Singapore, Aug 28, 2009:  In June this year, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) announced it had detected a large consignment of anti-malarial drugs from China, which had been labeled ‘Made in India’, and were being sold in that country.

In November 2008, INTERPOL announced that the police across Southeast Asia made 27 arrests in nearly 200 raids carried out with the support of the World Health Organization (WHO) and the World Customs Organization (WCO) officials across Cambodia, China, Laos, Myanmar, Singapore, Thailand and Vietnam, and seized fake drugs worth $6.6 millions. The arrested were involved in the manufacture and distribution of four classes of counterfeit medicines identified as posing a significant public health risk – anti-malaria, anti-tuberculosis, anti-HIV and antibiotics, specifically those for pneumonia and child-related illnesses.

In 2005, Indonesia’s International Pharmaceutical Manufacturers Group (IPMG) estimated that pirated drugs constituted 25 percent of Indonesia’s $2 billion pharmaceutical market. Similarly, the Philippine’s Bureau of Food and Drug (BFAD) in 2003, reported that 30 percent of drug store outlets visited by food and drug deregulation officers carry and sell counterfeit drugs.

In 2002, China’s research and development-based Pharmaceutical Association estimated that about 8 percent of over-the-counter drugs sold in China are counterfeit.

India’s pharmaceutical companies suggested that in India’s major cities, one in five medicines sold was a fake. They claimed a loss in revenue of between 4 to 5 percent, annually. According to industry estimates, illegal drugs shares has grown from 10 to 20 percent of the total market.

In the last many years, drug counterfeiting has been growing in Southeast Asian region, besides India and China. WHO estimates that as many as 30 percent of medicines sold in some regions of Southeast Asia are counterfeit.

Although precise and detail data on counterfeit medicines is difficult to obtain, estimates range from around 1 percent of sales in developed countries to over 10 percent in developing countries, depending on the geographical area.

According to WHO estimate, the value ascribed to counterfeit drugs across the world will reach $75 billion by the end of 2010, up by 90 percent over the 2005 level. WHO said that incidence of detection of counterfeit drugs in 2007 had increased to more than 1,500, ten times than that in 2000. It also indicated that in 2005-06, the volume of counterfeit drug seizures included 2.7 million articles and the main countries from where these articles originated from were India (31 percent), UAE (31 percent) and China (20 percent).

Earlier, the counterfeit drugs were confined to lifestyle drugs such as Viagra or conventional medications for cold, cough and fever. Nowadays, these have flooded the life saving drugs segment viz: AIDS/HIV therapy, antibiotics, insulin, cholesterol drugs, hormone replacement therapy and cancer drugs.

In 2006, a study conducted by the WHO’s International Medical Products Anti-Counterfeiting Taskforce (IMPACT) indicated that in most industrialized countries with effective regulatory systems and market control (e.g. the US, most of EU, Australia, Canada, Japan and New Zealand) the incidence of counterfeit drugs was less than 1 percent of the market value. Many countries in Africa and parts of Asia and Latin America have areas where more than 30 percent of the medicines on sale can be counterfeit, while other developing markets have less than 10 percent; overall, a reasonable range is between 10 percent and 30 percent.

Reports suggest that the problem is severe in the developing world such as Asia, Africa, Latin America than the developed countries. The WHO estimates that about 25 percent of the medicines consumed in developing countries are believed to be counterfeit. The vast majority of counterfeit drugs are thought to be supplied from China, India and Russia. According to a report released by the Organization for Economic Co-operation and Development (OECD), between 39 and 81 percent of all counterfeit drugs seized by European Union officials between 2005–2007 originated in China or India. A ban on drugs from these countries would be counter productive as China and India also produce and supply many good-quality, low-cost generic drugs.

Prof C S Gautam, department of pharmacology, Government Medical College Chandigarh, India, in his paper on ‘Spurious and counterfeit drugs: a growing industry in the developing world’ noted that poverty, high cost of medicines, lack of an official supply chain, legislative lacunae, inadequate /weak drug control infrastructure, light penalties give the counterfeiters an economic incentive without comparable risk. This trade is a well-organized white-collar crime. Highly lucrative trade, availability/ accessibility of advanced printing technology, sickness in small scale industry, lack of coordination between various enforcing agencies, inadequate testing facilities and poor infrastructure are some of the factors responsible for the growth of the counterfeit drugs. Another important factor to be considered in the spread of counterfeit dugs is smuggling and illegal cross-border trade of these drugs.

The counterfeit drugs are making their presence felt everywhere causing huge social and economic costs, besides undermining the confidence of the common man on health care system. So there is an urgent need to combat the problem.

The fight against the counterfeit medicines is a global challenge and calls for a unified strategic approach across participant countries worldwide. The problem of counterfeit medicines was first addressed at the international level in 1985 at the Conference of Experts on the Rational Use of Drugs in Nairobi. The meeting recommended that WHO, together with other international and non-governmental organizations should study the feasibility of setting up a clearing house to collect data, and to inform governments about the nature and extent of counterfeiting.

Then in 2006, in order to mobilize awareness and action in the fight against fake drugs, WHO created the first global partnership known as the International Medicinal Products Anti-Counterfeiting Taskforce (IMPACT). IMPACT comprises all 193 WHO member states on a voluntary basis and includes international organizations, enforcement agencies, national drug regulatory authorities, customs and police organizations, non-governmental organizations, associations representing pharmaceutical manufacturers and wholesalers, health professionals and patients’ groups. These groups have joined to improve coordination and harmonization across and between countries so that the production, trading and selling of fake medicines will cease. To accomplish this mandate, IMPACT has been focusing on the following five key areas: legislative and regulatory infrastructure, regulatory implementation, enforcement, technology and risk communication.

To tackle pharmaceutical counterfeiting in Southeast Asia and China, which is emerging as the hub for production and distribution of the counterfeit drugs, the WHO in association with the Association of Southeast Asian Nations (ASEAN), the Indonesian authorities and INTERPOL organized the first ASEAN-China Conference on Combating Counterfeit Medical Products in Jakarta in November 2007.

A consensus was reached with a mission to stop the manufacture and trade of counterfeit medical products and contribute to make medicines of assured quality accessible to all those who need them.

In addition to the regulatory bodies, pharmaceutical companies have been adopting latest technologies such as innovative packaging designs, bar coding and radio frequency identification (RFID) chips to arrest the menace of counterfeit drugs. The US Food and Drug Administration (USFDA) and other drug regulators are pushing for the adoption of RFID hardware and software throughout the pharmaceutical industry to combat sales of counterfeit drugs.

Although some initiatives have been mooted at the regulatory side, the resolve to kill this menace is still lacking among pharmaceutical companies who have focused more of their attention on newer drug research, patent protection and maintaining higher drug prices. Coupled with the inclusion of strategies to combat the counterfeit in the business plan of pharmaceutical companies, a strong political will of all participating countries, an efficient regulatory environment and enforcement of rules and laws and international cooperation is the need of the hour.