Toxic cough syrup probe: Haryana drug controller takes samples of medicines exported to Gambia

Hours after the World Health Organization linked contaminated cough and cold syrups made by an Indian drug manufacturer to the deaths of dozens of young children in the Gambia, the Haryana State Drug Controller has reportedly taken samples of the cough syrups exported to the Gambia for investigation. As per news reports, the result of the tests is expected in the next two days.

The samples for investigation have been collected from the manufacturing facility of Sonipat-based Maiden Pharmaceutical in Haryana, as per news reports.

Earlier in the day, the Central Drugs Standard Control Organisation (CDSCO) initiated a quick probe into the case after WHO alerted that four “contaminated” and “substandard” cough syrups made by Maiden Pharmaceuticals Limited in Haryana, which has been largely used for paediatric use, are believed to contain chemicals that are toxic and potentially fatal.

CDSCO reportedly said: “Urgent investigation in the matter has been already taken up by CDSCO with the State Regulatory Authorities immediately after receiving communication from WHO based on the available information," they said.

As per the primary investigation, it has been found that Maiden Pharmaceutical was a manufacturer, licensed by the State Drug Controller, for the cough syrups named, and held manufacturing permission for the products. The company had manufactured and exported these products only to Gambia, the statement read.

Which cough syrups have been banned?

The four products named by WHO in its report are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.  

WHO said that as per laboratory analysis of samples of each of the four products, the syrups have “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants”.

WHO said both the contents are toxic to humans when consumed and can prove fatal. It added that substandard medical products are products that fail to meet either their quality standards or specifications. Therefore, they are “out of specification”, the health body said.

What is diethylene glycol, and why is it harmful

According to an analysis in Sciencedirect.com, diethylene glycol is rapidly absorbed and distributed to the kidneys, brain, liver, spleen, and adipose tissue. It can cause kidney and neurological toxicity and has been associated with several cases of mass poisoning when consumed via drugs.

As per an analysis by the National Library of Medicine under the National Center for Biotechnology Information, the chemical is used in antifreeze, brake fluids, cosmetics, and lubricants and can cause renal damage, leading to its failure. This can also lead to death.

The analysis added that consumption of this chemical can lead to abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury.

On Wednesday, Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, said , “While the contaminated products have so far only been detected in the Gambia, they may have been distributed to other countries.”

He added that the global health body will ask all countries to detect and remove these products from circulation to prevent further harm to patients.