India watchdogs halt production at Maiden Pharmaceuticals after cough syrup deaths

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Oct. 13 (UPI) — The embattled Maiden Pharmaceuticals in India have been ordered to stop all manufacturing activities on Wednesday at a plant that produced four cough syrups connected with the death of 66 children in the Gambia.

India’s Central Drug Standard Control Organization and the Haryana Food and Drug Administration announced the order in a joint statement as a committee was established to look into the production problems at the plant.

“In view of the seriousness of the contraventions observed during the investigation and its potential risk to the quality, safety and efficacy of the drugs being produced, all the manufacturing activities of the firm are being stopped with immediate effect,” the two organizations said, according to the Deccan Herald.

The order comes on the heels of the World Health Organization issuing a warning last week against four cold and cough syrups. The organization released the alert for Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, all made by Maiden Pharmaceuticals Limited in Haryana, India.

The WHO said laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. Toxic effects can include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

For now, all drug production at the Sonepat unit of Maiden Pharmaceuticals has been stopped. Haryana officials have issued a show-cause notice to the company to explain “many contraventions” discovered during a probe by central and state drugs regulators.

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