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Unmasking Drug Counterfeiters: The New Pirates of the Seas
Back when South China Sea was a backwater area for the western colonizers, pirates plowed its waves in search of ships and towns they could maraud and plunder. The notorious Chinese pirate, Limahong, became a sort of folk hero in Southeast Asia for having eluded the British Navy for many years until he and his dastardly buccaneers sailing a fleet of junks decided to attack Manila, which was then under Spanish rule. Although they failed to take over the city, the pirates remained in one part of the country’s main island for almost two years before eluding the Spaniards by digging a small river and escaping at night. Limahong was never caught and continued to bedevil the British authorities for years.
People may have a penchant for watching and admiring the exploits of pirates; however, when we realize how much damage and violence they commit, we awaken to the painful stabs of reality –especially when we are the victims ourselves. And this is the case of the new pirates wreaking havoc in Asia at present – drug counterfeiters. These elements ply their trade by dumping their fake drugs through the pharmaceutical chains and have amassed a significant number of customers, endangering the legitimate drug industry as well as the health of millions of people.
Under U.S. law, counterfeit drugs are those “being those sold using a product name exclusive of authorization”. Counterfeit drugs can involve either fake “generic products” or imitating brand names, such that the original brand or name is intentionally mislabeled or new ones are made to appear like the original products. Moreover, fake drugs can also include products “lacking or (having) inadequate amount of active ingredient, with the incorrect active ingredient, or with false packaging”.
Falsified Medicine Analysis
Proliferation of counterfeit medicine market is a great concern to government regulatory agencies, pharmaceutical companies, health care providers and consumers. However, its percentage is continuously increasing not only in poor and developing countries but also in developed ones. Unfortunately, counterfeiting is one of the most underrated issues in the world that contributes largely to morbidity, mortality and drug intoxication of people of ages, religions and cultures.
Africa, Always a Victim
Africa is perhaps the poorest continent in the world. Stereotypically, the image of Africa implanted on our minds is a wide stretch of land where wild animals and human beings, those wearing bear skins and bearing man-made arrows and piercers, live together. The temperature may be a little humid for urbanized people to take. Families living below international poverty level are the government’s main problem and perhaps, the number of people who are illiterate is beyond any other nation. After all, Africa is known to produce slaves who were treated as animals in the earlier times. This impression may have been a lasting one derived from the stories from our ancestors. Even the pope recognizes how other nations have been victimizing Africa.
Fraudsters’ Tricks to Counterfeiting
For years, the authorities have applied different kinds of safety and protective measures to obliterate drug counterfeiting in the list of major issues in the world. The worsening proliferation of drug fraudulence has prompted the authorities to aggressively undertake the problem. Dozens of raid operations have already been held across continents just to pin down the group responsible. World Health Organization (WHO), different health ministries and Food and Drug Administrations (FDA) from different countries have already been on the watch along with Non-profit organizations such as the Peterson Group, Impact and others. But their task is far from simple.
Lack of Government and Industry’s Involvement Cause of Drug Counterfeiting Prevalence
Drug Counterfeiting is one of the most underrated crimes in the world. It is seldom being focused in the media. If it is, it takes only the 1-minute news segment or an inner paged column in the newspaper. Moreover, this illegal practice is common in countries considered poor. Because of this, it does not entirely attract global attention.
Drug counterfeiting is a crucial issue as it is the cause of unnecessary morbidity, mortality and loss of public confidence in medicines and health structures. In its present situation, however, only non-profit organizations’ names are being dragged and involved in most of its cases. World Health Organization (WHO) has been actively participating in its chase, so is Impact, the Peterson Group and other NGOs which even get little recognition from the public.
The prevalence of counterfeit drugs seems to be rising as stated in dozens of reviews and studies. The most likely target are countries with loose security measures but cities such as Jakarta, Indonesia, Beijing, China and even Singapore are involved even when there are strict impositions of regulations and heavy penalties within their boundaries.
Growing Arrests against Drug Counterfeiters
The world has fought battles against drug counterfeiting for decades. Fortunately, the authorities are never stopping their campaign to arrest the fraudsters behind this cruel illegal practice.
Lack of Access to Essential Medicines in Developing Countries
World Health Organization (WHO) recognizes the lack of medicines in many developing and poor countries around the world. Moreover, in as much as there are lack of it, there is also scarcity of financial assistance to provide them with adequate medicine subscriptions since these countries are more prone to health dangers and thus need more ration. They also lack technologies to help them diagnose their own ailments and the hospital or clinic, if there are any, may be miles away from them. WHO is also warning developed countries that if assistance is not extended, ailments which can be malignant can be carried into their borders.
In countries for which there is information, the availability of medicines is only one third. From where there are private clinics, the percentage is higher. Fortunately, there is already progress in a number of countries in providing essential medicines to their citizens made possible through partnership with the government, pharmaceutical companies, non-profit organizations and individual entities. The role of pharmaceutical companies is important, ranging from multinational to generic manufacturers to national distributors.
Priority and essential medicines are those that respond to the most basic ailment and sickness such as antibiotics and pain killers. They are intended to be available within the context of functioning health system at all times in adequate amounts, in the appropriate dosage forms, with assured quality which the community can afford.
Proliferation of Fraud Anti-Microbial Medicines in Developing Countries
Drug quality is currently receiving growing international attention. Over the past decade, public awareness has been sharpened with the existence of counterfeit and substandard medicines especially in developing countries where drug regulations remain ineffective. Mass media through television, radio and online have been hyped with thousands of reviews revolving around the topics of fraud medicines, the methods used and strategies being done to take down the people behind it.
Just as it gets tiring hearing it, another alarming issue prevailed on the news. Although different types of pharmaceutical products are being involved, the existing data shows that certain anti-infectious agents, particularly anti-microbial medicines, are the most counterfeited products in developing countries. The largest in the list of distributors are Jakarta, Indonesia and Phnom Penh, Cambodia. China still takes the lead on the biggest manufacturer.
