The Pharmaceuticals Export Promotion Council of India (Pharmexcil) on Thursday put on watch Maiden Pharmaceuticals, the drugmaker named in a medical product alert by the World Health Organization (WHO) following acute kidney injury and death of 66 children in the west African country the Gambia.
Citing the WHO communication that mentions the firm as manufacturer of four cold and cough syrup formulations potentially linked to the kidney injury and deaths, the exporters body under the Union Commerce Ministry asked Maiden to share details of the licensees and importers to whom the drugs were supplied as well as manufacturing licence copies and product permissions.
“You are advised to investigate reasons for the serious adverse events and update us with your findings at the earliest to take necessary further action,” Pharmexcil said. Failure to provide the information sought by October 7 will result in the company’s registration-cum-membership certificate (RCMC) being suspended without further notice, it said. Maiden has its corporate office in Delhi and manufacturing facilities in Haryana.
