Counterfeit medications encompass drugs that lack the appropriate quantity and quality of the required active pharmaceutical ingredient (API) or contain unwanted Counterfeit medications encompass drugs that lack the appropriate quantity and quality of the required active pharmaceutical ingredient (API) or contain unwanted substances, such as contaminants, erroneous APIs, and expired, repackaged products. Additionally, counterfeit medications can be incorrectly formulated or produced in suboptimal conditions, making them ineffective or even toxic to consumers. These are “out-of-specification products.” Counterfeit medications may also include unregistered and unlicensed drugs (that is, drugs that have not undergone regulatory approvals) or falsified medicines (that is, drugs that have been deliberately and fraudulently misrepresented as to their identity, composition, and source).
The Organization for Economic Cooperation and Development (OECD) reported that in 2013, 2.5% of drugs and devices were counterfeit in 2013, and this number rose to 3.3% in 2016. Globalization is creating new opportunities for criminal networks to expand the scope and scale of their illicit trade in counterfeit medications, with a market valuation at $4.4 billion in 2016, severely threatening public health and safety.
Communications Director, Active and Intelligent Packaging Industry Association
Fortunately, counterfeit medications are attracting countermeasures, such as those advocated by the Active and Intelligent Packaging Industry Association. To learn about these measures, GEN caught up with the organization’s communications director, Andrew Manly, who had recently attended the Convention on Pharmaceutical Ingredients event that was held in Bangkok in 2024 (CPHI Southeast Asia 2024). Responses to the following questions summarize his views about counterfeit medications.
How severe is the problem of counterfeit medications in Asia?
The incidence of counterfeit medications is a serious issue globally. Asia is the world’s second largest market for counterfeit drugs after North America. According to the OECD, the Asian counterfeit medication market is concentrated in China, Vietnam, and the Philippines, and the transit points often involve the United Arab Emirates and Hong Kong (China).
Figures from the World Health Organization (WHO) suggest that over 1 million deaths occur annually because of counter feit and substandard drugs. Since 2013, the WHO has received 1,500 reports of cases of substandard or falsified products. Antimalarials and antibiotics are the most commonly faked drugs. In low- and middle-income regions, about 10% of drugs are fake.
Why are counterfeit medications so prevalent?
Illicit markets for counterfeit medicine are attractive for counterfeiters, given the high profit margins, low risks of detection and prosecution, weak penalties, and ease with which consumers can be deceived. Common counterfeit medications include high-demand, expensive products such as chemotherapeutics, antibiotics, vaccines, erectile dysfunction drugs, weight loss aids, hormones, and antianxiety drugs, as well as over-the-counter analgesics, steroids, antihistamines, and antivirals. A major factor for the prevalence of counterfeit medications is the inability to meet the demand for drugs. Also, disrupted supply chains have created gaps that are filled by fakes, primarily from China and India, which are major generic medicine manufacturers. This rise in demand is also driven by a more affluent middle class in many Asian countries.
The popularity of online shopping has expanded the counterfeit medication industry as well. When pharmacies are circumvented, counterfeit generics for conditions such as erectile dysfunction and weight loss are easily sold without any security check. According to Pfizer, between 2015 and 2018, more than 10,000 Facebook accounts or profile selling counterfeit Pfizer medications were identified and report ed. False advertisements, especially over social media, are also prevalent online to mislead consumers.
Online purchases appeal to consumers because they offer speed, convenience, and potentially lower prices. They also allow consumers to do without prescriptions, which may require sensitive discussions with healthcare professionals. Consumers may disregard the consequences of purchasing and using products that may not be properly formulated. Also, consumers may be ill-equipped to differentiate original from fake medications.
Counterfeiters are using small shipments to cloak their illicit activities and minimize losses due to confiscation The OECD reports that between 2014 and 2016, almost 57% of seizures of all product categories worldwide concerned postal shipments and 12% express courier shipments. Air transport and sea trans port followed, with slightly more than 15% and 10% of seizures, respectively.
Furthermore, pharmaceutical companies are disincentivized to publicize how their drugs have been counterfeited. Revelations of counterfeiting could dis courage purchases of original products, and reputations could suffer. Companies registered in the United States are the most impacted by the trade in counterfeits: almost 38% of all seized counterfeit medicines infringe the intellectual property rights of these firms. Unfortunately, when the detection of fakes is publicized, counterfeiters may use the information to evade detection more effectively.
What are the dangers of counterfeit medications?
Counterfeit medications pose several dangers. They can be ineffective. They can mislead consumers that their health conditions are under control. They can be contaminated. They can have the wrong active ingredients or be wrongly formulated.
When counterfeit medications become common, consumers can become fearful and less inclined to undergo treatment. This has already happened with antivirals and the antimalarial chloroquine. Overall, counterfeit drugs can increase healthcare expenditures and reduce productive activities through prolonged illnesses and deaths.
For pharmaceutical companies, counterfeit medicines constrain revenues, damage reputations, and increase spending on security measures. By infringing on intellectual property rights, counterfeit medicines can reduce profitability, stifling innovation.
What technologies and policies do we have to fight counterfeit medications?
It is important to stay one step ahead of the counterfeit manufacturers, especially since some of these manufacturers have even mimicked the original packaging of medicine to create the impression that their products are genuine. Smart packaging technologies including radio frequency identification tagging, QR codes, and vision systems. They help identify individual packs and improve tracking through the supply chain.
For instance, Securikett has a patented VOID technology with antitamper ability. VOIDLabels automatically indicate any opening attempt. When a VOIDLabel’s top layer is removed, a lower layer re mains and presents a graphic that betrays the opening attempt. The top layer cannot be reapplied unnoticed. This ensures that the label cannot be reused, allowing consumers to recognize when a package has already been opened.
For smaller items like syringes, Avery Dennison has introduced miniaturized smart labels that can be easily applied. An other example is the QR code system from Acviss. The label is a reengineered QR code that enables multilayered authentication.
Several countries have also introduced laws to protect consumers, though it can be challenging to enforce them. Legislation to track, trace, and authenticate is widespread. The European Union has the Falsified Medicines Directive, and the United States has promulgated the Drug Supply Chain Security Act. China, Turkey, India, and several other countries have similar legislations.
Unfortunately, when supply chain infrastructure is not developed, monitoring is difficult. For example, many fake or damaged/spoilt COVID-19 vaccines ended up in Africa. Additionally, the risk of prosecution for counterfeiting pharmaceuticals is low. Most counterfeits are detected only when they reach retailers or patients, and it is challenging to trace their origins through complex supply chains, or to prove where criminal activity occurred.
However, it is promising that as of January 2023, the government of India, one of the world’s largest generic medicine producers, has ruled that all pack ages of active pharmaceutical ingredients will have to carry a unique QR code. This new requirement will make it easier to identify falsified batches of APIs and to track substandard or tampered products back to the producers.
Andy Tay, PhD, is a scientist and freelance writer based in Singapore.
