New Delhi: The World Health Organisation (WHO) has issued a medical product alert on three contaminated oral liquid medicines identified in India, following reports of diethylene glycol (DEG) contamination that has led to cases of acute illness and child fatalities in certain regions. The alert was issued after the products were reported to WHO on October 8, 2025.
According to the UN health agency, the contaminated medicines are specific batches of COLDRIF, Respifresh TR, and ReLife, manufactured by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma, respectively. These oral syrups are commonly used to relieve symptoms of the common cold, flu, and cough.
WHO flags substandard products
WHO said that the affected products have been classified as substandard as they failed to meet quality standards and specifications. “The products identified in this alert are considered substandard as they fail to meet their quality standards and their specifications,” the agency stated.
The organisation noted that the Central Drugs Standard Control Organisation (CDSCO) had reported the presence of Diethylene Glycol (DEG) — a toxic chemical compound — in at least three oral liquid medicines. The contamination was detected during quality testing after localised clusters of illness and fatalities among children were reported in India in late September 2025.
No evidence of export, says CDSCO
In its communication with WHO, the CDSCO confirmed that none of the contaminated medicines were exported from India. “There is currently no evidence of illegal export,” the agency said.
However, WHO has advised India’s National Regulatory Authorities (NRAs) to conduct targeted market surveillance, particularly focusing on informal and unregulated supply chains where such products might circulate undetected.
The NRAs have also been advised to carefully evaluate risks linked to other oral liquid medicines produced at the same manufacturing facilities, particularly those made since December 2024.
Production halted, recalls initiated
The CDSCO confirmed that relevant state drug authorities have ordered an immediate halt to production at all implicated sites and suspended product authorisations for the contaminated batches. Additionally, recalls of affected products have been initiated at the state level.
The Ministry of Health and Family Welfare has also launched a risk-based inspection drive of drug manufacturing firms following the contamination reports, especially after some cough syrup samples in Tamil Nadu tested positive for impurities.
DEG contamination and health risks
WHO warned that diethylene glycol is highly toxic to humans and can cause severe, potentially fatal health complications. “The contaminated oral liquid medicines referenced in this alert are unsafe, and their use, especially in children, may result in serious injury or death,” the statement read.
Toxic effects of DEG ingestion include abdominal pain, vomiting, diarrhoea, headache, inability to pass urine, altered mental state, and acute kidney injury, which can be fatal if untreated.
Global and domestic monitoring efforts
The WHO stated that it is working closely with Indian health authorities to monitor the evolving situation, identify the source of contamination, and mitigate public health risks.
It also urged healthcare professionals, regulatory authorities, and the public to promptly report detection of any substandard products or adverse effects to their National Regulatory Authorities or National Pharmacovigilance Centres.
The WHO reiterated the importance of sourcing medicines only from licensed and authorised suppliers, warning that unregulated markets pose a significant threat to patient safety. “Increased surveillance and diligence within the supply chains of countries and regions likely to be affected are advised,” it said.
WHO also requested that any information regarding the manufacture or supply of the contaminated products be shared via its official email channel at rapidalert@who.int
Previous related actions
The current WHO alert follows similar incidents in previous years involving contaminated cough syrups that caused child deaths in countries such as Gambia and Uzbekistan, both linked to DEG and ethylene glycol contamination. Indian authorities have since tightened surveillance measures, but recurring contamination cases have raised concerns about manufacturing compliance and quality control standards.
With production halted, recalls underway, and monitoring intensified, authorities are now racing to ensure that all contaminated products are swiftly removed from circulation to prevent further harm.