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Indian Drug Company Suspends Production Over Gambia Deaths

FILE - The logo of Indian pharmaceuticals company Maiden Pharmaceuticals Ltd is seen on a board outside their office in New Delhi, October 6, 2022.

Indian authorities Wednesday said production at Maiden Pharmaceuticals had been halted following a World Health Organization report that alleged links between cough and cold syrups produced by the company and the death of dozens of Gambian children.

Officials said health authorities recently found 12 violations of good practices by Maiden Pharmaceuticals amid an inspection of a factory near the town of Sonepat with alleged links to the death of 69 Gambian children.

Anil Vij, the health minister in India’s Haryana state, said all production at the company had ceased following the inspection.

“Keeping this in view, the entire production of the company has been banned and notice has also been issued” said Vij.

“Authorities are waiting for results on samples of three Maiden Pharma drugs which have been sent to the Central Drug Laboratory in the eastern city of Kolkata,” added Vij.

World Health Organization officials last week issued a medical product alert which called on regulators to remove Maiden Pharma goods off the market.

Analysis conducted by the global health body of four Maiden cough syrup products concluded that four products had unacceptable amounts of diethylene glycol, which can be toxic and lead to acute kidney injury.

A preliminary report issued on Tuesday by Gambian authorities said the deaths of the 69 children resulted from acute kidney injury and were linked to the cough syrups produced in India and imported by a U.S. based company.

The Haryana drugs controller was recently quoted in a report which alleges that Maiden did not perform quality tests of propylene glycol, diethylene glycol and ethylene glycol, while certain batches of propylene did not have the manufacturing and expiry dates.

Health experts say diethylene glycol and ethylene glycol are used in industrial applications such as antifreeze and brake fluid but is also a cheaper alternative in some pharmaceutical products to glycerin, a thickening agent used in many cough syrups.

Maiden officials declined to comment on the allegations but last week told Reuters that they were trying to find out from the buyer what happened in Gambia that led to the child deaths.