All pictures: Ministry of Health Facebook
BY INHLASE REPORTER
A decade after Eswatini passed a law to establish an autonomous Medicines Regulatory Authority to register and control the country’s medicines, the government took until January 2026 even to appoint its board — and still has no facility to test the drugs it buys. In the 2023/24 financial year alone it paid E4.8 million for medicines later recalled as sub-potent, mislabelled or contaminated, and a forensic review found no record that any of it was refunded.
The Medicines and Related Substances Control Act, passed in 2016, requires a medicines regulator and a quality-control system. Ten years on, neither exists. In 2023/24, E4.8 million went to drugs that were later recalled.
In the absence of routine testing, defects surface only after a drug has been bought, distributed and, in some cases, dispensed. The Central Medical Stores pays suppliers up front leaving quality problems to be discovered if at all, only at the patient’s bedside.
Quality Control (QC) testing is the bedrock of the pharmaceutical industry. Its purpose is to verify that a drug product meets specific safety standards, containing the correct active pharmaceutical ingredients (APIs) and remaining free from impurities.
Funduzi Forensic Auditors were engaged by the Office of the Auditor-General Eswatini to conduct a further forensic investigation into the circumstances and implications surrounding the recall of medicines and drugs. The Ministry of Health recalled medicines and drugs valued at E4 821 145.58 during the 2023/2024 financial year. By the time a recall is issued, the drugs have usually already reached clinics and patients across the country.
How procurement takes place
The current procurement process, while structured on paper, lacks the “teeth” required to ensure safety. The chain of custody is dangerously simplistic:
- Enlistment: Suppliers are selected via tender and placed on a database.
- Delivery: Suppliers deliver stock with batch numbers and delivery notes to the Central Medical Stores (CMS).
- Distribution: Public health facilities place orders with the CMS, which then delivers the stock.
The fatal flaw exists between delivery and distribution. There is no biological or chemical verification of the drugs upon delivery. Without a testing facility, the CMS relies solely on a visual inspection of the packaging. If a pill appears to be the correct colour and the box looks professional, it is assumed to be life-saving.
“There is no testing facility or mechanisms to determine if the drugs supplied are of adequate quality,” the Funduzi report concludes. “This implies that drugs that are substandard but do not show visible characteristics may continue to flood the system.”
Internal correspondence obtained by Inhlase shows how defective stock moved through the system.
In a letter dated 10 October 2024, Principal Secretary Khanya Mabuza told suppliers that a consignment of Cloxacillin Suspension had been rejected because it “does not dissolve and has multiple colours.” The defect was detected visually, but only after the stock had already been procured and delivered. With no laboratory to test consignments on arrival, problems such as this surface only after the government has already paid suppliers and distributed stock through the public health system.
In another case involving Carbamazepine CR, a critical anti-seizure medicine, the packaging omitted the “CR” (controlled-release) designation. Controlled-release formulations are designed to release medicine gradually over time, and confusion between controlled-release and immediate-release products may lead to inappropriate prescribing, dispensing or administration practices, potentially reducing therapeutic effectiveness or causing unintended adverse reactions. The supplier subsequently wrote to the Ministry apologising for the omission and describing it as a printing error.
The Financial Toll of Substandard Care
The financial cost is substantial.
The investigation identified several high-risk recalls that illustrate the depth of the crisis:
Table 1: High-Risk Recalls and Quality Defects (2023-2024)
| # | Product Name | Reason for Recall | Impact |
| 1 | Cloxacillin Suspension | Failed to dissolve; clumpy; multi-coloured. | Paediatric risk |
| 2 | Beclomethasone Spray | Misleading labelling (indicated spray, was drops). | Dosage error |
| 3 | Folic Acid Tablet | Black spots (contamination) found on tablets. | Infection risk |
| 4 | Phenoxymethyl Penicillin | Misleading/Incorrect labelling. | Treatment failure |
| 5 | Cold & Flu Syrup | Quality defects observed during storage. | Chemical instability |
There was no evidence that these medicines were replaced or that the suppliers refunded the state.
In the 2023/24 financial year, the state spent E4 821 145.58 on medicines that were later recalled. The investigation found no evidence that the medicines were replaced or that suppliers refunded the government.
