The World Health Organization has issued a medical product alert on three "substandard (contaminated) oral liquid medicines" identified in India and reported to the agency, earlier this month. The WHO also cautioned national regulatory authorities (NRA) on "informal and unregulated supply chains" that could fly below the radar and remain undetected.
"The contaminated oral liquid medicines have been identified to be specific batches of COLDRIF, Respifresh TR and ReLife, manufactured by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma," the UN health agency said, on the affected products that contained active ingredients commonly used to relieve symptoms of the common cold, flu, or cough.
The mentioned paediatric cough syrups are linked to over 20 child deaths in Madhya Pradesh and Rajasthan, which are currently being investigated by health authorities in India.
CDSCO suspends production, orders recall
"On 8 October the Central Drugs Standard Control Organization (CDSCO) of India reported to WHO the presence of Diethylene Glycol (DEG) in at least three oral liquid medicines. This followed information identified by WHO on 30 September 2025 of localized clusters of acute illness and child fatalities in India. CDSCO informed WHO that the contaminated products were reportedly consumed by the affected children," the WHO said. The Indian regulator had also confirmed that relevant state authorities had ordered "an immediate halt to production at implicated manufacturing sites and have suspended product authorizations. In addition, a recall of the contaminated products has been initiated by relevant state authorities," the alert said.
The last time the WHO medical alerts mentioned cough syrups from India was in 2022, when they were linked to over 60 child deaths in Gambia.
Targeted surveillance
"The CDSCO has informed WHO that none of the contaminated medicines have been exported from India and there is currently no evidence of illegal export. 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," it said. NRAs were also advised to "evaluate the risks associated with any oral liquid medicines originating from the same manufacturing sites -- particularly those produced since December 2024," it added.
The WHO continues to collaborate with Indian health authorities, it said, "to monitor the situation, identify the source of the contamination and mitigate any potential public health risks."
Severe health risks highlighted
These contaminated products pose significant risks to patients. They can cause severe and potentially life-threatening illness, the WHO said, adding that diethylene glycol (DEG) is toxic to humans when consumed and can prove fatal. Calling on authorities to remove the affected products from circulation, the WHO said, "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, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death."
The WHO called for "increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these substandard products," adding that "increased surveillance of the informal/unregulated market" was also advised. The UN health agency also urged healthcare professionals to report the detection of these substandard products and any incident of adverse effects, or lack of expected effects, to their NRAs or National Pharmacovigilance Centre.
Comments
Published on October 14, 2025
READ MORE