Africa’s Counterfeit Drug Crisis – Breaking Kenya News

Ministry of Health employee takes part in operation to clear shops selling counterfeit medicines

Medicine is intended to relieve the pain and discomfort of the patient and at the same time prolong life. But in the least cases, medicine is intended to do no harm or to do the least harm, while eliminating – where possible – the disease that afflicts the person.

These principles underscore why medical practice is one of the most highly regulated industries in the world, governed by international, regional and national laws.

But a shocking revelation has sent shockwaves through the African healthcare community, as new research suggests that as much as a fifth of medicines circulating on the continent are fake or of poor quality.

These alarming statistics highlight the silent but striking epidemic that claims an estimated 500,000 lives on the continent each year, underscoring a serious public health crisis that threatens the foundations of health systems.

Researchers from Bahir Dar University in Ethiopia examined 7,508 drug samples from 27 studies, finding that 21 percent (1,639 samples) were substandard or adulterated.

Dr Rupen Haria, a pharmacist in Nairobi, warns that these compromised medicines could lead to treatment failures and preventable deaths.

The UN Office on Drugs and Crime estimates that such drugs are responsible for about 500,000 deaths in sub-Saharan Africa each year.

Despite a robust pharmaceutical industry, Kenya faces challenges with counterfeit drugs. While the Pharmacy and Poisons Board (PPB) reports a prevalence of 1.42 percent of substandard drugs, independent studies suggest a more serious problem.

A 2018 study by the National Quality Control Laboratories and PPB found that 12 percent of marketed drugs were counterfeit.

Even more alarming, a survey by industry bodies including the Kenya Association of Pharmaceutical Industry (KAPI), Pharmaceutical Society of Kenya (PSK), Kenya Medical Association (KMA) and Kenya Association of Manufacturers (KAM) revealed that as much as 30 percent of medicines in Kenya are counterfeit, with a black market value of Shs15 billion.

Cartels are reportedly targeting popular over-the-counter painkillers and exploiting their widespread use.

Recent developments have also implicated Kenya as a major source of substandard medicines, suggesting that the problem may be more widespread than official figures indicate.

Data from the Rwanda Food and Drug Administration (FDA) shows that Kenya was the fourth largest source of drug recalls over the past four years, accounting for 13.2 percent of the total number of recalled drugs.

The recalls were primarily due to contamination, suspected poor quality and colour changes. The revelation has raised questions about the effectiveness of Kenya’s drug regulatory framework. An anonymous doctor, who spoke candidly about the role of the PPB, raised concerns about the board’s approval process for the import and distribution of drugs.

“How did that drug get on the market? And then you see it has the PPB number,” the doctor asked, pointing to possible systemic deficiencies in quality control measures.

Pharmacist Dr. Simon Nyairaria explains the sophisticated methods counterfeiters use.

“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 cheap alternative ingredients that could be harmful, and packaging is often designed to convincingly mimic reputable pharmaceutical brands.

The implications go beyond the immediate health risks. The doctor cites WHO data showing that caring for patients affected by substandard malaria drugs costs between US$12 and US$44.7 million annually in sub-Saharan Africa.

Moreover, poor-quality 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 medicines, said a statement from Judith Sirima, the agency’s head of communications.

Sirima says the administration has set up regional offices with special inspectors to monitor compliance with good distribution practices and works closely with customs officials at ports to intercept suspicious shipments.

PPB highlighted the recent technological developments in their arsenal.

“The acquisition of a new near-infrared technology is a game changer in our ability to identify suspect drugs,” Sirima added

She added that the ‘Pillscan’ device enables rapid on-site screening of medicines, allowing inspectors to quickly detect deviations from registered product specifications.

She said the council’s efforts have led to an increase in compliance rates for public health products from 94 percent to 100 percent between 2018 and 2023.

However, authorities warn that vigilance remains paramount as criminal networks continue to adapt and evolve their tactics.

PPB also says it has established partnerships with international organizations and other national regulatory authorities.

“The council works closely with the World Health Organization and participates in a global alert system to share information on substandard and counterfeit products,” Sirima said.

Equally important are efforts to educate the public about how to recognize potentially counterfeit medicines.

The PPB says it has also launched awareness campaigns that draw attention to signs such as inconsistencies in packaging, changes in the appearance of medicines and differences in taste, smell or texture.

“Patients should always be vigilant and confirm any changes with their pharmacist,” PPB says.

“It is crucial to obtain medicines from authorized outlets, and to report suspected poor-quality or counterfeit products to authorities.”

While Kenya has a significant fight against counterfeit medicines, the counterfeit medicines reflect a broader crisis on the African continent.

Malawi, for example, was identified in the Bahir Dar University study as the country with the highest rate of poor-quality medicines. 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 is highly dependent on a limited number of suppliers and many countries face significant challenges in sourcing products on time and effectively monitoring quality.”

This vulnerability is further exacerbated by the involvement of multiple intermediaries in the distribution of medicines, creating ample opportunities for criminal networks to infiltrate the supply chain. Unscrupulous actors exploit these weaknesses to flood markets with counterfeit medicines, often at prices that undercut those of legitimate manufacturers.

According to Dr Nyairaria, tackling Africa’s counterfeit medicines crisis requires a coordinated, multi-stakeholder approach.

“Strengthen regulatory oversight, especially for online pharmacies and e-health platforms, improve the pharmaceutical supply chain and import processes, and ensure that only qualified professionals staff pharmacy outlets,” he suggests.

The pharmacist adds that the public should be made more aware and conscious of the risks of counterfeit medicines and that stricter penalties should be introduced for those involved in the production and distribution of counterfeit medicines.

The PPB echoes these sentiments and stresses the need for continued vigilance and cooperation.

International organizations also play a crucial role.

By Maryann Muganda