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A counterfeit medication or a counterfeit drug is a medication or pharmaceutical product which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. 3


A counterfeit medication or a counterfeit drug is a medication or pharmaceutical product which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. 4


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“Everyday millions

of people are playing a vicious game of chance when it comes to thier medication.

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Would You Swallow a 7

The toxic substance known as Rat poison has been found to be contained within counterfeit drugs and medicines. Rat poison products generally kill rats by causing them to bleed to death internally. Thus one of the key ingredients in rat poison is typically an anticoagulant, which promotes the thinning of the blood in rats. Anticoagulants also have the same effect on the blood of humans. Observable signs of rat poisoning in humans can include external blood on the orifices of the body (mouth, nose and rectum), as well as bruising on limbs and other body parts.
Vomiting blood or blood in the urine or

stool are symptoms of rat poisoning. Other symptoms may be bruising and bleeding, low blood pressure and shock. One of the reasons that rat poisoning pellets work so well in killing rats is due to its delayed effect. For example, a rat ingests the poison on the first day, but it isn’t until several days later that it dies from the poison’s effect on its body. Therefore, since the rat did not experience any painful side effects the first or second day, it continues to eat the very item that will kill it by the third day. This delayed effect is also true for humans who ingest rat poison.



poison has been “Rat found to be contained

within counterfeit drugs and medicines.


Dead Rat?

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How Do They Make Them? А variety of factors account for why medicines are attractive for counterfeiting. Medicines are high value items in relation to their bulk and the demand for medicines is infinite. Furthermore, for the counterfeiter, ingredient costs can be very low if cheap substitutes are used or if these are omitted altogether, as is often the case. Producing counterfeit drugs may not require building huge infrastructure or facilities. They can be produced in small cottage industries or in backyards or under the

shade of а tree. There are also no overhead costs due to quality assurance or meeting Good Manufacturing Practices standards, since such standards are never implemented and gross margins are therefore very high. А counterfeit drug has а better capacity to deceive, particularly if it is copied to make it look like the original product and if it comes from а supposedly legitimate source so that purchasers are unlikely to be suspicious.

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can be “They produced in small

cottage industries or in backyards or under the shade of а tree.


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What is Missing? All medicines contain Active Pharmaceutical Ingredient (known as API), this is what makes the medicine work. Counterfeit medicines have been found to contain no API at all, not enough API to make the medicine effective, too much API and even an API that is for a

to brick dust, rat poison and other highly toxic substances. There is no doubt about it; counterfeit medicines are dangerous and in some cases deadly. Beyond the direct impact on the victims, medicines missing or with low amounts of API can fuel microbial resistance.

completely different illness or condition. They have also been found to contain all sorts of other ingredients including talcum powder, boric acid, lead based road paint, floor polish, heavy metals, nickel, arsenic through

Each under-medicated patient becomes an evolutionary vector though which “superbugs� can develop, posing a global threat to public health that normal medicine will be no longer able to treat.


Less then 1% 13

Where is it Happening? The United States Food and Drug Administration estimates that counterfeits make up more than 10% of the global medicines market. Many developing countries parts of Africa, parts of Asia, and parts of Latin America have areas where more than 30% of the medicines on sale can be counterfeit. European statistics show in particular a strong increase of drug counterfeit seizures at the European customs, with a total of 2.7 million of drugs seized in 2006, representing a growth of 384% compared to 2005. No country is free of drug counterfeiting. Most developed countries with effective regulatory systems and market control (e.g. USA, EU, Australia, Canada, Japan, New Zealand, etc.) currently

have a low proportion of counterfeit drugs, less than one percent of market value. However, trends point to a shift and there has been an increase in the prevalence of counterfeit medicines even in developed countries. Recently published WHO analysis shows that counterfeiting is greater in those regions where regulatory and legal oversight is weaker. The problem is further exacerbated by a number of other factors: scarcity and/or erratic supply of basic medicines, uncontrolled distribution chains, large price differentials between genuine and counterfeit medicines, lack of effective intellectual property right protection, lack of regard for quality assurance and corruption in the health-care system.

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35% 10%

20% 14

40%

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Less then 1%

Percentages represent individual areas counterfeit drug make up of total drug supply.


