ABOUT AUTHOR
Kunal Roy
NSHM Group of Institutions Knowledge campus,
Department of Pharmaceutical Analysis & Quality Assurance
Kolkata-700053
kunal.roy17@gmail.com
ABSTRACT:
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
INTRODUCTION:
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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CHALLENGES AND FACTORS ENCOURAGING THE CONTERFIET OF DRUGS
Because of a lack of regulation and enforcement, the quality, safety and efficacy of both imported and locally manufactured medicines in many developing countries cannot be guaranteed. Subsequently, smuggling and illegal importation of drugs are often rife. Substandard and counterfeit drugs are then not only sold in these countries but also exported or re-exported.
The situation is worsened by the fact that medicines exported from many industrialized countries are not regulated to the same level as those domestically consumed, while export of drugs to developing countries via free trade zones is increasing. Relabelling of products to mask details of their origin is also known to occur.
Some policy-makers now believe that drug regulation represents an unnecessary barrier to trade and should be reduced to a minimum. Pharmaceuticals, however, cannot be considered a standard commodity since consumers and prescribers are unable to assess their quality, safety and efficacy and the results can be harmful to patients’ health.
Growing international and national trade in alternative medicines, including herbal products, is also becoming more complex following rapid increases in demand. Significant quantities of herbal products are now imported by countries in Europe, North America and Asia. However, the use and production of herbal products remains largely unregulated and their safety and therapeutic value cannot always be guaranteed.
The production of counterfeit drugs need not occur in large infrastructures or facilities. The majority of the counterfeiters apprehended so far carried out their activities in ordinary households, small cottage industries, in backyards or under the shade of a tree.
Counterfeiting of medicines is a hugely lucrative business due to high demand and low production costs. The absence of deterrent legislation in many countries also encourages counterfeiters since there is no fear of being apprehended and prosecuted.
When prices of medicines are high and price differentials between identical products exist there is a greater incentive for the consumer to seek medicines outside the normal supply system. Poverty, then, is one of the major factors in the production and consumption of substandard products.
IMPROVING QUALITY IN ASIA AND OTHER COUNTRIES
The USP DQI program has also had success in Asia, another area rife with fake drugs. In the Southeast Asia/Western Pacific area, an estimated 10% to 35% of medicines are improperly made or illegally produced and sold. In 2004, USP DQI conducted a study revealing the wide availability of poor quality medicines in Mekong countries (Cambodia, Vietnam, Laos, Thailand, Myanmar, and Yunnan Province in China). The data suggest that up to 44% of artesunate (a common, highly efficacious antimalarial) samples collected from selected provinces contained no active ingredient at all.
The USAID Regional Development Mission sought help from USP DQI to turn the situation around, and the Mekong Antimalarial Drug Quality Surveillance Project was launched in Cambodia, Laos, Thailand, Vietnam, and Yunnan Province. Using established sentinel sites, USP DQI designed a protocol and trained staff in proper sampling techniques to collect and document medicines from area markets, pharmacies, and community healthcare facilities. The Mekong monitoring program has since grown from 17 to 39 sites and has expanded to collect other anti-infective medicines' for tuberculosis and HIV/AIDS, as well as some antibiotics. More importantly, the program serves as a model: Since 2005, USP DQI has established drug quality monitoring programs in 20 resource-limited countries, providing equipment, technical assistance, and training to almost 2,500 individuals.
The original Mekong program has expanded well beyond monitoring by recognizing the significance of maintaining drug quality at all levels in order to improve public health. In Vietnam and Laos, USP DQI and local partners have introduced an education program for community pharmacists, training them to provide care to people living with HIV/AIDS and supplying them with information on the safety and quality of medications. Because the community pharmacist is often the first place patients go to for drugs and medical advice, it can be a source of support for HIV/AIDS patients.
In Cambodia, the authorities have introduced an educational campaign to raise awareness among healthcare providers and the general public about the dangers of using fake drugs. With the help of USP DQI, several articles have been published in Health Messenger magazine and Medicam Health News, and 20,000 copies of the WHO Dealers in Death CD have been distributed to healthcare providers. In addition, USAID/Cambodia Mission, USP DQI, and the Thai production company Living Films have produced public service announcements (PSAs) illustrating the possible consequences of using substandard counterfeit medicines in the treatment of illnesses common to the region, such as malaria. The PSAs, which use local actors speaking in local languages, will air in Cambodia, Laos, Thailand, and Vietnam on government and private television, in village media presentations, on Web sites, and through cellular phone downloads.
