CHAPTER ONE

Introduction Background of the Study

 National Agency for Food, Drugs Administration and Control (NAFDAC, 1992) posited that the importance of food and drugs to man and animal are very obvious. They need food in-order to grow and sustain life and because of the inhe- rent disposition to illnesses, the organs of the body may not always function properly. Such body dysfunction may be due to infection arising from the intake of contaminated products it may also result from the effect of corrosive or poisonous chemical on the body or due to breakdown following exhaustive work or degeneration of the body organs. These situations of ill-health provide the compelling need for drug in order to modify the functioning of the body and restore it to normalcy. To be acceptable, the drug must not be deleterious to the body but should rather produce a positive effect, which leads to restoration of normal life. Furthermore cosmetics should have no harmful effect to the body to which they are applied.

The production of fake and substandard products especially drugs is a vast and underreported problem, particularly in poor countries. It is an important cause of unnecessary morbidity, mortality and loss of public confidence in medicines and health care. The prevalence of counterfeit drugs appears to be on the raise and has not been opposed by close cooperation between companies, governments, or international organizations concerned with trade, health, customs and exercise, and counterfeiting.

Fake products are products whose composition and ingredients do not meet the correct scientific specifications and which are consequently ineffective and often dangerous to patients (WHO, 2003). WHO continued that it is one which is deliberately and fraudulently mislabeled with respect to identity, composition, and  or source. It also includes those tampered with, adulterated, diluted, repackaged, or relabeled so as to misrepresent the dosage, origin, or expiration date, as well as those cheaply produced in order to make unlawful profits.

According to WHO (2003) the above products may occur as a result of negligence, human-error, insufficient human and financial resources or counterfeiting. NAFDAC (2003) stated that over 150 children died in 1989 as a result of a formulation error in a drug. The problem of fake drugs was so severe that neighboring countries such as Ghana and Sierra Leone officially banned the sale of drugs made in Nigeria (Rudol, 2004). 

Morris (2002) stated that issue of counterfeit drugs ‘’is a serious problem that drugs are hawked even in commercial buses”. All these problems affected Nigeria as a whole but the structure of NAFDAC is said to have put some of the problems under control. WHO (2005) reported that globally, counterfeit drug commerce will grow 13% annually through 2010. That means counterfeit drug sales will grow at nearly twice the rate of legitimate pharmaceutical commerce. In 2010 this illegal business will generate $75 billion in revenues – a $92 increase from 2005. The profits are high and the risk is high; that is a deadly combination.   A large proportion of the world’s counterfeit medicines originates in Asia and ends in the US and European Union (EU). In the EU, between 1998 and 2004 there has been a 100% increase in seizures of counterfeit prescription drugs. China particularly is a production center. In 2001, it was reported that Chinese Authorities closed 1,300 factories while investigating 48,000 cases of counterfeit drugs worth $57 million. The State Food and Drug Administration (SFDA) of China announced that from January – November 2005, it banned 114,000

unlicensed drug manufactures, destroyed 461 illegal pharmaceutical factories. It is estimated that in China “between” 200,000 to 300,000 people die each year due to counterfeit or substandard medicine; which are reported cases. The true number of cases is likely to be far higher (Lisa, 2007).

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