The War Against Counterfeit Medicne
Publication Year: 2012
Published by: African Books Collective
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Title Page, Copyright Page
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There is a general agreement that piracy; counterfeiting and passing off are unfair. However, there is often surreptitious – or even open – sympathy for, say, those who purchase counterfeit designer fashions or the latest technical gadgets. The pirate is sometimes represented as a dared evil hero who, like the historical pirate on the high seas, provides a kind of rough justice. In her book, as in her life, however, Prof. Dora Nkem Akunyili takes on a field in which the damage ...
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I decided to write this book entitled: The War Against Counterfeit Medicine: My Story , to chronicle my experiences as the Director General (DG) of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), between April 2001 and December 2008. I feel a compelling need to write this book for two reasons. Firstly, to document what my team and I did in over seven and a half years in the fight to protect the public from the fatal consequences ...
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My gratitude goes to Chief Olusegun Obasanjo, former President of the Federal Republic of Nigeria, who gave me the opportunity to serve as the Director General of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), despite stiff opposition from the political class. His support in this fight for life is immeasurable. ...
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Figures and Tables
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As a child, I never thought of studying pharmacy. In the early 1970s in Nigeria, medicine and law were popular career choices for young people aspiring to enter a university for higher education. It was the vogue for students with excellent West African School Certificate (WASC) results in the sciences to study medicine. As a science major, my first choice was medicine, and that was what my family desired for me. I performed very well in the WASC examination and passed with ...
PART I - HISTORICAL BACKGROUND OF FOOD AND DRUG REGULATION
CHAPTER 1 - EVOLUTION OF DRUG PRODUCTION AND SALE IN NIGERIA
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The development of pharmaceuticals in Nigeria has undergone significant evolution, from the concoctions infused from cocktails of leaves, fruits, barks and roots, to conventional Western medicine. Traditional remedies are still widely used, especially by the poor. The pharmaceutical industry in Nigeria has passed through a tortuous path: from the rudimentary era of pre-1957; through the foundation–laying era of the 1960s and the oil ...
CHAPTER 2 - EVOLUTION OF FOOD AND DRUG REGULATION IN NIGERIA
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Throughout history, society has been concerned with the quality of drugs, food and other health sensitive products. This prompted several societies to undertake some kind of regulation for the production and use of such products. For instance, in ancient Egypt, during the first century BC, physicians were required to administer their drugs in accordance with written laws. If they failed to do so in any respect and the patient died, they were tried ...
CHAPTER 3 -NAFDAC MANDATE, STRUCTURE, FUNCTIONS, LAWS AND REGULATIONS
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NAFDAC is a parastatal under the Federal Ministry of Health. It was established by Decree No. 15 of 1993, to regulate and control the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, medical devices, cosmetics, detergents, chemicals and all packaged drinks. NAFDAC, therefore, has a statutory responsibility to ensure the quality, safety and efficacy of these items, collectively referred ...
CHAPTER 4 -DEFINITIONS: FAKE / COUNTERFEIT / ADULTERATED / SUBSTANDARD DRUGS, UNWHOLESOME FOOD AND OTHER SUBSTANDARD REGULATED PRODUCTS
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Despite the global nature of fake and counterfeit drugs, the international community has not given the problem the attention it deserves, as evidenced by it not having a harmonised definition. Consequently, various countries and organisations have different definitions, according to their perception of the problem. The absence of a universally accepted definition not only makes information exchange between countries difficult, but also limits the ability ...
CHAPTER 5 - GLOBAL TRENDS IN DRUG COUNTERFEITING
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Counterfeiting of all products poses a great danger to every society. Almost all brands of commodities traded in international commerce are counterfeited. In most cases, it involves perfect copying of the original product. Some commonly known counterfeits are currencies, designer wristwatches, bags, perfumes, clothes, jewellery, pirated books and other stationery, audiocassettes, CDs, disks, diskettes, tyres, batteries and electrical products. These types ...
PART II - THE NAFDAC I MET
CHAPTER 6 - NAFDAC BEFORE APRIL 2001
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When I assumed office in April 2001, I was faced with the arduous task of reactivating a food and drug regulatory environment which had failed for over three decades, resulting in a crisis situation characterised by massive copying of original brands of drugs and other regulated products. Every part of the organisation was dysfunctional, from the staff to the NAFDAC had qualified but poorly trained personnel, overwhelmed by the enormous task ...
PART III - THE WAR AND THE STRATEGIES
CHAPTER 7 - DECLARING THE WAR
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I received my letter of appointment as Director General of NAFDAC on April 11, 2001, and assumed office the following day. I asked Dr Dere Awosika, the then CEO of the National Programme on Immunisation (NPI), to accompany me to NAFDAC office in Abuja, to give me the much needed support. Before we left her office, I hurriedly drafted my first address to the management staff of the agency. My heart skipped a beat when I first saw the ...
CHAPTER 8 - STRATEGY I: RESTRUCTURING AND REORGANISING NAFDAC
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Having been pressured into starting the public enlightenment campaigns, we quickly developed other strategies to support the fight. One strategy led to another. Staff reorientation and motivation were key, and the directorates needed to be restructured. We also needed to develop Standard Operating Procedures (SOPs) and Operational Guidelines. The existing offices and the old laboratories needed to be upgraded, while new ones needed to be built. ...
