The World Health Organisation (WHO) has issued an alert against three “substandard” oral cough syrups identified in India — Coldrif, Respifresh TR and ReLife — and urged national regulatory authorities worldwide to immediately notify it if these are detected in their country.
The WHO has also advised healthcare professionals to notify their national regulatory authorities or National Pharmacovigilance Centres if they detect these substandard syrups or encounter any adverse effects—or lack of expected effects—associated with their use.
The alert follows the deaths of at least 22 children, mostly under the age of five, in Madhya Pradesh due to suspected kidney failure after being given ColdRif. Additionally, at least three children in Rajasthan have reportedly died after consuming the cough syrup.
The WHO has further called for increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these substandard products.
“Increased surveillance of the informal/unregulated market is also advised,” the alert issued on Monday said.
The affected products are oral liquid medicines containing active ingredients commonly used to relieve symptoms of cold, flu, or cough. According to the alert, India’s Central Drugs Standard Control Organization (CDSCO) reported to the WHO on October 8 the presence of Diethylene Glycol (DEG) in at least three such oral liquid medicines.
The CDSCO informed the WHO that the affected children had reportedly consumed the contaminated products and confirmed that state authorities have ordered an immediate halt to production at the implicated manufacturing sites and suspended the products’ authorisations.
Meanwhile, the Manipur government recently imposed a ban on two cough syrup brands after laboratory tests detected the presence of a highly toxic chemical in them.
The Drugs Control Department under the Directorate of Health Services has prohibited the sale and consumption of these two products — Relife and Resipfresh TR— in Manipur and directed all retailers, distributors, and pharmacies to immediately withdraw the affected batches from shelves and report compliance.
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The Arunachal Pradesh government too has banned the sale and use of Coldrid cough syrup following the deaths of 14 children in Madhya Pradesh that were reportedly linked to the consumption of the medicine.
