Source: Zim on alert for substandard paediatric medicines | The Herald
Trust Freddy Herald correspondent
African countries, including Zimbabwe, are on high alert over batches of four substandard paediatric medicines that were imported from India by some countries to the continent.
A general warning has been sent to all national regulators by the World Health Organisation on Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup, all made by Maiden Pharmaceuticals Limited of Haryana in India.
In Zimbabwe, the regulator is the Medicines Control Authority of Zimbabwe (MCAZ), which is alerting health professionals and members of the public about these medicines.
Although none of the products is licenced for Zimbabwe or has ever been legally imported, the MCAZ is passing on the alert and warnings in case they could have been smuggled into the country.
MCAZ director general Mr Richard Rukwata urged the public to be on high alert as these products may find their way into the local market. The WHO medical product alert, Number 6/2022, said the products were identified in The Gambia and reported to WHO last month.
The claimed producer has not yet given WHO any assurances regarding the reliability and safety of the products.
WHO said the products had dangerous side effects and reportedly contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
“To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions,” said Mr Rukwata.
“Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.”
Mr Rukwata said the manufacturer was not registered in Zimbabwe and the authority never authorised any import of any products from the manufacturer.
“As a precautionary measure, the authority will intensify its market surveillance activities through strict premises inspection and public awareness to ensure that these products are not circulated,” he said.
In the unlikely event that anyone comes into possession of or comes across these goods, MCAZ urged members of the public to immediately contact the authority or a healthcare provider and stop giving them to children.
The mandate of MCAZ is to protect public health by ensuring that medicines and medical devices on the market are safe, effective, and of good quality. WHO guidelines are used.
The authority urges everyone to access medicines from licenced persons and premises for easier monitoring.