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Studies confirm that there is a high prevalence of substandard oxytocin circulating in many low- and middle-income countries (LMICs). According to a 2016 literature review by the World Health Organization (WHO), over one third of the 559 samples from studies in LMICs were substandard. Possible causes for substandard oxytocin products include poor quality of manufacturing, unsuitable storage, labelling and shelf-life, and inappropriate transport and storage conditions throughout the supply chain
Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publications and has been prepared to specifically assist national medicines regulatory authorities to understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
