THE HUNT FOR COUNTERFIET AND INFERIOR DRUGS
NSHM Group of Institutions Knowledge campus,
Department of Pharmaceutical Analysis & Quality Assurance
Counterfeit Culture is a one of the most important and dangerous crime in the world of drugs and its related products and explores the dangerous and sometimes deadly world of fake, fraudulent, and faux products. The pharmaceutical industry has a has history of peddled knock-off dosage forms, medical devices but during the last 15 years, it has mushroomed into a global phenomenon.
The range of counterfeit goods now being produced includes pharmaceuticals. The traffic in counterfeit goods is now estimated at a staggering $350 billion representing nearly 10% of all global trade. This illicit and highly profitable criminal enterprise continues to grow unabated and has been linked to organized crime syndicates around the world.
Shot on location in Canada, the USA, Asia, and Europe, Counterfeit Culture challenges consumers to take a deeper look at what would appear to be harmless knock-offs at prices and quality of drugs. This thought-provoking data provides an insight into what is now a world-wide menace that has been called the crime of the 21st century by WHO.
Recent statistical diagnostics reveal the detrimental effect of this fake drugs to the people due to their almost duplication of labels,API or other repective aspects related to the quality and safety of these products.some strict amendments and laws have been passed by the international organisations to fight these counterfeit drugs but awareness lies within mass with proper appeal and information.
REFERENCE ID: PHARMATUTOR-ART-1790
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. 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. Medicines which are deliberately mislabeled to deceive consumers—including mislabeled but otherwise genuine generic drugs—are counterfeit. 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.
Legitimate, correctly labeled, low-cost generic drugs are not counterfeit or fake (although they can be counterfeited), but can be caught up in anticounterfeiting enforcement measures.In that respect, a debate is raging as to whether "counterfeit products [are] first and foremost a threat to human health and safety or whether provoking anxiety is just a clever way for wealthy nations to create sympathy for increased protection of their intellectual property rights".Generic drugs are subject to normal regulations in countries where they are manufactured and sold.
Whether counterfeit or unintentionally substandard, poor quality medicines used to treat infectious diseases such as tuberculosis, malaria, and HIV/AIDs in developing countries may result not only in treatment failure but also in development of resistance to the few drugs available to treat them. The impact of these inferior drugs reaches beyond the health of the individual; it also leads to a loss of productivity and income due to death, disability, or extended disease duration.
In an effort to address the growing problem of poor quality medicines, the United States Pharmacopeia Drug Quality and Information (USP DQI) Program, with support from the U.S. Agency for International Development (USAID), is providing technical assistance to more than 30 developing countries. The program focuses on strengthening the capacity of medicine regulatory agencies to build quality into their processes. Strategies include increasing the ability of each country's national drug quality control laboratory to analyze medicines, providing current and unbiased information about drugs to consumers and healthcare providers, and exercising oversight of drug quality both before and after drugs hit the market.
THE EXTENT OF THE PROBLEM
The United States Food and Drug Administration estimates that counterfeits make up more than 10% of the global medicines market and are present in both industrialized and developing countries. It is estimated that up to 25% of the medicines consumed in poor countries are counterfeit or substandard.
These figures place the annual earnings from the sales of counterfeit and substandard medicines at over US$ 32 billion globally.
Trade in these medicines is more prevalent in countries with weak drug regulation control and enforcement, scarcity and/or erratic supply of basic medicines, unregulated markets and unaffordable prices. However, one of the most counterfeited drugs today is Viagra, which is sold extensively via the Internet in industrialized countries.
A World Health Organization (WHO) survey of counterfeit medicine reports from 20 countries between January 1999 to October 2000 found that 60% of counterfeit medicine cases occurred in poor countries and 40% in industralized countries.
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.
A recent study in The Lancet concluded that up to 40% of artusenate products (the best medicine to combat resistant malaria today) contain no active ingredients and therefore have no therapeutic benefits.
In 2002, GlaxoSmithKline in the United States discovered suspect bottles containing 60 tablets of Combivir (lamivudine plus zidovudine) that actually contained another medicine, Ziagen (abacavir sulfate). The company determined that counterfeit labels for Combivir tablets were placed on two bottles of Ziagen and labels on another two bottles were suspect. Both medicines are used as part of combination regimens to treat HIV infection and can cause potentially life-threatening hypersensitivity reactions in patients taking other medicines in the combination.
CONSEQUENCES OF SUSTANDARD DRUGS AND COUNTERFIET DRUGS
At best, the regular use of substandard or counterfeit medicines leads to therapeutic failure or drug resistance; in many cases it can lead to death.
During the meningitis epidemic in Niger in 1995, over 50 000 people were inoculated with fake vaccines, received as a gift from a country which thought they were safe. The exercise resulted in 2,500 deaths.
The consumption of paracetamol cough syrup prepared with diethylene glycol (a toxic chemical used in antifreeze) led to 89 deaths in Haiti in 1995 and 30 infant deaths in India in 1998.
Of the one million deaths that occur from malaria annually, as many as 200,000 would be avoidable if the medicines available were effective, of good quality and used correctly.
A study conducted in South-East Asia in 2001 revealed 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.
In 1999, at least 30 people died in Cambodia after taking counterfeit antimalarials prepared with sulphadoxine-pyrimethamine (an older, less effective antimalarial) which were sold as Artusenate.
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