Health Reporter
THE Medicines Control Authority of Zimbabwe (MCAZ) has adopted new guidelines that are expected to strengthen the fight against counterfeit and substandard medicines.
The Guidelines for Implementing Traceability for Medical Products (MCAZ/LED/GL-22) are expected to revolutionise the way medicines are monitored across the supply chain, aligning Zimbabwe with international standards and World Health Organisation recommendations.
For decades, counterfeiters have exploited weaker regulatory environments in low and middle-income countries, flooding markets with falsified and substandard medicines.
Advances in printing, tableting and packaging technology have made the criminal trade even more sophisticated, putting patients at risk and undermining confidence in genuine pharmaceuticals.
MCAZ director general Mr Richard Rukwata stressed that regulators and legal manufacturers could no longer afford to continue playing “cat-and-mouse games” with counterfeiters.
“This is a massive undertaking, but a necessary one. By securing our pharmaceutical supply chain from end to end, we are closing the gaps that counterfeiters exploit and safeguarding the lives of millions. MCAZ is committed to supporting all stakeholders with training, technical assistance, and regular updates throughout this transition,” he said.
Mr Rukwata said there was a need to fundamentally change the rules of engagement by securing the pharmaceutical supply chain from end to end.
The traceability system will involve placing unique identifiers on all medical product packaging, mandating GS1-compliant data carriers, and requiring electronic data sharing across the supply chain.
The framework will also strengthen recall systems, improve patient safety and restore consumer confidence in the medicines available on the local market.
Implementation is expected to follow a phased approach, beginning with pilot projects that focus on high-risk products during the first 12 months.
This will be followed by a gradual rollout across the supply chain over the next three years, before culminating in full national implementation and enforcement within five years.
“These guidelines apply to all medical products that are manufactured, imported, exported, advertised, sold, distributed or used in Zimbabwe. They are aimed at ensuring that such products are traceable throughout the entire supply chain,” Mr Rukwata added.



