Renthia Kaimbi
Two separate medicines have either been recalled or quarantined in the past two weeks, raising questions not only about the quality of medicines in circulation, but also about the transparency of the medicines regulator’s public communication.
The Namibia Medicines Regulatory Council (NMRC) issued a directive on 3 August 2026 ordering all public health facilities to immediately quarantine two batches of Azithromycin Oral Suspension, a widely used antibiotic manufactured by India-based Medicamen Biotech Ltd, after complaints that the product failed to dissolve properly and continued to exhibit lumps and granules even after thorough shaking.
The quarantine directive, signed by Registrar of Medicines Frieda Shigwedha, was circulated to Central Medical Stores, regional health directors, medical superintendents, pharmacists and nurses in-charge of health facilities across the country.
Just one week later, on 10 August 2026, Cospharm Investments issued its own voluntary recall notification for VCS Flumed Syrup (Batch 260180), a children’s cough, cold and flu syrup manufactured by Varichem Pharmaceuticals, after crystals were found in a number of units.
A source told the Windhoek Observer that crystallisation in medicines occurs when chemical reactions continue to take place after production and packaging.
Cospharm classified the recall as Class II, meaning it poses a potential but not immediate threat to patient safety, and stated that the recall would extend to retail level with consumer-level notification. A public notice was subsequently published by the Pharmacists Association of Namibia.
However, the contrast in how these two quality alerts have been communicated has drawn scrutiny from industry players.
While the NMRC’s directive regarding the Medicamen product was issued as an urgent official communication to healthcare facilities, the Cospharm recall was initiated and publicised by the company itself, with no equivalent formal public statement from the regulator.
This disparity, sources say, is particularly notable given that the NMRC’s Registrar of Medicines, Frieda Shigwedha, assumed office on 1 June 2026 and was employed by Cospharm from January 2026, before rejoining the regulator.
Sources previously alleged that Shigwedha is a close friend of both the health minister Dr Esperance Luvindao and NMRC chairperson Grace Nakalondo, and was appointed because the previous registrar refused to approve the entry of substandard medicines into Namibia amid a shortage of medicines countrywide.
The sequence of events raised questions about whether the regulator applied the same communication standards to both incidents.
The Medicamen recall was communicated directly by the NMRC with clear instructions for healthcare facilities to quarantine stock, cease distribution and report adverse events.
In contrast, sources say the Cospharm recall appears to have been handled primarily through the company’s own voluntary notification process, with the regulator’s role in overseeing or endorsing that recall remaining unclear.
“While Shigwedha’s previous employment with Cospharm does not, on its own, indicate any impropriety, the situation highlights the importance of transparent conflict-of-interest protocols, particularly when regulatory decisions involve a former employer. The public has a right to know whether the registrar formally disclosed her prior association with Cospharm and whether appropriate procedures were followed to ensure impartiality in any regulatory matters involving the company,” a source said.
The Windhoek Observer further established that Medicamen has received a significant number of direct procurement orders from the ministry of health and social services.
This has prompted broader concerns about the quality assurance protocols applied to medicines sourced through public tenders and whether the volume of direct procurement may have circumvented rigorous pre-qualification and quality checks.
The NMRC has stated that an investigation is ongoing and that further instructions will be communicated as more information becomes available.
In the case of Cospharm’s flu syrup, the recall was described as precautionary and that the manufacturer’s root-cause investigation is still ongoing.
Cospharm’s notification requested that all affected customers cease sale and distribution immediately, quarantine stock and arrange for its return.
The company also required that customers trace onward distribution and notify their own clients. However, no parallel public warning was issued by the NMRC to alert consumers directly, unlike the urgent quarantine directive issued for the Medicamen product.
“The distinction between a compulsory regulatory recall and a voluntary company-led recall is significant, but it does not fully explain why the regulator has not issued any public guidance or confirmation regarding the Cospharm product,” a source stated.
“If the NMRC was aware of the quality concern, has it independently verified that appropriate steps are being taken to protect public health? And if the regulator was not involved in the recall process, why was it not?”
Responding to questions from the Windhoek Observer, the executive director in the ministry of health and social services, Penda Ithindi clarified that the Azithromycin product was not formally recalled but rather placed under quarantine pending investigations.
He confirmed that following reports from health facilities that the affected batches of the suspension exhibited lumps and granules even after being thoroughly shaken, two batches were placed under quarantine, and these were the only batches imported.
Regarding procurement from Medicamen, the ministry revealed that it had procured an estimated 37 line items from the company since October 2025, with a total estimated value of approximately N$87 million.
On the Cospharm flu syrup, the ministry confirmed that the product was recalled due to quality complaints from the public and healthcare providers, however, no adverse reactions had been reported.
The ministry further stated that as per regulatory requirements, the distributor (Cospharm) was required to institute a voluntary recall of the affected product batch in consultation with the regulator, and that the recall notice was circulated to all relevant health professionals, pharmacies and health facilities, and made available to the public.
The ministry further clarified the distinction between the two regulatory actions taken. A quarantine, they explained, is an internal precautionary measure whereby the product batch is physically segregated and its use, sale or distribution is halted pending investigation. However, a quarantined product is not necessarily removed from the market.
A recall, by contrast, is the action taken to promptly and effectively remove from the market products already distributed that are known or suspected to be defective.
This means the product has left quarantine-level control and requires retrieval from distributors, pharmacies, or even patients.
In essence, the Azithromycin was held back before it could reach the public, while the flu syrup had already been distributed and had to be actively retrieved.
The ministry’s response also emphasised that the Registrar of Medicines does not procure medicines or award contracts, stating that procurement is done according to the Public Procurement Act and undertaken by relevant structures independent from the regulator to ensure transparency, objectivity and value for money.
“Medicine quality and registration to which the functions of the Registrar relate are subject to prior assessment and approval by the Medicines Regulatory Council,” Ithindi stated.
On the question of conflict of interest, he confirmed that Shigwedha’s previous employment at Cospharm was formally disclosed as part of her appointment process, which includes standard disclosure requirements administered by the ministry’s human resources division.
The ministry was keen to stress that Shigwedha does not take regulatory decisions in her individual capacity and attends council meetings only in an administrative and secretarial capacity with no vote.
“Decisions on the registration, licensing and recall of medicines are taken collectively by the Council, in terms of sections 2(3) and 19 of the Act, a structure specifically intended to ensure that no single individual can determine the outcome of a regulatory matter,” the response stated.
The ministry outlined the procedures in place for recall communication, noting that recall classification based on risk and distribution depth determines who must be notified, whether wholesalers, clinics, pharmacies or the general public.
According to the ministry, formal recall letters are issued to relevant parties, and communication is shared through emails to professional stakeholders, WhatsApp groups for rapid distribution among healthcare networks, and social media platforms for recalls that affect the wider public.
The ministry stated that records are kept of all communications, who was notified, how and when, to ensure accountability and traceability.
“The central issue is not to accuse any individual or company of wrongdoing, but to establish whether the same regulatory standards and communication procedures are being applied consistently to all pharmaceutical companies and products. When medicine safety is involved, the public has a right to clear, timely and transparent information, particularly where recalled products may already be in circulation,” a source stated.
When asked whether any other products from either Medicamen or Varichem were currently under investigation, the ministry stated that the NMRC was not aware of any other quality complaints or investigations involving products from either manufacturer.
“All reported concerns are tracked through regulatory channels, and any new issues would be formally communicated once verified,” Ithindi told the Windhoek Observer.
“This ensures transparency and consistency in how product quality matters are handled across manufacturers.”
