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Following the deaths of 18 children in Uzbekistan after consuming sub-standard cough syrups, the World Health Organization (WHO) has issued an alert against two liquid dosage medicines manufactured by Noida-based Marion Biotech Pvt Ltd.
The alert was issued January 11 against Ambronol and DOK-1 Max syrups, which have been found to contain ethylene glycol.
The stated manufacturer has not provided guarantees to WHO on the safety and quality of these products to date, the global health body said in a press statement.
WHO said:
Laboratory analysis of samples of both products, undertaken by national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan, found both products contained unacceptable amounts of diethylene glycol and /or ethylene glycol as contaminants.
Both of these products may have marketing authorisations in other countries. They may also have been distributed, through informal markets, to other countries or regions, the statement warned.
Sub-standard medical products fail to meet quality standards or specifications and are therefore “out of specification”.
WHO had issued two similar alerts for cough syrups after the deaths of children were reported in Indonesia and The Gambia. The syrups in Gambia were confirmed to be manufactured in India.
WHO had October 5, 2022 issued an alert for four cough syrups manufactured by a company based in Haryana, India.
Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup were identified in The Gambia. The cold medication was linked to the death of 66 children in the West African country in earlier media reports.
Laboratory analysis of samples of each of the four products had confirmed that they contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants, the WHO had said.
On November 2, 2022, the global health body issued an alert against paediatric liquid dosage medicines identified in Indonesia.
The eight products were Termorex syrup (batch AUG22A06 only), Flurin DMP syrup, Unibebi Cough Syrup, Unibebi Demam Paracetamol Drops, Unibebi Demam Paracetamol Syrup, Paracetamol Drops (manufactured by PT Afi Farma), Paracetamol Syrup (mint) (manufactured by PT Afi Farma) and Vipcol Syrup.
The products also contained unacceptable amounts of ethylene glycol and/or diethylene glycol, the WHO had said.
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. Consumption of products with these contaminants, 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.