A tragedy unfolded on a larger scale several years ago in Panama when a chemical manufacturer sold diethylene glycol, the active ingredient in antifreeze, as pharmaceutical-grade glycerin to a European company (Bogdanich and Hooker, 2007).

The poison caused acute kidney failure in the people who ingested it, often as the solvent in cough syrup (Bogdanich and Hooker, 2007; CDC, 2009). The Panamanian government counted 219 deaths from kidney failure brought on by diethylene glycol poisoning (Núñez, 2011). In 2o23 similar tragedy was reported in Uganda. The killer cough syrup that claimed more than 300 lives including 200 children. The incident received international media attention for months across mainstream media and social media platforms. Guardian, CNN, and causing investigative media professionals to look into the Tragedy.

Developing new medicine is indeed a costly endeavor even for Big Pharma. A 2010 estimate put the cost of developing a single drug at $1.3 billion (Kaitin, 2010), and a 2003 study showed that the cost of drug development grew 7.4 percent faster than inflation (DiMasi et al., 2003). Europol recent operations burst EUR 10million worth of fake medicines during a Narcotic sting operation. Not long ago and precisely during the Covid 19 pandemic, Europol seized EUR 63million worth of fake Pharmaceuticals in a Europ-wide operation that involved agencies across several countries including Finland, Italy, Spain, Greece and, France. China, India, Bangladesh, Nigeria, Egypt, Saudi just to mention a few are currently looking for silver bullet solutions to annihilate the rapidly growing monster of Fake and falsified medicine.

Ongoing global efforts championed by the United Nations, WHO and some partner organizations aimed to ensure access to safe supply of drugs as SDG goal. On National and regional levels different instruments tested have failed to guarantee access to safe drugs sometimes backed by political will and commitments but progress in the right direction remains insignificant. Standard operating procedures often fail to capture substandard especially when they are products of sabotage, process errors, quality assurance failures or operational defects by licensed stakeholders. Regulatory systems lack metrics that can reveal performance, they instead focus on legalese.

Since Manufacturers care about their reputation and Regulators care about legalese, there is a void, one so large and so deep in which Counterfeiters now hide in plain sight. The impact of this only fuels more counterfeiters. Widespread Public panic seems like a marshal curse that Regulators and Manufacturers would rather avoid. If total distrust in the health ecosystem especially Pharma is an undesirable outcome, then successfully stopping counterfeits may hinge on communication strategy and public empowerment.

The pharmaceutical industry excels in recruiting exceptional participants for clinical trials, a skill that presents a significant opportunity to engage the public in discussions about counterfeit and falsified drugs. Leveraging that approach to test and validate solutions that empower the public is an untapped potential that remains largely unexplored. In Europe, a public awareness initiative was discreetly launched by the EUIPO, EMA, and EUROPOL, yet its effectiveness remains limited due to its secretive nature.

Old ways won’t work. New Innovative solutions are needed to transform Pharmaceutical supply chain to ensure consistent access to safe products and in addition, Pharma stakeholders need to publicly show a passionate fight against fake, counterfeits and falsified products and pursue big audacious goals with collaborators across all sectors in the implementation and execution of the best Anti-counterfeit initiatives. Secretive initiatives by silently partnering with Think tanks or National agencies won’t work because such often lack effective solutions as Government agencies are not great at solution design. Government agencies are Transactional and are not service oriented.

Current focus on strengthening regulatory frameworks tends to inadvertently hinder legitimate business operations. This is primarily because it is more straightforward to regulate and introduce supervisory frameworks for legitimate operators. As a result, these frameworks, with their measurable in-process indicators, primarily create additional burdens for licensed operators rather than solution.

“It is widely recognized that regulatory agencies are not primarily tasked with innovation; their core expertise lies in the creation and implementation of policies and directives. When these agencies attempt to take on the role of innovators, forcing one particular solution it often results in the introduction of ineffective solutions, unintentional monopoly by lobbying and inadvertently facilitating the proliferation of counterfeit products followed by a plethora of unintended consequences.”

Counterfeiters are adept at identifying vulnerabilities as new frameworks are implemented. They exploit these gaps to align with market demand, taking advantage of the evident void and the pressure for on-shelf availability (OSA), coupled with intermittent shortages. This, combined with a misguided sense of purpose, contributes to the proliferation of fake products most especially in regions where informal channels dominate the retailing of pharmaceutical products. Supervisory frameworks continue to be ineffective and abortive.