Ranbaxy sued by US Goverment for falsifying records

The US Goverment (Justice department) has sued Indian pharma giant Ranbaxy for allegedly falsifying records that resulted in the production and sale of spurious, substandard dosage forms that did not meet federal standards. In its complaint filed at US District Court in Maryland , USFDA and Justice department alleged that Ranbaxy utilized substandard and unapproved outsourced API’s and fabricated stability and bioequivalent studies. Earlier, Ranbaxy have to recall around 70 million doses of generic Gabapentine, which is used to treat seizures. USFDA has also alleged that Ranbaxy produced fabricated data for antiretrovirals like anti AIDS medication which were approved as per President’s Emergency Plan for AIDS Relief program (PEPFAR) programme. USFDA has also accused Parexel (a consulting firm for plant audits), which hide its finding from USFDA w.r.t its assessment of Quality control, quality assurance and cGMP findings of Ranbaxy's Paonta Sahib plant (Himachal Pradesh). The trouble for Ranbaxy started in February 2006, when USFDA issued warning letter on finding less manpower and nonconforming cGMP compliance at Paonta Sahib plant
Similar type of charges was leveled against Able Laboratories and generic manufacturer has to recall products from US market in 2005.
It will be interesting to watch Ranbaxy’s defense against these allegations.
(The Federal agency’s complaint with all the details is here in Pharmalot)