A counterfeit medication or a
counterfeit drug is a
medication
A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field and ...
or pharmaceutical item which is produced and sold with the intent to deceptively represent its origin, authenticity, or effectiveness. A counterfeit drug may contain inappropriate quantities of active ingredients, or none, may be improperly processed within the body (''e.g.'', absorption by the body), may contain ingredients that are not on the label (which may or may not be harmful), or may be supplied with inaccurate or fake
packaging and labeling
Packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale, and use. Packaging also refers to the process of designing, evaluating, and producing packages. Packaging can be described as a ...
. Counterfeit drugs are related to
pharma fraud. Drug manufacturers and distributors are increasingly investing in countermeasures, such as traceability and authentication technologies, to try to minimise the impact of counterfeit drugs.
Antibiotics with insufficient quantities of an active ingredient add to the problem of
antibiotic resistance.
Legitimate, correctly labeled, low-cost
generic drugs are not counterfeit or fake (although they can be counterfeited much as brand name drugs can be), but can be caught up in anticounterfeiting enforcement measures.
[Kaitlin Mara]
Coverage Of Anti-Counterfeit Policy Debate Varies Widely Across Global Media
Intellectual Property Watch
''Intellectual Property Watch'' is a Geneva-based publication reporting on policy issues and influences relating to international organizations (IOs), especially those in Geneva such as the World Intellectual Property Organization, World Trade Orga ...
, August 2, 2010. Consulted on August 11, 2010. In that respect, a debate is raging as to whether "counterfeit products
refirst and foremost a threat to human health and safety or
hetherprovoking anxiety
sjust a clever way for wealthy nations to create sympathy for increased protection of their
intellectual property
Intellectual property (IP) is a category of property that includes intangible creations of the human intellect. There are many types of intellectual property, and some countries recognize more than others. The best-known types are patents, cop ...
rights".
Generic drugs are subject to normal regulations in countries where they are manufactured and sold.
Prescription and over-the-counter drugs
![CBP with bag of seized counterfeit Viagra](https://upload.wikimedia.org/wikipedia/commons/6/66/CBP_with_bag_of_seized_counterfeit_Viagra.jpg)
Counterfeit medicinal drugs include those with less or none of the stated active ingredients, with added, sometimes hazardous, adulterants, substituted ingredients, completely misrepresented, or sold with a false brand name. Otherwise, legitimate drugs that have passed their date of expiry are sometimes remarked with false dates. Low-quality counterfeit medication may cause any of several dangerous
health
Health, according to the World Health Organization, is "a state of complete physical, mental and social well-being and not merely the absence of disease and infirmity".World Health Organization. (2006)''Constitution of the World Health Organiza ...
consequences, including
side effects
In medicine, a side effect is an effect, whether therapeutic or adverse, that is secondary to the one intended; although the term is predominantly employed to describe adverse effects, it can also apply to beneficial, but unintended, consequence ...
or
allergic reactions
Allergies, also known as allergic diseases, refer a number of conditions caused by the hypersensitivity of the immune system to typically harmless substances in the environment. These diseases include hay fever, food allergies, atopic derm ...
, in addition to their obvious lack of efficacy due to having less or none of their active ingredients.
Since
counterfeiting is difficult to detect, investigate, quantify, or stop, the quantity of counterfeit medication is difficult to determine. In 2003, the
World Health Organization
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of ...
cited estimates that the annual earnings from substandard and/or counterfeit drugs were over
US$
The United States dollar (symbol: $; code: USD; also abbreviated US$ or U.S. Dollar, to distinguish it from other dollar-denominated currencies; referred to as the dollar, U.S. dollar, American dollar, or colloquially buck) is the official ...
32 billion.
The considerable difference between the cost of manufacturing counterfeit medication and price counterfeiters charge is a lucrative incentive. Fake
antibiotics with a low concentration of the active ingredients can do damage worldwide by stimulating the development of drug
resistance in surviving bacteria. Courses of antibiotic treatment which are not completed can be dangerous or even life-threatening. If a low-potency counterfeit drug is involved, completion of a course of treatment cannot be fully effective. Counterfeit drugs have even been known to have been involved in clinical drug trials.
Several technologies may prove helpful in combating the counterfeit drug problem. An example is
radio frequency identification
Radio-frequency identification (RFID) uses electromagnetic fields to automatically identify and track tags attached to objects. An RFID system consists of a tiny radio transponder, a radio receiver and transmitter. When triggered by an electrom ...
