The World Health Organisation on Wednesday warned that four "contaminated" and "substandard" cough syrups, allegedly produced by Maiden Pharmaceuticals Limited based in Haryana's Sonipat could be the reason for the deaths of at least 66 children in The Gambia. According to official sources, the global health body is yet to provide the exact "one to one causal relation of deaths".
The United Nations health agency, however, has not yet shared details of labels and products with the Central Drugs Standard Control Organisation (CDSCO), which would enable it to confirm the identity and source of manufacturing of the products, official sources said.
Based on available information, the CDSCO has already taken up an urgent investigation into the matter with the regulatory authorities in Haryana, they said.
"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.
According to the sources, the WHO on September 29 informed the Drugs Controller General of India that it was providing technical assistance and advice to The Gambia.
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.
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.
Further, a detailed investigation was launched to ascertain the facts and details into the matter in collaboration with Haryana State Drugs Controller, the source explained.
"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 source said.
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 PTI)
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