An Indian pharma company, Maiden Pharmaceuticals Ltd, has come under scanner after the global health body World Health Organisation (WHO) issued a 'global alert' over the deaths of 66 children in The Gambia.
The WHO has warned that medicines such as Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup could be linked to children's deaths in the African nation, which is also a popular tourist destination.
In its medical product alert issued on Wednesday, the WHO said these "substandard" products were identified in The Gambia in September 2022.
"The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products," said the global health organisation.
Laboratory analysis of the samples of each of the four products confirms they contain "unacceptable amounts of diethylene glycol and ethylene glycol as contaminants", says the WHO. It's worth noting that 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 has warned that to date, these four products have been identified in The Gambia only but may have been distributed, through informal markets, to other countries or regions as well.
Haryana-based Maiden Pharma has not issued any official statement on the issue so far. Reacting to the development, the Haryana State Drug Controller, however, has taken samples of the cough syrup, which was exported to The Gambia, from Maiden, suggest media reports. The results of the sample results could be revealed in at least two days. The Union health ministry is also reportedly probing if these cough syrups were sold in India as well.
The WHO has warned that all batches of the products highlighted above 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," says the WHO.
In light of the unfortunate deaths of children, the Gambian government has also suspended the use of all paracetamol syrups in the country and urged people to use tablets instead. The government in September revealed that dozens of kids had died, without giving the exact number.
As per the WHO, it's important to detect and remove these substandard products from circulation to prevent harm to patients. It has urged increased surveillance and diligence within the supply chains of countries and regions -- and also the informal and unregulated markets -- that may be affected by these products.
"If you have these substandard products, please DO NOT use them. If you, or someone you know, have used these products or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice," the WHO has warned.
National regulatory or health authorities have also been advised to notify the WHO if these substandard products are discovered in any country.