After dying of 66 youngsters in Gambia, WHO warns about 4 Indian cough syrups

FOLLOWING THE dying of 66 youngsters in Gambia, the World Health Organization (WHO) has raised an alert over 4 fever, chilly and cough syrups made by an Indian firm, urging individuals to not use them. All the 4 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 stated within the alert.

All batches of the merchandise “should be considered unsafe” until they’re analysed by the respective nationwide regulatory authorities, it stated.

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 knowledgeable concerning the problem on September 29. The state regulatory authority of Haryana confirmed that the corporate did manufacture and export the syrups to Gambia. The firm has up to now offered the product solely to Gambia.

Sources stated 4 of the 23 samples examined by the WHO have been discovered to be contaminated with diethylene glycol or ethylene glycol. However, the intra-government company has not supplied particulars to India on causal relation with the dying – or paperwork to indicate that the syrups led to the deaths.

Diethylene glycol and ethylene glycol may cause poisonous results, together with belly ache, vomiting, diarrhoea, incapability to go urine, headache, altered psychological state, and acute kidney harm which will result in dying. “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 stated.

It additionally stated that international locations ought to improve surveillance of the provision chains to detect and take away the substandard merchandise. Importantly, it additionally known as for the surveillance of casual 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 stated.

The nationwide authorities have been requested to report if any of those substandard merchandise are found of their international locations.

WHO Twitter deal with in a put up 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, dying of 17 youngsters have been reported from Jammu and Kashmir in 2020 after consuming one other model of cough syrup contaminated with the identical diethylene glycol. In one other incident, at the least three youngsters died in New Delhi final 12 months after consuming a cough syrup with dextromethorphan, one of many elements current in one of many 4 syrups flagged by WHO.