The World Health Organisation on Wednesday said that two cough syrups made by India’s Marion Biotech should not be used for children after the products were linked to 19 deaths in Uzbekistan.
What went wrong?
“Cough syrups made by India’s Marion Biotech should not be used for children, after the products were linked to 19 deaths in Uzbekistan,” WHO said in a statement on Wednesday.
“The two products are AMBRONOL syrup and DOK-1 Max syrup. The stated manufacturer of both products is Marion Biotech (Noida, Pradesh, India). Laboratory analysis found both products contained unacceptable amounts of diethylene glycol and /or ethylene,” it said.
The toxic substance in the two syrups – ethylene glycol – was administered in doses higher than prescribed, as per WHO. The WHO said, “To date, manufacturer has not provided guarantees to WHO on safety and quality of these products.”
Neither Dok-1 Max nor AMBRONOL is understood to be for sale in India.
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What is a WHO Medical Product Alert?
In a medical product alert, the WHO said the “substandard medical products” manufactured by Marion Biotech “are products that fail to meet quality standards or specifications and are therefore out of specification.”
“This WHO Medical Product Alert refers to two substandard (contaminated) products, identified in Uzbekistan and reported to WHO on 22 December 2022. Substandard medical products are products that fail to meet quality standards or specifications and are therefore out of specification,” the WHO said in an alert released on its website.
Noida-based pharma in eye of controversy
In December, the health ministry of Uzbekistan claimed that as many as 19 children have lost their lives in the country after consuming medicines manufactured by an Indian pharmaceutical company.
Noida-based Marion Biotech has been battling controversy since news of the deaths emerged.
Officials said the company had failed to respond to a ‘show cause’ notice served on December 30; they had been given seven days to reply. Production of all medicines at the plant had already been stopped per a directive by union health minister Mansukh Mandaviya.
Regarding reports from Uzbekistan concerning contaminated cough syrup made by Indian company Marion Biotech, Noida, Uttar Pradesh, the @CDSCO_INDIA_INF is in regular contact with the national drug regulator of Uzbekistan since 27th December. (1/3)
— Dr Mansukh Mandaviya (@mansukhmandviya) December 29, 2022
It is unclear who authorised the high dosages. The medication – tablet and syrup – have been withdrawn from all pharmacies in Uzbekistan.
Last week Uzbek authorities arrested four people as part of their investigations; this was after seven employees of the Uzbek health ministry were sacked.
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