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DNA Exclusive: Analysis of WHO’s global alert over India-made cough syrups linked to death of children in The Gambia

A global alert has been issued over four cough syrups after the World Health Organization (WHO) warned they could be linked to the deaths of 66 children in The Gambia. Samples of four cough syrups manufactured by a Sonipat-based firm have been sent to the Central Drugs Laboratory in Kolkata for examination on Thursday, a day after WHO potentially linked them to the deaths of children. WHO warned that four “contaminated” and “substandard” cough syrups allegedly produced by Maiden Pharmaceuticals Limited based in Haryana’s Sonepat could be the reason for the deaths of children in the West African nation.

In Today DNA, Zee News’ Rohit Ranjan will analyse WHO’s global alert over four cough syrups manufactured by an India-based pharmaceutical firm that could be linked to the deaths of 66 children in The Gambia.

India’s drug regulator Drugs Controller General of India (DCGI) has already initiated a probe and sought further details from the WHO. In a statement, the government said that samples of the four syrups have been sent for testing to Regional Drug Testing Lab, Chandigarh by CDSCO, the results of which will guide further course of action.

The development comes after WHO issued a medical alert in response to the deaths, labelling the four products – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – made by the company as “substandard medical products”.

“WHO has issued a medical product alert for four contaminated medicines identified in The Gambia that have been potentially linked to acute kidney injuries and 66 deaths among children,” WHO Director-General Tedros Adhanom Ghebreyesus said in a statement on Wednesday. “The loss of young lives is beyond heartbreaking for their families,” he said.

Maiden Pharmaceuticals Limited was licensed by the State Drug Controller for manufacturing these products and export them only to the Gambia. 

However, it may be noted that the WHO neither provided the exact “one-to-one causal relation of death” nor did it share the details of labels and products in question with the CDSCO.

Earlier, WHO informed the DCGI that it was providing technical assistance and advice to Gambia.

It had highlighted that a significant contributing factor to the deaths was suspected to be the use of medicines which may have been contaminated with Diethylene Glycol/Ethylene Glycol, and said its presence had been confirmed in some of the samples it tested.

The CDSCO said it responded to the WHO within an hour-and-a-half after receiving intimation, by taking up the matter with the state regulatory authority.