The World Health Organization (WHO) banned four India-made cough and cold syrups and issued a medical product alert saying that they are possibly linked to the deaths of 66 children in Gambia. The children died due to acute kidney failure.
The four cough and cold syrups which are banned are Promethazine Oral Solution, Kofexmalin Baby Cough syrup, Makeoff Baby Cough syrup and Magrip N Cold syrup. They are manufactured by the Haryana-based Maiden Pharmaceuticals Limited.
WHO in its alert said that laboratory analysis of samples of each of the four products confirmed that they contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
The inter-governmental agency alerted that while these products were sent only to Gambia they may have been distributed via informal channels to other countries as well.
Various media reports quoted sources saying that four of the 23 samples tested by the WHO were found to be contaminated with diethylene glycol or ethylene glycol.
Reports say that the WHO has not provided details to India on a causal relation with the death. This means that it is not yet established that the 66 Gambian children died because they consumed the “contaminated” cough syrups. There are no documents to show that the syrups led to deaths either, Indian authorities have claimed.
Diethylene glycol (DEG) is a common solvent for water-insoluble drugs and chemicals. It is commonly found in cigarettes, antifreeze, lubricants, brake fluids, cosmetics and wallpaper strippers. However, “unacceptable” levels of the chemical can be toxic according to WHO.
WHO has said that diethylene glycol and ethylene glycol are both “toxic to humans when consumed and can prove fatal.” Side effects of DEG include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which is the foremost cause of death.
According to a senior official at the Indian Pharmacopoeia Commission who spoke to Times Now on the condition of anonymity, DEG could be present as an “impurity in the solvents that are generally used in making medicinal products.” However, it is “difficult to say which products have the impurity unless and until it is analysed,” the official said.
They further added that India has robust checks for medicines that are sold after being licensed for use. “If products are made as per standard they should not have such contaminants,” they said.
Hundreds of solvents are generally used in medicinal products. However, DEG can be present as an impurity in glycerol and polyethylene glycols, which are common ingredients in oral care products, according to scientific reports.