The Global Fight against Counterfeit Pharmaceuticals

People unknowingly consume counterfeit drugs every day, even in developed countries with well-regulated healthcare systems. They put their lives at risk for something they should be able to trust. The pharmaceutical industry and global drug regulators are constantly working to keep any below standard and duplicitous drugs out of circulation.

The Internet is providing a progressively feasible option for distributing pharmaceutical products – both legitimate and counterfeit – to domestic and international consumers. The ability of sellers to hide their identity and misrepresent their products is particularly attractive to counterfeiters, providing criminals with a relatively easy point of entry into even the best regulated markets. There are two distinct areas to purchase counterfeit pharmaceuticals online: the dark web and the freely accessible surface web.

“As criminals seek to expand the use of the Internet, they are now using all types of platforms including social media to reach their audiences.”

“Falsified medical products are illegal and nearly at all times a threat to health. They can cause treatment failure, harmful effects and sometimes death for patients who take them”.

Impacts of Fake medicines

Damage to the health of people or failure to treat their medical needs successfully.
A loss of confidence in health care professionals, health programmes and health systems.
Loss of sales and damage to the reputations of authentic manufacturers.
Costs and lost revenues to governments and economies.
Costs of treating patients who have suffered adverse health consequences as a result of consuming counterfeit medicines.
Lost income due to prolonged illness or death.
Social costs in terms of an increase in organized crime and job losses.
Incorporating anti-counterfeiting technologies into their products and packages raises the costs for legitimate pharmaceutical manufacturers.
Damage to brands

The challenge is illustrated further by a simple web search carried out on a popular lifestyle medicine, which returned 764 million results in 0.23 seconds on 25, September 2024.

The driving factors behind counterfeit pharmaceuticals

Profitability: High unit profitability and/or large volume

Market Size: Large potential market

Brand power: High level of brand recognition

Logistics: Simple and cheap

Marketing and sale of products: Easy to establish/gain access to distribution channels

Ability to hide operations: Easy to hide illicit operations

Ability to cheat consumers: Easy to cheat consumers

Legal and regulatory framework: Weak laws

Enforcement: Weak enforcement

Efforts to fight against counterfeit medicines

Many initiatives are ongoing to tackle the growing problem of counterfeit medicines. The main global efforts include crime-fighting programmes run by INTERPOL, as well as initiatives by the Pharmaceutical Security Institute, the World Health Organization, etc.

Governments and industry have been working together to combat counterfeit, substandard and falsified pharmaceuticals.

INTERPOL

Several initiatives are in place at the international level to combat counterfeit and illicit drugs, coordinated by INTERPOL. Operation Pangea has been carried out since 2008, with the number of countries participating rising. The operation targets the online sale of counterfeit and illicit medicines and medical devices. Participating agencies carry out coordinated operational activities against illegal websites during the same week in order to identify the criminal networks behind the trafficking

Interpol Operation Pangea XVI in 2023 involved police, customs and health regulatory authorities from 89 countries. The annual campaign, targeting counterfeit and illicit medicines, resulted in USD $7m in illicit medicines seized, 72 arrests worldwide and the closure of more than 1,300 criminal websites and online marketplace pages containing adverts for illicit medicine products.

The Interpol-led Operation Lionfish Hurricane, conducted in April and May 2024, seized over 615 tonnes of illicit drugs and precursor chemicals worth USD 1.6 billion in 31 countries, resulting in 206 arrests. The operation targeted drug trafficking networks in South America, Africa, and Europe, highlighting the growth of transnational organized crime groups.

World Health Organization

WHO works worldwide to promote health, keep the world safe, and serve the vulnerable.

The World Health Organization (WHO) has issued a Medical Product Alert regarding a batch of falsified Oxymorphone Hydrochloride 40mg, found in an unregulated supply chain in Finland. The product, a semi-synthetic opioid, contains metonitazene, a potent psychoactive synthetic opioid drug.

The falsified product is identified by:

The falsified version label does not have a barcode on the bottle.
The falsified version is labelled 40 mg but only 5 mg and 10 mg doses are manufactured.
The falsified version of tablets lack embossed letters/numbers.
The falsified products label is missing the NDC of USA.

The high potency of metonitazene, which can cause serious adverse effects, poses a significant risk to users, even in small doses. The WHO advises increased surveillance and diligence within supply chains and the informal/unregulated market. If you are in possession of these products, seek medical advice or contact a poisons control centre. All medical products must be obtained from authorized suppliers.

Pharmaceutical Security Institute

The Pharmaceutical Security Institute (PSI) is a not-for-profit, membership organization dedicated to protecting the public health.

According to the Pharmaceutical Security Institute (PSI), law enforcement officials uncovered 6,897 incidents of counterfeiting, illegal diversion and theft of pharmaceuticals in 142 countries in 2023. The crimes involved more than 2,440 different medicines across every therapeutic category. The PSI documented 4,894 arrests for pharmaceutical crime in 2023, the largest number of arrests achieved in 22 consecutive years of data.

