LOBAMBA – After being implicated in the delivery of medical drugs that were later recalled, prominent pharmaceutical supplier Swazipharm has reaffirmed its commitment to regulatory compliance and the quality assurance of medicines.
While reaffirming the commitment, the company has, however, noted some inefficiencies on the part of the Ministry of Health.
The assurance was given to the Public Accounts Committee (PAC) during the Ministry of Health’s appearance before the committee to discuss a report by Funduzi Forensic Services on the recall of medical drugs and medicines.
During the investigation, the consultant made a forensic finding to the effect that several medicines were recalled due to quality concerns, mislabelling, unusual physical characteristics and short shelf life.
During the PAC sitting, the ministry acknowledged that a number of medicines were recalled during the period under review.
The recalls, the ministry said, demonstrated a post-market surveillance system that is functioning and capable of identifying medicines that fail to meet acceptable quality standards after delivery.
Principal Secretary Khanyakwezwe Mabuza informed the PAC that immediately upon identification of the affected batches, the ministry implemented a variety of measures, including issuing recall notices to all public health facilities.
The measures, according to the PS, also included giving an instruction to health facilities to immediately quarantine affected stock and stopping distribution.
The PS said suppliers were formally instructed to uplift the recalled medicines and produce the destruction certificate.
He said the suppliers were formally communicated with and directed to remove all recalled procedures.
According to Mabuza since the forensic investigation, the ministry has strengthened recall management by standardising recall communication templates, improving documentation of recalls, strengthening batch traceability, improving communication between the Central Medical Stores (CMS), procurement, pharmacy services and the Medicines Regulatory Unit (MRU).
He said the ministry is also developing a comprehensive National Medicines Recall Guideline to further strengthen the management of medicine recalls.
Elaborating, the PS informed the PAC that two suppliers, Swazipharm and MVJ Medical Suppliers, had been notified of the anomalies.
He said the latter has since refunded government the amount related to the drugs recall.
When shedding more light on Swazipharm, the PS said the company has acknowledged receipt of the ministry’s follow-up correspondence and remains committed to regulatory compliance and quality assurance.
“Swazipharm has requested reconciliation of the recalled products list to ensure accuracy, as some items were mistakenly included in previous communications,” the PS informed the PAC.
He said the logistics team is prepared to collect the recalled stock from the CMS once the correct list is confirmed and necessary arrangements are made.
“Financial reconciliation will be completed jointly once the final quantities are established.
“Additionally, Swazipharm has indicated their capacity to safely incinerate expired and controlled pharmaceuticals, as they operate the only licensed and functional medical waste incineration plant in the country,” the PS said.
He directed the PAC to annexures, one of them being the receipt from MVJ Medical Suppliers and correspondence with Swazipharm Wholesalers.
In its correspondence, Swazipharm has pointed out that this is the first official written communication from the ministry requesting to collect the stock from the CMS.
“We acknowledge the list of the recalled items highlighted in the letter and kindly request a reconciliation of the listed items. Some of the items should not be on the list as they were erroneously included. We hold the view that the list provided was not updated. We are committed to cooperating with your office in this regard. Hitherto, we have not received confirmation of the correct quantities of the recalled products to be collected by your organisation”.
Swazipharm, as per its correspondence, requested the ministry to make logistical the necessary arrangements for the collection of the recalled stock at CMS and nominate relevant personnel responsible for the release of the stock.
“We will then ensure the safe and compliant incineration of the recalled products through our duly appointed disposal service provider.
“As for the financial accounting, reconciliation shall be done once the amount of stock is jointly confirmed,” reads part of the correspondence from Swazipharm.
The company said it cannot evade its responsibility and as such, is disappointed with the notion that after ‘repeated notifications’, it has not taken any action, as this is a joint operation.
“Additionally, on numerous occasions we have in fact reached out requesting permission to collect items in the past, were met in silence,” the company said.
The PAC members, on the other hand, asked to know if government will be refunded and whether Swazipharm will pay the costs for destroying the recalled or expired drugs.
Legal fears raised over Funduzi report
LOBAMBA – Members of Parliament sitting in the PAC initially expressed reluctance to debate the forensic report into the procurement of medicines and medical supplies at the Ministry of Health.
The Public Accounts Committee (PAC) members cited fears that ongoing court proceedings involving Funduzi Forensic Services could expose the committee’s work to future legal challenges.
The concerns dominated the opening stages of the committee meeting before members were assured by the Auditor General’s Office, legal representatives and the Ministry of Health that the report before Parliament was not the subject of any court challenge.
Following the clarifications, the committee proceeded with its deliberations.
Matsanjeni South MP Sicelo Ndlangamandla was among the first to raise concerns, saying media reports had indicated that the Funduzi Report was before the courts.
He questioned whether proceeding with the discussion would amount to debating a matter that was sub judice and warned that the committee risked embarrassment should those challenging the process later seek to appear before Parliament.
PAC Chairperson Madala Mhlanga immediately clarified that the report before the committee was different from the one being referred to in court proceedings.
He explained that the forensic report tabled before Parliament had never been challenged in court and reminded members that the earlier report had already been adopted by Parliament.
Mhlanga further explained that any decision to summon suppliers implicated in the report would only arise after the Ministry of Health’s controlling officer had responded to the committee’s findings.
