A possible source of the contamination could be the solvent — propylene glycol — in the syrup made by Noida-based Marion Biotech, people familiar with the matter said, sharing new details about an investigation into a company that at least 18 Associated with mortality. Children in Uzbekistan who allegedly drank cough syrup.
According to local media reports in Uzbekistan, the chemical ethylene glycol was found in the syrup Doc One Max during laboratory tests. The Central Asian country’s State Security Service announced that it had opened a criminal investigation into the matter.
The Uttar Pradesh Drug Licensing and Controlling Authority on Monday, January 9, suspended the manufacturing license of the company – Marion Biotech, as it did not respond to the drugs regulator’s show cause notice for more than a week.
A solvent is one of the components of a syrup. “Procurement procedure of raw material which was being used for manufacturing of drugs is also being investigated and some discrepancies have been found in case of non-approved supplier used for procurement. Solvent should ideally But it needs to be tested for contaminants before use and it looks like a gray area in this case as it doesn’t seem to meet the standards,” said an official of the state regulatory division, nominated
Officials also said the company was found to be non-compliant with Schedule M-Good Manufacturing Practices (GMP), a certification standard, in production. “However, it is still an ongoing investigation and we are awaiting the test results of the samples taken,” the official said above.
Diethylene glycol (DEG) and ethylene glycol (EG) are highly toxic, colorless and viscous liquids with a sweet taste. Although they are popularly used in industrial products such as paint, stationery ink, brake fluids and antifreeze, they have been implicated in several large-scale poisonings since 1937.
According to the Centers for Disease Control, DEG and EG are often found as contaminants in glycerin, which is used as a sweetener in many pharmaceutical syrups taken orally.
DEG has also been illegally used as a cheap alternative solvent in drug manufacturing. DEG and EG have similar physical properties and both are often used in blending processes.
On Wednesday, the WHO also issued a medical product alert for two Marion Biotech products linked to the incident in Uzbekistan. The UN heath body said the matter was reported to it on December 22.