Of the E4.821 million expenditure, approximately E1.9 million remained unrecovered from suppliers.
The “Short-Dated” Dumping Ground
According to documents seen by Inhlase, a senior pharmacist at the Central Medical Stores (CMS), authorised acceptance of a Sodium Valproate consignment with 10 months of shelf-life remaining, against the CMS regulatory minimum of 18 months.
Accepting medicines with substantially reduced shelf life increases the likelihood that products will expire before they can be dispensed, particularly in remote facilities where stock turnover is slower. This exposes government to additional costs associated with both procurement and disposal of expired medicines.
The Invisible Threat: Counterfeits and Under-Dosing
The absence of a testing facility leaves the population vulnerable to three categories of dangerous medicines: counterfeit products containing little or no active ingredient, substandard medicines that fail to meet quality standards, and diverted medicines that have been removed from legitimate supply chains and resold. Each carries the risk of treatment failure, drug resistance, illness and, in severe cases, death.
Factors influencing this crisis include:
- Counterfeits: Fake copies of branded drugs containing only filling materials (like chalk) without active ingredients.
- Substandard Drugs: Genuine brands manufactured with poor standards to save costs.
- Drug Diversion: Donated medicines diverted and sold for profit in the private market.
The Funduzi investigation expressed concern that some recalled medicines and drugs may already have been consumed or ingested by patients before defects were identified. The World Health Organization has warned that substandard and falsified medicines can result in treatment failure, contribute to antimicrobial resistance and, in severe cases, cause serious injury or death. In Eswatini, where medicines are not routinely tested before distribution, defective products may only be detected after they have reached health facilities and patients.
Citing a USAID study, the report notes that Eswatini’s weak medicines regulation and limited enforcement create vulnerabilities that can be exploited by those involved in the regional trade of prohibited and counterfeit medicines.
The Funduzi report cites a USAID Promoting the Quality of Medicines Plus (PQM+) study which found that up to 25 percent of medicines sampled in parts of the SADC region were substandard or counterfeit, while some categories of antimalarial medicines recorded rates as high as 64 percent. These figures represent regional findings and are not estimates of the prevalence of poor-quality medicines in Eswatini.
Scientific Analysis: The Funduzi Findings
Funduzi’s forensic review drew on laboratory assays by the Institute of Pharmaceutical Services (IPS), a South African pharmaceutical-testing laboratory, which tested batches selected against United States Pharmacopeia (USP) standards.
Case Study: Cold and Flu Tablets (Batch XT28006)
- Chlorpheniramine: The concentration was determined to be 1.66 mg/tablet, which is only 83.1% of the labelled amount. This falls below the USP (United States Pharmacopeia) criteria of 90%–110%, meaning the product does not meet release criteria.
- The report’s IPS laboratory findings states that the Paracetamol concentration was 146 mg/tablet, representing 48.8% of the labelled amount based on a 300 mg/tablet label claim.
A tablet containing under half its stated paracetamol will not reliably relieve the symptoms it’s prescribed for. The assay shows the system is releasing sub-potent stock, not merely mislabelled stock.
Further students from Eswatini Christian Medical University a local institution of higher learning pharmaceuticals department also conducted random rests on the medication that was distributed in some public hospitals. It is safe to say the results were not far from those that were conducted by IPS thus emphasizing the need of the facility.
The Regulatory Framework: A “Toothless” Act
The Medicines and Related Substances Control Act of 2016 is, on paper, a robust piece of legislation. It provides for the establishment of a Medicines Regulatory Authority (MRA) to maintain a register of drugs and license suppliers.
However, because previous administrations failed to operationalise the MRA, its functions were performed by a Medicines Regulatory Unit (MRU) within the Ministry. The report further references findings from a previous investigation which concluded that some officials did not have sufficient technical training and experience to manage issues relating to drug quality, storage and inventory management.
The Funduzi report further alleges that some unnamed officials were “complicit to acts of wrongdoing” [sic] and that their relationships with suppliers had compromised their judgement. The report does not identify the officials or provide individual findings against specific persons.
Currently:
- There is no official register of medicines as contemplated in the Act.
- Licenses issued to suppliers lack complete details.
- There is no legal structure empowered to revoke the licenses of suppliers who violate safety conditions.