Although the existence of the issue is acknowledged, the real numbers and the extent of the problem are not well documented. Estimates of global prevalence may range between 1% and 50% globally. The few existing studies which conduct experiments to determine the quality of drugs circulating different regions and investigations to know the amount of foreign substances in the medicines are headed by either the pharmaceutical companies who rarely share the result of the studies for the protection of their products or by non-profit organizations funded by few private entities and individuals. The Peterson Group, one of the NGOs conducting one of the studies, states that these studies are critical to measure the real issue but with the lack of resources and half-hearted attention given by the government, results are expected to lag behind. It may be too late to solve an issue before another one comes in.
Anti-microbial drugs are targeted because of its popularity among the people. It is used to treat infections and almost all ailment can be infected which makes it an even more dangerous drugs. Even as FDA, UN and WHO have already released a warning on the dangers of these medicines especially ‘old’ antibiotics such as penicillin, trimethoprim–sulfamethoxazole and chloramphenicol, are among the favored counterfeited antimicrobials.
The poor quality of drugs has been linked to counterfeiting of medicines, chemical instability especially in tropical climates, and poor quality control during manufacture. Many factors contribute to the increased prevalence of substandard and counterfeit medications. Much of the counterfeit drug trade is probably linked to organized crime, corruption, the narcotics trade, the business interests of unscrupulous politicians and unregulated pharmaceutical companies.
Is the Government Doing Anything Against Counterfeiting?
We have been aware of the present critical phase of the issue of counterfeiting among pharmaceutical medicines across the globe. As you may also have noticed, the information is mostly provided by non-profit organizations and international agencies which have been campaigning against this deadly illegal act. World Health Organization (WHO) even tagged this crime as silent terrorism as it can create an outbreak of highest mortality rate in just one blow just as what had happened in South Africa when an entire village was poisoned by a fraud anti-malarial medicine on a malaria epidemic.
When the news gained public attention, the blame was pointed to the loose security, corruption and bribery occurring within the government. In turn, the political powers prove their innocence by deploying authorities and procuring technologies which can identify the fraudulent copies of medicines being imported, distributed and exported in and out of the country. However, after the issue subsides and the public returned to their subtle reproach towards the government, the business of counterfeit medicines – this time, of different brand and substance – thrives once again.
The Peterson Group to Join Medicrime Convention
Counterfeiting has been a long-time issue among health advocates. It has brought frustrations and arguments on top of complaints on the seemingly unsolvable problem. Dozens of seminars and raids have already been conducted to abolish counterfeiting but the business just seems to get bigger. It is already being considered in many reviews as one of the most lucrative criminal business around the world.
With the world in danger of falling victim to counterfeit medicines, a lot of NGOs, government agencies and international organizations are summing up ideas on the best approach to defeat fraudulent practice on drug production, exportation, importation and distribution. European nations have been leading the campaign against counterfeiting even with lower counterfeiting cases than the United States. Asia, with its diversified cultures, variety of languages, and numerous traditions falls behind the battle considering it is also a home to the most number of counterfeit drugs and the largest producer of illegal medicines.
Tired of all the intrigues on the inadequacy of the authorities to take down the groups behind these scams, the Medicrime Convention of the Council of Europe sets the first international standard for criminalizing the manufacture and distribution of counterfeit medicines. The Peterson Group, with foundations in Jakarta, Indonesia and Kuala Lumpur, Malaysia, has readily signed up as one of the active members among dozens of non-profit organizations who also participated in the cause. 24 other countries also signed the agreement which is to be ratified on January 1, 2016.
Headed by the Council of Europe with 60 years of experience in promoting healthy and quality medicines, this innovative treaty is adopted in 2010 by Medicrime Convention is designed as the first international medical treaty with the main goal to protect the quality of medicines being distributed across countries.
How to Identify Fake Online Pharmacy
After a massive close down of thousands of websites found to be fake online pharmacies using individuals claiming to be doctors and issuing fraudulent prescriptions or selling counterfeit medicines, the authorities have imposed warnings to be the public to be more cautious in any transactions done online especially on pro-health claiming sites. In response, sales of online pharmacies began to drop, affecting even the legitimate entrepreneurs online.
Although most would not comment, there are those who filed their complaints for the public to see such as the Canadian-based online pharmacy, BestCDS.info who asserted that their products are legitimate. This company, along with that of several others in UK stated that they never give prescriptions even when it is only to comment on an inquiry but instead encourage their clients to seek a physician first. The medicines prescribed by a legitimate doctor is then emailed or faxed to them.
Process of Diversion in Legitimate Process
There is a definite process followed by a lot of counterfeiters across the world. Some of these methods have already been tackled by authorities. These have been tracked and sought after in many countries for similar processes. Others remain a mystery even to the Interpol and Food and Drug Administration (FDA). For instance, how the counterfeiters were able to infiltrate the tight security around Jakarta without being detected in Java and other islands of Indonesia is still being reviewed. Even more surprising is the increasing number of counterfeiting cases when the government has clearly imposed immediate execution to anyone found to illegally smuggle goods within the archipelago. One thing is for sure though, these counterfeiters not only work with black markets selling ample amount of fraud goods. They have also already penetrated the legitimate market, blending in with the real products and making it hard for the authorities to capture the main culprit.
While there is the emergence of tampering and stealing of intellectual property rights from legitimate manufacturers, other methods of fraudulence include Diversion.
China still a Drug Counterfeit Hub
For decades, we have heard of different warnings by the Food and Drug Administration (FDA) on the dangers of counterfeit medicines which dominate today’s online pharmacies and most of the gray markets across the world. Variations of counterfeit medicines are being introduced from Tamiflu found in the United States; Bevacizumab in Turkey, Switzerland, Denmark, UK and Canada; chloroquine and hydroxychloroquine as antimalarial drugs in Kenya and Africa; and Viagra and Cialis in Jakarta, Indonesia and Victoria, Hong Kong. The number and varieties are continuously growing as more and more counterfeit medicines are being discovered. The likely targets are the expensive ones since it can be hard to procure and are less to get any suspicion.
