WHO issues alert! Coldrif named among 3 ‘substandard’ cough syrups in India after 22 children die in MP

THE World Health Organisation (WHO) issued an alert over three "substandard" cough syrups found in India, including Coldrif, Respifresh TR, and ReLife.

It has called on regulatory authorities across the globe to report immediately if any of these products are discovered in their countries.

This follows the deaths of 22 children in Madhya Pradesh, most of them under the age of five, due to suspected kidney failure after being administered Coldrif.

The WHO urged heightened vigilance and monitoring within the supply chains of countries and regions that may be at risk from these substandard medicines. As per a report by PTI, it stated, “Increased surveillance of the informal/unregulated market is also advised.”

The syrups in question are oral liquid formulations containing active ingredients commonly used to treat symptoms associated with the common cold, flu, or cough.

According to the alert, India’s Central Drugs Standard Control Organisation (CDSCO) notified WHO on October 8 about the presence of Diethylene Glycol (DEG) in at least three such oral liquid medications. This followed WHO’s earlier identification, on September 30, of localised clusters of acute illness and child deaths in India.

The CDSCO said that the affected children had reportedly consumed the contaminated products and specified that state authorities had taken immediate action by halting production at the identified manufacturing facilities and suspending product authorisations.

The alert mentioned, “Nevertheless, WHO encourages National Regulatory Authorities (NRAs) to consider targeted market surveillance, with particular attention to informal and unregulated supply chains where products may circulate undetected. NRAs are also advised to carefully evaluate risks associated with any oral liquid medicines originating from the same manufacturing sites, particularly those produced since December 2024.”

Diethylene glycol is a toxic substance harmful to humans if ingested and can be deadly. The oral liquid medicines highlighted in the alert are deemed unsafe, particularly for children, as their use may lead to severe harm or death. The toxic effects include symptoms such as abdominal pain, vomiting, diarrhoea, inability to urinate, headache, altered mental status, and acute kidney injury, which can be fatal.

To safeguard public health, the alert stressed the urgent need to identify and eliminate these contaminated products from circulation.

‘Healthcare professionals should report detection of substandard products’
"Healthcare professionals should report the detection of these substandard products and any incident of adverse effects, or lack of expected effects to their National Regulatory Authorities or National Pharmacovigilance Centre," the alert stated.

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It further recommended, “The WHO advises 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.”