, which uses electronic devices to track and identify items, such as pharmaceutical products, by assigning individual
serial numbers to the containers holding each product. The
U.S. Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA) is working towards an
electronic pedigree (ePedigree) system to track drugs from factory to pharmacy. This technology may prevent the diversion or counterfeiting of drugs by allowing wholesalers and pharmacists to determine the identity and dosage of individual products. Some techniques, such as
Raman spectroscopy and energy-dispersive X-Ray diffraction (EDXRD) can be used to discover counterfeit drugs while still inside their packaging.
China
The
State Food and Drug Administration is not responsible for regulating pharmaceutical ingredients manufactured and exported by chemical companies. This regulatory lack, which has resulted in considerable international news coverage unfavorable to China, has been known for a decade, but failure of Chinese regulatory agencies to cooperate has prevented improvement. On May 6, 2005, the
Chinese
Chinese can refer to:
* Something related to China
* Chinese people, people of Chinese nationality, citizenship, and/or ethnicity
**''Zhonghua minzu'', the supra-ethnic concept of the Chinese nation
** List of ethnic groups in China, people of ...
press agency
Xinhua
Xinhua News Agency (English pronunciation: )J. C. Wells: Longman Pronunciation Dictionary, 3rd ed., for both British and American English, or New China News Agency, is the official state news agency of the People's Republic of China. Xinhua ...
reported that the
World Health Organization
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of ...
had established
Rapid Alert System, the world's first
web-based system for tracking the activities of drug counterfeiters, in light of the increasing severity of the problem of counterfeit drugs.
India
“If I have to follow U.S. standards in inspecting facilities supplying to the Indian market,” G. N. Singh, India’s top drug regulator, said in a recent interview with an Indian newspaper, “we will have to shut almost all of those.”
According to Outsourcing Pharma in 2012, 75% of counterfeit drugs supplied worldwide had some origins in India, followed by 7% from Egypt and 6% from China.
The
Central Drug Standards Control Organisation (CDSCO), the drug regulatory authority of India conducted a nationwide survey in 2009 and announced that of "24,000 samples
hat
A hat is a head covering which is worn for various reasons, including protection against weather conditions, ceremonial reasons such as university graduation, religious reasons, safety, or as a fashion accessory. Hats which incorporate mecha ...
were collected from all over India and tested. It was found that only 11 samples or 0.046% were spurious." In 2017 a similar survey found 3.16% of the medicines sampled were substandard and 0.0245% were fake. Those more commonly prescribed are probably more often faked.
Industry body
ASSOCHAM
The Associated Chambers of Commerce and Industry of India () is a Non-governmental organization, non-governmental trade association and advocacy group based in New Delhi, India. The organisation represents the interests of trade and commerce i ...
wrote in the paper “Fake and Counterfeit Drugs In India –Booming Biz” that fake drugs constitute US$4.25 billion of the total US$14–17 billion of domestic drug market.
Around 25% of India's drugs are fake, counterfeit or substandard. If the fake drugs market grows at the current rate of 25%, it will cross US$10 billion mark by 2017. Trade in fake drugs is driven caused by lack of adequate regulations, shortage of drug inspectors and a lack of lab facilities to check the purity of drugs. Other key factors include storage of spurious drugs by chemists, weaknesses in drug distribution system, lack of awareness among consumers and lack of law enforcement.
Pakistan
The
2012 Pakistan fake medicine crisis
During late January 2012, a fake medicine crisis at the Punjab Institute of Cardiology (PIC) hospital in the Lahore region of Punjab, Pakistan, claimed the lives of over 100 heart patients.
According to various reports, the incident involved pati ...
revealed the scale of production of counterfeit medications in
Pakistan
Pakistan ( ur, ), officially the Islamic Republic of Pakistan ( ur, , label=none), is a country in South Asia. It is the world's fifth-most populous country, with a population of almost 243 million people, and has the world's second-lar ...
. Over 100 heart patients died after administration of adulterated drugs by the
Punjab Institute of Cardiology
Punjab Institute of Cardiology (PIC), located in Lahore, Pakistan, is a 347-bed tertiary care hospital providing nationwide comprehensive cardiac care services.
Services provided
This hospital services include cardiac emergency, OPD, diagnostic ...
.
Pakistan did not have any regulatory enforcement on production of medicines until this crisis occurred. In response to the crisis, a regulatory body was finally set up in February 2012.
United States
The United States has a growing problem with counterfeit drugs. In 2012, tainted
steroids killed 11 people near Boston and sickened another 100.