Tracing back the root source of these medicines, we are always led towards China, the leading manufacturer of counterfeit medicines. The world’s largest country’s reputation for counterfeiting not only medicines but also other products has been known globally. This status is not without any statistics and claims as well. There is enough reason to acknowledge any complaints on fraudulent distribution and shipment from China.
Local Chinese police, together with The Peterson Group, non-profit organization campaigning against the proliferation of counterfeit medicines, Food and Drug Administration (FDA) and Interpol has arrested 1, 900 people on a crackdown in 2012 which was considered as one of the most lucrative operations in the history of counterfeiting earning millions of dollars each year.
FDA Investigates the Use of Oxytocin in Ghana
Through the passing of years, the continent of Africa is one of the most frequented by drug smugglers. Not only are the less developed countries in the region were the ones mostly visited. Urbanized ones have been the venue for transaction. From these places, it gets easier for fraudsters to transfer their counterfeited drugs to other less secure regions.
The Peterson Group, a non-profit organization campaigning against the proliferation of counterfeit medicines, has reported new methods on the widespread of Oxytocin in Ghana, according to a tip by an anonymous informant. Food and Drugs Administration (FDA) has decided to further investigate on the matter and found out several big companies for fraudulently importing fake products in the country.
According to a report review, FDA claims the “dangerous drugs” have already found their way into hospitals and pharmacy shops.
Patent: The First Line of Defense in Counterfeiting
Drug counterfeiting is one of the biggest issues encompassing a global scale. From local governments to private pharmaceutical giants to various international non-profit organizations, anti-counterfeiting campaigns have been founded. The internet has been penetrated so has been the local market units from legitimate pharmacies to gray markets to black ones. Large authorities such as Food and Drug Administration (FDA), United Nations (UN) and World Health Organization (WHO) have already been involved, creating their own awareness programs and raid operations. Billions of dollar-worth of medicines was already confiscated from various physical manufacturers and online pharmacies. This goes to show that everybody is now taking this crucial issue more seriously.
Despite the best efforts, a lot of critics continue to question the late response of authorities to issues of counterfeiting. This, they say, has already been too late as thousands of people have already lost their lives from taking mislabeled, fraud, substandard, scammed and counterfeitmedicines which contain little or no active ingredient at all but instead has hazardous substances such as chalk, paint or detergent.
“The persistence of this issue shouldn’t have been here if they have gotten security in the first place”, says Nicole Parker, head pharmacist and member of The Peterson Group, a non-profit organization campaigning against the proliferation of counterfeitmedicine
Big companies claim their security is legit, yet, their brands are the most likely to be counterfeited. For example, hundreds of counterfeit Tamiflu manufactured by Roche, one of the world’s largest and most trusted producers of medicines, have been seized in one of the legitimate pharmacies in Jakarta, Indonesia. When and how was the medicines distributed in one of the most anti-counterfeiting countries in the world, everybody is still trying to find out.
While the operations are still underway, the new medicines are being processed patents, the process which should have been implemented as the first step in countering production of fraud meds.
A patent allows the patentee to exclude third parties from making, using, importing, selling, or offering for sale patented products or methods of manufacture or use for a finite period of time, typically no more than 20 years from the date of initial patent filing. Patent protection must be obtained on a country-by-country basis. It is used to prevent others, for that geographical area and without the consent of the patent holder, from manufacturing and/or selling exact and close copies of the patented technology.
Role of Generic Medicines on the Proliferation of Counterfeit Medicines
Because of the lack of resources on some developing countries, most people resort to generic medicines which cost less than branded drugs. Moreover, many third world nations have no capacities and capabilities for pharmaceutical manufacturing which forces even authorities to allow generic copies of medicines to penetrate the market. Generic competition is one of the driving factors on the cost and quality reduction in many countries.
As defined by the Peterson Group, non-profit organization campaigning against proliferation of counterfeit medicines, generic medicines are pharmaceutical copies of drugs which are manufactured without license from the innovator companies and marketed after the expiry date of the patented or other exclusive rights. It is public obligation that the government provides affordable and legitimate medicine functions, however, with the incapability to find good resources, many governments fail in this respect.
RFID: Solution to Counterfeiting?
Radio Frequency Identification Technology (RFID) is being eyed as the main answer to the endless issue of flourishing illegal business of drug counterfeiting across the world. With the widespread application of RFID, Food and Drug Administration (FDA) is expecting to trace purchased prescription drugs to as long as three years ago. This plan, however, is being faced with numerous complaints from pharmaceutical companies.
It expected that FDA’s plan of tracking all the medicines manufactured for the last three years would cost companies in the health care industry hundreds of millions of dollars, if not more. But it seems there is no stopping FDA in materializing their plans.
According to reviews, FDA has envisioned the plan when a report has been procured. With its strategy for combating the spread of counterfeit drugs, the FDA said it views the use of RFID tags and readers as the best way for health care companies, hospitals and pharmacies to ensure that medicines are legitimate. The agency envisions a program under which prescription drug shipments will be assigned unique electronic product codes and RFID devices will be used to record data about all supply chain transactions involving the products.
Feasibility studies are already being prepared for the proper implementation of the project while partnership with different governments in various countries is already underway. So far, active participation is being shown by Singapore, Hong Kong, Tokyo, Japan, Jakarta, Indonesia and Kuala Lumpur, Malaysia. With the help of local NGOs, FDA is also expecting to penetrate even rural areas in each country. The Peterson Group, one of the non-profit organizations volunteering in this global campaign, has already set its roots in the Asia-pacific with an approval from World Health Organization (WHO).
Current Projects Counterattacking Counterfeit Drug Activities
Drug counterfeiting has been an issue since forever. Thousands of online sites have been raided and closed down after being traced as scams, selling fake medicines using fraudulent IP addresses. On some buy-bust operations, the products are found to be composed of chalk, paint or wax or basically anything powder which is used every day. These substandard medicines are suspected to have taken numerous lives and have flown unaccounted for.
