The South African Health Products Regulatory Authority (SAHPRA) has announced a policy shift regarding the use of yohimbine in veterinary medicine, signaling a potential return of the substance to regulated veterinary use after more than four decades of prohibition.
Yohimbine, a compound known for its action on alpha-1 and alpha-2 adrenoreceptors, has historically been used in wildlife management, particularly as a reversal agent for sedatives like medetomidine and xylazine during game capture. Despite its pharmacological complexity and past regulatory concerns, SAHPRA is now reconsidering its status in light of evolving scientific understanding and expert consultation.
“Given the evolving nature of scientific understanding and the potential therapeutic benefits that yohimbine may offer in veterinary medicine, the Authority is of the view that its therapeutic use in animals may be in the public interest,” said Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA.
Yohimbine was declared undesirable in 1978 under Notice 2/78 of the Medicines and Related Substances Control Act, effectively banning its manufacture and sale in South Africa. However, SAHPRA now plans to recommend to the Minister of Health that yohimbine be scheduled for veterinary use only. This would be followed by a formal rescinding of the 1978 declaration, paving the way for the registration of yohimbine-containing veterinary products.
Currently, no yohimbine-containing medicines are registered in South Africa. Once the scheduling and regulatory amendments are in place, stakeholders will be able to submit applications for registration under Category C (sedative antagonists) of the Medicines Act. SAHPRA will also consider applications for the sale of such products under section 21 of the Act.
Despite this progressive move, SAHPRA remains firm on the need for regulatory compliance. “Both SAHPRA and the Registrar of Act 36/1947 strongly advise against the unauthorised use of yohimbine,” Dr Semete-Makokotlela emphasized. “Yohimbine is not registered in South Africa for the treatment of any antiparasitic toxicity, and its use outside of approved veterinary contexts remains prohibited.”
Until the regulatory process is complete, yohimbine remains classified as undesirable for all other categories of medicine. The authority’s cautious but forward-looking approach reflects its commitment to balancing innovation with public and animal safety.