To bolster and sustain regional initiatives, USP DQI initiated the Asian Network of Excellence in Quality Assurance of Medicines (ANE/QAM), which provides specialized training to local institutions. The University of Santo Thomas Center for Drug Research, Evaluation & Studies, located in the Philippines, concentrates on bioavailability/bioequivalence analysis. In Thailand, Mahidol University Faculty of Pharmacy specializes in good manufacturing practices (GMP), while Chulalongkorn University/Pharmaceutical System Research and Intelligence (PSyRIC) focuses on quality assurance/quality control and information management. PSyRIC is building a public drug quality database to centralize results of surveillance testing in Southeast Asia and the Western Pacific Region
In collaboration with the World Health Organization (WHO), USP DQI installed specialized drug registration software and trained the AMM registration division on its use, as well as on good registration procedures. With the upgraded laboratory equipment, updated standard operating procedures, and the essential supplies USP DQI provided, the LCQM is able to perform analysis using high performance liquid chromatography and other advanced techniques. USP DQI trained the LCQM staff on the essential concepts of good laboratory practices (GLP), pharmacopeial standards, and standard operating procedures. It also taught hands-on laboratory training on pharmacopeial testing methods from basic dissolution to advanced testing for bacterial endotoxins. In Antananarivo and in five provinces throughout Madagascar, USP DQI and the AMM have established a drug quality monitoring program that collects, documents, and tests medicines from area markets, pharmacies, and community healthcare facilities.
Sophisticated laboratory facilities are rarely available in the field, so USP DQI teaches simple, practical methods for early detection of substandard and counterfeit drugs. To reach rural areas where the disease burden is generally higher, USP DQI supplies surveillance sites with Minilabs, portable laboratories designed by the Global Pharma Health Fund that contain the necessary labware and reagents to test drugs for content, identification, purity, and dissolution. Local analysts are trained to perform basic tests, including visual inspection, disintegration, and thin layer chromatography. The LCQM now trains medical students from the Faculty of Medicine of Antananarivo and assigns them to sentinel sites to test the quality of drugs in the provinces. This collaboration introduces the importance of drug quality and its practical application into the university curriculum.
Within months of USP DQI training its staff, the LCQM had collected and tested a variety of drug samples for the first time in Madagascar and had discovered substandard drugs in the market. In Antananarivo, of the 46 drugs fully tested by the LCQM lab from public, private, and informal sectors, 22% were found to be substandard. Since that time, the drug quality monitoring program has analyzed more than 1,600 samples in two rounds of testing nationwide. As a result, the AMM has recalled three essential drugs from the market nationwide, closed two pharmacies, and withdrawn 16 lots of medicines.
USP DQI has also supported the AMM in establishing a pharmacovigilance program that routinely collects data on adverse drug reactions (ADRs) from drugs that are already on the market. USP DQI facilitated the training of all Ministry of Health staff, ensuring their support of all pharmacovigilance activities. In 2007, the program began expanding to the sentinel sites, anticipating the need to monitor ADRs that might arise from the country's rollout of ACTs for malaria.
USP DQI most recently assisted in establishing a Drug Information Center (DIC) in Antananarivo-the first in the country-which will provide drug information to healthcare providers and consumers.
NATIONAL ADDRESS TO COUNTERFIET DRUGS
Legislation forms the basis for drug regulation. Medicines need to be safe, effective and of good quality in order to produce the desired effect. Ensuring these properties requires the creation of competent national drug regulatory authorities with the necessary human and other resources to control the manufacture, importation, distribution and sale of medicines.
Governments need to develop strategies to reduce corruption and criminal activity and promote intersectoral cooperation between regulatory authorities, police, customs services and the judiciary to effectively control the drug market and enforce drug regulation.
Since the opening up of trade barriers between countries has led to an increase in counterfeiting, consistent and systematic efforts are needed at the international level. These should include the timely and appropriate exchange of information and the harmonization of measures to prevent the spread of these phenomena.
Some countries have begun to make serious efforts to address the counterfeit medicines issue. In China last year, for instance, the State Drug Administration closed 1,300 illegal factories and investigated cases of counterfeit drugs worth US$ 57million.
ANTICOUNTERFIET 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.
In 2010, NAFDAC 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 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 theyhandle. On January 5, 2007 EPCglobal ratified the Pedigree Standard as an international standard that specifies an XMLdescription of the life history of a product across an arbitrarily complex supply chain.As counterfeit drugs are becoming increasingly available (the US-based Centre for Medicines in the Public Interest predicts that counterfeit drug sales will be worth an estimated US$75 billion globally in 2010), the technology that is used to manufacture these fake medicines is becoming more and more sophisticated.
CERAM Surface and Materials Analysis, together with GlaxoSmithKline, has developed a method of identifying counterfeit tablets, when compared to genuine drugs, by utilising techniques such as XPS and ToFSIMS.
Further to normal methods of looking at composition, this method concentrates on process and the manufacturing route of the drugs, the end result being that previously undetectable chemical copies of pharmaceuticals can be identified.
Some products from ACG Worldwide that addresses the global challenge of drug counterfeiting are:
Brandshield 360
Brandshield 360 is a unique technology pioneered by ACG Associated Capsules that helps in protecting and retaining brand identity. This technology enables you to have your capsules printed in two colors, around the circumference with high accuracy. It creates a powerful impact and is difficult to duplicate.
