Cape Town - The South African Health Products Regulatory Authority (Sahpra) said measures have been put in place to ensure that no dubious health products find their way into the country, as the death toll of children in The Gambia and Indonesia rises due to contaminated cough syrups.
Earlier this month, the drug regulatory authority for all health products in the country issued an alert to the public, following the deaths of dozens of children in The Gambia due to kidney-related illness caused by health products from Indian company Maiden Pharmaceuticals.
Laboratory tests conducted by the World Health Organization had linked the 69 deaths of children to cough syrups manufactured by the company.
Sahpra spokesperson Yuven Gounden said these products have not yet been identified in the country, to their knowledge.
“Medicines have designated ports of entry and Sahpra has personnel at ports who check that imported health products have the requisite Sahpra approvals prior to release.
“If not, they are rejected or detained. Sahpra also works closely with ports entities such as Port Health, Customs and SAPS to prevent, detect and respond to any illicit products destined to South Africa.”
The products, not registered for use in South Africa, have since been identified in The Gambia with the possibility of their having been distributed to other countries. Maiden Pharmaceuticals distributes in Africa, South America and South East Asia.
The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.
Sahpra said the four products contain unacceptable amounts of toxic substances diethylene glycol and ethylene glycol, which can be fatal.
Toxic effects following ingestion include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.
“Sahpra’s mandate is to ensure that the public has access to quality, safe and effective health products. The safety of the public is of paramount importance.
“Our regulatory compliance unit will work with law enforcement agencies to eradicate any substandard and falsified health products,” said Sahpra CEO Dr Boitumelo Semete-Makokotlela.