["Bad Medicine"]
''The Economist'', Oct. 13, 2012 In another case, vials of the cancer medicine
Avastin
Bevacizumab, sold under the brand name Avastin among others, is a medication used to treat a number of types of cancers and a specific eye disease. For cancer, it is given by slow injection into a vein (Intravenous therapy, intravenous) and use ...
were found to contain no active ingredients. The vials were sourced in Turkey, shipped to Switzerland, then Denmark, finally to the United Kingdom from which they were exported to U.S. wholesale distributors.
The Wall Street Journal reported that the U.S. wholesale distributor was hired by Canada Drugs, which also owns CanadaDrugs.com, a retail pharmacy website that sells prescription medication internationally, with a focus on the American market.
In 2007-08, 149 Americans died from a contaminated blood thinner called
Heparin that was legally imported into the United States.
[ Investigated by the FDA Office of Criminal Investigations, the Albers Medical investigation is the most prolific example to date.
On August 21, 2005, the U.S. Attorney’s Office for the Western District of Missouri issued a press release announcing that three businesses and eleven individuals were indicted for their involvement in a $42 million conspiracy to sell counterfeit, smuggled and misbranded Lipitor and other drugs and for participating in a conspiracy to sell stolen drugs. As part of this investigation, the FDA initiated a recall of more than 18 million Lipitor tablets, which ranks as the largest recall in the history of criminal investigations of counterfeit medications. Participants in this scheme conspired to purchase and sell counterfeit, misbranded and illegally imported drugs. Foreign versions of Lipitor and Celebrex were smuggled into the U.S. from South America and resold after being repackaged to conceal the true origin of the drugs. Moreover, counterfeit Lipitor was manufactured in South America and smuggled into the US, where it sold after commingling with the genuine foreign Lipitor. In addition, participants conspired to buy, sell and traffic almost eight million dollars worth of stolen Glaxo Smith Kline and Roche drugs, using fake pedigrees to launder the drugs and thereby concealing that they were stolen. There also were charges related to the sale of counterfeit Procrit, as well as counterfeit and misbranded Serostim and Neupogen. Procrit is an injectable drug used in the treatment of anemia, Serostim is ]Serono
Serono was a biotechnology company headquartered in Geneva, Switzerland. It was acquired by the German pharmaceutical company Merck in 2006. The company was founded as the Serono Pharmacological Institute by Cesare Serono in 1906 in Rome, It ...
's brandname form of synthetic somatropin (''i.e.'' human growth hormone formed using laboratory methods of genetic recombination) marketed for HIV
The human immunodeficiency viruses (HIV) are two species of ''Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune ...
-associated wasting
In medicine, wasting, also known as wasting syndrome, refers to the process by which a debilitating disease causes muscle and fat tissue to "waste" away. Wasting is sometimes referred to as "acute malnutrition" because it is believed that epis ...
, and Neupogen is an injectable drug used by cancer patients to stimulate the production of white blood cells in order to decrease the incidence of infections.
The FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
held a Congressional hearing in 2005 to review the situation. The U.S. is an especially attractive market for counterfeiters because 40% of worldwide annual prescription drug sales were made in the United States in 2007. In 2011, a " PROTECT IP Act" was proposed to deter advertising.
Between 2002 and 2010, drug imports to the U.S. more than doubled, with 80% of drugs' active ingredients imported, now accounting for 40% of finished medicines.[
U.S. residents at greatest risk of exposure to counterfeit products through personal prescription drug importation are age greater than 45 years, residing in the south or west regions of the U.S., Hispanic ethnicity, college educated, poor or near poor poverty status, lacking U.S. citizenship, traveling to developing countries, lacking health insurance, managing high family out-of-pocket medical costs, having trouble finding a healthcare provider, self-reporting fair or poor health status, filling a prescription on the Internet, and using online chat groups to learn about health. Recent evidence suggests that provision of health insurance coverage may effectively reduce importation and the subsequent risk of exposure to counterfeit medicines, especially among particular subpopulations.
]
Africa
Fake antimalarial medication
Antimalarial medications or simply antimalarials are a type of antiparasitic chemical agent, often naturally derived, that can be used to treat or to prevent malaria, in the latter case, most often aiming at two susceptible target groups, young ...
has been threatening efforts to control malaria in Africa. According to the World Health Organization
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of ...
(WHO), in 2011, 64% of Nigeria's imported antimalarial drugs were fake.[ Nigeria is Africa's largest drugs market, and over 70% of its drugs are imported from India and China, considered the "biggest source of fakes.".][ Lately, Tramadol, a powerful and addictive opioid, has become a major problem. A huge black market has emerged, and an increasing number of addicts overdose and die.