CHAPTER 9 - STRATEGY II: OPERATIONAL STRATEGIES
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The Agency identified poor monitoring and enforcement as the weakest links in the chain of our regulatory activities. To address these problems, the management evolved new operational strategies to eradicate counterfeit medicines and other substandard regulated products, and create a strong regulatory environment. The strategies include developing new regulations, reviewing tariffs, developing guidelines and standard operating procedures, ...
CHAPTER 10 - STRATEGY III: ENGAGING STAKEHOLDERS
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Quite early on the job, I saw the need to take my message to the public, following the success we achieved with the pure water enlightenment campaign. It was clear to me that this strategy would help us sensitise the public to the high incidence of counterfeit medicines and engage the various stakeholders in frank and open discussions on the magnitude of the problem of counterfeit medicines and other substandard regulated products, with a view to ...
CHAPTER 11 - STRATEGY IV: WALKING THE ROUGH ROAD OF DISCIPLINE
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In 2002, Chief Afe Babalola, a Senior Advocate of Nigeria (SAN) stated: “Until recently, all sorts of food, drugs and other products were imported into the country from all parts of the world, with little or no control and without due payment of the customs’ duties. Serious monitoring in the real sense of it was virtually non-existent. ...
CHAPTER 12 - SPECIAL CASES
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NAFDAC received reports of frequent violations of our laws from different parts of the country. After investigations that usually follow such reports, the Enforcement Directorate and the Legal Division would work together to prosecute the offenders where applicable. In most cases, fines are imposed, but in the case of fake medicines, they are destroyed. We handled violations impartially, irrespective of persons and/or organisations involved in the ...
CHAPTER 13 - FACTORS MILITATING AGAINST EFFECTIVE FOOD AND DRUG REGULATION
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In our fight to safeguard public health in Nigeria, we encountered many challenges, but we were undeterred in our determination to rid Nigeria of the menace of counterfeit medicines and other substandard regulated products. The factors militating against effective food and dr ug regulation include corruption and conflict of interest, insecure and unfriendly environment, inadequate legislation, sophistication in copying technology, smuggling and ...
CHAPTER 14 - INSTITUTIONALISING THE CHANGE
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When the new management came on board, the food and drug regulatory environment in Nigeria was characterised by total chaos and confusion. There were no procedures and guidelines for the performance of our duties, decisions were subjective, and members of staff did not have a clear-cut understanding of their roles. These lapses and inefficiencies bred corruption and ineptitude in the organisation. In order to build a vibrant and sustainable ...
CHAPTER 15 - FOCUSING ON FOOD
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Ensuring the safety and quality of food products in Nigeria is one of the key responsibilities of NAFDAC. The Agency works towards the fulfillment of this mandate through the regulation and control of local production, importation, exportation, manufacture, storage, advertisement and distribution of food products. Ensuring national food safety for a country as vast in land mass (924,000km2) and population (150 million people) as Nigeria is a ...
PART IV - ACHIEVEMENTS, SUPPORT AND RECOGNITIONS
CHAPTER 16 - GAINS AND ACHIEVEMENTS
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Transparency in our regulatory processes enhanced our communication with stakeholders, thereby making them comply with NAFDAC regulations and guidelines. This helped us win public trust and confidence. It also contributed to the international credibility of the Agency, resulting in NAFDAC being chosen by several international organisations as the executing agency for their projects in Nigeria, the latest of which is the Global Alliance for Improved ...
CHAPTER 17 - SUPPORT, APPRECIATIONS AND RECOGNITIONS FROM THE NIGERIAN GOVERNMENT, NIGERIANS AND THE INTERNATIONAL COMMUNITY
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The support we received from the Nigerian Government was immense. Favourable policies that enabled us to launch a successful fight against counterfeit medicines and substandard regulated products were established. The tremendous successes we recorded in the war are attributable in part to the remarkable support from all the Governors of the immediate past and present administrations, who ensured that we were able to implement our policies in ...
PART V - LOOKING INTO THE FUTURE
CHAPTER 18 -FUTURE PLANS/WORK IN PROGRESS RECOMMENDATIONS AND CONCLUSION
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In charting a new course for the future, NAFDAC should consolidate on its present gains, work towards surmounting all outstanding constraints, improve on its administrative and operational capacities and explore new approaches to enhance efficiency and effectiveness. To achieve this, there is the need to consider the following critical areas: In addition to consolidating and continuing with the ongoing interactions with various ...
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...1. “The Pharmaceutical Industry In Nigeria: Historical Review, Problems And Expectations”, unpublished paper of the Pharmaceutical Manufacturers Group 2. Black’s Law Dictionary, 5th edn, St. Paul, MN: West Publishing Co., 1979. 3. “Counterfeit Drugs: Guidelines to develop measures to combat counterfeit drugs”, WHO/EDM/QSM 99.1, 1999, at:http://whqlibdoc.who.int/hq/1999/ ...
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ACT - Artemisinin-based Combination Therapy AGF - Accountant General of the Federation APIN - Association of Pharmaceutical Importers of Nigeria BSE - Bovine Spongiform Encephalopathy cGMP - Current Good Manufacturing Practice ...
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APPENDIX 1: Commendation letter from Ex- Head of State, General Mohammadu Buhari 1 . Food and Drugs Act (Cap 150) of 1990 (formerly called Food and Drugs Decree No. 35 of 1974). This law repealed state laws in operation at the time with respect to food and drugs. It provided among other things that no one was permitted to sell adulterated food or drugs or food unfit for human consumption or any cosmetic ...
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Page Count: 474
Publication Year: 2012