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”.

The extent of the plague of drug piracy is difficult to determine, particularly in the developing nations where legal and economic controls are less stringent. World Health Organization recognizes this dilemma and works hard at coordinating with its constituencies to minimize or eliminate the effect this problem has on the general health of the world’s population. The Peterson Group joins in this fight against fake drugs. It has estimated that the “global sales of fake drugs (adds up) to $75 billion annually”. That is a staggering figure, considering that in a city, for instance, that has about 10 million residents, every person could be spending $75 annually if that city had only 1% share of that global figure. And that is pretty much what every individual spends on vitamins or other common medications on a daily basis -- 20 cents on the average. That is roughly the price of one multi-vitamin tablet that every ordinary person can afford to buy to provide minimum maintenance for a healthy body. And if the chances of any person getting a fake drug at the counter is 7 out of 10, then the chances of that person keeping a healthy body is greatly reduced.

If the extent of the fake drugs industry is so widespread, this tells us at least two things, namely:

1. That a majority of people in Asia and in many parts of the world are not getting the right medication they need (not to mention the right kind of food that they eat).

2. That this counterfeit drug industry could be an operation that enjoys some kind of protection from illegitimate and/or legitimate authorities. (If drugs can be faked, so with official documents.)

As in many instances of crime, corruption is at the root’s end. The Peterson Group, a non-profit organization, helps to make people and governments aware of this creeping worldwide problem. Operating in Asia (particularly Hong Kong, Indonesia, Jakarta and Malaysia), The Peterson Group is strategically located to monitor the flow of this contraband and its effects on the welfare of people for it has committed itself to preventing the illegal drug smugglers in Asia.

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.

One of the reasons why there is the domination of counterfeit medicines is the lack of attention given by the rightful authorities. Even with the strict policies, many national governments are focused on the smuggling of illegal drugs such as opium and heroin in their countries that the seemingly “legit” pharmaceutical drugs pass their investigation. Cities know for strict implementation of policies against smuggled drugs includes Jakarta, Indonesia, Singapore, Victoria, Hong Kong and Kuala Lumpur, Malaysia, yet these countries are also among the countries which have the highest number of counterfeit cases.

Only a few and only those dedicated in this special case give concern for the worsening number of counterfeit medicines victims in the world - included in this are the non-profit organizations with the ultimate advocacy to obliterate the number of fraudulent cases.  In their effort to eliminate drug counterfeiting from the main problems of the world, studies and reviews are being created because of this.

The Peterson Group, one of these concerned NGOs has developed falsified medicine analysis for years and has reported special cases vital in determining the total scale of the problem. Their falsified medicine analysis expertise is ideally positioned to address the highly technical issues involved in investigating the increasingly sophisticated falsified medicines or counterfeit medicines being discovered in legitimate supply chains. As a key tool in our pharmaceutical supply chain surveillance for counterfeit medicines services, our laboratory network employ a wide scope of investigative analytical technology such as mass spectrometry (MS), infra-red (FTIR) spectroscopy, RAMAN spectroscopy, nuclear magnetic resonance (NMR) spectroscopy, gas chromatography - mass spectrometry (GC-MS), liquid chromatography - mass spectrometry (LC-MS) and more, to explore and assist in the identification of fake medicines.

With the assistance of advanced research labs funded by concerned pharmaceutical companies and individuals, these systems are already underway in determining the impact of counterfeit medicines in a region by region scale. Some of these methods  may take a lot of time to produce results but with proper effort and support, falsified medicine analysis, which seems too complicated in the early times, can be more comprehensive.

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. 

In his visit in the continent in 2015, Pope Francis exclaimed, “Africa is a victim, Africa has always been exploited by other powers, African slaves were sold in America. There are powers that simply want to take Africa’s great riches – it is perhaps the world’s richest continent – but they do not think about helping countries to grow so that everyone can work. Africa is a martyr of exploitation…”

However, as times are changing and equality has been implemented, people are eventually accepting Africans, their potential and their capabilities. A large part of the continent has shown growth in urbanization in the last couple of years. According to reviews, one third of Africa’s population is currently living in urbanized areas. By 2020, experts expect this to grow to more than half of the citizens.