]
United Kingdom
The MHRA (Medicines and Healthcare Products Regulatory Agency) are responsible for the regulation of prescription medication in the UK. Trafficking of counterfeit medication into the UK has become a growing problem, with ever increasing numbers of illicit drugs confiscated at the UK border. A large portion of the medication coming into the UK constitutes erectile dysfunction medication smuggled from abroad, one of the most popular of which is Kamagra (Sildenafil Citrate
Sildenafil, sold under the brand name Viagra, among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. It is unclear if it is effective for treating sexual dysfunction in women. It is taken by ...
). To help combat the issue of counterfeit drugs, the European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been de ...
directive on false medicines was published on January 2, 2013. This came into effect on February 9, 2019 and requires UK licensed medicine to have a unique identifier (UI) and an anti tamper device on each pack of medication. In addition, every Pharmacy dispensing the medication is required to check the anti tamper device and update the FMD online system every time a pack has been issued.
Anticounterfeit platforms
In 2007, the world's first free-to-access anticounterfeit platform was established in the West African country of Ghana. The platform, dubbed mPedigree, relies on existing GSM networks in that country to provide pharmaceutical consumers and patients with the means to verify whether their purchased medicines are from the original source through a free two-way SMS message, provided the manufacturer of the relevant medication has subscribed to a special scheme. Still in trial stages, the implementers of the platform announced in 2009 that they are in partnership with Ghana's Ministry of Health and the country's specialized agency responsible for drug safety, the Food and Drugs Board, to move the platform from pilot to full-deployment stage. A similar service is being rolled out in India.
In 2010, NAFDAC
The National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria is a federal agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertis ...
in Nigeria launched an SMS-based anticounterfeiting platform using technology from Sproxil. That system was also adopted by GlaxoSmithKline (GSK) in February 2011. In April 2011, CNN published a video highlighting Sproxil's solution in the fight against counterfeit drugs in Nigeria. In July 2011, Kenya's Pharmacy and Poisons Board
The Pharmacy and Poisons Board (PPB or the Board in short) is the Drug Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya.
The Board regulates the Practice of Pharmacy and the Manufacture and ...
also adopted text message-based anticounterfeiting systems and endorsed the Sproxil solution. In early 2012 it was announced that more than one million people in Africa had checked their medicines using the text-message based verification service developed by Sproxil.
An ePedigree is another important system for the automatic detection of counterfeit drugs. States such as California are increasingly requiring pharmaceutical companies to generate and store ePedigrees for each product they handle. On January 5, 2007 EPCglobal
The Electronic Product Code (EPC) is designed as a universal identifier (using a idiosyncratic numerical code for each different commodity) that provides a unique identity for every physical object anywhere in the world, for all time. The EPC stru ...
ratified the Pedigree Standard as an international standard that specifies an XML
Extensible Markup Language (XML) is a markup language and file format for storing, transmitting, and reconstructing arbitrary data. It defines a set of rules for encoding documents in a format that is both human-readable and machine-readable ...
description of the life history of a product across an arbitrarily complex supply chain.
Illicit drugs
Illegal drugs can be counterfeited easily because no standards or regulations govern them or their packaging though some examples of illegal drugs are sold under "brand names" to indicate certain standards or dosage levels were being adhered to, as in the case of 1960s-era LSD
Lysergic acid diethylamide (LSD), also known colloquially as acid, is a potent psychedelic drug. Effects typically include intensified thoughts, emotions, and sensory perception. At sufficiently high dosages LSD manifests primarily mental, vi ...
, which was sold with patterns or logos printed on blotter paper. These illegal "brands" can also be counterfeited by drug dealers who want to be able to sell their products at higher prices.
Counterfeit illegal and recreational drugs range from products which do not contain any active ingredient
An active ingredient is any ingredient that provides biologically active or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of humans or animals. The ...
s, as in cases where lactose powder is sold as heroin, or dried herbs such as oregano are sold as cannabis, to cases where the active ingredients are "cut" with a diluent (as in cases where cocaine is mixed with lactose powder), and cases where the claimed active ingredients are substituted by something cheaper (''e.g.'', when methamphetamine is sold as cocaine
Cocaine (from , from , ultimately from Quechua: ''kúka'') is a central nervous system (CNS) stimulant mainly used recreationally for its euphoric effects. It is primarily obtained from the leaves of two Coca species native to South Ameri ...
).
