Medicine intends to alleviate pain and discomfort for the patient while prolonging life. But in the least of situations, medical drugs are meant to do no harm or cause the least of it, while eliminating – where possible, the malady afflicting the person.
These principles underscore why medical practice is one of the most regulated sectors globally, governed by international, regional and national laws.
But a startling revelation has sent shock waves through the African healthcare community, with new research suggesting that up to one-fifth of medicines circulating in the continent may be fake or substandard.
These alarming statistics bring forth the silent, yet salient epidemic, that claims an estimated 500,000 lives across the continent annually, highlighting a critical public health crisis that threatens the very foundation of healthcare systems.
Researchers from Bahir Dar University in Ethiopia examined 7,508 medication samples from 27 surveys, which established that 21 per cent (1,639 samples) were sub-standard or falsified.
Dr Rupen Haria, a Nairobi pharmacist, warns that these compromised medicines can lead to treatment failures and preventable deaths.
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The UN Office on Drugs and Crime estimates that such medications contribute to approximately 500,000 deaths annually in sub-Saharan Africa.
Despite having a robust pharmaceutical industry, Kenya faces challenges with counterfeit drugs. While the Pharmacy and Poisons Board (PPB) reports a 1.42 per cent prevalence of substandard medicines, independent studies suggest a more severe problem.
A 2018 survey by the National Quality Control Laboratories and PPB revealed that 12 per cent of market drugs were counterfeits.
More alarmingly, a study by industry associations - including Kenya Association of Pharmaceutical Industry (KAPI), Pharmaceutical Society of Kenya (PSK), Kenya Medical Association (KMA), and Kenya Association of Manufacturers (KAM) - estimated that up to 30 per cent of medicines in Kenya are fake, with a black-market value of Sh15 billion.
Cartels reportedly target popular over-the-counter painkillers, exploiting their widespread use.
Recent developments have also implicated Kenya as a major source of substandard medicines. This indicates that the issue may be more pervasive than official figures indicate.
Data from Rwanda’s Food and Drug Authority (FDA) shows that over the last four years, Kenya was the fourth most prominent source of recalled drugs, representing 13.2 per cent of total recalls.
The drugs were primarily recalled for contamination, suspected poor quality, and color changes. This revelation has raised questions about the efficacy of Kenya’s drug regulatory framework. An anonymous doctor, speaking candidly about the PPB’s role, expressed concern over the board’s approval process for drug importation and distribution.
“How did that drug get into the market? And then you find that it has the PPB’s number,” the doctor questioned, pointing to potential systemic failures in quality control measures.
Dr Simon Nyairaria, a pharmacist, reveals the sophisticated methods employed by counterfeiters.
“The rise of online channels has made it easier to distribute prescription drugs directly to consumers with minimal regulatory oversight,” he says.
He adds, “Manufacturers may use cost-friendly alternative ingredients that could be harmful, and packaging is often designed to mimic reputable pharmaceutical brands convincingly.
The implications extend beyond immediate health risks. The doctor cites WHO data, which shows that caring for patients affected by substandard malaria medications costs between 12 and 44.7 million US dollars annually in Sub-Saharan Africa.
Moreover, substandard antibiotics contribute significantly to the growing crisis of antimicrobial resistance.
In response to these challenges, the Pharmacy and Poisons Board has implemented a multi-faceted strategy to combat the influx of counterfeit and substandard drugs, according to a statement by the agency’s Communications boss, Judith Sirima.
Sirima says the board has established regional offices with dedicated inspectors to monitor compliance with good distribution practices and collaborates closely with customs officials at ports of entry to intercept suspicious shipments.
PPB highlighted recent technological advancements in their arsenal.
“The acquisition of a new near-infrared technology is a game-changer in our ability to identify suspect medicines,” added Sirima
She added that the ‘Pillscan’ device allows for rapid, on-site screening of medicines, empowering inspectors to quickly detect any deviations from registered product specifications.
The board’s efforts, according to her, have seen compliance rates for public health products increase from 94 per cent to 100 per cent between 2018 and 2023.
However, authorities warn that vigilance is still crucial, as criminal networks continue to adapt and evolve their tactics.
PPB also says that it has forged partnerships with international organizations and other national regulatory bodies.
“The board collaborates closely with the World Health Organization and participates in a global alert system to share intelligence on substandard and falsified products,” disclosed Sirima.
Equally important are efforts to educate the public on how to identify potentially counterfeit medications.
The PPB says it has also launched awareness campaigns highlighting telltale signs such as inconsistencies in packaging, changes in medicine’s physical appearance, and differences in taste, smell, or texture.
“Patients should always be vigilant and confirm any changes with their pharmacist,” says PPB.
“Obtaining medicines from licensed outlets is crucial, as is reporting any suspected substandard or falsified products to the authorities.”
While Kenya’s struggles with counterfeit drugs are significant, the fake drugs reflect a broader crisis across the African continent.
Malawi, for instance, was identified in the Bahir Dar University study as having the highest proportion of poor-quality drugs. The problem is endemic across much of sub-Saharan Africa, with devastating consequences for public health.
Dr Haria points to systemic issues that exacerbate the problem: “Pharma supply chains in many low- and middle-income countries are often complex, inefficient, and fragmented. The region relies heavily on a limited number of suppliers, and many countries face significant challenges in procuring products in time and effectively policing quality.”
This vulnerability is further compounded by the involvement of multiple middlemen in drug distribution, creating ample opportunities for criminal networks to infiltrate the supply chain. Unscrupulous actors exploit these weaknesses to flood markets with fake medicines, often at prices that undercut legitimate manufacturers’s products.
Dr Nyairaria says addressing Africa’s counterfeit drug crisis will require a coordinated, multi-stakeholder approach.
“Strengthen regulatory oversight, especially for online pharmacies and e-health platforms, improve the pharmaceutical supply chain and importation processes, ensure that only qualified professionals staff pharmacy outlets,” he proposes
The pharmacist further adds that enhancing public awareness and education about the risks of counterfeit drugs and implementing stricter penalties for those involved in producing and distributing fake medications, should be applied.
The PPB echoes these sentiments, emphasising the need for continued vigilance and collaboration.
International organisations are also playing a crucial role.