Africa, however, still continuously remains a victim to many other issues despite their potential for growth. One of these hindrances is the proliferation of drug counterfeits in the continent. 

In a review released by World Health Organization (WHO), fraud drugs do not entirely affect all parts of the world, despite its global nature. It is estimated that fake medicines account to 50% in Sub Saharan Africa but only 1% in developed countries. Perhaps this is also the reason why assistance expected from other countries often fall on deaf ears. The Peterson Group also reports lack of awareness even among government bodies.

Headed by pharmaceutical experts from Kuala Lumpur, Malaysia and Jakarta, Indonesia, a seminar on the basics of this illegal practice was conducted in Nigeria last January 12, 2015 but these awareness programs will lay moot and academic if international and national policies are still inadequate or nonexistent. 

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. 

It is highly difficult to track counterfeiters — they might use several different planes to transit a single consignment. Batches are repackaged into smaller bundles at each stopover to thwart law enforcement agencies. In one case, the drug which was delivered to a customer in Nebraska through the internet was traced to have come from Toronto, Canada which had been moved from Dubai, smuggled from Jakarta, Indonesia and had been manufactured in China.

It is even more challenging to spot fakes from real ones. Counterfeiters seem to take extra effort into perfecting their packaging and product. Tiniest details including bar codes are even traced significantly from real ones that it can even pass code scanners.

While the battle is getting fiercer and the complaints increasing, specific countermeasures are being taken by the pharmaceutical industry which includes overt features, such as holograms, covert features, such as digital watermarks, and initiatives that track and trace products.

Just as suspected, counterfeit drugs are mostly available in black markets. In third world and poor countries, these black markets can be seen on the streets. In Africa and the Middle East, for instance, rows of kiosks show various medicines ranging from erectile dysfunction medicines to drugs claiming cure for cancer. However, the authorities cannot entirely take down street vendors as some of them are not entirely fraudulent. 

Michael Deats, a former head of enforcement at the MHRA, who now works for the WHO’s department of essential medicines and health products says, “Some pharmaceutical company sales representatives sell their wares in street markets to meet sales targets ‘which adds a certain legitimacy to these street-markets’”. Fraudsters take this chance to merge their own fake products with legitimate ones.

Drug counterfeiting is becoming a lucrative business and we can expect that the people behind this illegal practice are much more experienced in tricking the law than we can possibly imagine.

Growing Arrests against Drug Counterfeiters

The world has fought battles against drug counterfeiting for decades. Different government entities, private institutions, non-profit organizations and civilians continuously hold seminars, workshops and awareness campaigns to promote concrete law enforcement action in the field with the ultimate aim to obliterate drug counterfeiting and place behind bars fraudsters responsible for the increasing mortality rate caused by substandard and dangerous medicines.

Health advocate, Marie Pollack of The Peterson Group, an NGO campaigning against drug fraudulence in the Asia Pacific region stated, “Medicines were once trusted to cure people from their maladies. Now, it is being feared”. The increasing adaptation to herbal and alternative medicine shows that people are starting to doubt their confidence. The efficacy of the medicine being brought in the market and presented to people is being questioned.

Pollack added, “It is good that people are being cautious of their own choices but if this continues, credibility of scientifically tested medicines which underwent several methods of experimentations to prove its effectiveness would come to waste, not to mention the economic impact in the health sector”.

Fortunately, the authorities are never stopping their campaign to arrest the fraudsters behind this cruel illegal practice. With the likes of World Health Organization (WHO), Food and Drug Administration (FDA) and Interpol, other NGOs and local government units having the same cause are supported with 'interventions package' for all stages of an investigation from gathering intelligence, planning and implementing an operation, through to legal issues for cases that are brought to court.

Dozens of operations were already held in the last previous years to determine the illegal manufacturers and masterminds of this deadly trade. Interpol, for instance, has launched different actions in different regions of the world. Their flagship operations - Storm (Southeast Asia), Mamba (Eastern Africa) and Pangea (targeting the Internet) – continue to go from strength to strength. Successive raids on licit and illicit markets have shown improved results in terms of seizures, arrests, convictions and the closure of illicit websites.

