The South African Health Products Regulatory Authority (SAHPRA) and the South African Pharmacy Council (SAPC) have ramped up a nationwide crackdown on the illegal manufacturing and supply of unregistered weight-loss medicines.
The medicines contain Semaglutide, Tirzepatide, or a combination product containing both Semaglutide and Tirzepatide.
“SAHPRA and SAPC conducted a joint investigation inspection at iDexis (Pty) Ltd trading as Sentra Pharmacy in Silverton, Pretoria. The inspection focused on Semaglutide, Tirzepatide and combination formulations and discovered critical regulatory non-compliance, all GIP/GLP-1 injectable products found onsite were seized.
“The investigation revealed that the company was producing and supplying medicines under the pretext of ‘compounding’, but outside the legal framework permitted under South African law.
“While compounding is strictly limited to the preparation of medicines for individual patients based on a valid prescription, the facility was found to be manufacturing and marketing GIP/GLP-1-based products, including Semaglutide, Tirzepatide, and combination formulations, for broader commercial distribution, particularly for weight management purposes,” the two health watchdogs said in a joint statement.
Furthermore, the investigation revealed serious deficiencies in quality, safety, and regulatory compliance, including:
- The illegal importation of Semaglutide and Tirzepatide active pharmaceutical ingredients (APIs);
- The absence of analytical testing to confirm identity, potency and purity;
- Inadequate sterile manufacturing conditions, high risk of contamination;
- Inadequate equipment for aseptic medical preparations; and
- The lack of heating, ventilation, and air conditioning systems.
“The room allocated for producing GLP-1/GIP products didn’t meet the requirements of aseptically prepared products. In addition, no pharmacovigilance system was in place to monitor or respond to adverse drug reactions.
“SAHPRA has also noted reports of adverse events, including hospitalisations, linked to the use of these products, as well as concerns regarding possible illegal importation of APIs and promotional activities targeting healthcare providers and consumers,” the statement continued.
All finished products containing Semaglutide, Tirzepatide, and related combinations have been seized.
“The company has been instructed to initiate a full recall of affected products distributed through healthcare providers, pharmacies, and other channels.
“According to the Medicines and Related Substances Act, 101 of 1965, as amended, compounding must remain strictly within the applicable parameters of the law and cannot be used as a mechanism for large-scale manufacture, advertising, or distribution of unregistered medicines,” the statement read.
SAHPRA CEO, Dr Boitumelo Semete-Makokotlela said: “SAHPRA will continue to take decisive regulatory and enforcement action against any entity that contravenes the Medicines and Related Substances Act.
“The unlawful manufacture, importation, advertising, and distribution of unregistered medicines pose a serious risk to public health. We will not hesitate to act to protect patients and safeguard the integrity of South Africa’s regulatory system.”
SAPC CEO Vincent Tlala added that the council will be taking further action against pharmacy professionals involved in illegal manufacturing.
“Unlawful manufacturing, promotion and distribution of unregistered GLP-1 medicines for weight loss is a serious violation of the law and a direct threat to public safety.
“Following the inspection conducted at Sentra Pharmacy, the SAPC will pursue decisive regulatory action against those involved.
“Pharmacists and pharmacy support personnel found selling, compounding or distributing these unregistered medicines risk severe disciplinary action. Including possible removal from the register. Council will not tolerate any conduct that compromises patient safety or the integrity of the pharmacy profession,” Tlala warned. – SAnews.gov.za