He added that many of the suppliers’ responses were already contained in the report.
Somntongo MP Sandile Nxumalo sought further clarification, asking whether the legal challenge was directed at the report itself or at Funduzi Forensic Services as the consultant appointed to conduct the investigation.
Auditor General, Timothy Matsebula assured the committee that the report under consideration had not been challenged.
He explained that while any individual has a constitutional right to approach the courts, such legal action does not prevent constitutional institutions from carrying out their statutory responsibilities.
“The second report that was presented here in Parliament was never challenged in court. Every person has the right to file their cases.
“It does not stop anyone from doing the mandate they are given,” said Matsebula.
He disclosed that his office, Funduzi and the ministry’s principal secretary had all been served with court papers relating to the separate legal matter.
However, he stressed that the forensic investigation had been commissioned by the Office of the auditor general in line with its constitutional and statutory mandate, noting that the Audit Act empowers the auditor general to appoint suitably qualified persons to undertake investigations on the office’s behalf.
An advocate from the Auditor General’s Office reinforced this position, explaining that the Constitution and the Audit Act give the auditor general authority to conduct investigations and engage external specialists where necessary.
The advocate advised that any legal questions surrounding the court proceedings could be addressed by the attorney general if required, while noting that the issues before the courts should not distract the committee from carrying out its mandate.
Mhlanga also expressed concern that members were only raising reservations at committee stage despite the report having been tabled in Parliament in December.
Although satisfied with the explanations, MPs maintained that their concerns were intended to protect the integrity of Parliament’s work rather than undermine the report itself.
Nxumalo said members simply wanted assurance that their deliberations would not later be invalidated by court proceedings.
“We are not trying to cast an aspersion on the report; we want to ensure that we do it with a clear conscience,” he said.
Funduzi Forensic Services Director Zweli Dlamini also addressed the committee, explaining that the legal proceedings stemmed from challenges brought during the consultancy’s earlier work in 2023, rather than the contents of the current forensic report.
He recalled that when the matter first reached the courts in June 2023, an interim ruling had temporarily restricted further engagement before the court later allowed Funduzi to continue with its work after considering the legal issues.
Dlamini said the current court proceedings largely centred on attempts to question the credibility and existence of Funduzi rather than the forensic findings themselves.
“The issue was, who is Funduzi. People claimed that I do not exist, I am a fly-by-night and that I am from Mankayane,” he said, before adding that he was an emaSwati born in Mankayane under Ngwempisi Inkhundla.
He emphasised that the investigation had not targeted any individual or company but had relied entirely on documentary evidence obtained during the audit.
According to Dlamini, the sample of medicines examined during the forensic exercise was selected randomly without regard to suppliers. Investigators subsequently analysed expenditure patterns, product quality and procurement processes to determine whether the Ministry had received value for money.
He said one of the major concerns identified was the supply of medicines with short remaining shelf lives. The investigation also found weaknesses in the country’s medicine quality assurance systems, particularly the absence of laboratory testing facilities capable of independently verifying pharmaceutical products before they enter the health system.
Dlamini said officials at the Central Medical Stores had informed investigators that their role was largely limited to confirming delivery of goods rather than testing the medicines themselves.
He warned that the existing procurement and inspection system could allow substandard medicines to enter the country because border authorities did not routinely test imported pharmaceutical products.
Responding on behalf of the Ministry of Health, Principal Secretary Khanyakwezwe Mabuza said the ministry had carefully studied the forensic report and submitted its formal responses to the Office of the Auditor General.
He stated that the ministry had also consulted its legal office while reviewing the report and its recommendations.
Mabuza made it clear that Funduzi bore no liability for the contents of the report, describing it as a report commissioned by the auditor general in accordance with the law.
He welcomed many of the report’s recommendations, saying they would contribute to strengthening Eswatini’s health system.
The PS said the ministry had already recognised the need to strengthen the regulation of medicines and reinforce the country’s regulatory institutions through Parliament. He pointed to the existing Medical Regulatory Unit as part of those efforts.
Mabuza also acknowledged concerns raised about the operations of the Central Medical Stores, saying government had already begun implementing reforms.
He disclosed that the ministry had held meetings with suppliers and discovered that poor communication between suppliers and ministry officials had contributed to several procurement challenges, adding that efforts were underway to improve those relationships.
Before debate continued, Ndlangamandla sought further legal clarity after observing that copies of the report circulated to members did not bear signatures. He questioned whether unsigned copies affected the report’s authenticity.
Matsebula explained that the original reports submitted to the Speaker, the minister for Health and the PAC chairperson had all been duly signed. The unsigned copies distributed during the meeting, he said, were internal working copies prepared for the Auditor General’s Office.
Mhlanga confirmed that the copy officially submitted to his office carried the required signatures.
Kubuta MP Masiphula Mamba nevertheless sought one final assurance from the ministry before proceeding with debate. He requested confirmation that the ministry’s legal advisers were satisfied that discussing the report would not violate the sub judice rule or expose Parliament to legal complications.
Following the series of explanations from the Auditor General’s Office, Funduzi and the Ministry of Health, members accepted that the report before them was not subject to the pending litigation and proceeded to debate its findings.
