CDSCO initiates probe after WHO links 66 child deaths in Gambia with Indian-made drugs

The World Health Organization on Wednesday flagged four cough and cold syrups produced by Maiden Pharmaceuticals Limited which have been linked with acute kidney injuries and 66 deaths among children in The Gambia.

Sonipat: The Central Drugs Standard Control Organisation (CDSCO) has taken up a probe against Haryana-based pharmaceutical company 'Maiden Pharmaceuticals Limited' after the World Health Organization issued an alert for four "contaminated" medicines manufactured by the company that has been "potentially linked" with acute kidney injuries and 66 deaths among children in The Gambia.

News agency ANI while quoting CDSCO sources reported that an “urgent investigation” into the matter has been taken up with the State Regulatory Authorities after receiving communication from WHO based on the available information. “While all required steps will be taken in the matter, as a robust National Regulatory Authority, WHO has been requested to share at the earliest with CDSCO the report on the establishment of causal relation to death with the medical products in question, photographs of labels/ products, etc. which is awaited," sources said.

The CDSCO also took up the matter with the concerned State Regulatory Authority in Haryana, under whose jurisdiction the drug manufacturing unit is located even as a detailed investigation was launched to ascertain the facts/ details in the matter in collaboration with State Drugs Controller, Haryana. Sources said that a preliminary inquiry has revealed that Maiden Pharmaceutical Limited, Sonipat, 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 The Gambia so far. "It is a practice that the importing country tests these products on quality parameters, and satisfies itself as to the quality of the products before their release for usage in the country," said a source and explained the quality parameter needs to be followed by the country that imports these products

Earlier, WHO Director-General Tedros Adhanom Ghebreyesus Wednesday said that the four medicines are cough and cold syrups namely Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup produced by Maiden Pharmaceuticals Limited in India. Ghebreyesus said the WHO is conducting further investigation with the company and regulatory authorities in India," he said, adding that the loss of young lives due to the products is "beyond heart-breaking for their families".

As per the WHO, Maiden Pharmaceuticals Limited, Haryana has not provided guarantees to WHO on the safety and quality of these products. The WHO chief said while the contaminated products have so far only been detected in The Gambia, they may have been distributed to other countries thereby increasing the risk further.

It has been learned that as per the tentative results received by WHO, out of the 23 samples tested, four samples have been found to contain Diethylene Glycol/ Ethylene Glycol as indicated. It has also been informed WHO that the certificate of analysis will be made available to WHO in near future and WHO will share it with India. At the same time, the exact one-to-one causal relation of death has not yet been provided by WHO, nor have the details of Labels/ products been shared by WHO with CDSCO enabling it to confirm the identity/ source of the manufacturing of the products, sources said.

WHO has recommended all countries detect and remove these products from circulation to prevent further harm to patients. Following WHO's warning, a team from Delhi and Sonipat Health Department raided the company to check the medicines.