The UN health agency has released an urgent call to action to countries to prevent, detect and respond to incidents of substandard and falsified medical products.
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 (DEG) and ethylene glycol (EG).
The cases are from at least seven countries, associated with more than 300 fatalities in three of these countries. Most are young children under the age of five. These contaminants are toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even in small amounts, and should never be found in medicines.
Based on country reports, the World Health Organization (WHO) issued three global medical alerts addressing these incidents. Medical Product Alert N°6/2022 on October 5, 2022, focused on the outbreak in the Gambia, Medical Product Alert N°7/2022 on November 6, 2022, focused on Indonesia, and Medical Product Alert No1/2023 on January 11, 2023, focused on Uzbekistan.
The WHO's medical product alerts were rapidly disseminated to the national health authorities of all of its 194 member states. These medical product alerts requested included the detection and removal of contaminated medicines from circulation in the markets, increased surveillance and diligence within the supply chains of countries and regions likely to be affected, immediate notification to the 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.
Since these are not isolated incidents, the WHO called on various key stakeholders engaged in the medical supply chain to take immediate and coordinated action.
The UN health agency urged regulators and governments to detect and remove from circulation in their respective markets substandard medical products that have been identified in the WHO medical alerts referred to above as potential causes of death and disease.
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The WHO also called on them to ensure that all medical products in their respective markets are approved for sale by competent authorities and obtainable from authorised/licenced suppliers; assign appropriate resources to improve and increase risk-based inspections of manufacturing sites within their jurisdiction following international norms and standards.
The UN health agency urged medicine manufacturers to only buy pharmaceutical grade excipients from qualified and bona fide suppliers; conduct comprehensive testing upon receipt of supplies and before use in the manufacture of finished products.
Source: United News of Bangladesh