Several other operations are being conducted. In developing countries, WHO has headed countless arrests and ambush procedures. For instances, last year, WHO, TPG and local authorities of Jakarta, seized more than 300 packs of counterfeit Viagra and Cialis in a dilapidated building in Menteng, Indonesia. In Europe, customs officers seized 34 million counterfeit pills in just two months while China has closed down 2,000 websites offering online prescriptions.

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.

It is, however, reviewed that counterfeit medicines are most prevalent in these countries. According to the Peterson Group, an international NGO which campaigns against the proliferation of fraud medicines, the number of counterfeits has been surpassing those of legitimate medicines and is being patronized because of its cheap price despite bearing no active ingredient at all. Black and fly-by-night markets for medicines are rampant in most of the Middle East including India, Pakistan and Turkey as well as in South East Asia especially in Indonesia, Cambodia and Thailand. News of thousands of dollars-worth of counterfeit Tamiflu were seized as they were being imported to Jakarta using the loose borders of Malaysia and East Timor towards Southern Java last September.

These fraud operations were driven by the need to have sufficient medicines for those in need.

Both WHO, which is mostly concerned on the quality of health care and World Trade Organization (WTO) which is focused mostly on the economic aspect crazily flustered by this illegal lucrative business are extending their efforts to lessen the issue.

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. 

Indonesia is no different despite the strict death penalty on anyone found guilty of smuggling and distributing illegal medicines within the archipelago. The country is known to have lucrative manufacturing business of counterfeit medicines in Jakarta, second to China which still holds the title of the most productive country for counterfeiting. 

On the other hand, the United States boasts of their 1% counterfeiting rate when the rest of the world records 30% of the overall medicines as counterfeited. Still, as the Peterson Group, one of the NGOs providing information on counterfeit drugs, points out, this number is nothing to be proud of. As long as there is a number existing, the citizens are still not safe from the dangers of counterfeiting can bring. 

The warnings of WHO and Food and Drug Administration (FDA) are being disregarded with the issues of poverty and illiteracy. There may have hopes and solutions for these problems, yet, with the time dragging by and no active measures still being implemented, it may well be improbable that these are not meant to be solved. 

There are only a few World Health Organization (WHO) pre-qualified quality control laboratories across the world. Drug buyers and suppliers should utilize these facilities. Laboratory testing assures quality and ensures the procurement and supply of safe and quality medicines.

However, these laboratories alone cannot meet the needs of the entire population. 

The government and other non-state actors should invest in more testing equipment, especially in rural areas. 

But without any possible feedback from them, we can’t help but ask, is the government doing anything against counterfeiting?

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.

Global pharmaceutical companies welcomed the entry of force by Medicrime convention.

According to an interview with Eduardo Pisani, director general of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), strong legislative framework is needed to combat the rampant issue and Europe has the sense to lead international parties in strengthening the policies which has lacked stern implementation in the last few years.

The criminals who deliberately endanger the health and lives of the patient and the overall public have been undermining the confidence in public health system and should therefore be considered as a matter of urgency.

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.

The manager, under the name Carl, admitted he had lost most of his clients who suspected his business and has therefore spoiled his good name. In an interview with The Peterson Group, a non-profit organization providing imperative information on counterfeit medicines, one of Carl’s clients who chose to speak anonymously accused Carl’s company for selling “sugar pills”. Carl then resolutely stated that these allegations are without merit and that his company has never sold any fraud medicines. The case is still under investigation as the drugs were traced to be manufactured in Jakarta, Indonesia.

According to Food and Drug Administration (FDA), “Legitimate pharmacy sites on the Internet provide consumers with a convenient, private way to obtain needed medications, sometimes at more affordable prices. The elderly and persons in remote areas can avoid the inconvenience of traveling to a store to purchase medications. Many reputable Internet pharmacies allow patients to consult with a licensed pharmacist from the privacy of their home.”

But this is not without risk. There is still no knowing whether the site is safe just because the purchase is convenient and the appearance looks legitimate enough.

