January 30, 2023

WHO calls for action to prevent substandard, falsified medicines

•As contaminated cough syrups kill over 300 children in 3 countries

By Gabriel Olawale

The World Health Organisation has admonished countries to be vigilant  in preventing and responding to incidents of substandard and falsified medical products.

The global health body said that 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 and ethylene glycol.

The 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, the UN body warned.

“Last year, WHO raised the alarm by issuing medical alerts in October focused on the Gambia, in November about Indonesia, and earlier this month regarding Uzbekistan,” the statement reads.

“The cases in these three countries are associated with more than 300 deaths, but we know that at least seven countries have been affected. Most of the deaths have been in children under the age of five

“WHO’s medical product alerts were rapidly disseminated to the national health authorities of all 194 WHO member states.”

The WHO said since the incidents were not isolated, various key stakeholders engaged in the medical supply chain should take immediate and coordinated action.

“WHO calls 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; ensure that all medical products in their respective markets are approved for sale by competent authorities and obtainable from authorised/licensed suppliers; assign appropriate resources to improve and increase risk-based inspections of manufacturing sites within their jurisdiction in accordance with international norms and standards,” the statement reads.

It added that governments should “increase market surveillance including risk-based targeted testing for medical products released in their respective markets including informal markets; and enact and enforce, where relevant and as appropriate, laws and other relevant legal measures to help combat the manufacture, distribution and/or use of substandard and falsified medicines”. WHO also calls on manufacturers of medicines to

only purchase pharmaceutical grade excipients from qualified and bona fide suppliers; conduct comprehensive testing upon receipt of supplies and before use in manufacture of finished products; 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.

Further, the global health body urges all suppliers and distributors of medical products to always check for signs of falsification and physical condition of medicines and other health products they distribute and/or sell.

They should only distribute and/or sell medicines authorized by, and from sources approved by, competent authorities, keep accurate, complete and proper records relating to the medicines and their distribution and/or sale; and engage competent personnel to handle medicines and provide advice to the public on appropriate use of the medicines.

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.