WHO Issues Urgent Global Alert: Toxic Cough Syrups Linked to Child Deaths in India

The World Health Organization (WHO) has released an alert concerning three "substandard" oral cough syrups identified in India - Coldrif, Respifresh TR, and ReLife. The organization has requested national regulatory authorities worldwide to promptly report if these products are detected in their respective countries.

Healthcare professionals have been advised to report any detection of these substandard products, along with incidents of adverse effects or lack of expected effects, to their national regulatory authorities or National Pharmacovigilance Centers.

This alert follows a tragic incident in Madhya Pradesh where at least 22 children, primarily under five years of age, died due to suspected kidney failure after consuming Coldrif. Additionally, three children in Rajasthan have allegedly died after taking cough syrup in various districts across the state.

The WHO has emphasized the need for increased surveillance and vigilance within supply chains in regions likely affected by these substandard products. "Increased surveillance of the informal/unregulated market is also advised," stated the alert issued on Monday.

The affected products are oral liquid medicines containing active ingredients commonly used to alleviate symptoms of common cold, flu, or cough. According to the alert, India's Central Drugs Standard Control Organization (CDSCO) reported to WHO on October 8 that Diethylene Glycol (DEG) was present in at least three oral liquid medicines. This report followed WHO's identification of localized clusters of acute illness and child fatalities in India on September 30.

The CDSCO informed WHO that the contaminated products were reportedly consumed by the affected children. Relevant state authorities have ordered an immediate halt to production at implicated manufacturing sites and have suspended product authorizations. A recall of the contaminated products has also been initiated by relevant state authorities.

The contaminated oral liquid medicines have been identified as specific batches of Coldrif, Respifresh TR, and ReLife, manufactured by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma, respectively.

The CDSCO has assured WHO that none of the contaminated medicines have been exported from India, and currently, there is no evidence of illegal export. However, WHO encourages National Regulatory Authorities (NRAs) to consider targeted market surveillance, particularly focusing on informal and unregulated supply chains where products might 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.

The products identified in this alert are considered substandard as they fail to meet quality standards and specifications. These contaminated products pose significant risks to patients and can cause severe and potentially life-threatening illness, according to the global health agency.

Diethylene glycol is toxic to humans when consumed and can be fatal. The contaminated oral liquid medicines referenced in this alert are unsafe, and their use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury, which may lead to death.

To protect patients, it is essential to detect and remove these contaminated products from circulation, the alert emphasized.

"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 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."

"National regulatory authorities and law enforcement authorities are advised to immediately notify the WHO if these products are detected in their country," the alert stated.

"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 healthcare professional or contact a poisons control center," it added.