“WHO calls on regulators and governments to detect and remove from circulation in their respective markets, any substandard medical products that have been identified in the WHO medical alerts”
The World Health Organisation (WHO), says 300 children have died due to the use of contaminated cough syrups in three countries.
WHO issued a medical product alert on October 5, 2022, focused on the Gambia regarding four products — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.
It issued another alert on November 6, 2022, focused on Indonesia concerning about eight products — Termorex syrup (batch AUG22A06 only), Flurin DMP syrup, Unibebi Cough Syrup, Unibebi Demam Paracetamol Drops, Unibebi Demam Paracetamol Syrup, Paracetamol Drops (manufactured by PT Afi Farma), Paracetamol Syrup (mint) (manufactured by PT Afi Farma), and Vipcol Syrup.
On January 11, it also published an alert focused on Uzbekistan regarding two products — AMBRONOL syrup and DOK-1 Max syrup
The organisation in a statement said over the past four months, countries have reported several incidents of over-the-counter cough syrups for children with confirmed or suspected contamination with high levels of diethylene glycol and ethylene glycol.
It said the contaminants are toxic chemicals used as industrial solvents and antifreeze agents that could be fatal even taken in small amounts, and should never be found in medicines.
“Last year, WHO raised the alarm by issuing medical alerts in October focused on the Gambia, in November about Indonesia, and earlier this month regarding Uzbekistan,” the statement reads.
“The cases in these three countries are associated with more than 300 deaths, but we know that at least seven countries have been affected. Most of the deaths have been in children under the age of five
“WHO’s medical product alerts were rapidly disseminated to the national health authorities of all 194 WHO member states.”
The WHO said since the incidents were not isolated, various key stakeholders engaged in the medical supply chain should take immediate and coordinated action.
“WHO calls on regulators and governments to detect and remove from circulation in their respective markets, any substandard medical products that have been identified in the WHO medical alerts referred to above as potential causes of deaths and disease; ensure that all medical products in their respective markets are approved for sale by competent authorities and obtainable from authorised/licensed suppliers; assign appropriate resources to improve and increase risk-based inspections of manufacturing sites within their jurisdiction in accordance with international norms and standards,” the statement reads.
It added that governments should “increase market surveillance including risk-based targeted testing for medical products released in their respective markets including informal markets; and enact and enforce, where relevant and as appropriate, laws and other relevant legal measures to help combat the manufacture, distribution and/or use of substandard and falsified medicines”.