Counterfeiting is a global problem. Many goods moving through international commerce are counterfeited. Industry data show that 5-7% of world trade, valued at about US$280 billion is lost to counterfeiting. It is estimated that about US$20 billion worth of products in the Information Technology (IT) sector move through unauthorized channels annually. The pharmaceutical industry and the personal care products industry are also riddled with counterfeits. Millions of dollars of counterfeit pharmaceuticals and personal care products are reported to move through various authorized and unauthorized channels. These channels make it possible for counterfeits, expired, repackaged and relabelled products to be shipped internationally.

Several criminal networks involved in drug faking and counterfeiting have evolved over the years. They include manufacturers, importers, distributors and retailers. Other collaborators are inspection agents, shipping and clearing agents and corrupt government officials of drug regulatory agencies, customs and police. Drug counterfeiting was highlighted at the World Health Organization’s Conference of Experts on the Rational Use of Drugs, held in Nairobi in 1985.At the World Health Assembly (WHA) in May 1988, a number of countries expressed concern over counterfeit drugs that were circulating in their markets. The Assembly adopted resolution WHA 41.16,12 which requested governments and pharmaceutical manufacturers to cooperate in the detection and prevention of the increasing incidence of the export or smuggling of falsely labelled, spurious, counterfeited or substandard pharmaceutical preparations.

The World Health Organization (WHO), since 1984, has been collaborating and collating data related to counterfeit drugs. This has enabled the organization to develop a database on counterfeit drugs. The World Health Organization received 771 reports of counterfeit drugs from different countries between 1984 and 1999. Twenty-two percent of these reports came from industrialized countries, while the rest came from developing countries.13 Forty six confidential reports of counterfeit drugs were received by WHO from 20 countries from January 1999 to October 2000. About 60% of these reports came from developing countries while the remaining 40% were reported by developed countries.14 However, most of these reports, according to WHO, were not independently verified and might not be useful for quantitative purposes. The data also shows that only a few countries were willing to provide information about cases detected. This silence is one of the major driving forces for counterfeiting.

Counterfeit pharmaceutical products were previously thought to be a substantial and increasing problem of low-income countries, most of the time caused by weak administrative systems. At the global forum on pharmaceutical anti-counterfeiting held in Geneva, in September 2002, many participants brought to light the counterfeiting problems that existed in their various countries. There have been cases of court actions resulting from patients treated with fake or counterfeit drugs in United States; the U.S. has one of the most regulated and policed pharmaceutical markets. Counterfeit medicines had been detected through referrals from public and professional bodies, whistle blowers and covert test purchases, according to a report presented by the Medical Control Agency (MCA) of the United Kingdom. It is noteworthy that the types of counterfeit pharmaceuticals found in the UK are similar to those found in other countries, include look-a-likes, identical copies, relabelled products, expired authentic and rejected authentic products that found their way back to the markets. Some examples of counterfeit pharmaceuticals found in the UK include Nubian (Nalbuphine HCl) injection, multi-dose presentations not licensed in UK and Viagra (Sildenafil Citrate) with contents varying between 40-100% of claim

Reports from Russia showed that 12% of drugs in circulation are counterfeit and that there is a growing problem of look-a-like drugs. This prsoblem could be attributed to a lack of enforcement of prescriptions and qualified medical personnel to handle the healthcare environment. The distribution of drugs also poses a problem, as there are about 40,000 small outlets and kiosks selling drugs. New pharmacies on wheels have also joined in this business of distributing drugs and causing further chaos.

Interest in the problem of counterfeiting is relatively new for transitional economies, such as Ukraine. It is estimated that the amount of counterfeit drugs found in some countries of the former USSR is up to 30%. In Ukraine, this figure goes up to 40% and as high as 80% for certain pharmaceutical products. This is because there is no control of import and distribution of pharmaceutical products despite a national legislation for the control of the pharmaceutical market
Counterfeiting of drugs, especially anti-malaria drugs, has been in existence in Asia from as early as the seventeenth century when cinchona bark from which quinine is derived was faked.19 A WHO report indicates that counterfeit drugs are prevalent in Vietnam.20 Reports indicate that Asia is the centre of a complex global network that manufactures and distribute fake medicines all over the world.

It is believed that in some extreme cases within Asia, companies may be producing legitimate goods at one end of the factory and counterfeits at the other. Another WHO report indicated that India is responsible for about 35% of the World’s fake drugs, which is worth US$200 million annually, representing 20% of the World’s total drugs market. Recognizing the dangerous trend in spurious drug trade, the Indian Government established the Mashelkar Committee which recommended stringent punitive system for spurious drug makers, including death penalty for those who cause “grievous body harm or loss of life. Offences related to spurious drugs would also be made cognizable and non-bailable.

