WHO says using these medicines may result in death and that it's conducting investigations with their manufacturer, Maiden Pharmaceuticals in Haryana, and regulatory authorities in India.
Following the death of 66 children in Gambia, the World Health Organization (WHO) has raised an alert over four fever, cold and cough syrups made by an Indian company, urging people to not use them. All the four syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – are made by Haryana-based Maiden Pharmaceuticals.
“Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. To date, these four products have been identified in Gambia, but may have been distributed, through informal markets, to other countries or regions,” the WHO said in the alert.
All batches of the products “should be considered unsafe” till they are analysed by the respective national regulatory authorities, it said.
According to sources, India's apex drug regulatory authority – the Central Drugs Standard Control Organisation (CDSCO) – has already launched an investigation into the matter after it was informed about the issue on September 29. The state regulatory authority of Haryana confirmed that the company did manufacture and export the syrups to Gambia. The company has so far sold the product only to Gambia.
Sources said four of the 23 samples tested by the WHO were found to be contaminated with diethylene glycol or ethylene glycol. However, the intra-government agency has not provided details to India on causal relation with the death – or documents to show that the syrups led to the deaths.Diethylene glycol and ethylene glycol can cause toxic effects, including abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury that may lead to death. “The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death,” the WHO alert said.
It also said that countries should increase surveillance of the supply chains to detect and remove the substandard products. Importantly, it also called for the surveillance of informal or unregulated markets.
“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 from a qualified healthcare professional and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre,” the WHO alert said.
The national authorities have been asked to report if any of these substandard products are discovered in their countries.
WHO Twitter handle in a post quoted its Director General Dr Tedros Adhanom Ghebreyesus as saying, “The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited, in India. WHO is conducting further investigations with the company and regulatory authorities in India.”In India, death of 17 children were reported from Jammu and Kashmir in 2020 after consuming another brand of cough syrup contaminated with the same diethylene glycol. In another incident, at least three children died in New Delhi last year after consuming a cough syrup with dextromethorphan, one of the components present in one of the four syrups flagged by WHO.