To be sure, FDA encourages consumers to first check http://www.nabp.net/ where a list of illegitimate online pharmacies is published.  These include those that claim to dispense drugs without a prescription or sell products not approved by the FDA, and, of course, fake online pharmacies that are downright fraudulent.

In addition to being included on this list, other warning signs of fake online pharmacies include sites that don’t provide a physical address for their business or don’t list a verifiable phone number.

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. 

In this level, medicines created and designed for a specific market or function is remarketed in violation of the producer’s instructions. These counterfeiters mostly target non-profit and humanitarian organizations or the supply of free samples to hospitals and clinics. 

According to a study conducted by The Peterson Group, a non-profit organization campaigning against the proliferation of counterfeit medicines across the world shows that between 1992 and 2002, prescriptions written for unscheduled and scheduled drugs increased by 56.6% and 154.3% respectively.

Further emphasized in the study is that diversion can happen within the limits of a specific country or it may become an international scope.

Drug diversion in North Korea is one of the examples the first form of this kind of phenomenon. Since there are no other sources of medicines in this secluded country, some corrupt officials steal some of the medicines and resell it to the citizens even when it is marked as “UN aid”.

The other form of this phenomenon is driven by economic motive. For instance, an aid from the western countries can be halted by other leading countries and sold to neighboring nations for a higher price. The entity can also fraudulently acquire the products from the producer, declaring an intention to deliver the drugs for humanitarian purposes but in reality it re-markets the drugs after acquiring them at low cost. These international exchanges are implemented through multiple transfers and involve frequent repackaging of the product, thereby providing opportunities for counterfeit products to penetrate the legal distribution chain.

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.

Despite this arrest three years ago, the problem of fake medicines was far from being rooted out as operation after operation are still being raided every year. If so, fraudsters have even become more elusive and deceptive with new methods of production and distribution.

Fortunately, local units and organizations in the People’s Republic of China have realized the danger of the business that they too, started to create laws and regulations against the illegal practice. As reported by World Health Organization (WHO), the Chinese government has developed strict legal scheme for anti-counterfeiting by creating the Drug Administration Law of the PRC. The amendment not only adapted the need of drug supervision, but also represented the public will, somehow reflecting China’s determination in combating counterfeit medicines and not tolerating it, just as many people believe.

Since 2009, the local task force has also been in an active participation to any raids and buy-bust operations against illegal marketers of counterfeit medicines and has since joined forces with international organizations. The battle continues even until today.

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.

Some women have apparently been administered with two such drugs, Oxytocin and Ergometrine, which are injected to control bleeding after delivery.

The contaminated Oxytocin reportedly was manufactured in China by companies with fake addresses.

In the case of Ergometrine, the FDA said their investigations showed that it was imported from Jakarta, Indonesia and contained no active pharmaceutical ingredients.

Critics, on the other hand, blame the laxity of FDA security in order to prevent the proliferation of the counterfeited drugs earlier. If not for NGOs and local units who are actively gathering more information, FDA, which has the main function to take down counterfeiting, would have never found out about the new methods. The authority does not have any idea on how the medicines are distributed in the country and on how it has been circulating between legitimate pharmacies.

Statistics show that on the Ghanaian market between August and September 2012. A total of 303 samples— 185 Oxytocin injection, 103 Ergometrine injection, and 15 Ergometrine tablets—were sampled from both public and private hospitals, clinics, medical stores, pharmaceutical outlets, and the informal sector across the ten regions of Ghana

In addition, the storage conditions recommended by the manufacturers of more than 50% of both the Oxytocin and Ergometrine injections were not consistent with recommendations in the official compendia. This indicates a lack of awareness of the appropriate storage conditions for these uterotonic products. The pharmacies involved also face complaints from critics. FDA, on the other hand, has promised to undergo proper implementation of jurisdiction if the companies are found to be involved in the distribution. 

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 counterfeit medicines 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 counterfeit medicine.

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.

Generic medicines are not entirely fraudulent per se but are mostly substandard.  Nonetheless, the threat can still be bona fide with what many health professions fear of: circumvention of health regulation, undercutting public confidence, and potentially providing a comparatively easy source of income to criminal elements.

