Marion Biotech, the Indian manufacturer of cough syrups that Uzbekistan said last year had poisoned 19 children, had allegedly used a toxic industrial-grade ingredient, which is only for commercial use, rather than the legitimate pharmaceutical version.
This is according to a source, who said that additionally, it was not tested before being added to the medicine.
The company had bought the ingredient – propylene glycol (PG) – from trader Maya Chemtech India, as reported by Reuters, which did not have a licence to sell pharmaceutical-grade materials and “dealt only in industrial-grade”.
“We did not know Marion was going to use it to make cough syrups,” said the source. “We are not told where our material is used.”
The syrup was apparently made with industrial-grade PG, a toxic material widely used in liquid detergents, antifreeze, paints or coatings, and to enhance the effectiveness of pesticides.
“Marion bought commercial-grade propylene glycol,” said a second source, an investigator, who declined to be named while the inquiry is ongoing.
“They were supposed to take Indian Pharmacopoeia-grade,” the source added, referring to national standards for the composition of pharmaceutical products.
Marion also did not test the ingredient before using it in the syrups it sold to Uzbekistan, the investigator said. India’s drugs and cosmetics rules say manufacturers are responsible for ensuring the safety of ingredients they use.
Maya is not facing charges but the investigation by federal drug authorities is ongoing. Marion has previously denied any wrongdoing.
An analysis last year by Uzbekistan’s Health Ministry showed the Marion-made cough syrups, Ambronol and DOK-1 Max, contained unacceptable amounts of toxins diethylene glycol (DEG) and ethylene glycol (EG), used in products that are not for human consumption.
In January, Uzbekistan arrested four people in connection with the 19 deaths, including two executives at a company that imported the Marion drugs.
DEG and EG have been used by unscrupulous actors as a substitute for propylene glycol because they are cheaper, according to pharmaceutical manufacturing experts.
The WHO believes that in 2021, when prices of propylene glycol spiked, one or more suppliers mixed the cheaper toxic liquids with the legitimate chemical.
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.
Authorities in the state of Uttar Pradesh, where Marion is based, cancelled Marion’s licence in March. Police arrested three of its employees and issued warrants for the arrest of two directors. The three employees have since been released on bail.
A lawyer for the two directors told the High Court in April that the drugs had been found “not of standard quality” but not adulterated, adding that the directors had not committed any offence in India as the drugs were meant exclusively for export.
The court barred police from arresting the directors unless they had been convicted.
Standards
Besides the deaths in Uzbekistan, at least 70 children died in Gambia last year after taking cough syrups made by another company in India that were found to be contaminated with the toxins, and tainted cough syrups made in Indonesia were linked to the deaths of more than 200 children there.
The deaths prompted an international inquiry into the pharmaceutical supply chain.
International standards allow only trace amounts of EG and DEG in pharmaceutical-grade propylene glycol. Limits for the industrial or commercial grade version are not as stringent, because they are not supposed to be ingested by humans.
The toxins were found in cough syrups exported to Gambia by the other Indian company, Maiden Pharmaceuticals. The WHO linked these syrups to the children’s deaths; Maiden has denied any wrongdoing.
Gambia told India’s drug regulator in June that from 1 July it would make it mandatory for all pharmaceutical products from India to be inspected and tested in India, at the cost of the Indian exporter, before shipment – the first known restrictions on national exports since the deaths, while India made it mandatory for companies to have their cough syrups tested before export, from June.
See more from MedicalBrief archives:
More countries affected by toxic cough syrups
Gambia hires US legal team over Indian cough syrup deaths
WHO alert after more contaminated Indian cough syrups detected
India cancels licence of company linked to deadly cough syrups
India cancels licence of company linked to deadly cough syrups