WHO warns against India-made contaminated cough syrup supplied to Iraq

New Delhi: The World Health Organization (WHO) has raised an alert over a batch of contaminated cough syrup found in Iraq and manufactured by an Indian drug company. This is the latest in the series of such warnings about substandard medicines from India.

The cough syrup, manufactured by Fourrts (India) Laboratories Pvt Ltd and branded COLD OUT, was found to contain unacceptable amounts of contaminants diethylene glycol (0.25%) and ethylene glycol (2.1%). Paracetamol and chlorpheniramine combination syrups are used to treat and relieve symptoms of common cold and allergy.

The UN agency said that both the manufacturer and marketer Dabilife Pharma Pvt Ltd, India, have failed to provide guarantees to WHO on the safety and quality of the product.

“A sample of the COLD OUT syrup was obtained from one location in Iraq and submitted for laboratory analysis. The sample was found to contain unacceptable amounts of diethylene glycol (0.25%) and ethylene glycol (2.1%) as contaminants. The acceptable safety limit for both ethylene glycol and diethylene glycol is no more than 0.10%,” WHO said in a statement. “To date, the stated manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product.”

Queries sent to the health ministry did not elicit any response till the time of publishing.

Diethylene glycol and ethylene glycol can prove fatal for humans on consumption. The contaminated batch of the product is unsafe and its 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 has directed all healthcare professionals to promptly report any suspicious or confirmed cases of adverse events linked to the use of contaminated drug product to the national regulatory authorities and national pharmaco-vigilance centre.

Indian-made cough syrups have been linked to the death of dozens of children in Uzbekistan and Gambia, prompting the government to tighten the export policy for cough syrups. It is now mandatory to test before supplying to other countries.