India’s Uttar Pradesh state on Thursday said Marion Biotech, whose cough syrups Uzbekistan linked to the deaths of 65 children last year, will have to file a report of “corrective and preventive action” before being allowed to reopen its factory.
The statement from the state’s drug controller came after Reuters on Wednesday reported an order from him dated Sept. 14, saying that an appeal from the company to restart the factory had been partially accepted. It said the company could resume production and sale of items that do not contain an ingredient linked to the cough syrup deaths, but did not give a timeline for resumption of production.
The drug controller, Shashi Mohan Gupta, said in the statement that the article was misleading and that the Uttar Pradesh government had asked Marion to file a report of Corrective and Preventive Action (CAPA) to address its shortcomings. Marion is based in the state near New Delhi.
That report will have to be verified by a team of inspectors from federal and state regulators, he said in the statement.
“The firm will not carry out any medicine manufacturing work until the final decision of the appellate authority,” Gupta said.
Marion did not respond to a request for comment.
Marion is among three Indian companies whose cough syrups the World Health Organization and other agencies have linked to the deaths of 141 children in Uzbekistan, Gambia and Cameroon since the middle of last year, in one of the world’s worst such waves of poisoning.
Gupta said in the September order seen by Reuters that the Uttar Pradesh government on Aug. 11 overturned cancellation of Marion’s manufacturing licence by the state in March because “there’s no known case of a lack of quality in other medicines manufactured by the firm”.
“Its permission to make products using propylene glycol is cancelled, and it is allowed to make and sell all other products,” the order read.
The company’s production was suspended on Dec. 27 last year after Uzbekistan said Marion’s Ambronol and DOK-1 Max syrups contained unacceptable amounts of toxins diethylene glycol (DEG) and ethylene glycol (EG), which are typically used in products not meant for human consumption.
Tests in January by an Indian government laboratory found 22 samples of Marion-made syrups were “adulterated and spurious,” the country’s drug controller said in March.
India’s pharmaceuticals department told parliament the same month that tests had also shown that a sample of cough syrup-ingredient propylene glycol taken from Marion’s factory contained EG.
Marion’s then-head of operations, Tuhin Bhattacharya, earlier told Reuters the company had exported cough syrups for more than a decade without testing propylene glycol for impurities like DG or EG.
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