The likely source of contamination could be the solvent— propylene glycol— in the syrups manufactured by Noida-based Marion Biotech, people familiar with the matter have said, sharing new details about the probe into a company that has been linked to at least 18 deaths in Uzbekistan of children who purportedly consumed its cough syrup.
According to local media reports in Uzbekistan, the chemical ethylene glycol was found in the syrup— Dok-1 Max— during lab tests. The State Security Service of the Central Asian nation announced that it started a criminal probe in the matter.
The Uttar Pradesh drugs licensing and controlling authority suspended the manufacturing license of the company— Marion Biotech— on Monday, January 9, after it did not respond for over a week after the drugs regulator’s show cause notice.
A solvent is one of the ingredients of a syrup. “The purchase mechanism of raw material that was being used to make the drugs is also being investigated and there have been found some discrepancies in terms of an unapproved supplier used to make the purchase. The solvent also ideally needs to be tested for contaminants before being used and that also looks like a grey area in this case as it didn’t seem to conform to the standards,” said an official from the state regulatory division, asking not to be named.
Officials also said that the company was found defaulting on schedule M-good manufacturing practices (GMP) in production, a certification standard. “However, it is still an ongoing investigation and we are awaiting test results of samples lifted,” added the official cited above.
Diethylene glycol (DEG) and ethylene glycol (EG) are highly toxic, colourless and viscous liquids with a sweetish taste. While they are popularly used in industrial products such as paints, stationery ink, brake fluids and antifreeze, they have been involved in several mass poisoning cases dating as far back as 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 used illegally as a cheap substitute solvent in drug manufacturing. DEG and EG have similar physical properties and both are often used in adulteration process.
On Wednesday, WHO also issued a medical product alert pertaining to two products from Marion Biotech linked to the Uzbekistan incident. The UN Heath body said that the matter was reported to it on December 22.
