Adding to the spate of contaminated medicines linked back to India, the World Health Organization (WHO) has flagged another cough syrup for the presence of contaminants. 

This is the fifth medical product alert for an Indian formulation issued by the WHO since October 2022. 

“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 WHO medical product alert issued on 7 August said. The acceptable amounts of both substances in cough syrups is up to 0.10%. 

The syrup is generally used in Iraq to treat and relieve symptoms of common cold and allergy. The WHO tested a sample from a specific batch of the syrup after it received a report on 10 July about possible contamination. The cough syrup was manufactured by Fourrts  Laboratories (India), on behalf of another Indian company, Dabilife Pharma, the WHO added. 

Since October 2022, the WHO has issued four medical product alerts concerning at least eight liquid medical formulations manufactured in India. In October 2022, the WHO reported that at least 66 children in the Gambia died after consuming cough syrups manufactured in India. 

Most recently, WHO’s Africa region reported that cough syrup laced with high amounts of Diethylene glycol (DEG) – as much as 28.6% – were found in samples of NATURCOLD sold in Cameroon.

While the product alert stated that the agency is unclear about the real manufacturer of the product, Reimann Labs, an Indian pharmaceutical company that was allegedly the manufacturer of the tainted product found in Cameroon, was ordered to shut down production by the Indian drug regulators. 

When cough syrup is manufactured, it needs a solvent to dissolve all its active ingredients, add sweetness, and act as a lubricant. Either glycerine or propylene glycol are usually used, with Glycerine Indian Pharmacopoeia (IP) the grade used in drugs and medicines. 

The cheaper industrial glycerine, which can contain DEG and ethylene glycol, is supposed to be used only in chemicals and cosmetics, according to the good manufacturing practice framed by the WHO. 

While many generic medicines are made in India, the country generally lacks the capacity to conduct rigorous checking of much of the medicine that is produced.

Image Credits: WHO.