Verif-i (Track and Trace Solutions)
Verif-i by ACG Inspection empowers businesses to protect their brands in real time. With Verif-i, the end user can authenticate the genuineness of the product via an SMS. It is an ideal counterfeit solution that will help you generate valuable customer data, monitor usage patterns and provide customer service. Verif-i combats counterfeiting as an open, flexible, and efficient monitoring solution for capturing and managing end-to-end supply chain events.
Brandshield Galaxy
Brandshield Galaxy from ACG Pharmapack is an advanced holographic film for blister packaging. This anti-counterfeiting solution focuses on security and brand protection along with an aesthetic appeal. The holographic images embedded cannot be tampered with, duplicated or copied.
COLLABORATING WITH INTERNATIONAL ORGANISATION
USP DQI is also called upon by international organizations to provide technical assistance in quality assurance. Acting on a request from UNICEF in 2005, USP DQI was instrumental in rolling out the provision of zinc supplements for childhood diarrheal disease control. At that time, zinc was not marketed as a sole active ingredient-much less in the recommended dosage-with reliable quality or in a form conducive to easy distribution or willing consumption. USP DQI worked with French manufacturer Nutriset to increase its capacity in GMP and to become WHO pre-qualified for production of zinc supplements. USP developed monographs for zinc formulations, helped draft guidelines for the production of those formulations, and helped manufacturers to comply with GMP guidelines. USP DQI has also assisted the Bangladeshi company Square Pharmaceuticals to become WHO pre-qualified and is now working toward the same goal with Shelys Pharmaceuticals Limited in Tanzania.
USP DQI and WHO are also collaborating on Quality of Antimalarials in Sub-Saharan Africa (QAMSA), a joint study to assess the quality of antimalarials in 10 sub-Saharan African countries. The study will provide baseline data on the extent of the problem of counterfeit and substandard products in sub-Saharan African countries and identify possible causes. USP DQI staff has trained representatives from each country on sampling procedures and basic tests, in addition to providing Minilabs and equipment to the three countries it sponsors. USP DQI continues to provide technical oversight, train additional country representatives and lab analysts, oversee sample analyses, and disseminate the data obtained to all countries involved. With the information from the QAMSA study, USP DQI and other stakeholders can propose possible strategies to address drug quality problems.
Countries with operational drug quality monitoring programs recently have begun to focus on pharmacovigilance. The same ADR reporting systems used in developed countries cannot be used in developing countries; they must be adapted to each individual setting. USP DQI sets up ADR reporting systems with a focus on new medicines used in the treatment of malaria, tuberculosis, and in the management of HIV/AIDS.
USP DQI collaborates with WHO pharmacovigilance experts to design programs based on available human and financial resources. With WHO and USAID, USP DQI has facilitated workshops on how to develop a pharmacovigilance program in Tanzania, Madagascar, and Cambodia and has provided support with implementation. The 2007 workshop for Francophone Africa, held at the National Pharmacovigilance Centre of Morocco, offered a first-of-its-kind hands-on training that examined the general aspects of pharmacovigilance, as well as issues specific to the safety of HIV/AIDS and antimalarial medicines in African countries.
CONCLUSION
The increasing globalization of commerce and trade, and the merging of pharmaceutical companies, are internationalizing pharmaceutical production. International pharmaceutical norms and standards are thus more important than ever before since they serve as global tools aiming to ensure safety and quality of medicines
Rapidly evolving science and technology are likewise creating problems for regulatory authorities everywhere. Training and specialization requirements for dealing with the ever-increasing complexity of assessing technologically advanced products can be especially burdensome. But by developing norms and standards for use in new areas of health technology and product development, WHO can reduce this problem, while at the same time helping to minimize unnecessary duplication of scientific expertise and effort.
Globalization of the pharmaceutical industry is also bringing other safety issues to the fore. For example, non-prescription medicines are becoming increasingly available to the general public in all countries, including through such channels as the Internet. Yet resources for monitoring their safety and quality are often lacking and fight must be fought for safety,health and well-being by all against these kind of fake,inferior and fake drugs.
REFERENCES
1. United States Food and Drug Administration. U.S. Department of Health and Human Services. Counterfeit Drug Task Force Interim Report. Rockville, Md.: U.S. Food and Drug Administration; 2003. Available at: fda.gov/oc/initiatives/counterfeit/report/interim_report.html. Accessed November 18, 2008.
2. United States Pharmacopeia Drug Quality and Information Program. Mekong Malaria Initiative. Antimalarial Drug Quality Monitoring and Evaluation: Project Update. Rockville, Md.: United States Pharmacopeial Convention; 2004.
3.Mark Davison, "Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs", Wiley, 2011, 426pp
4. "WHO | Substandard and counterfeit medicines". Who.int. August 25, 2004. who.int/mediacentre/factsheets/2003/fs275/en/. Retrieved March 12, 2012.
5. allAfrica.com: Ghana: Country to Use SMS to Fight Fake Drugs .
6. Drug Anti-counterfeit Solution:ACG solutions.
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