Urgent probe launched into Gambia cough syrup deaths as fatalities report awaited from WHO

WHO's director-general Tedros Adhanom Ghebreyesus (File image: AP)

The Central Drugs Standard Control Organization (CDSCO) has launched an ‘urgent investigation’ after the World Health Organization (WHO) issued an alert over four cough and cold syrups made by Haryana-based Maiden Pharmaceuticals, which could be linked to the deaths of 66 children in the Gambia.

“Urgent investigation in the matter has been already taken up by CDSCO with the State Regulatory Authorities immediately after receiving communication from WHO based on the available information,” sources said.

One of the sources said that the exact one to one causal relation of death has not yet been provided by WHO, nor have the details of labels or products been shared by WHO with CDSCO enabling it to confirm the identity and the source of the manufacturing of the products.

"As per the tentative results received by WHO, out of the 23 samples tested, four have been found to contain Diethylene Glycol and Ethylene Glycol as indicated," the source added.

“It has also been informed by WHO that the certificate of analysis will be made available to WHO in the near future and it will share that with India,” the source said.

According to the sources, WHO on September 29 informed Drug Controller General of India that it is currently providing technical assistance and advice to Gambia, where children died and a significant contributing factor is suspected to be the use of medicines which may have been contaminated with Diethylene glycol or Ethylene glycol.

“The CDSCO took prompt action and within an hour and a half, took up the matter immediately thereafter with the concerned State Regulatory Authority, under whose jurisdiction the drug manufacturing unit is located. Further, a detailed investigation was launched to ascertain the facts/ details in the matter in collaboration with the State Drugs Controller, Haryana,” the source added.

The sources further said that the preliminary enquiry suggested that Maiden Pharmaceutical, Sonepat, Haryana is a 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 Gambia so far,” the source added.

The WHO yesterday issued a medical product alert for four contaminated medicines identified in The Gambia that have been potentially linked with acute kidney injuries and 66 deaths among children.

“The loss of these young lives is beyond heartbreaking for their families,” said Dr Tedros Adhanom Ghebreyesus, WHO DG, at a media briefing.

The WHO said that four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited, in India adding that it is conducting further investigation with the company and regulatory authorities in India.

“While the contaminated products have so far only been detected in The Gambia, they may have been distributed to other countries. WHO recommends all countries detect and remove these products from circulation to prevent further harm to patients,” Ghebreyesus added.