Toxins Found in Indian Cough Syrup Linked to Death of Uzbekistan Kids, Says WHO

The UN body has issued a 'product alert' against two products and asked regulators across world to remove them from markets.

New Delhi: The World Health Organisation (WHO) on the evening of Wednesday, January 11,  issued a product alert against two cough syrups made by an Indian firm that are potentially linked to the death of 18 children in Uzbekistan. The alert said the two cough syrups contained diethylene glycol (DEG) and ethylene glycol (EG)  in unacceptable levels. 

This development comes on the heels of another such incident in the Gambia in which four paediatric syrups were found to contain DEG and ethylene glycol, according to another product alert of the WHO. 

Wednesday’s product alert is against two products – Ambronol cough syrup and Dox-1 Max syrup – both manufactured by Marion Biotech, a Noida-based pharmaceutical company. There has been no response from the company on the WHO alert. Its website has been taken down. 

The UN body health alert said the samples in question were tested by the ‘national quality control laboratories’ at the behest of Uzbekistan’s health authorities. 

“To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products,” the alert said. The WHO has warned that the two products might have had market approvals in other countries or have been supplied through informal markets. 

“It is important to detect and remove these substandard products from circulation to prevent harm to patients,”  the WHO alert said. It asked drug regulators across the world to increase surveillance of these products in their respective markets.

“It is important to detect and remove these substandard products from circulation to prevent harm to patients,” it said. 

The Wire had reported earlier that the syrups used in the Gambia contained DEG in amounts as high as 21%. Later, a report from the Gambia parliament concluded that those syrups were responsible for the deaths of 70 children in their country. The Indian government has so far not reacted to the parliamentary report from Gambia and had cleared the name of the Indian firm responsible for making those syrups. 

Uzbekistan first raised alarm against one of the two products – Dox-1 Max syrup – on December 27, 2022. 

“To date, 18 out of 21 children with acute respiratory disease have died as a result of taking Doc-1 Max syrup (sic).”

“It was found that the deceased children, before admission to hospital treatment, took this drug at home for 2-7 days 3-4 times a day, 2.5-5 ml, which exceeds the standard dose of the drug for children,” it added. The statement from the Uzbekistan health ministry said that the formulation contained EG. 

Also read: Maiden Pharma, the Company Whose Syrup Killed Gambian Children, Is a Habitual Offender

Two days after the red flag, a team from the Indian drug regulator, the Central Drug Standard Control Organisation (CDSCO), collected the control samples for investigation. For every batch of products released in the market, a manufacturer has to preserve the samples for any future investigation and those samples are known as control samples. 

The results of the Indian investigation are pending but the Uttar Pradesh state drug controller cancelled the licence of Marion Biotech on January 10. 

“We have suspended the production license of Marion Biotech company after they did not provide us with enough documents,” news agency ANI quoted Vaibhav Babbar, drug inspector of Gautam Buddha Nagar (Noida).

Babbar also told ANI: “A show cause notice was given by the state licensing authority depending on the documents asked during inspection which they [Marion Biotech] didn’t provide.” The manufacturing of all drugs have been stopped at the company. 

The Pharmaceuticals Export Promotion Council of India, a body that functions under the Union commerce ministry suspended the licence of Marion Biotech after the Uzbekistan incident. The council had demanded details from the company asking where the Dox-1 Max syrup was exported, the names of importers and a manufacturing licence copy, among other things. The company allegedly failed to provide these details.