World Health Organisation has showed concerns as countries reported on several incidents of over-the-counter cough syrups for children with confirmed or suspected contamination with high levels of diethylene glycol (DEG) and ethylene glycol (EG).
According to the World Body on Tuesday, stated that these incidents of substandard and falsified medical products with cases which are from at least seven countries, associated with more than 300 fatalities in three of these countries.
WHO released an urgent call to action to countries to prevent, detect and respond to incidents of this substandard and falsified medical products which have taken lives mostly are young children under the age of five.
Stated further that these contaminants are toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even taken in small amounts, and should never be found in medicines.
Based on country reports, WHO has issued three global medical alerts addressing these incidents. The Medical Product Alert N°6/2022 on 5th October 2022 focused on the outbreak in the Gambia.
Medical Product Alert N°7/2022 on 6 November 2022 focused on Indonesia, and Medical Product Alert No1/2023 on 11th January 2023 focused on Uzbekistan.
Since these are not isolated incidents WHO called on various key stakeholders engaged in the medical supply chain to take immediate and coordinated action.
WHO called 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.
To ensure that all medical products in their respective markets are approved for sale by competent authorities and obtainable from authorized/licensed suppliers.
Also, assign appropriate resources to improve and increase risk-based inspections of manufacturing sites within their jurisdiction in accordance with international norms and standards.
While increase market surveillance including risk-based targeted testing for medical products released in their respective markets including informal markets.
And enact, enforce, where relevant and as appropriate, laws and other relevant legal measures to help combat manufacture, distribution and/or use of substandard and falsified medicines.
Furthermore, the World Body called on manufacturers of medicines to: only purchase pharmaceutical grade excipients from qualified and bona fide suppliers and conduct comprehensive testing upon receipt of supplies before use in manufacture of finished products;
To provide assurance of product quality including through certificates of analyses based on appropriate testing results; and keep accurate, complete and proper records of purchase of materials, testing, manufacture, and distribution to facilitate traceability during investigations in case of incidents.
Meanwhile, WHO’s medical product alerts were rapidly disseminated to the national health authorities of all 194 WHO Member States.
These medical product alerts requested, inter alia: (a) the detection and removal of contaminated medicines from circulation in the markets, (b) increased surveillance and diligence within supply chains of countries and regions likely to be affected.
(C) immediate notification to WHO if these substandard products are discovered in-country; and otherwise inform the public of the dangers and toxic effects of the substandard medicines at issue.
