Uzbekistan’s Ministry of Health said Wednesday that at least 18 children have died in Samarkand after allegedly consuming an India-manufactured syrup, Doc-1 Max prepared by Noida-based Marion Biotech.
In a statement, the Uzbekistan ministry said laboratory tests of the preparation found presence of the contaminant ethylene glycol. It said the medicine was consumed without prescription and in a higher dose by the children affected.
According to the statement, preliminary laboratory studies indicate the presence of ethylene glycol in a particular batch of the syrup. The statement said the substance is toxic and consuming 1-2ml/kg of 95% concentrated solution can cause vomiting, fainting, convulsions, cardiovascular problems and acute kidney failure.
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The contaminant ethylene glycol – along with di-ethylene glycol – is the same as the one found in four India-manufactured syrups that have been linked to the deaths of 70 children in The Gambia earlier this year.
The World Health Organisation told The Indian Express: “WHO is in contact with health authorities in Uzbekistan and is ready to assist in further investigations.”
Marion Biotech, the manufacturing company, and the Union Health Ministry did not respond to queries from The Indian Express.
With paracetamol being one of the active ingredients in Doc-1 Max, the Uzbekistan ministry statement said it was incorrectly used by parents as an anti-cold remedy on the recommendation of local pharmacies.
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It said the children had taken the medicine for 2 to 7 days, in doses of 2.5 to 5 ml, three to four times a day, before hospital admission, which exceeded the standard dose for children.
The statement said that at a body temperature of 38 to 38.5 degrees Celsius, 100 to 125 mg should be given to a child under the age of one year, 200 mg for children between 1 and 3 years, and 250 mg for children between 3 and 5 years. The medicine should not be taken with normal body temperature, it stated.
A letter dated December 15 from the Samarkand Regional Children’s Multidisciplinary Medical Center to Davronbek Zhumaniyozov, head of the Regional Health Department, quoted in regional news reports, claimed that 21 cases of kidney damage and failure in children were reported over two months. Anuria, the inability to produce urine, was observed and 17 with severe disease had to undergo dialysis, of whom 15 died.
Following this, tablets and syrups of Doc-1 Max were withdrawn from sale. The ministry, in its statement, asked parents to remain cautious. It said seven employees had been dismissed because they failed to analyse child mortality and take necessary measures.
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The Uzbekistan incident is similar to the deaths of 70 children in The Gambia after allegedly consuming India-manufactured syrups contaminated with ethylene glycol and di-ethylene glycol.
Last week, The Indian Express reported that a select committee of the Gambian National Assembly had concluded that the deaths of 70 children due to acute kidney injury were linked to their consumption of four contaminated syrups made by Indian pharma firm Maiden Pharmaceuticals. The committee, in its report, recommended that Maiden be blacklisted, its products banned in the Gambian market and legal action be pursued against the company.
Between June and November this year, 82 children were confirmed to have suffered acute kidney injury in The Gambia. Of them, 70 died.
Maiden has denied the allegations. Its manufacturing unit in Sonepat was shut down by the Central Drugs Standard Control Organisation for alleged irregularities in processes. But India maintains that sufficient clinical details to establish causality between the deaths and the consumption of medicine hasn’t been shared by the country or the WHO that raised an alert in October linking the deaths to Maiden’s four syrups.