WHO issues alert over contaminated India cough syrups
The World Health Organization (WHO) has raised an alarm, issuing a health advisory warning about three contaminated cough syrups from India that have been linked to the deaths of children.
The WHO urged the authorities to report any detection of these medicines in their countries to the health agency.
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.
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.
CDSCO has confirmed that relevant state authorities have 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 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. NRAs are also advised to carefully evaluate the 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 their quality standards and their specifications.
As per the WHO, these contaminated products pose significant risks to patients and can cause severe and potentially life-threatening illness. Diethylene glycol is toxic to humans when consumed and can prove 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, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death.
Read also: 3 cough syrups recalled, none exported: CDSCO responds to WHO
