Now, USFDA comes under scanner over Ranbaxy issue

NEW YORK: The US drug regulator Foodand Drug Administration (FDA), which has charged Ranbaxy with selling unsafemedicines in the country, has come under the Congress scanner and will be probedfor its conduct in approving the Indian pharma major's products and otherviolations in the matter.A Congressional Committee has said that itwould examine Ranbaxy's drug approvals in the US and potential violations ofmanufacturing regulations, a media report said. Besides, the House Energy andCommerce Committee would also "look at why the FDA continued to approvemedicines made by the company and allow shipments into the US," the reportsaid.According to report the Committee "wants to find out whetherthe FDA knowingly allowed unsafe and ineffective medicine to enter the US." Theinquiry stems from a federal court filing by the US Department of Justice (DoJ),where it has been alleged that there have been "a pattern of systematicfraudulent conduct, including submissions by Ranbaxy to the FDA that containfalse and fabricated information about stability and bio-equivalence of thecompany's generic medications."The Justice Department has also citeda failure by Ranbaxy to report in a timely fashion it distributed drugs that didnot meet proper specifications, and has accused the company of concealingviolations of good manufacturing practice regulations from FDA. "If theseallegations are true, Ranbaxy has imperiled the safety of Americans in a mannersimilar to the generic drug scandal we uncovered twenty years ago," the reportquoted house energy and commerce committee chairman John Dingell as saying.Meanwhile, Ranbaxy said that its deal to sell promoters' stake tothe Japanese firm Daiichi Sankyo is "binding and final." "Following intensespeculation in sections of the media and the stock market, Daiichi Sankyo andRanbaxy reiterate the agreement between Daiichi, Ranbaxy and the Singh family,the promoters of pharma major, is binding and final, subject to regulatoryapprovals," a joint statement issued by the companies said.