The World Health Organization (WHO) has issued an alert regarding three “substandard” oral cough syrups in India—Coldrif, Respifresh TR, and ReLife—urging national regulatory authorities worldwide to report immediately if these products are found in their countries.
Healthcare professionals are advised to notify their national regulatory authorities or National Pharmacovigilance Centres if they detect these products or encounter any adverse effects, or lack of expected therapeutic effects.
The alert follows reports of at least 22 child deaths, mostly under five years old, in Madhya Pradesh due to suspected kidney failure after taking Coldrif. Additionally, three children have reportedly died in Rajasthan after consuming cough syrup in different districts.
WHO called for heightened surveillance and diligence in supply chains, including informal and unregulated markets, in regions likely to be affected. The affected syrups contain active ingredients commonly used for relieving cold, flu, and cough symptoms.
According to the alert, the Central Drugs Standard Control Organization (CDSCO) of India detected Diethylene Glycol (DEG) in at least three oral liquid medicines on October 8. WHO had earlier identified clusters of acute illness and child fatalities in India on September 30. CDSCO confirmed that contaminated products were consumed by affected children and that state authorities have halted production at implicated sites, suspended product authorizations, and initiated recalls.
The contaminated batches of Coldrif, Respifresh TR, and ReLife are manufactured by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma. The CDSCO informed WHO that none of the contaminated products have been exported and there is no evidence of illegal export.
WHO emphasized that these products are substandard, failing to meet quality standards, and pose serious, potentially life-threatening risks. Diethylene Glycol is toxic and can cause abdominal pain, vomiting, diarrhea, reduced urine output, headache, altered mental state, acute kidney injury, and death.
Authorities are urged to remove these contaminated products from circulation immediately. WHO recommends that anyone in possession of these syrups should not use them. Anyone who has used them or experienced adverse effects should seek immediate medical attention or contact a poisons control centre.