During a Public Accounts Committee visit to Mkhuzweni Health Centre in November 2024, MP Sandile Nxumalo asked Senior Pharmacist Desmond Nyoni whether the country was “gambling with the lives of emaSwati.”
Nyoni, who was first reluctant to give a response to the question, submitted that patients are not safe, because for one to know that drugs are of the expected quality and standard, they would have to be tested.
About one in 10 medical products in low- and middle-income countries is substandard or falsified, according to a 2017 World Health Organization estimate. By contrast, a USAID study cited in the Funduzi report found higher rates in parts of the SADC region, estimating that up to 25% of medicines sampled were substandard or counterfeit, with some categories such as antimalarials recording even higher rates. The figures are not directly comparable, as the WHO estimate is global while the USAID findings relate to a specific regional sample.
This means that people are taking medicines that fail to treat or prevent disease.
In 2024, Eswatini’s Public Accounts Committee (PAC) visited the Kingdom of Lesotho to benchmark their healthcare system.
The Committee found that Lesotho, which runs an independent medicines body (the NDSO), has largely eliminated stock-outs and expired stock, and attributed this to the body’s independence.
Because of this independence, Lesotho:
- Does not experience medical drug stock-outs.
- Distributes ARVs to both public and private hospitals seamlessly.
- Ensures that every Loti spent on medication results in a usable product reaching a patient.
A year after the House of Assembly’s resolution to speed up the formation of a drug-testing facility, progress remains slow. Nsindiso Tsabedze, the Ministry of Health’s Information and Communications Officer, states that in the absence of a facility, the country relies on manufacturer and supplier agreements.
“Suppliers are expected to source from accredited manufacturers. If a supplier uses a manufacturer not on the list, the order is rejected,” Tsabedze explained. However, when pressed on the timeline for a local testing facility, he admitted that such a project is “not yet on the cards.”
This admission highlights the disconnect between the legislative mandate and the executive’s actions. While the Ministry claims to rely on “accreditation,” the chemical analysis of Paracetamol and Chlorpheniramine proves that accreditation on paper does not guarantee quality in the bottle.
A New Hope? The Establishment of EMRA
On 8 January 2026, Health Minister Mduduzi Matsebula named the board of the Eswatini Medicines Regulatory Authority (EMRA).
The EMRA is tasked with:
- Registering medicines, medical devices, and complementary medicines.
- Regulating labelling and advertising.
- Controlling the sale and manufacture of scheduled substances.
The board has no laboratory to draw on. The Funduzi report and health experts offer these urgent recommendations to save the nation’s health:
- Immediate Funding for a National Lab: The government must prioritize the construction of a drug-testing facility to verify all imports before they are distributed.
- Civil Recovery of Funds: The Ministry of Health must initiate legal action against suppliers to recover the E4.8 million spent on substandard and recalled drugs.
- Strict Blacklisting: Under Section 63 of the Medicines Act, any supplier responsible for delivering substandard or mislabelled stock must be permanently blacklisted from government tenders.
- Interim Outsourcing: Until a local lab is built, every batch of medicine should be verified by accredited South African laboratories (like IPS) as a mandatory condition of the CMS.
- Autonomy for the CMS: Following the Lesotho model, the CMS must be moved out of the Ministry of Health and transformed into a semi-autonomous entity to reduce political interference and corruption.
On 8 May 2026, Health Minister Mduduzi Matsebula named the board of the new Eswatini Medical Supplies Agency, created under the Eswatini Medical Supplies Agency Act of 2025 to take over the Central Medical Stores’ procurement and distribution. Under Section 7 of the Act the minister appoints the board, chaired by Siegfried Musizi Nyahoza; its first task is to hire a chief executive.
EMSA Board:
1. Siegfried Musizi Nyahoza – Chairperson
2. Khanyakwezwe Mabuza
3. Thulisile Constance Gamedze
4. Mfundi Makama
5. Dr. Charity Newton
6. Garikai Shambira
7. Sibongile Zondi-Hlatshwayo
8. Okwakhe Phungwayo
9. CEO (yet to be hired)
For years, Eswatini has been exploited by suppliers who treat the Kingdom as a dumping ground for substandard goods. With the lives of the nation at stake, the time for visual inspections and supplier apologies is over. Eswatini needs science, not blind trust, to protect its people.