In-depth: A Dollar a Dose, a Life Saved: The search for safer pharmaceuticals amid the challenge of widespread substandard medications

By Million Beyene @MillionBeyene

Addis Abeba – In the world of illicit trade, a dangerous threat looms in the form of substandard and illegally sold pharmaceuticals that endanger millions of lives worldwide.

A recent study conducted by the World Health Organization (WHO) has uncovered the massive scale of this problem, revealing that the illicit drug trade generates nearly a trillion dollars annually.

Surprisingly, this makes it the second-largest illicit financial stream globally, coming in just behind arms sales. However, the true impact of this hidden industry extends far beyond just monetary value.

In sub-Saharan Africa, including Ethiopia, the cost is counted in human lives.

Every year, almost half a million individuals fall victim to the dangerous consequences of using substandard and counterfeit medical products.

The ramifications of this issue are severe, as individuals often unwittingly procure and consume medications that prove to be ineffectual or even detrimental to their well-being.

The recent experience of Getachew Belay, a resident of Addis Abeba, serves as a poignant illustration of the predicament faced by such individuals.

He told Addis Standard about the distressing ordeal of procuring medications at a substantial cost of 90,000 birr, only to find them ineffective in treating his mother’s liver disease.

Regrettably, despite the doctor’s acknowledgment of the ineffectiveness of the “albumin” medication and subsequent refusal to administer it, this intervention was belated.

“Consequently, my mother succumbed to her condition shortly after discontinuing the ineffective treatment and before a suitable alternative could be provided,” recounted Getachew, reflecting on the most devastating experience of his life.

Dr. Mehari Tesfaye (name changed), a prominent medical director at a public hospital in Addis Abeba, shared insights with Addis Standard regarding Ethiopia’s escalating issue of substandard medications.

According to him, a notable example is “albumin,” a vital medicine employed in treating liver disease.

“The substandard variants of this medication are not only ineffective but also potentially harmful,” he emphasized, underscoring the peril associated with such drugs.

A nationwide study conducted in 2013 found that 7.8% of medications in Ethiopia were substandard.

Nevertheless, medical experts interviewed by Addis Standard disclosed that the incidence of substandard drugs has notably increased in Ethiopia over the past decade.

This observation aligns with research findings.

According to a study published last year, 21.8% of the drugs sampled in Ethiopia exhibited failures in one of the product quality parameters: dissolution, disintegration, identity, or chemical assay.

An anonymous medical expert disclosed the extensive availability of substandard, illicitly manufactured, or imported drugs in numerous pharmacies throughout Addis Abeba.

The expert highlighted a particularly troubling trend: the heightened involvement of licensed drug importers in the illicit drug trade, particularly over the past two years.

In Ethiopia, a particularly troubling issue arises from the presence of ineffective medications, even among those legally imported.

Medical experts have apprised Addis Standard of instances where drugs lack medicinal properties, aligning with public grievances about medications failing to provide therapeutic benefits.

Dr. Solomon Tezera (name changed), an infectious disease specialist, is among the medical professionals who express profound concern regarding the prevalence of ineffective medications.

“These concerns extend beyond smuggled drugs to encompass medications legally imported by some organizations,” he states. “Patients diagnosed through lab tests and prescribed medication often fail to experience improvement due to these defective products, resulting in a frustrating situation for both patients and medical staff.”

Patients diagnosed through lab tests and prescribed medication often fail to experience improvement due to substandard medications.”

An infectious disease specialist

Dr. Solomon further emphasizes the critical role of effective medications in managing chronic conditions such as diabetes, hypertension, and heart disease. He underscores that substandard medications for these illnesses can lead to a rapid exacerbation of symptoms.

“Medical professionals have recently identified and reported these problematic drugs to the appropriate regulatory bodies,” he added.

Recently, the Ethiopian Diabetic Association (EDA) also raised concerns about the efficacy of a medication named ‘Galvanez’.

Tackling substandard medications

The Ethiopian Food and Drug Authority (EFDA), a governmental regulatory body responsible for ensuring the safety, quality, and efficacy of medicines, has addressed these concerns.

Officials from the EFDA have stated that no official reports regarding the specific medication in question have been filed.

Gezahegn Endale, the head of the EFDA’s South East Addis Abeba Branch Office, affirmed, “No reports of substandard or defective medications related to Galvanez have been presented to the authority thus far.”

While no issues with Galvanez have been reported, the EFDA has noted a concerning trend of unauthorized drugs entering the country. These drugs often lack registration, approval from their country of origin, and information about their manufacturers.

Additionally, the EFDA recognizes the ongoing challenge of smuggled medications, particularly those targeting critical areas such as cancer treatment. The Authority has stated its active efforts to strengthen controls at border entry and exit points.

