iDexis pushes back on Sahpra’s GLP-1 recall, denies compliance breaches

This article was first published on Business Day.By Tamar Kahn - Health & Science Correspondent.Local pharmaceutical company iDexis has fought back against regulators' allegations of irregularities with its GLP-1 weight-loss jabs, saying it can guarantee their quality and safety. The South African Health Products Regulatory Authority (Sahpra) issued a joint statement with the South African Pharmacy Council (SAPC) on Saturday, announcing that it instructed iDexis to issue a recall for its compounded semaglutide and tirzepatide shots. These medicines were originally developed as diabetes treatments but are increasingly used for weight loss. 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..Sahpra cracks down on illegal weight-loss drugs as GLP-1 demand booms.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 Business Day's detailed questions on the grounds that the company is involved in an ongoing legal dispute with Sahpra. "iDexis respects the court process and does not intend to litigate the matter through the media. For that reason, and because the matter is sub judice, iDexis will not comment on the merits of the pending proceedings or on disputed factual allegations," he said. The regulators said at the weekend that iDexis is producing and supplying compounded medicines outside the legal framework permitted by South African law. "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 SAPC said pharmacists and support staff who dispense recalled products will face disciplinary action, including possible removal from the pharmacy register. "Once a product is recalled, the expectation from the SAPC is that such products should not be dispensed by anyone, in the interest of patient safety," 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' 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..This article was first published on Business Day and is republished with permission.Sign up for your early morning brew of the BizNews Insider to keep you up to speed with the content that matters. The newsletter will land in your inbox at 5:30am weekdays. Register here.Support South Africa’s bastion of independent journalism, offering balanced insights on investments, business, and the political economy, by joining BizNews Premium. Register here.If you prefer WhatsApp for updates, sign up to the BizNews channel here.

iDexis pushes back on Sahpra’s GLP-1 recall, denies compliance breaches

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Sahpra cracks down on illegal weight-loss drugs as GLP-1 demand booms