The Gambia has initiated a door-to-door campaign to collect cough and cold syrups that have caused the deaths of more than 60 children from kidney injury in the tiny West African country, according to ndtv.com.
After the World Health Organization issued an alert that cough syrups supplied by an Indian manufacturer could potentially be linked to the death of children in Gambia, India’s pharma authority launched an investigation and requested additional information from the WHO.
The World Health Organization (WHO) issued a warning on Wednesday that the deaths in the West African country may have been caused by four cough syrups that were purportedly manufactured by Maiden Pharmaceuticals Limited, a company situated in Sonepat, Haryana.
Anil Vij, the health minister for Haryana, announced on Thursday that samples of four cough syrups produced by the company had been sent to Kolkata’s Central Drugs Laboratory for testing.
According to Vij, who spoke to PTI, the samples were gathered by a team from the DCGA and the Haryana Food and Drug Administration Department and sent to the CDL, Kolkata, for testing.
He said that a senior representative of the Center’s Department of Pharmaceuticals spoke with the Additional Chief Secretary of Haryana (Health).Vij claimed that the pharmaceutical company’s cough syrups had received export authorization. It is not offered for purchase or marketing within the nation.
“Once the CDL report is released, we’ll take whatever necessary measures. We cannot draw any conclusions till the report is received,” Vij added.
According to government sources, neither the precise “one-to-one causal relation of death” nor the details of labels and products that would have allowed the Central Drugs Standard Control Organization (CDSCO) to confirm the identity or source of the products’ manufacturing to be confirmed by the UN health agency.
According to the facts at hand, the CDSCO has already requested that the regulatory authorities in Haryana conduct an expedited investigation into the situation.
The WHO has been asked to share with CDSCO as soon as possible the report on the establishment of a causal relation to the deaths with the medical products in question, photographs of labels/products, etc., a source said. “While all necessary steps will be taken, the WHO has been requested to share with CDSCO at the earliest opportunity,” the source said.
The WHO reportedly informed the Drugs Controller General of India on September 29 that it was giving the Gambia technical support and advice.
The use of medications that may have been tainted with Diethylene Glycol/Ethylene Glycol was emphasized as a significant contributing cause to the deaths, and it was noted that its presence had been confirmed in some of the samples it studied.
Within an hour and a half of receiving notification, the CDSCO claimed to have responded to the WHO by raising the issue with the state regulating body.
According to the source, a thorough investigation was started in cooperation with the Haryana State Drugs Controller to discover the facts and specifics surrounding the situation.
According to the results of the preliminary investigation, Maiden Pharmaceutical Limited is the supplier of the products in question who has been granted manufacturing authorization by the state drug controller.
According to the source, “the company has only produced and exported these products to Gambia so far.”
Prior to approving their use abroad, the importing nation routinely verifies the products’ quality.
Out of the 23 samples analyzed, four samples were found to contain diethylene glycol/ethylene glycol as indicated, according to preliminary results sent to WHO. Additionally, WHO has informed it that it would soon have access to the certificate of analysis, and that it will also share it with India.The official source added, “At the same time, the precise one-to-one causal relation of death has not yet been provided by WHO, nor has WHO shared with CDSCO the specifics of labels/items enabling it to establish the identity/source of the production of the products.”