In this fight for life, NAFDAC was faced by many challenges. These include; • Corruption and Conflict of Interest/Insecure and Unfriendly Environment  Counterfeiters deposited fetish objects in Prof. Akunyili’s office. These included blood stained feathers, African beads and a tortoise.  In August 2001, 6 armed men invaded her residence at Abuja from 8pm to 10pm, searched for her and did not steal a pin. Fortunately, she was out of town.  In August 2002, NAFDAC laboratory in Lagos was vandalized and most of the sensitive equipment were destroyed.  Some time in 2003, her son narrowly escaped being kidnapped, and was only released when he swore that she was not his mother but his aunt.  On December 26, 2003 an assassination attempt was made on her life. During this near-death encounter, bullets shattered the back windscreen of her car, pierced through her head scarf and burnt her scalp. A bus driver was killed on the spot.  Three months later, between 7th and 11th March 2004, there was a synchronized burning of NAFDAC’s facilities across the country.  In 2004, irate drug hawkers beat up NAFDAC officers in Gombe State and destroyed the Agency’s car.  In June 2006, NAFDAC officers were attacked and driven out of Onitsha drug market along with the 12 policemen that accompanied them for the screening operation. Their 6 vehicles were also destroyed.  On June 13th 2007, NAFDAC staff working with ten armed policemen were beaten up when they went to evacuate counterfeit products in Kano market and one staff sustained fractures in one leg. NAFDAC vehicles were vandalized. It took the stationing of an armored tank and over two hundred policemen at the NAFDAC office in Kano to contain the angry mob and save the lives of our officers. NAFDAC has also recorded twenty other documented attacks against their staff and facilities in different parts of the country. Realizing how desperate the drug counterfeiters are to terminate my life, the Nigerian government has ensured that I am always guarded by at least 8 armed policemen wherever I go. Policemen also guard NAFDAC officials and facilities in all the 36 states of Nigeria. • Lack of Awareness Product counterfeiters succeeded for about three decades in Nigeria largely because of lack of awareness which was worsened by the culture of silence that enshrouds the issue of drug and other regulated products counterfeiting. People died inexplicably after the right diagnosis and correct medication were given without being able to link the deaths to fake drugs. This was tackled using the massive public enlightenment campaign. • Discriminatory Regulation by Exporting Countries • Sophistication in Copying Technology • False Declaration By Importers • Inadequate Legislation - Weak laws are further hampered by abuse of judicial process and granting of inordinate injunctions to counterfeiters, long delays of trials and other handicaps • Chaotic Drug Distribution System • Poor Database on Health Related Activities

d. What resources were used for the initiative and what were its key benefits? In no more than 500 words, specify what were the financial, technical and human resources’ costs associated with this initiative. Describe how resources were mobilized
The major resources used in this initiative are human and financial resources. On assumption of office, Prof. Dora Akunyili engaged the staff in various consultative and interactive meetings and held management retreat for the management staff. These were to identify human capacity as well as functional and other deficiencies and need for the Agency. Human resources include adequately qualified and competent staff employed in the Agency to carry out its functions. There are just above one thousand staff in NAFDAC and there is huge human resource development such staff training and capacity building using both local and international expertise organized for the staff. With technical support from various international organizations and development partners, NAFDAC staff have received continuous training programs to develop and improve their skill and competence in their various activities. Huge Financial resources have been expended in implementing this initiative. These include in the areas of building and upgrading NAFDAC laboratories, acquisition of a befitting administrative headquarters for the Agency, improving staff welfare package, establishing new state and zonal offices, provision of uninterrupted supply of laboratory chemicals and reagents for NAFDAC laboratories, staff training and capacity building, provision of modern office equipment, etc. The financial resources are soured from Government and internally generated funds. Both resources have been crucial to the success of this initiative.

Is the initiative sustainable and transferable?
Yes this initiative is sustainable and indeed transferable. The strategic implementation of this initiative has been holistic and separate from Prof. Dora Akunyili who proposed it. Through her exemplary leadership, the culture of change, accountability transparency and progress has been instilled in every staff and therefore the initiative will stand the test of time even in the absence of Prof. Akunyili. She has continuously shared her experience with various government agencies, corporate organizations and international groups so as to provide ample opportunity for replication of this initiative in these organizations as applicable. Internationally, she has proposed and continuously advocated for the establishment of an international convention on counterfeit drugs, just as it is for narcotics and psychotropic substances. In 2006, WHO proposed the International Medicine Products Anti-counterfeiting Taskforce (IMPACT), which was subsequently established to formulate and execute strategies for international collaboration. She is currently a vice chair in IMPACT. Furthermore, she initiated and is currently heading the West African Drug Regulatory Authorities Network (WADRAN) which is a forum where heads of drug regulatory authorities in West Africa can share strategies and experiences and carry one another along in the fight against drug counterfeiters. Through these avenues, African and the International community at large will be able to replicate the initiative in their countries.

What are the impact of your initiative and the lessons learned?
Several lessons can be leaned from Prof. Dora Akunyili and this initiative in NAFDAC and Nigeria as a whole. Notably among these is that irrespective of the state of decay in a system, it can be revitalized. All regulatory anomalies prior to 2001 are offsprings of corruption, moral/ethical decadence and absence of sound values in the system and the society at large. The turn around experienced in NAFDAC underscores the role of commitment and effective leadership in revitalizing an ailing system.


Institution Name:		National Agency for Food and Drug Administration and Control
Institution Type:		Government Agency
Contact Person:		DORA NKEM AKUNYILI
Title:		DIRECTOR GENERAL
Telephone/ Fax:		+2348034700560
Institution's / Project's Website:		+23495241461
E-mail:		dnakunyili@yahoo.com
Address:		PLOT 2032 OLUSEGUN OBASANJO, WAY, ZONE 7, WUSE, ABUJA
Postal Code:		234001
City:		ABUJA
State/Province:		ABUJA
Country:		Nigeria

The Problem

Solution and Key Benefits

Actors and Stakeholders

(a) Strategies

(b) Implementation

(c) Overcoming Obstacles

(d) Use of Resources

Sustainability and Transferability

Lessons Learned

Contact Information