WHO issues global alert against substandard oral cough syrups in India
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New Delhi: The World Health Organisation (WHO) has issued a global alert warning against three “substandard” oral cough syrups identified in India—Coldrif, Respifresh TR, and ReLife—and urged national regulatory authorities worldwide to immediately report if these products are detected in their countries.
The WHO advisory also calls on healthcare professionals to report the detection of these substandard products, as well as any adverse effects or lack of expected therapeutic effects, to their national regulatory authorities or National Pharmacovigilance Centre.
The alert comes following the deaths of at least 22 children, mostly under five years old, due to suspected kidney failure after being administered Coldrif in Madhya Pradesh. Additionally, at least three children reportedly died in Rajasthan after consuming cough syrup in different districts of the state.
WHO has emphasised the need for increased surveillance and diligence within supply chains in countries and regions likely to be affected by these substandard products. “Increased surveillance of the informal/unregulated market is also advised,” the alert 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 WHO on October 8 the presence of Diethylene Glycol (DEG) in at least three oral liquid medicines. This followed information identified by WHO on September 30 about localised clusters of acute illness and child fatalities in India.
CDSCO confirmed that the contaminated products were reportedly consumed by the affected children. Relevant state authorities have ordered an immediate halt to production at the implicated manufacturing sites and have suspended product authorisations. A recall of the contaminated products has also been initiated.
The contaminated oral liquid medicines have been traced to specific batches of Coldrif, Respifresh TR, and ReLife, manufactured by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma, the alert said. CDSCO informed WHO that none of the contaminated medicines have been exported from India, and there is currently no evidence of illegal export.
Nevertheless, WHO has urged national regulatory authorities to carry out targeted market surveillance, particularly in informal and unregulated supply chains where these products may circulate undetected. Authorities are also advised to carefully evaluate risks associated with any oral liquid medicines produced at the same manufacturing sites, especially since December 2024.
The WHO classified these products as substandard, noting they fail to meet quality standards and specifications. The contaminated syrups pose serious health risks and can cause severe, potentially fatal illness. Diethylene glycol is toxic to humans, and ingestion may lead to abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, acute kidney injury, and death.
To protect patients, WHO stresses the urgent removal of these products from circulation. Healthcare professionals are urged to report any detection or adverse incidents to national authorities. National regulatory and law enforcement authorities are also advised to notify WHO immediately if these products are found in their country.
WHO strongly recommends that anyone in possession of these products should not use them. Those who may have consumed them, or experienced adverse effects, should seek immediate medical advice from a healthcare professional or contact a poisons control centre.
With PTI inputs