WHO yet to provide 'one to one causal relation of deaths' in cough syrup case: Report

Published on Oct 06, 2022 07:01 AM IST

The CDSCO responded to WHO withing 1.5 hours after WHO alerted India about 4 cough syrups which are suspected to be one of the contributing factors to the death of 66 children in the Gambia.

WHO is yet to provide India's drug controller with the details of labels and products that have been linked with the death in the Gambia. 
WHO is yet to provide India's drug controller with the details of labels and products that have been linked with the death in the Gambia. 

The World Health Organization is yet to provide the exact "one to one causal relation of death" in the Indian cough syrup case, news agency PTI reported quoting official sources after WHO on Wednesday warned against four Indian cough syrups linking them to the deaths of 66 children in The Gambia. The cough syrups are reportedly produced by Haryana's Maiden Pharmaceuticals Limited.

According to the report, WHO is yet to share the details of labels and products with the Central Drugs Standard Control Organisation. Once the details are shared, the identity and the source of the manufacturing of the products will be confirmed.

"While all required steps will be taken, as a robust regulatory authority, WHO has been requested to share with CDSCO at the earliest the report on the establishment of a causal relation to the deaths with the medical products in question, photographs of labels/products etc," an official source said to PTI.

On September 29, the WHO informed the Drugs Controller General of India about the deaths in the Gambia and 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. According to the tentative results received by the WHO, four out of the 23 samples tested have been found to contain either Diethylene Glycol/Ethylene Glycol.

The CDSCO responded to WHO within 1.5 hours and took up the matter with the state regulatory authority. Further, a detailed investigation was launched to ascertain the facts and details of the matter in collaboration with the Haryana State Drugs Controller, the report said.

"From the preliminary inquiry, it has been made out that Maiden Pharmaceutical Limited, Sonepat, Haryana, is the manufacturer licensed by the state drug controller for the products under reference, and holds manufacturing permission for these products. The company has manufactured and exported these products only to The Gambia so far," the PTI report said quoting a source.

The WHO alert covers four products: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, Reuters reported.

What happened in the Gambia?

According to Reuters, dozens of children began falling ill with kidney problems a few months ago. Medical officers raised the alarm in July. A pattern emerged that the deaths took place in patients younger than five and all of them took a locally sold paracetamol syrup three to five days before death. Gambia's director of health services Mustapha Bittaye said the sale of products made by Maiden Pharmaceuticals was banned.

(With inputs from ANI, PTI, Reuters)

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