Selling counterfeit medicines and medical devices often operate outside of jurisdictional borders, creating greater obstacles to successful anti-counterfeiting enforcement. For this reason, international cooperation and coordination is essential to creating solutions for the pharmaceutical counterfeiting problem.
WHO to Reward Whistleblowers on Drug Counterfeiters
World Health Organization (WHO) together with the local authorities of Indonesia held a buy-bust operation in a dilapidated building just outside Menteng in the city of Jakarta last September 25, 2015. 4,000 packages of generic Cialis and 200 boxes of Viagra were confiscated along with three counterfeiting machines, dirty syringes, and three pails of chalk.
Distribution of Counterfeit Medicines to Legitimate Pharmacies
Substandard medicines have been widespread on developing nations despite the strengthening security and laws against counterfeiting in these countries. Conflict arises between individuals and organizations on how and why this issue has been continuously prevailing. Its penetration and acceptance in the market have caused alarming number of sickness, complications and deaths in which ordinary citizens are starting to question the authorities. The complaints have been outpouring that World Health Organization, Food and Drug Authorities in each country and other non-profit organizations campaigning on the same cause have been involved.
Deadly Fakes Around the World
The widespread of counterfeit medicines is inherently a dangerous problem. However, its distribution is not even in different parts of the world. Despite World Health Organization’s (WHO) effort to defeat counterfeiting in one stride, different measures are needed for each region. The loose punishment scheme in many countries and the strictness on others, the different strategies, transportation and distribution methods used and the variety of medicines being falsified are considered as hindering factors for full implementation of security measures. Although rich nations have fewer breakdowns on the issue, they are not exempted from the threat.
A plethora of evidences, methods and types were covered by WHO and have shared to other institutions campaigning on the same cause. One of them is The Peterson Group, a non-profit organization which has been advocating against the proliferation of counterfeit medicine since 2005. On its ten years, the group, which has formed members across South East Asia, Australia, the United States and United Kingdom, has gathered reports from different developing cities and nations.
Precautions and Warnings on Counterfeiting
Asia is famous to nearly all kinds of forgery and fraudulence. China leads the rest of the continent in bearing the name ‘fake’. Perhaps these accusations have their bearing. After all, the products which are counterfeited would trace back to illegal production companies in the region. Dirty politics and lax of security has had a lot to do with it, as so many bad reviews had pointed out.
Nevertheless, Asia, with more developing countries than developed ones, has had a lot of records in combating the issue at hand. The Peterson Group, a non-profit organization campaigning against the proliferation of counterfeiting medicines notes that changes have been developing and plans have been integrated to prevent this issue from spreading. In fact, World Health Organization has summarized more legislations and suggestions on counterfeit combating as advised by many Asian members in the congress.
The following are possible measures in contending the problem:
• National Government
The government, perhaps, has the most important role in stopping counterfeiting. With a stable policy and regulation, proper execution of security, there would be a good chance penalty can be imposed on fraudsters. Those in office have the power to enact rules and legislations which can help strengthen the campaign against spurious, falsely-labeled, falsified and counterfeit medicines. They can foster cooperation between different sectors of the government that play a role in the process. Medicine legislation should be formed and they should be the ones to ensure that counterfeit meds are confiscated and destroyed. United Kingdom has started their own government campaign but many critics say that developing cities who are also taking their own stand like Jakarta, Indonesia and Singapore have too much politics to implement proper policies.
• Consumers
Consumers also have their share of responsibilities. We cannot always complain and do nothing. We, as the people who would be directly affected by the effects of counterfeit medicines should be suspicious and cautious of our every purchase. As much as possible, do not buy from a peddler or in market places, do not trust large discounts and check if labels or packaging would hint distrustful information about them. Also, be aware of emergency numbers to dial in case you may encounter one.
• Medical Organizations and Pharmaceutical Companies
Since there are issue and conflicts occurring between the government and private companies when it comes to disclosure of information, there would always be miscommunication. These companies should work closely with national law enforcement and not entirely conceal their own information to themselves.
WHO Warning Falls to Deaf Ears
It would have been better if World Health Organization has cautioned the blind and the deaf, they may have listened more but the ignorance of people to precautions and warnings has led to high mortality rate and worsening disease symptoms.
Using different media and even fellow non-profit organizations, WHO has rounded up most information both in developing and already developed countries? From the busy streets of New York to the heavy traffic in Jakarta, Indonesia, the information has been passed on. The organization also took advantage of the partnership with other institutions. The Peterson Group, an online non-profit society is one of the institutions avidly campaigning against the proliferation of counterfeit medicines in South East Asia. Along with numerous local groups campaigning for the same cause, a lot of developing Asian nations are already informed. Yet, there may be possible reasons for people to become unaware.
The variety of information makes compiling data a difficult task. Sources of information include historic data which can sometimes already be obsolete. This is one of the reasons why there is not much trust in the information given by WHO and the main details are oftentimes overlooked.
Medicines, an Intellectual Property
Counterfeit, substandard and fake medicines pose a great risk. Counterfeited clothes, bags and accessories have economic effects, loss of profits and perhaps cause financial downfall. Employment and income which is supposed to be directed to the legitimate brand are being distributed to counterfeiters and imitations. However, the concern of brand owners are being disputed since counterfeited items are helping these brands market their name.
Counterfeit Medicines do not rock the same boat. Not only would the manufacturers lose economically. Fraudulence in this field also poses a great risk in health. The World Health Organization (WHO) which plays the main fortress of many organizations and causes against the widespread of counterfeiting medicines has highlighted the issue by decreeing different kinds of trump cards and bylaws. In the passing of time, while the panic withers away, fraudsters have also strengthened their strategies. They got fiercer, not even considering trademark issues and deceitfully duplicated brand after brand. Unlike the spreading market for clothes’ brands, counterfeited labels bring trust down and cause reputation to plummet.