Firstly, health regulations are mostly underrated on generic pharmacies starting from the fact that issuance of prescription are often ignored and neglected. Added to this fact is that generic pharmacies often employ unlicensed pharmacists who do not have enough knowledge on medical terminologies and lexicons.

The second main concern of authorities is that generic pharmacies may undercut public confidence. Faith and trust placed on medicine for safety and proper health treatment implementation is put into question. Even branded medicines being sold in generic pharmacies are doubted to be substandard.

Furthermore, patronization to legitimate medicines has dropped dramatically in the recent years. According to reviews, the cost and effectiveness of genuine medicines are discarded as mere marketing stance by most pharmaceutical companies as loyalties shift to generics which cost less and promise the same effects.

Lastly, generic medicines pave an easier way for criminal counterfeiting. 

Recent seizures of drug shipments in one of the hidden ports in outer Jakarta area in Indonesia have sparked concern that efforts to control counterfeits are a smokescreen to curb the sale of generics in the archipelago. Officials claimed generic drugs were counterfeit, placing efforts to adopt and enforce anti-counterfeit legislation in domestic laws as well as in bilateral and multilateral agreements into jeopardy.

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).

On the other hands, critics of RFID which is also being used for other economic sectors such as manufacturing, supply chain, agriculture, transportation, healthcare, and services to name a few, are still facing issues on the effectiveness of this technology.

The problem is that decades after RFID technology was invented, and years after the U.S. Food and Drug Administration started touting it as the most promising way to authenticate drugs, RFID technology as an anti-counterfeiting technology remains just that: "promising"-yet far from proven. WHO has even stated that despite years of implementation of RFID, the number of fraud cases has not slowed down but continues to escalate. Some scammers are also suspected to counter RFID technology by creating their own system which can mask counterfeited products into what RFID considers as legit.

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.

Regional and global non-profit organizations starting from the World Health Organization (WHO) to the Local Government Units (LGU) in each community have finally become aware of the rampant spread of counterfeit medicines especially in third world countries. Africa and Asia are likely the most targets.

According to activity reviews of 2010, WHO and INTERPOL have led the effort to combat counterfeit medicines in Asia. Operation Storm was a multi-country operation combating counterfeit pharmaceuticals. It brought together the Customs, Drug Regulatory Agencies and the Police of each participating country: Cambodia, China, Indonesia, Laos, Myanmar, Singapore, Thailand and Vietnam. The operation seized over $12M in counterfeit medicines and more than 16 million pills, including antibiotics, anti-malarials, contraceptives, anti-tetanus vaccines, aspirin and drugs to treat erectile dysfunction. In late 2009, Operation Storm II resulted in the seizure of 20 million counterfeit and illicit drug outlets. This year, the number has dwindled to a minimum as fewer countries have participated.

The Peterson Group, one of the non-profit organizations campaigning against counterfeit medicines, noted that only more or less 15 organizations have gathered in the annual event held in West Jakarta last August.

However, WHO has stated that this is not because other countries and NGOs have stopped their campaign. Instead, in their absence in the annual event, they are also hosting their own seminars and awareness programs in their own respective nations.


Take for example the in 1999 when the International Pharmaceutical Federation (FIP) adopted a statement on counterfeit medicines during the Council meeting at the FIP Congress in Barcelona. Because of the growing and changing aspect of this major public health care issue, FIP has updated its Policy statement on counterfeit medicines in 2003 during its Council meeting at the FIP Congress in Sydney. This statement is a strong political message of the pharmacists‟ profession to support the fight against counterfeit medicines to protect the safety of their patients.

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.

The five personnel, all local, admitted to packaging and sealing these drugs to be picked up by a dealer known by “Sam” at dawn every day. As to where the products are distributed and how it is being supplied, the workers do not have knowledge of. Another man named Jafar is in charge of refilling their supplies every week while a woman named Alice comes by every two days to give their wages. They are not allowed to ask any further questions and are not able to do so as even if they, most of the times, work by themselves inside that building for their activities seemed to be monitored. One of their fellow workers was once killed while going home after he told a friend where he was working. A few days later, that friend was also dispatched. Living in fear for their lives and their families, they cannot complain nor tip the authorities of their illegal employment.