In a recent statement, the EFDA underscored its commitment to “identifying and removing any smuggled drugs to safeguard public health.” The authority highlighted its rigorous protocols for ensuring the safety and efficacy of all medications entering the Ethiopian market.

This includes thorough pre-market registration checks, which meticulously examine a drug’s production methods, ingredient lists, and accompanying scientific documentation before granting a market license.

Furthermore, to ensure quality, imported medications undergo extensive sampling, testing, and verification procedures beyond registration. Additionally, the EFDA conducts physical inspections at entry and exit points to enhance its safeguards.

Acknowledging the challenge of precisely quantifying the volume of smuggled drugs, officials at the EFDA assert that their regulatory measures are more stringent compared to those of neighboring countries. They underscore their “continuous endeavors to ensure the quality, safety, and efficacy of medications” across the entire supply chain.

However, stakeholders emphasize that the shortage of legally imported medications has compelled certain private pharmacies, licensed drug importers, and domestic drug producers to resort to smuggled alternatives.

Dr. Mehari underscored the challenges Ethiopia encounters in securing an adequate supply of legal medications.

“This susceptibility exposes the population to the hazards of smuggled drugs,” he elucidated. “Patients who unwittingly depend on substandard medications are at an elevated risk of complications.”

Gezahegn acknowledges the potential vulnerabilities within the distribution system and unethical practices by some wholesalers, such as auctioning off medications of dubious origin to retailers, which could introduce smuggled or unregistered drugs.

“The recent license revocation of four wholesalers supplying unregistered drugs to St. Paul Millennium Medical College’s Hospital exemplifies the EFDA’s commitment to addressing such practices,” he highlights.

Forex shortage, soaring prices

However, Gezahegn attributes a significant factor in such health risks to the scarcity of foreign currency in the country.

“This limitation restricts the ability of importers to acquire essential medications in sufficient quantities, potentially leading to drug shortages,” he explains.

Ethiopia meets the yearly requirement for medications and medical equipment primarily through imports, as domestic production satisfies only 15% of the national demand.

The Ethiopian Pharmaceuticals Supply Service (EPSS) oversees the acquisition of drugs and medical equipment, whether sourced locally or imported.

The scarcity of foreign currency in the country restricts the ability of importers to acquire essential medications in sufficient quantities, potentially leading to drug shortages.”

Gezahegn Endale, the head of the EFDA’s South East Addis Abeba Branch Office

Annually, EPSS supplies over 1,000 medicines and medical equipment to more than 5,000 public health institutions. In the previous year, it allocated over 40 billion birr for the procurement of drugs and medical equipment, with drug procurement alone amounting to over 15 billion birr.

Dr. Solomon further contends that the limited availability of foreign currency is hampering the capacity of local pharmaceutical manufacturers to import essential raw materials necessary for drug production.

Leaders of the Ethiopian Pharmaceutical Manufacturers Association also attribute their underperformance to the unavailability of foreign currency. They highlighted that 85% of the challenges they face are related to foreign currency shortages.

Mukamil Abdella, vice president of the association, recently stated in a state media interview that foreign currency is not accessible in the required quantity and timeframe for procuring raw materials essential for medicine production, adversely affecting their operations.

Another senior manager from a local pharmaceutical company disclosed that his firm requested $21 million for the acquisition of raw materials and other essentials. However, after an 11-month waiting period, the company was only allocated $5 million, which proved insufficient.

The persistent scarcity of foreign currency in Ethiopia continues to render the nation vulnerable to the influx of smuggled drugs, exacerbated by disruptions in the global supply chain that have led to inflated prices for pharmaceutical products.

Studies indicate that disruptions caused by the COVID-19 pandemic, further compounded by the Russia-Ukraine conflict, have resulted in a more than 200% increase in drug costs.

During his appearance before parliament to present the central bank’s quarterly report in November 2023, Mamo Mihretu, the governor of the National Bank of Ethiopia (NBE), acknowledged the escalating pharmaceutical costs, which are depleting the country’s foreign currency reserves.

According to Mamo, the costs of three key import items for Ethiopia—pharmaceuticals, petroleum, and fertilizers—have more than doubled in the past three years.

Although acknowledging that Ethiopia encounters obstacles in ensuring a consistent provision of legally imported medications due to factors such as limited foreign currency reserves, public health experts contend that these challenges should not serve as justification for the increase in illegal drug trafficking and the availability of substandard drugs in pharmacies.

Officials, however, assert that they are actively addressing the issue of smuggled medications despite the persistent challenge of detecting and eliminating any illicit drugs that may already be present within the country.

“The Authority is intensifying surveillance at entry points to deter smuggling,” stated Gezahegn. AS