CHAPER 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

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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

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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).

On April 29, 2006 the Chinese Department of Health announced that fake medicines purporting lower blood sugar resulted in the least three blood-poisoning cases in 2005. Patients have received fake medicines with illegal chemicals. In 2004, Chinese authority arrested 22 manufactures of grossly substandard infant milk powder and closed three factories after the death of over 50 infants (Lisa,

2007). In 2005 December, United States (US) custom agents intercepted more than 50 ships of counterfeit Tamifliu, the antiviral drug being stockpiled in anticipation of bird flu pandemic. The fake drugs had none of Tamiflu’s active ingredients. Jeffrey, Director of the Commerce Department’s office of Health and

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Consumer Goods, announced that the US government is working on stopping the illicit flow of

Active Pharmaceutical Ingredient (API), which can be used in counterfeit medicines (Burns, 2006). A 2003 report produced by Michele Forezley of the International Intellectual Property Institute (11PI) at the request of PTO compiled data from numerous sources found reports that more than 1,000 hospital admissions resulted from counterfeit insulin in Russia.

Since early 2005, health regulatory officials in Leizou have seized 308 types of fake and substandard medicines and medical devices. Taiwan’s Criminal Investigation Bureau (TCIB) announced recently that roughly $ 9 million worth of counterfeit drugs was seized in Taipei. The products were China originated and includes among others are cold treatment, gastrointestinal medicines, sedatives, anti-obesity and erectile dysfunction drugs, and unknown pills (Bryce, 2005). During a recent Food and Drug Administration (FDA) blitz operation at airports in New York City and Miami, over 25 different controlled substances were counterfeit and of Chinese origin. The EU council of ministers recently approved a plan issued by the European commission to improve customs coordination against counterfeit goods. Currently, 70% of seizures of counterfeit are from China (Charatan, 2001).

In Haiti, Nigeria, Bangladesh, India, and Argentina, more than 500 patients, predominantly children are known to have died from the use of the toxin diethyleneglycol in the manufacture of fake paracetamol syrup (WHO, 2003). The

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recent discovery of counterfeit antiretrovirals (stavudine-lamivudine-nevirapine and lamivudine- zidovudine) in Central Africa raises the prospect of a disastrous setback in the treatment of AIDS in sub-Saharan Africa, unless vigorous action is taken now (Burns, 2006). The effects on patients of counterfeit medicines are difficult to detect and quantify; and are mostly hidden in public health statistics. The estimate of 192,000 patients killed by fake drugs in China in 2001 gives an indication of the scale of human suffering (Dondorp et al, 2004). It has been estimated that up to 15% of all sold drugs are fake, and in parts of Africa and Asia this figure exceeds 50% (Cockburn ,1984 WHO, 1998 & Newton, 2002).

In a study conducted in South-East Asia in 2001, it was reported that 38% of 104 antimalarial drugs on sale in pharmacies did not contain any active ingredients and had resulted in a number of preventable deaths. The consumption of paracetamol cough syrup prepared with diethylene glycol (a toxic chemical used in antifreeze) lead to 89 deaths in Haiti in 1995 and 30 infant deaths in India in 1998. In 1999, at least 30 people died in Cambodia after taking counterfeit antimalarial prepared with sulphadoxine-pyrimethamine (an older, less effective antimalaria), which were sold as Artusenate (WHO, 2003). WHO (2003) reported that regular use of substandard or counterfeit medicines leads to therapeutic failure or drug resistance; in many cases it can lead to death. In April 1999, reports of 771 cases of substandard medicines had been entered into the WHO database on counterfeits, 77% of which were from developing countries. Data analysis showed that in 60% of the 325 cases, an active ingredient was missing from the product. WHO survey

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of counterfeit medicine reports from