Counterfiet in Africa? 15

The problem with counterfeit drugs is direr in Africa, where some countries report that 30 to 50 percent of all prescription and over-the-counter medicines sold to consumers are counterfeits. While the issue of counterfeit drugs has long been treated as a criminal matter of intellectual property infringement, this view has often obscured what is in fact a public health crisis. Counterfeit and substandard pharmaceuticals are not just duping consumers, they are taking lives. The WHO estimates that one fifth of global malaria deaths each year are a result of the use of fake drugs. The roundtable discussion, which was hosted by the African Union, gave African health leaders the opportunity to share both their concerns and their innovative approaches to combating counterfeit drugs with representatives from the US government, the pharmaceutical industry, and others engaged in this important fight. The need for stronger responses to counterfeits was a recurring theme during a week-long visit of African health leaders from to the U.S. The discussion’s moderator Bright Simons called fake drugs “the most systemic threat to healthcare in Africa”. Mr. Simons is the founder of, an innovative mobile phone-based system, which enables consumers through instant messaging to check the authenticity of their

medications against a central database. This kind of consumer empowered identification capacity is increasingly important as drugs are being manufactured by increasingly sophisticated counterfeiters who are able to reproduce medications, packaging and even security holograms that are indistinguishable to the consumer from the authentic products. At the country level, Nigeria has been a pioneer in Africa in fighting counterfeits. According to a 2006 study, Nigeria was able to cut the proportion of fake drugs in the Nigerian market, from 48% in 2004 to 16.7%, at least over the period under observation. Mr. Linus Awute, Permanent Secretary of Nigeria’s Ministry of Health, who spoke at the panel discussion, attributed this success to Nigeria’s multi-faceted anti-counterfeit strategy which includes stronger regulation as well as better enforcement of existing laws. Most importantly though is the support that the entire Nigerian government has provided, in terms of resources and public diplomacy, to demonstrate the seriousness with which the country views this problem. While there are many strategies and methods for addressing the issues of fake drugs in Africa, none of them can succeed without the collaboration, cooperation, and support of both African governments and African consumers.


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drugs “Fake are the most

systemic threat to healthcare in Africa.


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is cause for “There optimism in India’s fight against fake drugs.


Counterfiet

in India? The Indian government has at last signaled its intention to combat the menace of fake pharmaceutical products. The upper house of parliament approved measures to create a comprehensive national food and drug authority. Penalties for those manufacturing and trading in fake drugs have been increased, and it will now be easier to capture and convict counterfeiters. The U.S. Food and Drug Administration recently banned a host of drug imports from India’s largest pharmaceutical company, Ranbaxy Laboratories, citing alleged breaches in manufacturing practices. The ban will be lifted if Ranbaxy offers credible evidence that its production processes are adequate. Analysts put the nationwide figure for counterfeit drugs in India market as high as 35 percent. The Indian health minister, Anbumani Ramadoss, insists the real figure is much lower, but he acknowledges that India has a serious problem. Speaking to journalists last week in New Delhi, Ramadoss pledged that the Indian government would “go all out to do away with spurious drugs.” As Indian MPs debated the new legislation, some wanted to impose capital punishment on

drug counterfeiters, noting that substandard drugs have proven deadly. The Indian health minister, however, replied that “the government feels it is not necessary to have the death penalty at this point in time.” Instead, the new law increases jail time for convicted drug counterfeiters from a minimum of five years to a minimum of ten years and increases the minimum fine for such offenses from 10,000 to a million rupees. Squashing the trade in substandard drugs also require better policing and enforcement. If counterfeiters can simply bribe police or prosecutors as they have traditionally done in India the problem will only get worse. Thankfully, the new legislation strengthens police powers and establishes an autonomous Central Drug Authority. The CDA will coordinate all regulatory activities, including an expanded national drug quality monitoring program that will connect medical colleges and hospitals across the country. Whether these new anti-counterfeiting mechanisms will function effectively remains to be seen. But for the first time in a long time, there is cause for optimism in India’s fight against fake drugs.