Studies carried out on seven hundred samples by the Pharmaceutical Security Institute in the Philippines showed that 7% of products marketed were definitely counterfeit.In Lebanon in 1982, factories around Beirut were reported to be faking about 57 Western drugs due to the civil war and Israeli invasion. The Lebanese government did nothing to stop these companies or alert the public of the problem. These drugs were still killing people long after the guns had stopped.

It appears that drug piracy was officially allowed to thrive in countries, such as Lebanon and Thailand, since the governments failed to address the counterfeiting problem in their countries. Even in Britain, with its wealth of copyright and drug laws, this silence prevails. The official reason for the silence is that patients run greater risks if the fear of fakes put them off taking the real product. However, a spokesman for the Association of the British Pharmaceutical Industry (ABPI) was reported to have stated the real reason for the silence. “It is difficult to declare a problem without damaging legitimate business. In other words, they believed there was more money to be made by keeping silent."

In African countries, the incidence of fake and counterfeit drugs is difficult to estimate because of poor communication, the non-existence or ineffectiveness of drug regulatory authorities, poor drug procurement practices, low literacy levels, low awareness of the existence of fake and counterfeit drugs, political instability, and high level of smuggling of pharmaceutical products in the region.
The Essential Drug Monitor (EDM) report on transforming drug supply in Dar es Salaam, Tanzania sums up the picture in most African countries: “There was chronic shortage of drugs at health facilities, supplies were erratic as was government funding, resulting in poor drug supply management and irrational use of drugs. Drug quality was questionable and pharmacy premises were often unsuitable, hot, humid, and cluttered with piles of drugs, some of which had expired. Pharmacists had low professional visibility.” This clearly mirrors the situation in many African countries with the exception of a few countries such as South Africa, Nigeria, Ghana, Gambia and Egypt, which have some level of systematic drug regulation and drug distribution. In a survey of 519 drugs in three African countries between 1991 and 1993, 77 drugs (18%) were found to be substandard.

Within the West African sub-region, there are very high activities in inter-boundary trade on pharmaceuticals. Many West African countries, such as Togo, Benin, Chad, Niger, Ghana and Cameroon buy their drugs from Nigeria because Nigeria has the biggest drug market in the sub-region. In the Republic of Benin, for instance, this inter-boundary trade is known as the “parallel market.” An EDM report quotes the Beninoise National Office of Health Protection as estimating patronage of this parallel market to be around 85% of the population. These counterfeit drugs were generally reported to come from Gabon, Nigeria, and from Asia, Europe and North America. This market is often controlled by travelling sales persons who have no training and lack all necessary skills to dispense drugs.28 In view of this trade on pharmaceutical products between Nigeria and other neighbouring countries, the situation in Nigeria naturally reflects that of the other countries in the sub-region. Even though the counterfeiting of pharmaceutical products is a global phenomenon, some countries, including Nigeria, are more affected than others. Fake and counterfeit drugs were first noticed in Nigeria in 1968, when the Crown Agents divested as the sole distributors of pharmaceuticals in Nigeria. The problem assumed greater proportions during the import license era of the early 1980s and worsened with the adverse economic effects of the Structural Adjustment Programme (SAP) introduced in mid 1980’s. The situation got progressively worse with time until 2001 when NAFDAC started an aggressive war against fake drugs.

A 1989 study conducted by Denham Pole in Nigeria indicated that 25% of samples studied were fake, 25% genuine and 50% inconclusive (See chart 1).A study conducted in Nigeria in 1990 by the former Deputy Director General of WHO, Adeoye Lambo, for a pharmaceutical firm in Lagos showed that 54% of drugs in every major pharmacy shop were fake, a figure that had risen to about 80% in the subsequent years.30 In another study of 581 samples of 27 different drugs from 35 pharmacies in Lagos and Abuja (Nigeria), 279 (48%) of the samples did not comply with set pharmacopoeia limits and the proportion was uniform for the various types of drugs tested.

The first phase of the study in six major “drug markets” across the country by NAFDAC in 2002, to measure the level of compliance to drug registration revealed that 67.95% were unregistered by the Agency. A repeat of this study in 2003 revealed an 80% reduction. The second phase of the study to be conducted in collaboration with WHO and DFID includes laboratory testing and further investigations of the surveyed drug products will reveal the level of fake and substandard drugs in the country.