While these personnel spent their time in prison before their trial, their spokesperson they call Matti was killed in what the authorities say is caused by a prison fight. The others, now fearing more for their lives and unsure of their fate and security even within the prison walls refused to talk and testify. The government also takes full control of the situation and does not communicate well with non-profit organization anymore.

Once again, WHO would have to restart from scratch. Calling a conference with other non-profit organizations campaigning on the same cause, WHO has opened its willingness to offer a reward to anybody who has lead information on the continuous fraudulent operations on counterfeit medicines.

The Peterson Group, a fellow NGO who campaigns against the proliferation of counterfeited medicines            stated that a bounty of up to 20% of the value of any drugs being seized is available for anyone who can provide assistance. Private pharmaceutical companies also stated that they are to give their own rewards when generic copies of their own medicines are to be found.

Of course, counterfeit medicines are a global problem and both eastern and western pharmaceutical industries are equally disturbed by the presence of phony drugs in the supply chain.

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.

Reasons have led to one and another. Politics, bribery to the government, the worsening case of poverty and the weak security system have been pointed as factors to its continued existence. One of the reasons which is noted by The Peterson Group, one of the NGOs exclusively working against counterfeited medicines, has caused extra agitation to the government, private pharmaceutical companies and consumers: trade within legitimate pharmacies and counterfeit fraudsters.

Trade in legal commerce has been overlooked with the common perception that legal businesses remain untouchable against counterfeit medicine scams.

United Nations Interregional Crime and Justice Research Institute (UNICRI) has been able to confirm the suspected loophole in private pharmacies’ products. In reviewing the methods used, the term parallel trading came to light.

The practice of parallel trading is legal in the commercial world; however, its application and contribution in the current issue have weighed the issue even further. At this rate, it is near impossible to trace the real culprit as the process involves at least 20 parties.

In a raid in one of the biggest counterfeit drug smuggling in Jakarta, Indonesia last 2013, fraudsters admit to following a cycle but they themselves hardly have any idea as to how the medicines managed to travel and be distributed.

The perpetrators explained that parallel trading involves a drug that is sold in a given country, which after having already moved through the various stages of the ordinary distribution chain, is acquired again by the major distributors and is entered into the parallel distribution chain. The product is then transferred to a new and more lucrative market by means of parallel intermediaries/distributors. The times a pharmaceutical product is transferred can be numerous. It is estimated that, on average, a drug which is entered into the parallel market may be subject to 20-30 intermediary transactions.

This extension of the distribution chain creates a problem of verifiability since some of the intermediaries do not need licensing to operate.

The issue is still under investigation. Our greatest fear is that by the time the real mastermind has been apprehended, it can be too late.

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. The following is the summary of each region’s brief background on counterfeiting medicines:

North America

Counterfeit medication is a recognized and well documented problem in the United States. One case in 1937 has featured more than a hundred deaths after consuming medicines containing the dangerous solvent diethylene glycol.

Some counterfeiters in the United States are even found to be using fraudulent connections to terrorism. WHO has also found that the profit from counterfeit medicines have been used to fund the famous terrorist group Hezbollah.

Europe

There are few fake and substandard drugs in most European countries for reasons similar to those articulated above for the United Sates: quality producers dominate the market, supply chains are generally well regulated, and officials provide strong oversight and strict enforcement when pharmaceutical standards are violated. Still, preventing fakes from entering or travelling through the two dozen European territories is a constant challenge for enforcement officials.

Cambodia

Cambodian Ministry of Health has released a statement stating that 13% of the nation’s medicines are fraudulent. Warnings on health precautions are already released by local government units and private pharmaceutical companies as most counterfeit medicines are found in informal and unlicensed units.

Indonesia

Counterfeiting in Indonesia has grown despite the warnings of death penalty as punishment. By 2008, 44% of medicines in the market are counterfeited, even sold in legitimate pharmacies. 11 men were arrested in the capital city, Jakarta for refilling syringes with water, forging expiration dates and repackaging.