With demand for weight-loss drugs soaring, and cheaper unregulated alternatives entering the market, the South African Health Products Regulatory Authority (SAHPRA) is intensifying enforcement against unregistered medicines, with a raid on a Pretoria pharmacy this week allegedly producing and supplying medicines “under the pretext of compounding but outside the legal framework of the law”.
But the pharmacy, iDexis (Pty) Ltd, trading as Sentra Pharmacy in Silverton, has denied it is non-compliant and is challenging the findings against it in court.
MedicalBrief notes that this comes as a flood of unregulated medicines, from weight loss injections to unsafe pain tablets, substandard and falsified medical products pose a massive health threat and pose a challenge for regulators in South Africa. (See Spotlight report in sidebar).
Working with the South African Pharmacy Council (SAPC), SAHPRA said it had “intensified enforcement action against the unlawful manufacturing and distribution of unregistered weight-loss medicines containing semaglutide and tirzepatide”, reports The Star.
SAHPRA and SAPC on Saturday announced that it instructed iDexis to issue a recall for its compounded semaglutide and tirzepatide shots.
The regulators said their joint investigation found “serious deficiencies” in iDexis’ quality, safety and regulatory compliance, including the illegal importation of semaglutide and tirzepatide active pharmaceutical ingredients (APIs) and inadequate sterile manufacturing conditions.
“These allegations are disputed,” iDexis MD Ruaan Louw told Business Day on Monday. An independent evaluation of the company’s compounding area and processes concluded it complied with all the applicable statutory and regulatory requirements, he said.
In a letter to medical practitioners, iDexis said it sourced its APIs from “reputable, internationally approved pharmaceutical manufacturers”, and the APIs were tested for sterility and quality in independent laboratories.
“We can guarantee the quality and safety of the S&T (semaglutide and tirzepatide) product of choice prescribed by you for the treatment of your patients,” it said.
“To date we have dispensed our S&T compounded peptide product to 214 406 patients on prescription … without any reports of adverse reactions or conditions,” it said.
Compounding pharmacies prepare customised formulations of medicines specific to the needs of patients.
iDexis said its compounding processes comply with the Medicines Act, as well as Sahpra’s guidelines for good compounding practices and the good pharmacy practice guidelines published by the SAPC.
iDexis did not specify the source of its APIs or the laboratory that tested its products. Louw declined to answer questions on the grounds that the company is involved in an ongoing legal dispute to which SAHPRA is a party.
Business Day understands the legal dispute Louw was referring to is an application launched by pharmaceutical manufacturer Novo Nordisk against iDexis, which cites SAHPRA as a respondent. Novo Nordisk holds the patent on semaglutide in South Africa.
“While compounding is strictly limited to the preparation of medicines for individual patients based on a valid prescription, iDexis was found to be manufacturing and marketing GIP/GLP-1-based products, including semaglutide, tirzepatide and combination formulations for broader commercial distribution,” it said.
The Pharmaceutical Task Group (PTG), an umbrella group for pharmaceutical manufacturing associations, said iDexis’ response to the regulators’ announcement is disappointing.
PTG chair Stavros Nicolaou said iDexis’ alleged lapses in good manufacturing practice place patients at risk. “We condemn this in the strongest terms,” he said. The sale of compounded, substandard, falsified and counterfeit GLP-1 products is one of the PTG’s biggest concerns, he said.
However, in a statement, iDexis said its compounding processes “comply with all requirements of subsection 14(4) of the Medicines Act 1965, the General Regulations published in terms thereof and the Guidelines for Good Compounding Practices (GCP) published by SAHPRA, and the Good Pharmacy Practice Guidelines (GPP)”.
The company accused the regulator of “questionable” tactics, saying all relevant concerns had been addressed two years ago, but “been ignored by the regulator “until now.
Authorities also said the facility lacked appropriate equipment for aseptic preparation and did not have a heating, ventilation, and air conditioning (HVAC) system required for sterile pharmaceutical production. No pharmacovigilance system was in place to monitor or respond to adverse drug reactions. SAHPRA claimed it had also received reports of adverse events, including hospitalisations, linked to the use of the products.
SAHPRA chief executive Dr Boitumelo Semete-Makokotlela said it had ordered the company to initiate a full recall of all affected products distributed through healthcare providers, pharmacies and other channels.
The SAPC said would pursue disciplinary action against pharmacy professionals implicated in the illegal manufacturing practices, with chief executive Vincent Tlala warning that pharmacists and pharmacy supporting personnel found selling, compounding or distributing unregistered medicines could face severe sanctions, including possible removal from the professional register.
However, in its statement, iDexis said the findings would all be challenged under section 28A of the Medicines Act 1965, and section 6 of the Promotion of Administrative Justice Act 2000 (PAJA).
“Our compounding processes comply with all requirements …We have confirmation … from an independent regulatory expert and our legal team, comprising senior and junior counsel, as well as experienced industry attorneys,” said the statement. It added that the APIs used to compound its semaglutide and tirzepitide are sourced from reputable, internationally approved pharmaceutical manufacturers and have been tested in independent analytical laboratories for sterility and quality.
“The Gauteng High Court (Pretoria) will definitively adjudicate all of the above on 10 and 11 June 2026,” the statement added. “We are of the opinion that the impugned findings of SAHPRA are nothing other than unsophisticated attempts orchestrated to improperly influence the outcome of the court case, especially in the light of an investigation by SAHPRA launched in 2025, into the desirability of compounding peptides … in respect of which we submitted detailed comments and expert scientific opinion and public comment, of which SAHPRA has not published any findings.”
Additionally, added the statement: “SAHPRA, electing to abide by the decision of the High Court by not participating in the court process, suddenly, after more than two years – while the court process is sub-judice – has taken unwarranted steps and published unsubstantiated findings which SAHPRA is aware are disputed by iDexis and are potentially harmful to its good name and reputation”.
“SAHPRA has, to date, not filed a response to our revised answering affidavit and the factual allegations and expert reports forming part of the contents thereof and as such is deemed to have agreed/acquiesced therewith which, makes its current actions so much more questionable.
“Without SAHPRA or any medical practitioner, retail pharmacy, or patient to whom our compounded S&T peptide was dispensed, reporting any material adverse reaction as a result of the use thereof to iDexis, it must also be accepted that the compounded product is safe, of good quality and effective for the purpose of its intended purpose.”
The company said that “to date we have dispensed our S&T compounded peptide product to 214 406 patients on prescription of their treating clinicians through the practices of their clinicians, or retail pharmacies of choice, without any reports of adverse reactions or conditions, only reports of great success and gratitude being expressed”.
iDexis said it had addressed all concerns raised by SAHPRA in 2024.
“To date SAHPRA has not been able to refute any of the allegations made by iDexis in this regard – and in fact has not even responded to the comprehensive submissions. It seems these submissions were simply ignored, giving rise to a reviewable irregularity of SAHPRA’s conduct and specifically the impugned findings under PAJA.
“As set out above, we are in the process of challenging the impugned SAHPRA findings in terms of section 28A of the Medicines Act 1965, and section 6 of the Promotion of Administrative Justice Act 2000.”
The Star article – Pretoria Pharmacy busted for illegal weight-loss drug production (Open access)
Business Day – iDexis rejects Sahpra claims in GLP-1 weight‑loss drug recall order
See more from MedicalBrief archives:
SAHPRA and drug companies flag risks of compounded weight-loss drugs
Lilly warns of potentially toxic compounded tirzepatide