New Delhi: The production licence of Noida-based pharmaceutical firm Marion Biotech, allegedly linked with the deaths of children in Uzbekistan, has been suspended while the results of its controversial cough syrup are awaited, an Uttar Pradesh drug official said Thursday.
The World Health Organisation (WHO) has said that two cough syrups manufactured by Noida-based company Marion Biotech should not be used for children in Uzbekistan.
Reports of death of some children from Uzbekistan emerged after consuming cough syrup made by Noida-based pharma Marion Biotech.
On December 22, Uzbekistan alleged that 18 children had died after consuming medicines manufactured by Marion Biotech company.
In a medical product alert on Wednesday, the WHO said the 'substandard medical products', made by Marion Biotech, 'are products that do not 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.
No guarantee on safety or quality provided: WHO
'The two products are AMBRONOL syrup and DOK-1 Max syrup. The stated manufacturer of both products is MARION BIOTECH PVT. LTD, (Uttar Pradesh, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products,' the alert added.
According to WHO, laboratory analysis of samples of cough syrups, 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 in the region. They may also have been distributed, through informal markets, to other countries or regions,' the WHO alert added.
WHO said 'the substandard products referenced in this Alert are unsafe and their use, especially in children, may result in serious injury or death'.
The Union Ministry of Health and Family Affairs conducted an inspection of Marion Biotech, for allegedly manufacturing and exporting contaminated cough syrup to Uzbekistan in violation of rules. The Central Drugs Standard Control Organisation (CDSCO) is in regular contact with the national drug regulator of Uzbekistan.
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