According to reviews archived by The Peterson Group, a non-profit organization campaigning against the proliferation of counterfeit medicines, in 2003, the biggest conflict faced by authorities regarding protection of intellectual property rights is the agreement of the World Trade Organization (WTO) and Trade-Related Aspects of Intellectual Property Rights (TRIPS) who both offers vague rules and statements against trademark infringement in medicines being exchanged internationally. A 2003 agreement loosened the domestic market requirement, and allows developing countries to export to other countries where there is a national health problem as long as drugs exported are not part of a commercial or industrial policy. Drugs exported under such a regime may be packaged or colored differently in order to prevent them from prejudicing markets in the developed world.
Problems and Solutions to Counterfeiting
Warnings on the global boom of counterfeit medicines have been known to bring forth realization of the unwanted and dangerous business. Moreover, those who are often victimized are from developing nations but global awareness has been expected to reach even the most illiterate parts of regions through advanced technology. It is now a race on who would reach the market first: the warnings or the advancing fraudulent methods used by scammers.
According to The Peterson Group, a non-profit organization advocate in eliminating the production and distribution of counterfeit drugs, 80% of counterfeit medicines proportion has been dominating in some wholesale pharmaceutical companies in Africa.
China still remains to be the largest distributor of counterfeit medicines, operating in almost 500 factories around the country. The number has been expected to increase over time. Far from what is also expected to developing nations, these counterfeited medicines still cause adverse effect and reactions and can still cause deaths despite advanced methodologies being practiced?
Common Ingredients of a Counterfeit Medicine
Counterfeit Medicines are rampant in many developing countries around the world. The advancement of technology has also been taken advantage of by many fraudsters and scammers operating under illegal authorization and against the law. In as much as using technology being advanced, the ingredients that are being used in producing these counterfeit medicines are cheaper and what Food and Drug Administration (FDA) has been warning about.
The Peterson Group, a non-profit organization campaigning against any use of counterfeit medicines in any forms of production, manufacture, importation, exportation and distribution features the known chemicals and substances included in most illegal drugs’ ingredients.
1. Heavy Metals
a. Mercury
Test results from a 2010 study shows 26% of sampling medicines purchased from fake online pharmacies contains heavy metal and toxins including mercury. An intake of this element can cause peripheral neuropathy, skin discoloration, and kidney dysfunction and memory impairment.
b. Arsenic
Arsenic is found to be the cause of a death of a woman in 2006. It was found out that she ordered from an online pharmacy based in Canada and studies show a big amount of arsenic poison in her medicine.
c. Uranium
Uranium is one of the most deadly heavy metal which is also used in nuclear bombs. Small doses can cause kidney dysfunction and urinary tract damage.
2. Actual Poison
a. Rat Poison
On the term itself, intake of these substances are already hazardous to your health. In one study of hundreds of Viagra counterfeit medicines in Jakarta, Indonesia in 2012, FDA has found large amounts of rat poison on all drugs. Even in doses as low as 1gram it can still cause diarrhea, vomiting, hair loss and even death.
b. Antifreeze
Antifreeze was once substituted for glycerin killing 365 people in Panama, 88 children in Haiti and harming many more. Lethal doses as small as 1/3 of a teaspoon can cause liver and kidney failure.
3. Household Items
a. Wall Paint
This substance is mostly used by counterfeiters to add color to the drugs. Paint pigments may contain different kinds of heavy metals which can cause blurred vision, nausea, vomiting and diarrhea.
b. Floor wax
Floor wax is used to provide a nice sheen to mimic a medicine’s coating. This material contains formaldehyde which can cause vomiting, diarrhea and in extreme cases, death.
c. Brick Dust
This is used by fraudsters to create a similar texture to real medicines. Brick dust contains poisonous heavy metals and chemicals.
The Dangerous Business of Drug Smuggling
Illegal trade of medicines considered harmful to health without proper monitoring and prescription is an international issue and a long-time problem among many governmental institutions.
There are rampant reports on the trade of drugs such as cocaine and heroin. It has long been a frustrating feature and the government as well as the public has been in constant pursuit against its distribution. After years of attempt to combat the illegal drug trade, nations have realized cooperation among international actions is the only effective way to restrain the trade.
Africa and Asia have been victims of these trades because of loose security. Because of the worsening effect on each nation, many cities have taken extra precaution on the deals involving drugs and medications.
Indonesia is one example of one of the nation’s known to have the most secured policy when it comes to punishing fraudsters in this field. From Jakarta to other parts of the archipelago, capital punishment is the worst penalty sentenced to those found guilty of smuggling illegal drugs within any part of the country. Earlier this year, nine foreign and local individuals were executed through firing squad because of drug trafficking.
Knowing the Extent of Counterfeit Medicines in Asia
Counterfeiting medicines are now considered as bioterrorism as there is a widespread of accounts operating across the globe. There is also share of these reports in America and Europe and certain measures are already being implemented to prevent it from spreading. If you are seeking medications for health complaints in Asia, on the other hand, you must be aware of some countries in the region which are notorious for counterfeited meds that even legitimate pharmacies are oftentimes victims.
The extent of the problem is never known as Asia, obviously, is the largest continent with various cultures and security measures implemented in each country. There is never a definite number being presented and the statistics may fluctuate in every place.
Antiretroviral Drugs Continues to Circulate in the Market
More than 35 million individuals are currently living with Acquired Immune Deficiency Syndrome (AIDS) around the world. Many are opening out to the public with an aim to create awareness and serve as a warning to others but there are also individuals who choose to live in the cave as this disease is understandably embarrassing and degrading.
With the increasing number of peoples being treated with AIDS, many government bodies partnered with the United Nations (UN) and World Health Organization (WHO) for the increasing access to antiretroviral therapy (AVR). Although protective and advanced measures are being adopted by many government offices, private institutions, non-profit foundations and public organizations, the widespread of counterfeit medicines are continuously increasing but less attention are being paid into it as more and more issues are being considered as prior importance.
