“The cases occurred in at least seven countries, associated with more than 300 deaths in three of these countries”, says in a statement from the World Health Organization (WHO), noting that the majority are children under five years old.
The organization adds that, in the last four months, several countries have reported incidents with over-the-counter cough syrups for children, with confirmed or suspected contamination of high levels of diethylene glycol (DEG) and ethylene glycol (GE).
“These contaminants are toxic chemicals used as industrial solvents and antifreeze agents that can be fatal in even small amounts, and should never be found in medicines,” the WHO said in the statement.
Based on country-by-country reports, WHO has released three global medical alerts addressing these incidents, with the first issued in October 2022 focusing on the Gambia outbreak, the second in November focusing on Indonesia and the third on 11 January focusing on the Uzbekistan.
As these are not isolated incidents, WHO has called for urgent action by regulators and governments to detect and withdraw from circulation in their respective markets any substandard medical products that have been identified in WHO medical alerts as potential causes of death and illnesses.
It also asks for it to be ensured that all medical products in the respective markets are approved for sale by the competent authorities and obtained from licensed suppliers.
WHO also calls on regulators and governments to allocate adequate resources to improve and increase risk-based inspections of manufacturing sites, in line with international norms and standards.
“Increase market surveillance, including risk-based targeted testing for medical products launched in the respective markets, including informal markets, and enact and enforce, where appropriate and as appropriate, laws and other relevant legal measures to help combat the manufacture , distribution and/or use of non-compliant and counterfeit medicines”, are other measures requested by the WHO.
The WHO also called on drug manufacturers to buy only “pharmaceutical grade excipients from qualified and bona fide suppliers”, to carry out exhaustive tests after receiving supplies and before their use in the manufacture of finished products, and to ensure the product quality, through analysis certificates based on adequate test results.
It also calls for keeping “accurate, complete and adequate records of material purchase, testing, manufacturing and distribution to facilitate traceability during investigations in case of incidents”.
The WHO urges all suppliers and distributors of medical products to always check “for signs of counterfeiting of medicines and other health products that they distribute and/or sell” and only distribute or sell those approved by the competent authorities.