In the aftermath of deaths of 18 Uzbeki children due to cough syrup, all manufacturing activities at Marion Biotech’s Noida unit were suspended on Friday. This happened after two rounds of inspection by state and central regulators.
Deviation from rules and regulations was noticed by the inspectors and more details have been sought from the pharma company.
Health minister Mansukh Mandaviya tweeted on Friday and said following an inspection by the Central Drugs Standard Control Organisation (CDSCO) inspection team and in view of reports of contamination in cough syrup Dork1Max, all manufacturing activities of Marion Biotech’s Noida unit have been stopped on Thursday night. Further investigations were going on, the minister said.
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Joint inspection was conducted at Marion Biotech’s Noida manufacturing facility by the Uttar Pradesh Drug Control officers and the CDSCO team after the Uzbekistan health ministry accused Marion Biotech’s cough syrup of being contaminated and causing the death of 18 Uzbeki children.
The first inspection was carried out on December 27 and the second on December 29.
Samples were collected from Marion’s manufacturing facilities on December 27 and sent for testing to the Regional Drugs Testing Laboratory, Chandigarh. Further action would be initiated based on the inspection report, the minister said. Marion is a licensed manufacturer and holds the licence for manufacturing Dok1 Max syrup and tablets for export purposes granted by the Drugs Controller, Uttar Pradesh.
Uzbekistan health authorities issued a statement which said that 19 of the 21 children with acute respiratory disease had died as a result of taking Doc-1Max syrup manufactured by Marion Biotech. According to the Uzbeki health ministry, before admission to the hospital for treatment, the deceased children had taken 2.5 ml of the drug at home three to four times a day and for two to seven days which exceeded the standard dose of the drug for children. These children were below the age of six.
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The Uzbekistan authorities have launched a criminal probe into the children’s death. Several officials, involved in the registration of the medicine, its import and sale, were arrested, news agencies from Uzbekistan have reported. The Uzbekistan health ministry has withdrawn the drug from all pharmacies across the country after their investigation show presence of ethylene glycol in the syrup.