The Central Drugs Standard Control Organisation (CDSCO) has launched a probe after the World Health Organisation issued an alert against four India-made cold and cough syrups that have been “potentially linked” with acute kidney injuries and 66 deaths among children in the African country, The Gambia.
According to government sources, CDSCO has taken up the matter and ordered a detailed investigation against the cough and cold syrups produced and exported to The Gambia by Maiden Pharmaceuticals Limited, which is based in Haryana’s Sonepat, on the basis of available information shared by WHO.
WHAT INDIAN GOVT SAID
In a statement, the Indian government stated, “The CDSCO, while responding to WHO, 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 or details in the matter in collaboration with State Drugs Controller, Haryana (the concerned State Drug Control Authority).”
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According to the primary investigation, it has been made out that M/s Maiden Pharmaceutical Limited was a manufacturer, licensed by the State Drug Controller, for the products under reference, and held manufacturing permission for the products. The company had manufactured and exported these products only to Gambia, the statement reads.
“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,” it states.
WHO TEST RESULTS
Sources said according to the tentative results received by WHO, out of the 23 samples tested, four samples were found to contain diethylene glycol or ethylene glycol as indicated. It has also been informed by WHO that the certificate of analysis will be made available to WHO in the near future and WHO will share it with India, government sources said.
They said WHO had been requested to share the report on the establishment of a causal relation to death with the medical products in question, photographs of labels at the earliest.
WHO ADVISORY
WHO Director-General Tedros Adhanom Ghebreyesus said, “The four medicines are cough and cold syrups 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”.
The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The manufacturer of these products is Maiden Pharmaceuticals Limited, Haryana, India, and “to date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products”, WHO said.
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. WHO has recommended all countries detect and remove these products from circulation to prevent further harm to patients.
The WHO Medical Product Alert refers to four substandard products, identified in The Gambia and reported to WHO in September 2022.
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WHO said substandard medical products are products that fail to meet either their quality standards or specifications. Therefore, they are “out of specification”, the health body said.
Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
Outlining the risks associated with the products, WHO said diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
“Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death,” it said.
All batches of these products should be considered unsafe until they can be analysed by the relevant National Regulatory Authorities. The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death, it added.