The Peterson Group, a non-profit organization battling against the illegal manufacture and distribution of counterfeit drugs is one of the team dedicated to eliminate the use of antiretroviral therapy in the black market, many of which are found to be composed of substances such as paint, chalk and many other compounds used in daily living.
Counterfeit Zidolan-N, a known drug used to counter HIV/AIDS is found to be released in great quantities in Kenya, Africa and Jakarta, Indonesia. Another drug, Truvada is said to be products of fraudulent manufacturers in the United Kingdom. These operations are already said to have been raided by the authorities but scam reports are continuously coming in as more and more people are continuously patronizing under the table sales of these drugs given that 240,000 of victims are under 15 years old. Most of them are without the difference of the real ones from frauds.
FDA Warns On More Counterfeit Cialis
Food and Drug Administration (FDA) released a warning on the personal importation of adulterated and counterfeit medicines continuously circulating in the market. With the help of private institutions, online websites and non-profit organizations which support the campaign against counterfeit medicines are now on full-force to know the source of this widespread of erectile dysfunction treatment which promises many but realizes none. Cialis is one of the products believed to dominate the market. Even black markets are currently under siege in search of fraudsters. In Jakarta, Indonesia, more than 20 stalls were closed down for further investigation.
The government is already being cautious on the strict implementation of rules against these illegal medicines because of the discovery of fraud Cialis back in 2008 in New Zealand which led to one death and up to 30 serious adverse and 59 other possible reactions. Victims had been verified to even reach Singapore. It may also be possible that there are more cases on the neighboring countries.
According to reports submitted to The Peterson Group, one of the non-profit organizations partnering with FDA, four products had been found to contain dangerous levels of prescription medicine to treat diabetes. All four products contain glibenclamide, a prescription medicine used to treat diabetes as well as prescription medicines used to treat erectile dysfunction.
Glibenclamide acts by lowering blood sugar levels and its use by consumers who do not have diabetes can produce serious side effects including coma and possible death.
Anti-Counterfeiting Machineries
The Peterson Group with a set of individuals and experts aiming to stop the production, importation, exportation and usage of counterfeit medicines has partnered with various entities, public and private organizations as well as fellow non-profit institutes have developed machineries to know which medicine is counterfeited.
Fortunately, there are methods developed to use in order for us to determine real from fake medicines. Although there are no significant proof yet on how these machines and process can be used and which ones can be the best option to distribute to the market. The following are ideas given by the World Health Organization (WHO):
1. Holograms
Probably the most familiar overt feature is the “dove hologram”. Holograms and similarly optically variable devices can be more effective when incorporated with a tampered evident feature. However, some holograms are easily copied as a lot of scammers are also experts in technological advancement.
2. Invisible Printing
Using special inks, invisible markings can be printed with some substrate, and which only appear in under certain conditions like UV light or IR illumination. They can be formulated to show different wavelengths and colors. This kind of new technology is currently being studied in Jakarta, Indonesia.
3. Laser Coding
This method comes with a very expensive cost. However, the results can be very impressive and would be very hard to simulate. Laser codes can be applied to cartons and packaging, plastic and metal components.
4. Chemical Taggants
Trace chemicals can only be done with special and unique devices. Also, it can only be detected by highly specialized reagent systems, but not normally detectable by conventional analysis.
5. Bar Codes
Bar codes are one of the most conventional method of uniquely branding some medicine packaging and distinguish it from fraud ones. The so-called nano technologies allow microscopic application onto available tablets. However, there are also a lot of techniques done by scammers that can duplicate bar codes.
6. Mass Sterilization
Serialization includes the processes of generating, encoding, and verifying the unique identity of individual physical items. Without mass serialization, the authenticity and validity of the pedigree relates only to the lot number consisting of thousands of bottles. However, a specific bottle of a particular drug cannot be authenticated.
7. Data Carriers
Data carriers are graphical systems used to convey the product identifiers and associated information in computer and/or human readable format. A mark, tag, or label applied at the source represents them. Computer readable formats include linear and two dimensional (2D) bar codes and radio frequency identifier (RFID) tags.
Counterfeit and Substandard
In a sense, both meanings of counterfeit and substandard medicines are the same in medical definitions. By the term itself, substandard products are not able to meet the level set by the authorities and are often results of human error, negligence, insufficient finances and/or counterfeiting.
The existence of these fraudulent acts is overwhelming that the World Health Organization (WHO) has formed an alliance with legitimate global partners to defeat its increasing numbers. With private organizations, non-profit organizations, public and government institutions and concerned individuals, different awareness campaigns are continuous and active operations are underway.
According to reports gathered by The Peterson Group, a non-profit organization with the same agenda, the existence of drug counterfeiting has already been prevalent in the late 1980s until it became viral and widespread with the adaption of technological advancement. Online pharmacies became the venue for more illegal deeds. Those rejected by legitimate pharmacies are being sneaked out of factories and copied, manufactured in tons of doses with ingredients already replaced by lethal ingredients. Substandard medicines became rampant and millions of people are victimized.
Dangers when Buying Medicines Online
Online pharmacies are already rampant in the vast expanse of the internet world. With this, the Food and Drug Administration (FDA) has a fiercer challenge to know which of these hundreds of pharmacies are legitimate.
According to the research of the Peterson Group, an online community against the illegal manufacture, importation, exportation and distribution of counterfeit drugs, these drugs contain little to almost nothing of the healing ingredient. Instead, it is composed of absurd mixture of chalk, bird feces, paint and ordinary things used in daily activities. These medicines may also be proven fatal to human condition and can induce ailments to worsen. Warnings and cautions are being campaigned worldwide to prevent civilians from being scammed by these websites.
