COUNTERFEIT pharmaceuticals, an age-old phenomenon, target consumers with low purchasing power who find cheap prices irresistible, falling prey to substandard or falsified products. The counterfeiting industry, of which pharmaceuticals are a minority player, thrives in a price-sensitive market.

A counterfeit medicine is defined by the WHO (World Health Organisation) as any medicine that is “deliberately and fraudulently mislabeled,” masking its identify and/or the source or origin. The US FDA (United States Food and Drugs Administration) gives a more detailed definition to encompass the actual product, the container and or the label bearing an “unauthorised trademark, tradename or any likeness thereof,” with respect to the manufacturer, processor, packer or distributor.

The distinction between substandard and falsified products is that the former fails to meet the quality standards or specifications, whilst the latter fraudulently or deliberately misrepresent their identities.

According to a 2018 WHO publication, it was estimated that 1 in 10 medical products in middle and low-income countries is substandard or falsified, that is 10 percent globally which translates to approximately US $21B. Prevalence rates of this illegal trade in developed countries is one per cent, but can escalate up to 50 per cent in developing countries.

Both branded /ethical POMs (prescription only medicines which are high-quality, more expensive medications formulated, researched and tested) and generic (chemically equivalent economical version) drugs are counterfeited.

The composition of such drugs may contain either no active ingredient; an inaccurate amount of active ingredients; an inferior quality of active ingredient; a wrong ingredient or contaminants which maybe toxic like chalk, paint, brick dust, sheetrock and flour.

Since 2012, a system to address this scourge officially through WHO was launched and referred to as the Member State Mechanism on Substandard and Falsified Products. However, under-reporting of incidents result in edited versions or under-representation of cases in reality.

According to a 2019 European Union Intellectual Property Office publication, there has been a rise in the risks caused by counterfeiting and pirated goods, threatening intellectual property and thereby discouraging innovation. The gains from trafficking and distribution of goods from the counterfeiting industry now is in the range of billions of dollars and has become an organised criminal entity. Further, in some cases it has financed other criminal gangs and terrorism.

The counterfeiters copy high-priced, branded products that are in high demand. “Cash cows” such as Viagra is the most targeted counterfeit pharmaceutical product. They present a cheaper look-alike option that is gobbled up in price-sensitive markets, where it is assumed by the ordinary unsuspecting consumer to be a smart purchase. Additionally, other needed medications for chronic illnesses such as medications for high cholesterol, high blood pressure, antibiotics, cancer and HIV may also be falsified, since they are lucrative to them.

There are some reputable high-quality generics manufactured in India for the export market, whose reputations are verifiably outstanding to local authorities. Some are registered with the GAFDD (Government Analyst Food and Drugs Department) and have provided all the necessary dossiers, certificates and samples for quality-control purposes. However, it must be noted that there are about 15,000 illicitly operated fake companies in India accounting for seventy-five percent of the global counterfeit medical supplies, as highlighted in a 2014 study published by the International Journal of Management and International Business Studies.

Three decades ago, paediatric syrups produced by an unlicensed Chinese manufacturer caused the death of 88 Haitian children. In 2007 and 2011, 78 and 219 Panamanians, respectively, died after consuming a counterfeit glycerine as reported in a 2013 study by the International Institute of Research Against Counterfeit Medicines.

Online counterfeiting has become rampant since the COVID-19 pandemic. It is the general consensus from many ethical companies such as Pfizer and AstraZeneca, that there is a 50 per cent chance of getting a fake drug online, especially if an address is not linked to the website. Many opportunistic “catfish-like” entrepreneurs (online imposters) fake the identity of a professional company and scam persons with fake products. In 2014, more than 9600 websites linked to illicit online pharmacies were identified and shut down and payment facilities suspended. So to help online shoppers for medications, the WHO website has a screening checklist that guides authentic purchases.

Our local regulatory framework for curbing counterfeit commodities is the GAFDD, which maintains quality of both foods and medications through its inspectorate system. In 2014 the GRA (Guyana Revenue Authority) partnered with GAFDD in an international anti-counterfeiting campaign referred to as Operation PANGEA, whereby19,618 packages were compromised out of the 543,531 inspected from online sales of illegal and counterfeit medicines. Some of the other policing partners in Operation PANGEA were INTERPOL, World Customs Organisation, Permanent Forum for International Pharmaceutical Crime, the Heads of Medicines agency, Visa, Master Card, PayPal, Pharmaceutical Security Institute and Centre for Safe Internet Pharmacies.

In an Interpol release in June 2021, it was revealed that in the UK three million fake medicines were seized, 3100 illegal advertising links were removed and 43 websites were shut down. The total worth of medicines and devices such as COVID-19 test kits was valued around US$ 31M; the latter was estimated to contribute to half of the total seizure. In Italy, 500,000 fake surgical masks were seized and 35 industrial machines used in the fabrication was confiscated. Interpol coordinates operations in 92 countries.

Endorsement from PAHO (Pan America Health Organisation) to root out all fake pharmaceuticals on the Guyanese market was the premise for the revival campaign launched. In 2019, an unnamed perpetrator in a clandestine operation released an unevaluated quantity of products on the market for stomach ailments. This local businessman, who is known by the authority, was being investigated and subsequently faced either a heavy fine or imprisonment.

The question beckons, what should be the punitive measures for enabling counterfeiting, whatever the level of the supply chain you may find yourself. Are the current fines and imprisonment considered sufficient for such classified criminal operations?

Pharmacies must have a moral and legal obligation to buy authentic medications from authorised distributors for retail sales. Unprofessionalism and unscrupulous competition can be the driving force behind business owners of pharmacies, mostly who are not pharmacists by profession. The unexplained, rapid expansions of some business entities may leave many unanswered questions.

The consequences of counterfeiting as a result of substandard and falsified medicines, vaccines and in-vitro diagnostics are many and ranges in severity from wastage of resources, economic loss and increased out-of-pocket spending to exacerbation of antimicrobial resistance and adverse health effects.

Generally, education, training and heightened awareness will enhance the public’s knowledge, more so the consumer, where they become more vigilant on quality and not on price when purchasing not only pharmaceuticals, but other commodities in high demand such as masks, sanitizers, gloves, detergents, vitamins and flu medications.

For further consultations, contact the founder/pharmacist of Medicine Express PHARMACY located at 223 Camp Street, between Lamaha and New Market Streets. If you have any queries, comments or further information on the above topic kindly forward them to medicine.express@gmail.com or send them to 223 Camp Street, N/burg. Tel #225-5142.