Authorities have “permanently cancelled” the manufacturing licence of an Indian firm that produced cough mixtures linked to 18 child deaths in Uzbekistan after analysis found unacceptably high levels of diethylene glycol and ethylene glycol in the drugs.
The substances are toxic to humans and could be fatal if consumed, reports the BBC.
India launched an investigation into Marion Biotech after the WHO issued a global medical alert, saying the cough syrups Dok-1 Max and Ambronol, linked to the deaths of the 18 children, were substandard.
Initially, Marion Biotech had said that it “did not agree” with the WHO’s findings and that it was co-operating with investigations by the Indian Government.
It isn’t the first Indian drug maker to get into trouble over its cough syrups.
In October, WHO had sounded a global alert and linked four cough syrups made by another Indian company, Maiden Pharmaceuticals, to the deaths of 66 children from kidney injuries in The Gambia.
Both the Indian Government and Maiden Pharmaceuticals denied the allegations.
India is the world’s largest exporter of generic drugs, meeting much of the medical needs of developing countries. But in recent months, many local firms have come under the microscope for the quality of their drugs, with experts raising concerns about the manufacturing practices used to make these medicines.
In the case of Marian Biotech, tests by a government laboratory found 22 drug samples of the firm’s cough syrup to be “adulterated and spurious”.
“The … drugs can cause grievous hurt to the public,” said Asheesh Kaundal, inspector of India’s Central Drugs Standard Control Organisation (CDSCO).
Earlier this month, the Uttar Pradesh police had also arrested three employees of the company for selling adulterated products.
See more from MedicalBrief archives:
India issues product ban after cough syrup deaths
Cough syrups ‘almost certainly’ to blame for children’s deaths – US CDC
WHO probes raw materials link in lethal cough syrups
Probe into Indian cough syrup link to Gambian children’s deaths