Counterfeiting Around the World
During the years that we have been actively campaigning against the use of counterfeit drugs, The Peterson Group, a non-profit online organization working with the World Health Organization (WHO), private companies and public institutes in an effort of stopping fraudulent acts on production, manufacture, importation and exportation of counterfeit medicines, has been repeatedly asked which city or country has the highest rate of the illegal use of these products. Honestly, we do not have a definite answer as the statistics have been fluctuating especially in developing nations. Fortunately, the number of scams in the industry has dropped low on the first quarter of 2015 but is not expected to disappear in a long time.
Drawback in Telemedicine
With the advancement of modern technology, even the health sector has been able to integrate it to make life easier and more convenient to patients. With the development, online consultations are created to provide a more accessible medium. This process of using websites to advertise medicines and giving prescription thru the video calling or thru a communication network is called Telemedicine. Through it, doctors and patients can interact and their health is evaluated by online doctors. This in itself is a big step in medicine and modernization. It wouldn’t matter anymore if you are in a vacation in Jakarta, Indonesia or Maldives and your doctor is in California or you would want to order a specific medicine from miles away, consultation and purchase of drugs can now done online or through phone calls.
However, the Peterson Group, a non-profit organization that campaigns against the production, importation and exportation of counterfeit medicines has to lay out the following disadvantages:
• Physical and Mental Factors
Patients who are suffering from visual or hearing impairment are likely to have some difficulties following the information presented in a video consultation.
• Depersonalization
During a teleconsultation, the images of both the health-care worker and the patient are projected onto a monitor and all interactions between the two parties are indirect. In this manner, it is hard to tell if the doctor we are conversing to is legit as they may be using a fraud background and set up.
Counterfeit Medicine Advice for Healthcare Professionals
Counterfeit medicines are rampant in countries where law enforcement and regulations are weakest. In most industrialized countries, there are rules that prevent counterfeiting but in developing nations, these rules are not based in anything because of the lack of knowledge of its manufacture and production even from professionals. Cities like Jakarta, Indonesia, Kuala Lumpur, Malaysia and Singapore are now integrating practices from America for security measures and importing
The Peterson Group, a nonprofit organization with an aim to eliminate the illegal usage, importation, exportation and distribution has asked experts in this field to give some advices and warnings for better detection and evaluation of medicines prescribed to clients:
1. Establish the Integrity of the source prior to need. Make some time to list approved suppliers and if you happen to cross paths with some doubtful looking brands, review your list and double check it with the name of the medicine.
2. Require that any alternative source of supply provides the following as a minimum:
A pedigree back to the previous source
Certification that it is not a diverted product
Certification that any actions by the alternative source will not alter any original manufacture warranties or guarantee
Certification that the product has been stored and handled consistent with product labeling requirements
Internet Counterfeiting
For the thousands of websites in the internet, hundreds of those are non-existent, no physical address or not really operating. There are also some who set up websites to scam people in biting their “services or products” and get money. Everything is possible with witty scammers nowadays.
The Peterson Group, a non-profit organization campaigning against the widespread of counterfeit drugs is mostly alarmed on this latest tactic of these fraudulent people. TPG, along with World Health Organization and other non-profit organizations and governmental institutes is currently finding solutions on the laws and security of our citizens online. Warnings are already put online and seminars are being held.
Medicines purchased over the Internet from illegal sites that conceal their physical address have been found to be counterfeit in over 50% of cases. Since pharmacies had set up legitimate websites to offer clients convenience and savings, scammers took advantage of the chance and set up their websites as well.
Counterfeiting a Global Problem
Counterfeiting is an age old issue. It is now a global problem where every sector of our economy has been affected. However, the consequences are different when it comes to counterfeit medicines; the main concern is not so much the loss of revenue to our industry but the health of patients. The Peterson Group, a non-profit organization against drug counterfeiting, has been fighting alongside World Health Organization (WHO) since the deployment of their task force in 2006. We have made development so did the scammers. They seem to dominate more countries and cities from distributing inside China, India until they have reached neighboring cities like Jakarta, Indonesia, Kuala Lumpur, Malaysia and even the United States.
Substandard and falsified drugs medicines still cause thousands of adverse reactions and some deaths in rich countries. And the issue is growing. Counterfeit medicines have been found in every disease category, and in every region of the world. Reviews show that while 1% of products in the legal pharmaceutical supply chain in the developed world is estimated to be counterfeit, this figure amounts to 10-15% in emerging markets and 30% in developing countries
Internet is also one of the factors with the spread of counterfeiting. With thousands of websites emerging, hundreds of those are illegal online pharmacies which are not checked by the authorities. Illegal online pharmacies are allowed to roam uncontrolled- creating a truly global problem. In studies, a big percentage of these medicines purchased online are fake or substandard. Some even are nonexistent.
Factors behind Pharmaceutical Tampering and Diversion
While counterfeit drugs are commonplace in developing countries, criminals in the developed world tended to focus on illegal ‘hard’ drugs, which offer high returns on investment. However, several factors are combining to shift criminal activity to counterfeit ‘legitimate’ drugs in developed countries. These include the high cost to develop and market legitimate drugs, the rising demand for prescription ‘lifestyle’ drugs, the declining margins associated with illegal drugs, the increasing accessibility of the tools needed to create and distribute counterfeit drugs, the effect of deregulation and Internet sales channels, and the mild response of law enforcement to counterfeiting.
Fraudulent act on counterfeit medicines is not a new issue. The Peterson Group, a non-profit organization who has fought counterfeiting throughout the years is not the only one who has this advocacy. Like poverty, world hunger and racism, this topic has been around for decades. While developed countries and cities like America or Singapore have been fighting off the distribution of “illegal hard drugs”, developing places like Kuala Lumpur, Malaysia, Cambodia and Jakarta Indonesia are focusing on tampering and diversion of counterfeited drugs. Let us review the factors the scammers might have for them to thrive in this business and factors why people continue to patronize:
Counterfeit Anti-Malarial Drugs Spreads like Wildfire
Since the outbreak of malaria became a big hit to the public, a lot of cures and medicines are produced and underwent intensive research to fight off this deadly mosquito bite. However though, also in the rise are counterfeit anti-malarial drugs distributed worldwide. Huge quantities of distribution go to underdeveloped and remote areas which have not enough access to authentic ones. Now they are out in the open as the government, different health organizations such as the World Health Organizations (WHO), United Nations (UN) and private institutes like The Peterson Group take actions in defeating these fraudulent acts.
