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.