01/23/2023 | Press release | Distributed by Public on 01/23/2023 07:09
WHO is releasing 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 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). 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 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°6/2022on 5 October 2022 focused on the outbreak in the Gambia, Medical Product Alert N°7/2022on 6 November 2022 focused on Indonesia, and Medical Product Alert No1/2023on 11 January 2023 focused on Uzbekistan.
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 the 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.
Since these are not isolated incidents WHO calls on various key stakeholders engaged in the medical supply chain to take immediate and coordinated action.
WHO calls on regulators and governments to:
WHO calls on manufacturers of medicines to:
WHO urges all suppliers and distributors of medical products to:
In addition, WHO will continue to work with the Member State Mechanism on substandard and falsified medical products in implementing its mandate to promote effective collaboration in the prevention, detection and response to substandard and falsified medical products to save lives.