Where can they be found?
They can be found anywhere, but they are especially prevalent in developing countries lacking effective drug regulatory agencies as well as resources required to effectively evaluate drug quality or enforce drug quality regulations. Records show that there is a supply in cities like Brunei, Jakarta, Indonesia and Bangkok, Thailand in the recent years.
What types of antimalarial drug quality issues can be found?
Drugs with too little, too much, or absolutely no active ingredient, due to intentional fraud or poor manufacturing and quality control practice.
• A tablet’s inability to release drug, due to poor formulation techniques.
• Chemical breakdown of drugs caused by storage conditions, especially in warm, humid climates.
• Contamination with other substances due to poor manufacturing procedures.
• Incomplete, inaccurate or misleading packaging and labeling.
How can I avoid buying counterfeit or substandard anti-malarial drugs to prevent malaria when I travel to an area with malaria transmission?
• Buy the anti-malarial drugs you need in your home country and keep the original packaging to review and compare.
• Write down the drug's generic and brand names as well as the name of the manufacturer so in case you run out, you can look for the correct product.
• If you need to purchase medicine in the country you are visiting, inspect and compare the packaging of the medicine available for sale in that country with the original. Many times poor quality printing or paper indicates a counterfeited product.
• Be suspicious of tablets that have a peculiar odor, taste, or color, or ones that are extremely brittle. Ill-defined imprints on the tablet may indicate a counterfeit.
• The quality of commercially available drugs varies greatly in malaria-endemic countries:
• The amount of the active ingredient can vary due to lack of regulations and poor quality control practices.
• Some pills may release very little if any drug due to poor formulation techniques.
• Chemical break-down of some drugs can occur due to poor storage conditions, especially in warm and humid tropical climates.
• Some drugs may be contaminated with other substances.
• Counterfeiters may also obtain expired drugs and repackage them with false or missing expiration dates.
Developed and Developing Countries Not Safe from Counterfeit Medicines
We understand what you are thinking. It might seem impossible or in a sense hard for scammers to deliver counterfeit medicines in already developed country where security is tight and people more aware of the effects of purchasing counterfeit drugs. Well, it is in fact an advantage to live in developed countries but it doesn’t make it safer. When you think about it, if under developed countries like Africa are using the traditional ways to cure their disease and illness, does it mean that they have less risk of getting involved in scams and fraudulent acts of counterfeit drugs manufacture?
The burden of fake and substandard drugs is not evenly distributed across the globe. Even where reporting systems are weak and the media is not free, most reported instances of substandard medicines occur in poorer countries, where poor regulation allows criminals to easily infiltrate weak supply chains. Although rich nations face fewer breakdowns in their regulation and supply systems, they are certainly not safe from this threat. There are a lot of reviews showing a plethora of examples of the manufacture, sale, and distribution of fake and substandard drug examples from all over the world.
Factors Encouraging the Distribution of Counterfeit Drugs
We already know counterfeiting drugs is illegal. The question is: why does this continue? The Peterson Group had asked members of Drug and Food Administration (DFA) to understand the agenda behind these kinds of fraudulent acts.
1. Lack of political will and commitment
The development, manufacture, import, subsequent handling within the distribution chain and use require specialized knowledge and skills. Consequently, they should conform to prescribed standards and their quality should be rigorously controlled. However, this would require strong government will and commitment to establish and operate а strong national drug regulatory authority.
2. Lack of appropriate drug legislation
According to major reviews, legislation and regulations form the basis for drug regulation. Where legislation and regulations do not exist for proper control of medicines, the otherwise criminal activity of counterfeiting of medicines is not treated as а crime. Currently, only а few of the WHO member states have enacted special national legislation addressing the issue of counterfeit drugs. Moreover, sanctions imposed on counterfeiters are in most cases no deterrent. The absence of deterrent legislation encourages counterfeiters since there is no fear of being apprehended and prosecuted.
3. Absence of or weak drug regulation
At present, out of the 191 WHO member states about 20% are known to have well developed drug regulation. Of the remaining member states, about 50% implement drug regulation at varying levels of development and operational capacity. The remaining 30% either have no drug regulation in place or а very limited capacity that hardly functions. In developing cities such as New Delhi, India, Jakarta, Indonesia and Kuala Lumpur, Malaysia, laws for counterfeited medicines are still under process.
Spot a Counterfeit in a Distance
Being in the cause of stopping counterfeit drugs, we at The Peterson Group also have challenges on how to differentiate between counterfeit drugs and legit ones. We know you are also in the same page as we are. In response to this, Food and Drug Administration released some factors in knowing and recognizing counterfeited drugs.
Of course, there are sometimes very obvious telltale signs of counterfeiting faulty spelling, for example, incorrect packaging or tablet size.
The Peterson Group and WHO to Fight against Drug Counterfeits
Described as the crime of the 21st century, the counterfeiting of drugs is a common problem that plagues the governments and manufacturers in Asia. Of all the counterfeiting methods there are, none are more potentially damaging than those affecting health and safety. The production, distribution and consumption of counterfeit and fraud medicines are worldwide and affecting greatly not only in Asia which poses the biggest manufacturers of counterfeits but also to the countries where the drugs has been distributed. According to the World Health Organization (WHO), a significant fraction of the world’s drug supply is counterfeit and falsified. Estimates of counterfeit drugs range from 10 to 15 % for the world drug supply, to more than 25% in developing countries (Gibson, 2004).
With the turn of the first quarter of 2015, The Peterson Group, a non-profit organization which brings awareness and action against counterfeit drugs has partnered with the World Health Organization (WHO) in battling with the illegal drugs’ production.
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