Anti-Counterfeiting Technologies

Anti-counterfeiting technologies are essential tools in the fight against counterfeit medicines, helping to ensure product authenticity and protect brands. Here are some key types of anti-counterfeiting technologies:

Overt Features

Overt features in anti-counterfeiting technologies are designed to be easily recognizable and verifiable by the public without the need for special tools. Here are some common overt features:

Holograms: These are three-dimensional images that change appearance when viewed from different angles, making them difficult to replicate. Holograms are effective for: Multi-Layered Security, Instant Verification, Brand Protection, Regulatory Compliance, Supply Chain Security, etc.

Colour-shifting inks: Colour-shifting inks contain special pigments that change colour when viewed from different angles or under different lighting conditions. Colour-shifting inks are a highly effective anti-counterfeiting measure used across various industries, including pharmaceuticals. Colour-shifting inks are effective for: Easy Verification, Difficult to Replicate, Enhanced Security, etc.

Microtext: Microtext is a security printing technique that involves printing extremely small text, often so tiny that it is not visible to the naked eye and requires magnification to read. Microtext is effective for following reasons: Difficult to Replicate, Easy Verification, Cost-Effective, etc.

Covert Features

Covert features are hidden and not easily seen by counterfeiters or those who might misuse your brand. Identifying these markings needs special training and expertise, making them very hard to copy exactly.

Forensic markers: Forensic markers are a sophisticated anti-counterfeiting technology used to verify the authenticity of products. Forensic markers often rely on unique chemical or biological signatures that are embedded into the product or its packaging. These markers are not visible to the naked eye and require specialized equipment or laboratory testing to detect.

UV inks: UV inks, also known as ultraviolet inks, are a type of ink that becomes visible only under ultraviolet light. They are widely used in anti-counterfeiting measures due to their unique properties.

Taggants: Taggants are microscopic materials or chemicals embedded into products to provide a unique “fingerprint” for authentication.

Track and Trace Technologies: Track and trace systems are well-known within the pharmaceutical sector as a mainstream method of fighting counterfeiters who risk the lives of thousands of people across the globe by producing fake medicines. Certainly, pharmaceutical track and trace systems allow an individual package of drugs, or an exact vial of vaccine, to be pinpointed at any stage in the supply chain in real time. These solutions provide a sure guarantee that the product is authentic, giving valuable peace of mind in the ongoing battle against counterfeit goods.

Serialization (Unique Codes): Serialization involves assigning a unique code to each individual unit of a product. This code allows for tracking and authentication throughout the entire supply chain.

Blockchain: Blockchain technology is increasingly being used to combat counterfeiting across various industries. Each product is assigned a unique identifier, such as a QR code or NFC tag, which is recorded on the blockchain.

Geo-fencing: Geo-fencing technology is increasingly being used in the pharmaceutical industry to enhance security, improve supply chain management, and ensure regulatory compliance. Geo-fencing sets up Virtual Boundaries, Real-Time Monitoring with GPS or RFID tags and Alerts and Notifications.

Online Anti-Counterfeiting Technologies

Artificial Intelligence

Artificial Intelligence (AI) is transforming the fight against online counterfeiting with advanced tools to detect and prevent fake products. AI analyzes thousands of images daily to spot counterfeit items by comparing them with real ones. It scans product descriptions, reviews, and listings to find suspicious patterns or keywords that suggest counterfeits. AI algorithms learn from large amounts of data to become more accurate over time, identifying new counterfeiting methods and adapting to them.

Conclusion

The fight against counterfeit pharmaceuticals is a global challenge requiring coordinated efforts from governments, industries, and international organizations. By leveraging advanced technologies and strengthening regulatory frameworks, we can protect public health and ensure the integrity of the pharmaceutical supply chain.

References:

OECD/EUIPO (2020), Trade in Counterfeit Pharmaceutical Products, Illicit Trade, OECD Publishing, Paris, https://doi.org/10.1787/a7c7e054-en
https://www.interpol.int/en/News-and-Events/News/2024/Record-seizures-in-INTERPOL-operation-against-drug-trafficking
https://www.who.int/news/item/05-08-2024-medical-product-alert-n-3-2024–falsified-(contaminated)-oxymorphone-hydrochloride-40mg#:~:text=This%20WHO%20Medical%20Product%20Alert,Finnish%20Medicines%20Agency%20(FIMEA)
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Rameshwar Verma is part of the leadership team of an esteemed pharmaceutical organisation as an Executive – Packing (Serialization Specialist), bringing a decade of experience to the role. He possesses extensive expertise in serialization systems, pharmaceutical packaging, Industry 4.0, Quality Management Systems (QMS), electronic records, computer system validation, and compliance. He is the author of two notable books: 1) Basic concept of track and trace system for pharmaceutical industry. 2) Pharmaceutical track and trace system: A guide to optimizing efficiency and compliance.