WHO yet to provide relation of deaths in Gambia due to Indian syrups: Report
2 min read 06 Oct 2022, 05:44 AM ISTThe World Health Organization (WHO) on Wednesday issued a medical product alert on four cough and cold syrups made by India's Maiden Pharmaceuticals Limited and said that these "substandard" products are unsafe, especially in children, and may result in serious injury or death.
PremiumAfter the WHO cautioned that cough syrups manufactured by an Indian company could potentially be linked to the deaths of at least 66 children in The Gambia, official sources said that the global health body is yet to provide the exact 'one to one casual relation of deaths', according to the news agency PTI.
The World Health Organization (WHO) on Wednesday issued a medical product alert on four cough and cold syrups made by India's Maiden Pharmaceuticals Limited and said that these "substandard" products are unsafe, especially in children, and may result in serious injury or death, as per ANI reports.
However, the health agency has not yet shared details of labels and products with the Central Drugs Standard Control Organization (CDSCO) which would enable it to confirm the identity and source of manufacturing of the products, official sources told PTI.
They added that the CDSCO has already taken up an urgent investigation into the matter with the regulatory authorities in Haryana.
"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," sources told PTI.
On September 29, the WHO informed the Drugs Controller General of India that it was providing technical assistance and advice to The Gambia, according to sources as quoted by the news agency.
It highlighted that a significant contributing factor to the deaths was suspected to be the use of medicines that may have been contaminated with Diethylene Glycol/Ethylene Glycol, and said its presence had been confirmed in some of the samples it tested.
In a response to the WHO, the source explained that a detailed investigation was launched to ascertain the facts and details of the matter in collaboration with the Haryana State Drugs Controller.
Preliminary investigation revealed 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," according to PTI sources.
It is a practice that the importing country tests the products for quality before sanctioning their usage there. 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.
WHO has also informed India that it will share the certificate of analysis soon.
"At the same time, the exact one-to-one causal relation of the deaths has not yet been provided by the WHO, nor have the details of labels or products been shared with CDSCO, which would enable it to confirm the identity and source of the manufacturing of the products," the source added.
(With inputs from agencies)
