India-made cough syrups deaths in Gambia: Drug regulator initiates probe
A probe has been initiated by India’s drug regulator after the WHO issued an alert saying cough syrups manufactured by an Indian firm in Haryana’s Sonepat could potentially be linked to the death of children in The Gambia, official sources said.
The World Health Organisation (WHO) on Wednesday (October 5) warned that four “contaminated” and “substandard” cough syrups allegedly produced by Maiden Pharmaceuticals Limited based in Haryana’s Sonepat, could be the reason for the deaths in the West African nation.
The sources also pointed out that the exact “one-to-one causal relation of death” has neither been provided by the United Nations Health Agency nor details of labels and products been shared by it with the Central Drugs Standard Control Organisation (CDSCO), enabling it to confirm the identity or source of the manufacturing of the products.
Based on the available information, the CDSCO has already taken up an urgent investigation into the matter with regulatory authorities in Haryana. Further, the sources said that 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.
Also read: WHO yet to provide ‘one to one causal relation of deaths’ in Gambia due to Indian cough syrups
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 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.
A detailed investigation was launched to ascertain the facts and details into the matter in collaboration with Haryana State Drugs Controller, the source explained.
Preliminary inquiries have revealed that that Maiden Pharmaceutical Limited 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.
Also read: WHO alert for 4 Indian cough syrups as 66 children die in Gambia
It is a practice that the importing country tests the products for quality before sanctioning their usage there. 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 by WHO that the certificate of analysis will be made available to it 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,” said the official source to the media.
The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
WHO Director-General Tedros Adhanom Ghebreyesus told reporters on Wednesday (October 5) that the four medicines are cough and cold syrups are produced by Maiden Pharmaceuticals Limited in India. “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”.
