Cough Syrup
On Monday, the World Health Organization (WHO) issued a critical alert to pharmaceutical manufacturers worldwide regarding the discovery of five batches of propylene glycol that were contaminated and mislabeled as products manufactured by Dow Chemical’s subsidiaries in Asia and Europe.
The alert underscores a growing concern over the safety of medicinal ingredients used in products like cough syrups.
The Drug Regulatory Authority of Pakistan (DRAP) has been actively investigating this issue, having issued three separate alerts between January and March concerning the detection of dangerously high levels of ethylene glycol (EG), a toxic industrial solvent, in drums falsely branded as originating from Dow facilities in Thailand, Germany, and Singapore.
This substance, propylene glycol, is commonly utilized as a solvent in over-the-counter medications, including cough syrups, due to its sweet taste.
Tests conducted on these suspect propylene glycol samples revealed EG contamination levels ranging from 0.76% to an alarming 100%. This is starkly above the international safety standard which permits only trace amounts of EG below 0.1%.
The implications of such contamination are severe, as evidenced by the tragic incidents in India and Indonesia where cough syrups containing excessive levels of EG and diethylene glycol were linked to the deaths of more than 300 children globally since late 2022. These incidents resulted in acute kidney injuries and fatalities.
In a troubling development in Indonesia, it was discovered that a supplier had intentionally replaced Dow Thailand labels on drums filled with EG, which were then sold to a pharmaceutical distributor. This deceit not only misled consumers but also endangered lives.
Furthermore, the WHO noted that several contaminated batches had labels indicating they were manufactured in 2023, which was after the WHO had already issued a global alert urging drugmakers to ensure the integrity of their supply chains.
The WHO’s recent statement emphasized that the materials in question were confirmed by Dow to have neither been produced nor distributed by them, indicating a deliberate act of fraud.
Adding to the concern, the WHO alerted that these fraudulent batches might have been distributed to other countries and could still be in circulation or storage.
This global health alert has resonated across continents as similar regulatory actions have taken place in Africa.
Health regulators in Tanzania, Rwanda, Nigeria, Kenya, and South Africa have initiated recalls for Johnson & Johnson’s children’s cough syrup after high levels of diethylene glycol were detected in products manufactured in South Africa by J&J, now owned by Kenvue following a recent spin-off.
This series of events highlights the critical need for stringent quality control measures in the production and distribution of pharmaceutical ingredients to prevent such health crises and safeguard public health.
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