homehealthcare NewsWHO says 'do not use' for 4 Maiden Pharma baby cough syrups linked to 66 deaths in Gambia
WHO says 'do not use' for 4 Maiden Pharma baby cough syrups linked to 66 deaths in Gambia
CDSCO has launched a detailed investigation in collaboration with Haryana State Drugs Controller. The WHO has identified four paediatric cough syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — as substandard.
The World Health Organization (WHO) has warned people not to use four paediatric cough syrup products from drug company Maiden Pharma that has been linked to the deaths of 66 children in The Gambia in West Africa from kidney injuries.
The WHO has identified four paediatric cough syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — as substandard.
It said of the 23 samples tested, four samples contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. All four products were manufactured in December 2021 and expiring in November 2024.
As per WHO, diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. Their toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury.
"All batches of these products should be considered unsafe until they can be analysed... The substandard products referenced in this alert are unsafe, and their use, especially in children, may result in serious injury or death," the WHO said.
To date, these four products have been identified in The Gambia and may have been distributed, through informal markets, to other countries or regions, the agency said. Teaming up with the Gambia Red Cross Society, the Gambian government has dispatched hundreds of young people to collect the suspect syrups through a house-to-house campaign.
Health ministry sources told CNBC-TV18 that an urgent investigation in the matter had been started by the Central Drugs Standard Control Organisation (CDSCO) with the state regulatory authorities immediately after receiving communication from the WHO based on the available information.
"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," the sources from the health ministry said.
The sources said the WHO has informed that the certificate of analysis would be made available to WHO shortly and it would be shared with India.
Maiden Pharma has manufactured and supplied drugs since 1990. The firm started with manufacturing basic drugs like paracetamol and Riboflavine 5'-phosphate etc. Exports began in 2000. The company has its plants in Kundli, Haryana, and Solan, Himachal Pradesh. According to the company, they comply with WHO and are ISO certified.
First Published: Oct 5, 2022 11:19 PM IST
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