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Counterfiet in Latin America? 19

In Mexico Counterfeiting is the primary problem, accounting for 80 percent of the illicit market. Theft including assaults on pharmacies and warehouses, cargo robbery, and pilferage inside health institutions represents an additional 12 percent, while the illegal sale of drug samples accounts for 5 percent. Sales of counterfeit drugs in Mexico are estimated at $1.5 billion. Counterfeit medications are the product of a sophisticated and lucrative shadow industry, with global reach. Well organized counterfeiting rings slip fake medications into Mexico’s legitimate drug supply. The operations of the legitimate industry are replicated by shadow players who engage in importing, manufacturing, packaging and distributing of their false merchandise. Counterfeiting usually takes place in small laboratories, often located within residential dwellings, supported by a network of suppliers and intermediaries. Legitimate business activities can be used

as a front, but fictitious corporations or ghost companies often provide cover. Two types of counterfeiting practices are rampant in the Mexican market: Partial or total product substitution: It is common practice for counterfeit medication to include the original active ingredient but in smaller dosage, thus creating a sub-potent drug. Although the active ingredient is present, the medications may be laced with potentially hazardous material. In one case, counterfeit medication for erectile dysfunction was found to have traces of LSD, a psychedelic drug. 
Counterfeiting of expired drugs: Organized crime rings acquire expired medicines in order to repackage and reinsert them into the distribution channels. The absence of a formal waste management system for expired drugs encourages the “recycling” of drugs back into the formal distribution system.


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Medication was found to have traces of LSD


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Between 200,000 and 300,000 people in China die.


Counterfiet in China? While China’s pharmaceutical industry is experiencing rapid growth, a boom in counterfeit drugs is costing human lives and eroding the public’s confidence in medical products. Among 32 drugstores investigated in Nanjing 22 are selling counterfeit drugs and health foods, claimed Gao Jingde, a fake-drug investigator based in Shanghai. National figures on fake drugs are unavailable, but according to a 2006 report released by London-based International Policy Network, between 200 000 and 300 000 people in China die from counterfeit or substandard medicine in China each year. Another report, Prescription Drug Counterfeiting, released by Dublin, Ireland-based company Research and Markets on 1 May, says that China has become a major source of counterfeit drugs in the international market. Despite frequent media stories in China reporting the success of the State Food and Drug Administration and its local branches in cracking down on counterfeit drug makers, Gao says he

has growing concerns that fake drugs are expanding from rural markets to bigger drugstores in major Chinese cities. Gao has also investigated drugstores which enjoy the support of public medical insurance, and found that four out of 15 carried fake medicines. ‘These drugstores are equipped with more professional physicians who should be able to easily detect the fakes,’ Commercial corruption and poor performance of drug regulators should be blamed for the prevalence of fake drugs; simply many of the offending drugstores have been punished. The high price of medicines is a significant factor driving counterfeit drug making, most counterfeiters target expensive drugs sold by international pharmaceutical firms in China. Although most Chinese drugs are generics whose production costs are quite low, many domestic pharmaceutical companies have successfully registered their medicines as highly priced new medicines, thanks to China’s loose regulation on new drugs.

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tuberculosis “Fake and malaria drugs

alone are estimated to kill 700,000 people a year.

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What is the Cost? The overall death toll attributable to counterfeit medicines, like the scale of the business, is unknown but the costs to public health are huge. Quite apart from the direct impact on individuals, counterfeits can cause resistance to medicines for tackling diseases that are leading causes of mortality. Malaria, which kills around a million people a year, is a prime example Fake tuberculosis and malaria drugs alone are estimated to kill 700,000 people a year. That’s equivalent to four fully laden jumbo jets crashing every day. This lays bare the ballooning problem

of counterfeit and substandard drugs, which can constitute one third of the drug supply in certain African countries. These dodgy drugs result in unnecessary death and increased levels of drug resistance. Counterfeit prescription pharmaceuticals are a growing trend. It is thought that the counterfeit drug industry is worth $75 billion. It’s expected to grow by 20 percent annually in the coming years. If estimates are correct, the counterfeit drug industry generates nearly as much cash as the world’s fourthlargest health care company in the world.


What is Being Done? Mobile phones are now sufficiently widespread in that access can be considered nearuniversal. This has enabled the development of a range of technologies that enable purchasers of medicines to check the authenticity of their packs using text message services. The systems rely on a unique identifying code in the form of a simple series of numbers, which is printed on the pack and then concealed. When the packet is bought, the purchaser scratches off the concealing panel to reveal

the code and then sends the code by SMS to a central registry, which contains a copy of each code made for that medicine. If the code is unique, then the purchaser will shortly receive an SMS response informing them that the medicine is real. If the code is not in the system or is not unique, then they will be told that the medicine is likely to be a counterfeit. Such SMS systems have been developed in Ghana, India and the USA, and are currently being offered across Africa and Asia.

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systems have “SMS been developed in Ghana, India and the USA.

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“Counterfeit

drugs are making viruses mutate,the consequences of which is yet unknown.

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Genuine