Regulatory compliance and quality of veterinary oxytetracycline injections in Zambia: findings from post-market surveillance

Objective Substandard antimicrobials affect the One Health ecosystem comprising both human and animal health, food production and food security, driving up Antimicrobial Resistance (AMR) rates. This study assessed compliance with regulatory and quality specifications of oxytetracycline injection marketed for veterinary use in Zambia. Methods Between August 2023 and December 2023, a total of 48 samples of assorted marketed brands of oxytetracycline injection for veterinary use on the Zambian market were collected and analyzed for conformity to marketing authorisation terms on labeling and quality parameters, including identification, assay, and pH tests at the National Drug Quality Control Laboratory, Lusaka, Zambia. Results Conformity to labeling for information such as product name, active pharmaceutical ingredient, dosage form, batch number, expiry date, manufacturer, and container description were assessed at 100%. However, compliance with storage conditions and product registration numbers was assessed at 95.8% and 43.8%, respectively. All samples met requirements for specific quality tests such as identification, assay, and pH. Conclusion Although the sampled oxytetracycline injections met some labeling requirements and specific quality parameters, essential factors for effective disease treatment and combating AMR, the low rate of product registration compliance indicated that many such products in use on the market lack official regulatory oversight, leaving their long-term safety, efficacy, and quality unconfirmed. There is a need to continue monitoring the quality of antimicrobials in Zambia’s One Health AMR mitigation strategy, alongside enforcement of product registration requirements.