MCAZ warn on substandard paediatric medicines

Judith Phiri, Business Reporter 

THE Medicines Control Authority of Zimbabwe (MCAZ) has warned health professionals and members of the public to be on the lookout for sub-standard paediatric medicines identified in the World Health Organisation (WHO) region of Africa.

Like other regulators globally, MCAZ said it has been notified by WHO through Medical Product Alert Number 6/2022 of the circulation of sub-standard products identified in The Gambia and reported to WHO in September 2022.

In a statement, MCAZ acting director-general Mr Richard Rukwata said: “The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup. The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products.”

He said the products are reported to contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants, while to date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions.

Mr Rukwata said toxic effects include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

“The authority wishes to inform health professionals and members of the public that these products are not registered in Zimbabwe. Furthermore, the manufacturer is not registered in Zimbabwe and the authority has not authorized any importation of any products from this manufacturer.”

He, however, said through illegal means, these products may find their way into the local market and as a precautionary measure, the MCAZ will intensify its market surveillance activities through strict premises inspection and public awareness to ensure that they are not circulated.

Mr Rukwata said in the unlikely event that members of the public are in possession of and/or come across these products, they should notify the authority and/or healthcare provider immediately and desist from administering them to children.

“The mandate of the MCAZ is to protect public health by ensuring that medicines and medical devices on the market are safe, effective, and of good quality and will continue to monitor the situation through the WHO guidelines.

“The authority also urges members of the public to access medicines from licenced persons and premises for easier monitoring. The Authority and law enforcement agencies continue to work together to eradicate any substandard and falsified health products,” he said.