The World Health Organisation (WHO) has issued a medical product alert for three adulterated oral liquid medicines (cough syrups) manufactured in India.
It has warned that the identified syrups commonly used to treat cold, flu, and cough symptoms, have been linked to cases of severe illness and child fatalities and could cause severe and potentially life-threatening illnesses.
The global health body has urged authorities worldwide to report to the agency if any of these products are detected in their countries. The Organisation said that such medications should not be prescribed or dispensed to children below two years of age and are generally not recommended for those under five.
The WHO has identified specific batches of Coldrif from Sresan Pharmaceuticals, Respifresh TR from Rednex Pharmaceuticals, and ReLife from Shape Pharma as the affected medicines.
The products identified in this alert are considered substandard as they fail to meet their quality standards and specifications, the WHO said.
On October 8, India’s Central Drugs Standard Control Organisation (CDSCO) reported to the WHO the presence of Diethylene Glycol (DEG) in at least three products–COLDRIF, Respifresh TR and ReLife. These medicines were manufactured by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma, respectively.
Following the deaths of several children in Madhya Pradesh a week ago, linked to the consumption of Coldrif cough syrup, the Government of India had issues an advisory to all states and union territories, urging extreme caution in the prescription of cough syrups for children.
The Coldrif syrup, manufactured in Tamil Nadu by Sresan Pharmaceuticals, was found to be dangerously contaminated with the toxic chemical diethylene glycol. The company’s manufacturing license was revoked, and its owner, G. Ranganathan, was taken into custody.
“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,” WHO said.
The CDSCO has confirmed that relevant state authorities have ordered an immediate halt to production at implicated manufacturing sites and have suspended product authorisations. In addition, a recall of the contaminated products has been initiated by the 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.
WHO continues to collaborate closely with Indian health authorities to monitor the situation, identify the source of the contamination and mitigate any potential public health risks. (ANI)
