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The World Health Organization (WHO) has issued an alert for four India-made paediatric medicines following the death of 66 children due to acute kidney injuries in the west African nation of The Gambia.
According to a WHO Medical Product Alert issued on Wednesday, toxic chemicals such as diethylene glycol and ethylene glycol were found in the products, which were reported to it in September 2022.
The four "contaminated" medicines have been produced by Maiden Pharmaceuticals Limited, located in Haryana, India. These include Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, all cough and cold syrups.
"WHO is conducting further investigation with the company and regulatory authorities in India," the organization said in a series of tweets, quoting its Director General Tedros Adhanom Ghebreyesus.
Suggesting that contaminated products may have been distributed to other countries as well, WHO recommends all countries to find out and remove these products from circulation to prevent further harm to patients.
"WHO has today issued a medical product alert for four contaminated medicines identified in #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"-@DrTedros
World Health Organization (WHO) (@WHO) October 5, 2022
"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," another tweet stated.
"Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants," the alert sated.
Further it said that the substandard products (referenced in this alert) are unsafe and their use, especially in children, may result in serious injury or death. Elaborating on the health risks, the UN health agency noted, "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."
The WHO alert also mentioned that to date, the Maiden Pharmaceuticals Limited has not provided guarantees to WHO on the "safety and quality of these products."
WHO added that until the products are analyzed by the relevant National Regulatory Authorities, all batches of these products should be considered unsafe.
CDSCO launches a probe into the matter
Quoting a source news agency IANS said that the Central Drugs Standard Control Organisation (CDSCO) has taken up the matter and ordered a detailed investigation against the medical products in the question.
Further, the CDSCO has requested the WHO to share the report on the establishment of causal relation to death with the products at the earliest.
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