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 submit a report on “corrective and preventive actions” before being allowed to reopen its factory.
The state drug inspector’s statement came after Reuters on Wednesday reported his order dated September 14 saying the company’s call to restart the factory was partially upheld. It said the company could resume manufacturing and selling items that did not contain an ingredient linked to the cough syrup deaths, but did not give a timeline for resuming production.
Drug Controller Shashi Mohan Gupta said in the statement that the article was misleading and that the Uttar Pradesh government had asked Marion to submit a Corrective and Preventive Action (CAPA) report to address the deficiencies. Marion is based in the state near New Delhi.
That report will have to be reviewed by a team of inspectors from federal and state regulators, he said in the statement.
“The firm will not carry out any drug manufacturing work pending the final decision of the appellate body,” 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 poisonings.
Gupta said in the September order seen by Reuters that the Uttar Pradesh government on Aug. 11 overturned the state’s March cancellation of Marion’s manufacturing license because “there is no known case of non-quality of other drugs manufactured by the firm.”
“Its authorization to manufacture products using propylene glycol is revoked and all other products are permitted to be manufactured and sold,” the order reads.
The company’s production was halted on December 27 last year after Uzbekistan said Marion’s Ambronol and DOK-1 Max syrups contained unacceptable amounts of the toxins diethylene glycol (DEG) and ethylene glycol (EG), which are commonly used in products that are not intended for human consumption.
Tests in January by an Indian government laboratory found that 22 samples of syrups produced by Marion were “falsified and counterfeit,” the country’s drug watchdog said in March.
India’s pharmaceutical department told parliament that month that tests also showed a sample of the cough syrup ingredient propylene glycol taken from the Marion factory contained EG.
Marion’s head of operations at the time, Tuhin Bhattacharya, previously told Reuters the company had been exporting cough syrups for more than a decade without testing propylene glycol for impurities such as DG or EG.
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