Govt launches probe after WHO alert on 4 India-made cough & cold syrups for kids

After the World Health Organization (WHO) issued an alert on four India-made cough and cold syrups used for paediatric groups, the country’s Central Drugs Standard Control Organisation has launched an urgent investigation into the issue.

The World Health Organization (WHO) issued an alert over four cough and cold syrups, warning they could be linked to the deaths of 66 children in The Gambia.

According to the medical product alert issued by WHO, the four products made by Maiden Pharmaceuticals in India are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

WHO chief Tedros Adhanom Ghebreyesus told reporters that the four cold and cough syrups in question “have been potentially linked with acute kidney injuries and 66 deaths among children” in The Gambia.

The alert said laboratory analysis of samples of the products “confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.”

“Those substances are toxic to humans and can be fatal.. the toxic effect can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death,” the alert said.

Meanwhile, immediately after receiving communication from the WHO,  India’s Central Drugs Standard Control Organisation (CDSCO) has taken up the matter with State Regulatory Authority of Haryana, under whose jurisdiction the drug manufacturing unit is located, the ANI report said.

“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,” ANI news agency cited sources as saying.

From the preliminary enquiry, it has been found that Maiden Pharmaceutical Limited, Sonipat, Haryana is a manufacturer licensed by the State Drug Controller for the products under reference, and holds manufacturing permission for these products. The company has manufactured and exported these products only to The Gambia so far.

“It is a practice that the importing country tests these products on quality parameters, and satisfies itself as to the quality of the products before their release for usage in the country,” said a source and explained the quality parameter needs to be followed by the country that imports these products,” the ANI report further stated.