After FDA, Ranbaxy under scanner of Indian authorities too
30 Jan 2014
After falling foul of the US Food & Drugs Administration, generic drug maker Ranbaxy Laboratories' Toansa plant in Punjab is under the scanner of India's drug regulator too.
The Drug Controller General of India ( DCGI) has ordered Ranbaxy to furnish a comprehensive explanation for the violation of manufacturing practices at its Toansa plant, discovered by the US FDA, which earlier this month banned the export of drugs manufactured at the unit, according to an Economic Times report.
The DCGI has also dispatched a team of officials to inspect the plant. "The company has seven days, starting Monday, to explain violations cited by USFDA at the Toansa plant," Drug Controller General G N Singh told the paper.
While Singh did not specify what steps the regulator would take if it found Ranbaxy's response to be unsatisfactory, any action by the local watchdog would deepen the drugmaker's woes.
So far, USFDA has banned exports from three Ranbaxy plants in India, but Indian authorities have not taken any action, citing lack of evidence.
The FDA earlier this month banned exports to that country from Ranbaxy's Toansa plant, citing data integrity issues found during inspection. The US regulator also placed all of Ranbaxy's other India-based facilities on import alert.
The US authorities had earlier banned exports from two other Indian Ranbaxy plants, and last year the Indian drugmaker agreed to a $500-million penalty as it pleaded guilty to civil and criminal charges regarding manufacturing malpractices.
