Indian pharma company Maiden’s syrups tied to deaths of 66 children in Gambia?
The World Health Organization (WHO) has issued a medical product alert over four contaminated medicines identified in the Gambia. Addressing a media briefing on 5 October, the WHO Director-General Dr. Tedros Adhanom Ghebreyesus said that the contaminated medicines found in the Gambia “have been potentially linked with acute kidney injuries and 66 deaths among children.” He said that the four medicines are cough and cold syrups manufactured by Maiden Pharmaceuticals Limited in India.
India’s Health Ministry has launched an “urgent investigation” after the World Health Organization (WHO) 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 Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, MoHFW — the National Regulatory Authority in the country — has taken up the matter with the State Regulatory Authorities “immediately after receiving communication from WHO.
WHO has also 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. That report is awaited.
Maiden Pharmaceutical Limited of Sonepat in Haryana is a manufacturer licensed by the State Drug Controller for the products and holds manufacturing permission. The company has made and exported these products only to the Gambia so far.
According to the medical product alert issued by WHO, the four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup. It noted that the manufacturer of these products is Maiden Pharmaceuticals Limited and so far, it has failed to provide guarantees to WHO on the safety and quality of these medicines. The WHO in a statement revealed that the laboratory assessment of samples of the four products shows that they contain “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.” According to WHO, diethylene glycol and ethylene glycol are “toxic” to humans and can even prove “fatal.” Furthermore, it said that the toxic effects of these substances include “abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.”
“WHO has today 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,” Dr. Tedros Adhanom Ghebreyesus said in the press briefing.
Dr. Tedros said, “The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited, in India. WHO is investigating further with the company and regulatory authorities in India.”
The WHO Chief Dr. Tedros Adhanom Ghebreyesus said that the contaminated products have been found in the Gambia. However, he warned that the contaminated medicines might have been distributed in other nations as well. He stated that WHO is investigating further with the company and regulating authorities in India. He called on all nations to identify and stop the sale of these products in order to protect patients from further harm.
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