|Rediff India Abroad Home | All the sections|
Aussie regulator probes Ranbaxy
March 04, 2009 20:20 IST
Australian health regulator Therapeutic Goods Administration is investigating Indian pharma major Ranbaxy [Get Quote], following US allegations of the company falsifying data and test results of new drug applications, a media report says.
Last week, the US Food and Drug Administration had halted the review of new drug applications from the company's Paonta Sahib plant after the American regulator found evidence of falsifying data on drugs requiring its approval.
"The administration is investigating the latest allegations against the Ranbaxy plant but has withheld further action against the company insisting that previous Australian checks cleared the plant," the Sydney Morning Herald has reported.
When contacted, a Ranbaxy spokesperson declined to comment on the report.
Quoting a TGA spokesperson, the publication said, "There are 62 products registered on the Australian Register of Therapeutic Goods which have identified Ranbaxy's Paonta Sahib site as a manufacturer. All have undergone extensive pre-market assessment and the TGA reviewed the data relating to these products again when the US FDA warnings were first raised last year."