Assessment of shelf life and storage conditions of registered oxytocin in the Southern African Development Community
regulatory requirements, policies, and practices in countries for storage conditions and shelf life of cold chain reproductive health medicines
Overview
The value of oxytocin for various indications, including the prevention and treatment of postpartum haemorrhage (PPH) in obstetric practice, is well established, yet its stability is compromised if not stored at 2–8°C as recommended by the 2019 WHO/UNFPA/UNICEF joint statement. This survey of oxytocin products in 10 SADC countries found that while 71% of products were approved for cold chain storage, only 65% met the recommended shelf life of up to 36 months, with the remainder stored at room temperature, exceeding 36 months, or with unknown conditions. Non-compliance in two countries highlights gaps in policy alignment, regulatory decision-making, and reviewer training. The study recommends adopting oxytocin-specific policies, improving regulatory review practices, and implementing post-marketing surveillance to ensure product quality and adherence to cold chain requirements
