India cancels manufacturing licence for Marion Biotech after cough syrup deaths
pharmafile | March 23, 2023 | News story | Medical Communications |
Uttar Pradesh, a state in India, has cancelled the manufacturing licence of Marion Biotech after two cough syrups made at its Noida city facility ‒ Dok-1 and Ambronol ‒ were linked to the deaths of children in Uzbekistan. Three employees at the Uttar Pradesh site have also been arrested for selling adulterated products.
In December, the deaths of 18 children in Uzbekistan were linked to the Dok-1 cough syrup. An Indian government lab then found 22 samples of Dok-1 to be “adulterated and spurious”, which led to the WHO issuing a global medical alert in January 2023. Marion Biotech’s licence was then suspended while investigations took place.
The cough syrups were found to contain diethylene glycol and ethylene glycol, both toxic to humans. WHO stated: “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…Laboratory analysis of samples of both products, 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.”
“The firm’s licence was under suspension since January after which a detailed inquiry was initiated. Now the licence of the firm has been cancelled by the Uttar Pradesh Drugs Controlling and Licensing Authority. The firm can no longer manufacture the syrup,” a government official stated.
Another Indian manufacturer ‒ Maiden Pharmaceuticals ‒ had a WHO global medical alert issued regarding its cough syrups; four of which have been linked to the deaths of 66 children from kidney injuries in The Gambia.