NEW DELHI: The Centre on Wednesday formed a four-member committee to examine details and ‘adverse event’ reports received from the WHO on the deaths of 66 children in Gambia that are being linked potentially to four made-in-India cough syrups.
The development comes on a day the Haryana government ordered the halting of drug manufacturing at the Sonipat unit of Maiden Pharmaceuticals Ltd, and asked it to explain within a week “many contraventions” found during a recent inspection, or face suspension or cancellation of license. The order came days after the WHO potentially linked four cough syrups manufactured at the facility to the deaths of 66 children in the African nation of Gambia.
The members of the committee of technical experts are YK Gupta, vice-chairperson, standing national committee on medicines; Pragya D Yadav of NIV Pune, Arti Bahl, division of epidemiology, NCDC; and K Pradhan from the Central Drugs Standard Control Organisation. Health ministry sources said after examining and analysing the adverse event reports, causal relationship and all related details shared by or to be shared by WHO, the committee will advise and recommend further course of action to the Drugs Controller General of India.
The UN body said the drugs in question contained 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. Its effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.
The health ministry clarified that 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,” sources in the health ministry said.