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India probes cough syrups linked to Gambia deaths

October 7, 2022

Products from Maiden Pharmaceuticals were found to have "unacceptable" levels of substances that can be toxic and lead to acute kidney injury. The WHO says they could be responsible for the deaths of dozens of children.

Logo of the Maiden Pharmaceuticals Ltd. company is seen on a board outside their office in New Delhi, India
WHO laboratory analysis found 'unacceptable' amounts of diethylene glycol and ethylene glycol in Maiden's productsImage: Anushree Fadnavis/REUTERS

Indian authorities are testing samples of cough syrups produced by a local pharmaceutical company after the UN's health agency said they were linked to the deaths of 66 children in Gambia.

According to the World Health Organization (WHO), laboratory analysis found "unacceptable" amounts of diethylene glycol and ethylene glycol in four products manufactured by Maiden Pharmaceuticals. These compounds can be toxic and lead to acute kidney injury.

In addition to being utilized as cheaper substitutes for glycerine, a solvent or thickening ingredient in many cough syrups, diethylene glycol and ethylene glycol are also employed in antifreeze, braking fluid, and other industrial purposes.

The four products tested were Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup — all manufactured by Maiden.

The WHO is looking into whether these products were distributed to other countries besides Gambia.

Indian authorities await lab test results

The WHO's findings were disclosed to the Indian Health Ministry last month. Late Thursday, the ministry said it was conducting its own lab testing of the four medicines and was still awaiting the results.  

According to the ministry, Maiden exported the cough syrup only to Gambia. The company is not licensed to distribute the four products in India.

"It is a usual practice that the importing country tests these imported products on quality parameters, and satisfies itself as to the quality of the products," the ministry statement said.

Anil Vij, the health minister in northern Haryana state where Maiden has its factories, said that strict action would be taken "if anything is found wrong" in the tests.

Company warned about 'substandard' products

Naresh Kumar Goyal, a Maiden director, told Reuters that the company only learned of the deaths on Thursday.

"We are trying to find out the situation," he said. "We are trying to find out with the buyer and all that what has happened exactly. We are not selling anything in India."

The company, which began operations in November 1990, has repeatedly attracted the attention of Indian regulators.

According to the website of the country's Food and Drug Administration, the company has been warned four times this year about manufacturing "substandard" products based on batch tests.

ss/nm (Reuters, AFP)