The War Against Counterfeit Medicine: My Story

Preface

xi PREFACE 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 NationalAgency for Food and DrugAdministration and Control (NAFDAC), betweenApril 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 fromthe fatal consequences of fake medicines and unwholesome food products. It is my hope that it will help compel individuals, organisations and governments to recognise the heightened level of the dangers posed by medication counterfeiters, and thus ensure that strategies that have led to our globally recognised achievements over this period are not jettisoned, but improved upon. Secondly, I believe that the publication will help countries improve on their food and drug regulatory environments and strategies where they already exist, or create new ones where none exists. Considering the fact that drug counterfeiting is an emerging phenomenon, it is understandable that there is currently no clear-cut strategy in any literature on how to tackle the menace. Thus, it is my hope that this publicationwillcontributetotheeffortsofregulatorsallovertheworld. The book is divided into five parts of eighteen chapters and gives an overview of many of the events that took place during the period under discussion. In the prologue, I give some background on my upbringing, growing up and life in a Nigerian village before and during the Nigerian Civil War between 1967 and 1970. Looking back, I have no regrets about the hardship I went through because it prepared me for the life ahead. As a child, I never thought of studying pharmacy. Medicine was my career of choice and my family’s desire for me at the time. However, that did not happen as my love for mathematics and chemistry spurred me to study pharmacy, the course that unexpectedly prepared me for the journey towards becoming the Director General (DG) of NAFDAC. In the prologue, I tell the story of my journey from academia to public service, starting from 1994, and all the events that led to my being appointed the Director General of NAFDAC. I was encouragedandmotivatedinthe longyearsofservice for manyreasons: First, former President Olusegun Obasanjo appointed me to the position despite stiff opposition from the political class. He believed in my ability to do the job following my performance in my former job at the Petroleum (Special) Trust Fund (PTF). I am also mindful that many families have lost loved ones because of the effects of fake drugs, an experience my family shared with the loss of my favourite sister, Vivian. In addition, I felt the appointment was an opportunity for me to give back to the country that has given so much to me. My entire education, from high school through to university in Nigeria, to doctorate and post-doctoral studies in London, was possible due to government scholarships. Finally, against the barrage of criticisms following my appointment, I was determined to succeed, to prove my critics wrong and to remain uncompromisinginmyjob. Chapter 1 outlines the historical background of food and drug regulation in Nigeria. It also chronicles the evolution of drug production and sale from the rudimentary era of pre-1957, through thefoundation-layingera ofthe 1960s to the potentiallybright post-2001 era. Chapter2outlinesthedevelopmentoffoodanddrugregulationinNigeria.Takingacuefromthe USFDA, which was established in June 1906, NAFDAC was established by Decree No. 15 in 1993. xii xiii In Chapter 3, the mandate, structure, functions, laws and regulations by which NAFDAC performs its duties are explained. Decree No. 15 of 1993, mandates NAFDAC 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, including table water. NAFDAC therefore, has a statutory responsibility to ensure the quality, safety, efficacy and wholesomenessoftheseitems,collectivelyreferredtoasregulatedproducts. Chapter 4 explains the various definitions of fake, counterfeit, adulterated, substandard drugs, unwholesome food and other substandard regulated products. These various definitions show that despite the global nature of fake and counterfeit drugs, the international community has not given the problem the attention it deserves, as evidenced by the non-existence of a harmonised definition. The absence of a universally accepted definition not only makes information exchange among countries very difficult, but also limits their ability to understand the true extent of the problemofcounterfeitmedicines. Chapter 5 gives a global overview of...