Tuesday, October 14, 2025 - The World Health Organization (WHO) on Monday, October 13, issued a medical product alert for three cough and cold syrups identified in India, advising national regulators worldwide to notify the agency if the medicines are found in their markets and to step up targeted surveillance, especially in informal supply chains.
The affected products are specific batches of Coldrif
(Sresan Pharmaceutical), Respifresh TR (Rednex Pharmaceuticals), and ReLife
(Shape Pharma). India’s Central Drugs Standard Control Organization (CDSCO)
told WHO on October 8, 2025 that laboratory tests detected diethylene glycol
(DEG) in at least three oral liquid medicines, with the toxic solvent present
at levels “nearly 500 times the permissible limit.” CDSCO said the syrups were
reportedly consumed by children under five who recently died in Chhindwara,
Madhya Pradesh.
WHO’s alert notes the products “are oral liquid medicines
containing active ingredients commonly used to relieve symptoms of the common
cold, flu, or cough.” It adds: “The contaminated products pose significant
risks to patients and can cause severe and potentially life-threatening
illness. Diethylene glycol is toxic to humans when consumed and can prove
fatal.” The agency stresses the syrups are substandard because they “fail to
meet their quality standards and their specifications,” warning that use, especially
in children, “may result in serious injury or death.”
According to CDSCO, state authorities have halted production
at implicated sites, suspended product authorisations, and initiated recalls.
The regulator also informed WHO that none of the contaminated medicines have
been exported from India, and there is “no evidence of illegal export.” Even
so, WHO is urging National Regulatory Authorities to consider targeted market
surveillance, particularly for any oral liquid medicines from the same
manufacturing sites since December 2024.
WHO outlines potential toxic effects of DEG ingestion,
including abdominal pain, vomiting, diarrhoea, inability to pass urine,
headache, altered mental state, and acute kidney injury, which may be fatal. It
emphasizes the need to detect and remove the products from circulation and
calls on healthcare workers to report detections or adverse events to their
national pharmacovigilance systems.
The agency’s advice to the public is unequivocal: “If you
are in possession of any of these products, WHO recommends that you do not use
them. If you, or someone you know, has, or may have, used these products, or
suffered an adverse event or unexpected side-effect after use, seek immediate
medical advice from a health-care professional or contact a poisons control
centre.” It further reminds consumers that “All medical products must be
obtained from authorised/licensed suppliers,” and asks anyone with information
on manufacture or supply to contact rapidalert@who.int.
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