WHO Issues Alert Over India-Made Cough Syrup in Iraq; Fifth in 10 Months

The cough syrup had 0.25% diethylene glycol and 2.1% ethylene glycol, which is higher than the acceptable limit.

The World Health Organization on Monday, 7 August, sent out a 'substandard medicine alert' from Iraq for a cough syrup manufactured by a Tamil Nadu-based pharmaceutical company.

The cough syrup, COLD OUT – manufactured by Fourrts (India) Laboratories Pvt Ltd for DabLife Pharma Pvt Ltd India – had 0.25 percent diethylene glycol and 2.1 percent ethylene glycol.

This is much higher than the acceptable safety limit for both the substances – which is 0.10 percent.

Why this is important: This is the fifth alert worldwide about a drug manufactured by an Indian company and the fourth alone for an India-made cough syrup. 

The WHO has now advised global health authorities, and countries likely effected by these products, to increase surveillance on product supply chains and informal market places.

They have also advised citizens who are in possession of the cough syrup to not use it. 

What are the risks? 

"Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal."

World Health Organization

The WHO has alerted that the substandard cough syrup is unsafe and its use, especially in children, may result in serious injury or death. 

It can also cause:

• Abdominal pain

• Vomitting

• Diarrhoea

• Inability to pass urine 

• Headache 

• Altered mental state

• Acute kidney injury

• Risks of death

A comment from the Union Health Ministry is still awaited on the Issue. 

Substandard products brought to light in the last year: 

• October 2022- WHO issued an alert against four cough syrups manufactured by Haryana-based Maiden Pharmaceuticals Limited after 66 children reportedly dead in the Gambia. 

• January 2023- WHO again raised alarm after 18 children allegedly died in Uzbekistan after consuming a cough syrup manufactured by Uttar Pradesh-based Marion Biotech. 

• February 2023- The US Food and Drug Administration raised alarm against the use of eye drops manufactured by Global Healthcare Pharma and Delsam Pharma's Artificial Tears after 55 people allegedly suffered from blindness and one person reportedly died.

• April 2023 - A third cough syrup alert was issued by the WHO against Punjab-based QP Pharmaceuticals. 

All the alerts so far have raised concerns about higher quantities of diethylene glycol and ethylene glycol than what is considered safe to consume, especially by children.