Story by Abigirl Tembo, Health Editor
ZIMBABWE is taking bold steps to protect citizens from substandard and counterfeit medical products after the government approved key principles to amend a decades-old law that governs medicine safety and regulation.
At this week’s Post-Cabinet Media Briefing, the Minister of Information, Publicity, and Broadcasting Services, Dr Jenfan Muswere, revealed that Cabinet had considered and approved the Principles for the Amendment of the Medicines and Allied Substances Control Act, a move aimed at modernising the country’s regulatory framework for medicines and related health technologies.
Promulgated in 1969, the current Act has seen only minor changes over the years, leaving significant regulatory gaps in a fast-evolving health landscape.
Health and Child Care Minister Dr Douglas Mombeshora explained the rationale behind the proposed amendments, highlighting the urgency of aligning the country’s legislation with emerging technologies, international standards, and modern health delivery systems.
“The act was promulgated in 1969. That was too long ago. The last amendments were made more than a decade ago. So there are a lot of things that have changed in terms of health service delivery, which we wanted to align the legislation. The first thing is that the legislation looks at the control of quality, safety, and efficacy of all medical products and light substances.
“The old act refers to medicines only. But the functions of the medicines control authority, which actually is governed by this law, there has been no mandate now to also ensure the quality and safety of other medical products. And when we say now medical products, we include even medical devices and their accessories. So there has been quite a lot of change in terms of the medical products that we refer to, the medical devices and their accessories.
“You know how we are also doing even artificial intelligence, digital transformation, moving from analogue to digital equipment. So we need to align our laws to make sure they take care of that new function of medicines control authority. So we want to empower the authority to be able to do the full range of inspections,” he said.
Medicines Control Authority of Zimbabwe (MCAZ) Head of Licensing and Enforcement Division, Ms Caroline Samatanga said the authority is grateful for the approval, noting the changes are aligned with MCAZ’s strategic vision to become an efficient, globally respected regulatory body.
“We are quite grateful to the Cabinet for the approval of the amendment of the Act because this is in line with our strategic goal as the Medicines Control Authority of Zimbabwe. When we look at our vision, where we want to be an effective and efficient regulatory authority in Zimbabwe and across the globe, where we also want to be strategically positioned in the region, we are looking forward to achieving maturity level four of the WHO Global Benchmarking two, which promotes transparency, efficiency, and accountability.
“This aligns also with the vision of the African Model Law, which has given the standards that African regulators would also have to follow in terms of legislation. And so, it is clear that this would provide a framework for certain missing pieces. For example, we did not have a clear illustration of how substandard and falsified medical products would be regulated. And so, this amendment would give us clarity in terms of such control. Also, the establishment of the Pharmacovigilance Centre would be clearly outlined in this amendment.
“We are quite excited that we are moving forward to aligning with the global standards in line with our vision. And so, we think that this amendment would be our framework for regulation, which is the laws and regulations, and we are quite thankful for that,” she said.
The proposed amendments also prioritise public safety, ensuring Zimbabwe has the legal muscle to deal with the growing threat of substandard and falsified medicines a concern across Africa, where weak regulations often expose populations to harmful products.
Once finalised, the amended Act is expected to support stronger market surveillance, enhanced product quality assurance, and improved health outcomes across Zimbabwe.
