India’s Central Drugs Standard Control Organisation (CDSCO) has initiated an “urgent investigation” and sought for more details from the World Health Organization (WHO), which has warned that four "contaminated" and "substandard" cough syrups, allegedly produced by Maiden Pharmaceuticals Limited based in Haryana's Sonepat, could be the reason for 66 deaths in the West African nation of Gambia.
The samples of the cough syrups have been sent to the Central Drug Lab in Kolkata for testing and affirming any possible “contamination”. Government sources said the exact "one-to-one causal relation of death" has neither been provided by the UN health agency nor the details of labels and products shared by it with the CDSCO, enabling it to confirm the identity or source of the manufacturing of the products. "Based on available information, the CDSCO has already taken up an urgent investigation into the matter with regulatory authorities in Haryana.
While all required steps will be taken, as a robust regulatory authority, the 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 said. Sources said the Union Health ministry would take all “required steps”.
"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 said. WHO has also informed India that it will share the certificate of analysis soon, they pointed out.
Haryana Home Minister Anil Viz said , “The Central government officials are gathering complete information. Samples have been sent to the Central Drug Lab in Kolkata. After reports come, stern action will be taken if anything wrong is found.”
Vij said the cough syrups manufactured by the pharma company were approved for export. "It is not available for sale or marketing in the country. Whatever action has to be taken will be taken once the CDL report comes. Only after the report is in, we can arrive at any conclusion," he said. According to the sources, the WHO had on September 29 informed the Drugs Controller General of India that it was providing technical assistance and advice to The 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. 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," sources 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.