
The World Health Organisation, on Wednesday, issued an alert against two cough syrups made by Noida-based Marion Biotech that was linked to the death of 19 children in Uzbekistan. The organisation said that Marion, till date, has not provided any guarantee on the safety and quality of these products – AMBRONOL syrup and DOK-1 Max syrup.
It added that laboratory analysis of the samples of both products undertaken by the Ministry of Health of the Republic of Uzbekistan found that these syrups contain “unacceptable” amounts of diethylene glycol and /or ethylene glycol as contaminants.
WHO added that these products might also have marketing authorisations in other countries of the region, and may have distributed these products through informal markets in other countries or regions.
“The substandard products referenced in this Alert are unsafe and their use, 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,” the alert stated.
The organisation urged authorities to detect and remove these “substandard products from circulation to prevent harm to patients”. It has also requested increased surveillance and diligence within supply chains of countries that are likely to be affected by these products. Moreover, national regulatory authorities and health authorities have been advised to immediately notify WHO if these products are discovered in their countries.
Manufacturers of liquid dosage forms, especially syrups that contain excipients including propylene glycol, polyethylene glycol, sorbitol, and/or glycerin/glycerol were asked by WHO to test for the presence of contaminants such as ethylene glycol and diethylene glycol.
WHO also urged people who have these products to not use them, and seek medical advice if they have used them.
Also read: Uzbekistan cough syrup deaths: Marion Biotech halts manufacturing; drugs controller launches probe
Also read: Uzbekistan cough syrup deaths: India's pharma exports body suspends membership of Marion Biotech
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