WHO warns against 3 India made cough syrups after child deaths

The World Health Organization (WHO) has issued a medical product alert concerning three adulterated oral liquid medicines (cough syrups) manufactured in India, following reports of child fatalities linked to their consumption.

The WHO warned that these syrups, commonly used to treat cold, flu, and cough symptoms, have been associated with severe illnesses and deaths in children. The organisation urged authorities worldwide to report any detection of these products. WHO also stated that these medicines should not be prescribed to children under two years and are generally not recommended for those under five.

The affected products include specific batches of Coldrif from Sresan Pharmaceuticals, Respifresh TR from Rednex Pharmaceuticals, and ReLife from Shape Pharma. These syrups are considered substandard as they fail to meet required quality standards.

On October 8, India’s Central Drugs Standard Control Organisation (CDSCO) reported the presence of Diethylene Glycol (DEG) in these products. The contamination came to light after 17 child deaths in Madhya Pradesh due to kidney failure linked to Coldrif syrup, which was found to be contaminated with 48.6% DEG. The Indian government subsequently issued an advisory to all states and union territories, urging extreme caution when prescribing cough syrups to children.

The Coldrif syrup, manufactured in Tamil Nadu by Sresan Pharmaceuticals, was found to contain the highly toxic chemical diethylene glycol. The company’s manufacturing license has been revoked, and owner G. Ranganathan has been taken into custody.

“Diethylene glycol is toxic and can prove fatal. The contaminated medicines referenced in this alert are unsafe, and their use, especially in children, may result in serious injury or death. Toxic effects may include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury, which may lead to death,” the WHO stated.

The CDSCO confirmed that state authorities have halted production at implicated sites, suspended product authorisations, and initiated a recall of contaminated products. There is currently no evidence that these medicines were exported from India.

This incident is not isolated. India has faced similar tragedies in the past, where adulterated or toxic medicines caused child deaths. Notably, there have been repeated cases of cough syrups contaminated with diethylene glycol in various states over the past two decades. Internationally, some Indian medicines have also been found unsafe in countries like Nepal and Gambia.

The problem is broader than just medicines. Many food items, spices, and consumer products in India are adulterated with harmful chemicals. Products banned in countries like the US due to toxicity, such as certain MTR masala products, unsafe preservatives, or artificial dyes, continue to be consumed daily in India at cheaper costs. This exposes millions, including children, to serious health risks without their knowledge.

Experts and the public have raised concerns that such incidents reflect regulatory lapses, weak enforcement, and systemic failures. Children, being most vulnerable, should never be exposed to such preventable hazards. There is an urgent need for stricter monitoring, stronger quality control, severe penalties for violations, and increased public awareness to ensure the safety of medicines and everyday consumables.

The WHO has encouraged National Regulatory Authorities (NRAs) to carry out targeted market surveillance, particularly focusing on informal or unregulated supply chains, and to assess risks associated with medicines produced at the implicated sites since December 2024. WHO continues to work closely with Indian health authorities to monitor the situation, identify the source of contamination, and mitigate potential public health risks.