The World Health Organization on Monday urged countries to prevent, detect and respond to substandard and counterfeit medicines after reports of hundreds of children dying after taking cough syrup.
“The cases have occurred in at least seven countries, with three of those countries killing more than 300 people,” the World Health Organization (WHO) said in a statement, noting that most of them were children under the age of five.
The organization adds that over the past four months, several countries have reported incidents of over-the-counter cough syrups for children with confirmed or suspected contamination with high levels of diethylene glycol (DEG) and ethylene glycol (GE).
“These contaminants are toxic chemicals used as industrial solvents and antifreezes that can be fatal even in small amounts and should never be found in medicines,” the WHO said in a statement.
Based on country reports, WHO issued three global health alerts on these incidents, the first of which was issued in October 2022 on the outbreak in the Gambia, the second in November in Indonesia, and the third in Uzbekistan on 11 January . .
Because these are not isolated incidents, WHO has called on regulators and governments to act urgently to identify and withdraw from circulation in their respective markets any substandard medical devices that have been identified in WHO health alerts as potential causes of death and disease.
It also requires that all medical products in the respective markets be approved for sale by the competent authorities and obtained from licensed suppliers.
WHO is also calling on regulators and governments to allocate sufficient resources to improve and increase risk-based inspections of manufacturing sites in line with international norms and standards.
“Strengthen market surveillance, including risk-based targeted testing of medical products launched in relevant markets, including informal markets, and adopt and enforce, where appropriate and appropriate, laws and other relevant legal measures to help combat production, distribution and/or use of substandard and counterfeit medicines” are other measures required by WHO.
WHO also urged drug manufacturers to purchase “pharmaceutical grade excipients only from qualified and conscientious suppliers”, to conduct exhaustive testing upon receipt of materials and before they are used in the manufacture of finished products, and to ensure product quality through certificates of analysis based on adequate test results.
It also calls for keeping “accurate, complete and adequate records of the purchase, testing, production and distribution of materials to facilitate traceability during incident investigations.”
WHO urges all suppliers and distributors of medical products to always check “for signs of counterfeit medicines and other health products that they distribute and/or sell” and only distribute or sell medicines that are approved by the competent authorities.
Author: Portuguese
Source: CM Jornal
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