The use of diluents in illegal drugs reduces the potency of the drugs and makes it hard for users to determine the appropriate dosage level. Diluents include "foodstuffs (flour and baby milk formula), sugars (glucose, lactose, maltose, and mannitol), and inorganic materials such as powder." The diluents used often depend on the way drug purchasers consume particular drugs. Drug dealers selling heroin to users who inject dilute the drug with different products from dealers selling to users who smoke or insufflate the drug; diluents which can easily form a solution with water for injecting heroin can be problematic for users who are sniffing the powder. When cocaine is mixed with diluents for the purpose of injection, the "...diluents can produce serious abscesses and pain if the user misses the vein and injects into muscle tissue." "Diluents and adulterants are often added to No. 3 heroin", including sugar, quinine, barbital and caffeine, some of which "can cause serious side effects." Dr. Hirsch, the New York Medical Examiner, claimed that buying illegal drugs is "... like playing Russian roulette," because "there is no way of knowing just what a heroin dealer has slipped into the packets." In some cases, if a dealer does not take the time to dilute the drug with lactose or other fillers, a "very potent blend of heroin" is sold, which can lead to overdoses.
Claims that illegal drugs are routinely cut with substances such as rat poison and crushed glass, often cited in antidrug pamphlets, are largely unsubstantiated.
Some countries, cities and organizations deploy drug checking Drug checking or pill testing is a way to reduce the harm from drug consumption by allowing users to find out the content and purity of substances that they intend to consume. This empowers users to make safer choices: to avoid more dangerous substa ...
services in order to improve the ability of users to make a more accurate risk assessment.
Packaging
Custom package seals, authentication
Authentication (from ''authentikos'', "real, genuine", from αὐθέντης ''authentes'', "author") is the act of proving an assertion, such as the identity of a computer system user. In contrast with identification, the act of indicatin ...
labels, hologram
Holography is a technique that enables a wavefront to be recorded and later re-constructed. Holography is best known as a method of generating real three-dimensional images, but it also has a wide range of other applications. In principle, i ...
s, and security printing
Security printing is the field of the printing industry that deals with the printing of items such as banknotes, cheques, passports, tamper-evident labels, security tapes, product authentication, stock certificates, postage stamps and identity ...
, can be valued parts of an entire security system. They help verify that enclosed drugs are what the package says they are. Drug counterfeiters, however, often work with package counterfeiters, some of whom can be sophisticated. No packaging system is completely secure.
See also
* Authentication
Authentication (from ''authentikos'', "real, genuine", from αὐθέντης ''authentes'', "author") is the act of proving an assertion, such as the identity of a computer system user. In contrast with identification, the act of indicatin ...
* Counterfeit consumer goods
* Counterfeit medicines online
* Drug checking Drug checking or pill testing is a way to reduce the harm from drug consumption by allowing users to find out the content and purity of substances that they intend to consume. This empowers users to make safer choices: to avoid more dangerous substa ...
* Drug fraud
Drug fraud is a type of fraud in which drugs, legal or illegal, are cut or altered in such a way that diminishes their value below that which they are sold for.
Illegal drug fraud
This type of drug fraud occurs when the dealer cuts or commin ...
* Health care fraud
* Lists about the pharmaceutical industry
These are Wikipedia lists about the pharmaceutical industry. The pharmaceutical industry develops, produces, and markets drugs or pharmaceuticals licensed for use as medications. Pharmaceutical companies are allowed to deal in generic or brand m ...
* New Scientist
''New Scientist'' is a magazine covering all aspects of science and technology. Based in London, it publishes weekly English-language editions in the United Kingdom, the United States and Australia. An editorially separate organisation publish ...
* Pharmaceutical fraud
Pharmaceutical fraud involves activities that result in false claims to insurers or programs such as Medicare in the United States or equivalent state programs for financial gain to a pharmaceutical company. There are several different schemes us ...
* Regulation of therapeutic goods
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are reg ...
* Robert Courtney Robert Courtney may refer to:
* Robert Courtney (fraudster)
* Robert Courtney (Paralympian)
Robert George Courtney (27 April 1959 – 28 January 2016) was a champion New Zealand Paralympian.
Early life
Born on 27 April 1959, Courtney spent ...
— American pharmacist who dispensed diluted cancer drugs between 1991 and 2001
* Security printing
Security printing is the field of the printing industry that deals with the printing of items such as banknotes, cheques, passports, tamper-evident labels, security tapes, product authentication, stock certificates, postage stamps and identity ...
* VAWD
References
External links
*{{Commonscatinline, Counterfeit medications
Pharmaceuticals policy
Pharmaceutical industry
Medications
Medical crime