The Centre has formed a four member committee to examine the details of ‘adverse event’ reports received from the World Health Organisation (WHO) on the deaths of 66 children in Gambia that are being linked potentially to four made-in-India cough syrups.
The development occurred on the same day that the Haryana government ordered the suspension of drug production at Maiden Pharmaceuticals Ltd's Sonipat facility and demanded that it provide an explanation for "many contraventions" discovered during a recent inspection within a week, or risk having its licence suspended or revoked.
The UN said that the medications in question had impurities such as diethylene glycol and ethylene glycol in prohibited concentrations. When taken by humans, diethylene glycol and ethylene glycol are fatally poisonous. In addition to acute kidney injury, which may be fatal, it can also cause abdominal discomfort, vomiting, diarrhoea, the inability to pass urine, headaches, and altered mental status.
The Drug Controller General of India was informed about the issue on September 29. “CDSCO took up the matter immediately with Haryana state regulatory authority as Maiden’s Sonepat unit is under its jurisdiction. A detailed probe has been launched to ascertain the facts/details in the matter in collaboration with the state drugs controller, Haryana.”
