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 waves of poisoning.
“There’s no known case of a lack of quality in other medicines manufactured by the firm,” the drug controller of Uttar Pradesh where Marion is based, and which cancelled the firm’s licence in March, said in the Sept 14 order sent to the company.
“Therefore, in view of natural justice, the appeal of the manufacturing firm is partially accepted. Its permission to make products using (cough syrup ingredient) propylene glycol is cancelled, and it is allowed to make and sell all other products.”
The drug controller, Shashi Mohan Gupta, said in the order that the decision to allow the company to reopen its factory was taken by the state’s health department on Aug 11 after an appeal by the company.
Gupta declined to comment on the letter. He told Reuters yesterday that the drugs controller general of India, Rajeev Singh Raghuvanshi, had written to Marion Biotech to initiate a plan of corrective and preventive actions by the company.
Raghuvanshi and the company did not respond to a request for comment. Marion, which says on its website it deals in pharmaceuticals, herbal, and cosmetics products, has previously denied any wrongdoing.
Uttar Pradesh closed Marion’s factory after Uzbekistan’s health ministry found that two cough syrups made by Marion, Ambronol and DOK-1 Max, contained unacceptable amounts of toxins diethylene glycol (DEG) and ethylene glycol (EG), which are usually 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 propylene glycol taken from Marion’s factory contained EG.
Two sources with knowledge of the matter told Reuters on condition of anonymity that the Marion factory remains closed for now, pending an inspection and a review of its paperwork.
Reuters has reported that DEG and EG have been used by unscrupulous actors as a substitute for propylene glycol because they are cheaper.
In June, the WHO told Reuters its working theory was that in 2021, when prices of propylene glycol spiked, one or more suppliers mixed the cheaper toxic liquids with the legitimate chemical.
Uzbek state prosecutors told a court in Tashkent in August that distributors of the contaminated Marion syrups paid officials a bribe of US$33,000 to skip mandatory testing.
The Central Asian nation has put on trial 21 people – 20 Uzbeks and one Indian – for the deaths.
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 DEG or EG.