The World Health Organization (WHO) has recommended against using two cough syrups made by Noida-based Marion Biotech due to their "substandard" quality. "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," it said on Wednesday. These two products are AMBRONOL syrup and DOK-1 Max syrup.
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diethylene glycol and /or ethylene glycol as contaminantsThe syrups were administered in doses higher than the standard for children, either by their parents, who mistook it for an anti-cold remedy, or on the advice of pharmacists, revealed the analysis.
So far, Marion has not provided guarantees to WHO on the safety and quality of these products, the agency said.
What's matter
The matter came to light after Uzbekistan alleged that 18 children had died in the country after consuming medicines manufactured by Marion Biotech. As per reports on a local Uzbek news website, the Uzbek government said 21 kids were hospitalised with acute respiratory diseases. It was said to be a side-effect of consuming the cough syrup Dok-One Max.
Following this, Marion Biotech was asked to stop all productions at its manufacturing facility in Noida. Citing the reason for this halt, sources told CNBTV-18, "Drug regulatory authorities from central and state governments found deviations from rules and regulations on manufacturing practices."
Authorities conduct inspection of Marion Biotech
Two rounds of inspections were conducted at Marion Biotech in December and the third one was conducted on Thursday, January 12.
On Thursday, the Central Drugs Standard Control Organization (CDSCO) and the Uttar Pradesh Food Safety and Drug Administration Department (UPFSD) conducted fresh inspection at the manufacturing plant of Marion Biotech in Noida. This time, samples of Ambronol cough syrup have been taken for testing. Earlier, authorities had taken samples of Dok-1Max cough syrups.
This week, the Uttar Pradesh government suspended the manufacturing license of the company after it did not respond to the show cause notice sent by the state government.
Last week, the Uzbek state security service arrested four people in an investigation into the cough-syrup related deaths of 19 children.
The Uzbekistan case follows deaths of at least 70 children in Gambia that a parliamentary committee had linked to cough and cold syrups manufactured by New Delhi-based Maiden Pharmaceuticals. The company denied any wrongdoing and Indian government inspectors found no contamination in test samples.
First Published: Jan 12, 2023 10:32 AM IST
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