According to Valisure LLC, a reputable US laboratory, a bottle of Cold Out purchased in March at a drugstore in Baghdad contains 2.1% ethylene glycol. That is around 21 times the acceptable upper limit. Small doses of the substance are fatal to humans, and it contributed to the widespread child fatalities last year in the Gambia and Uzbekistan that were brought on by cough syrups prepared in India.
In an interview, the health ministry of Iraq’s Saif al-Bader stated that the organization had “strict regulations for the import, sale, and distribution of medicines.” He declined to respond to inquiries concerning Cold Out in particular.
Concerns about Indian medication exporters
This is the seventh time in a year that testing has revealed that medications exported from India contain too much ethylene glycol. Testing by government laboratories has found more tainted items in the Marshall Islands and Liberia in addition to the outbreaks in the Gambia and Uzbekistan, even though there haven’t been any illnesses linked to those medications there.
The producer listed on the Cold Out label is Fourrts (India) Pvt. Ltd., a company situated in Chennai that ships medications to more than 50 nations, including the UK, Germany, and Canada. According to Bala Surendran, a vice president there, Fourrts outsourced the production of Cold Out to Sharun Pharmaceuticals Pvt. Ltd., an additional Indian business with headquarters in Puducherry.
Also read: China: Export Restrictions On Drones & Semiconductor Metals
According to Surendran, Fourrts examined a sample of Cold Out it had on hand and discovered it was uncontaminated. He said that more samples from Sharun’s factory were confiscated by Indian authorities, and Fourrts was not told of the outcomes of those tests. Two local regulators and representatives from the national drug agency either did not reply to requests for comment or indicated they had nothing to add.
Cough medicines with contamination
The WHO employs a recommendation of 0.1 percent for determining whether a medicine product has dangerous amounts of ethylene glycol or diethylene glycol. Levels exceeding that “would be considered non-compliant and therefore a health risk,” said Rutendo Kuwana, the team’s leader in an email about faulty medications.
Using the 0.1 percent limit for testing the raw ingredients needed to make syrup, the US Food and Drug Administration has issued recommendations, according to WHO spokesperson Sarah Sheppard.
Five different tests conducted by Valisure on the Cold Out sample revealed an average ethylene glycol concentration of 2.1% and a diethylene glycol value of 0.251%. More than twice as much diethylene glycol is present as is allowed. None of the other contaminated syrups went beyond the 0.1% percent mark.
