FDA declines to comment on motion against Ranbaxy
The United States Food and Drug Administration refused to comment on a motion filed by the Department of Justice in a US District Court in Maryland against drug major Ranbaxy Pharmaceuticals.
By PTI |
WASHINGTON: The United States Food and Drug Administration on Monday refused to comment on a motion filed by the Department of Justice in a US District Court in Maryland against drug major Ranbaxy Pharmaceuticals.
"We do not comment on an ongoing litigation," an FDA spokesperson at Rockville, Maryland, said when reached over phone.
The Federal prosecutors are investigating if the Indian generic drugmaker falsified records that resulted in the production of generic drugs that did not meet the standards of the FDA.
A comment from Ranbaxy's communications chief Chuck Caprariello was not immediately available.
The Star Ledger of New Jersey reported that authorities were alleging that Ranbaxy���s plant in northern India used raw chemicals from unapproved sources, fabricated in-house test data to meet FDA standards and attempted to conceal the ruse from FDA inspectors.
Meanwhile, Ranbaxy in a statement issued in New Delhi has said it would file on Monday its response denying allegations by US Department of Justice.
According to court papers, "Specific allegations under investigation include fabricating bioequivalence and stability data to supportanti-retrovirals drugs to be paid for by the Presidents Emergency Plan for AIDS Relief program (PEPFAR) and distributed to foreign countries,
"...the government is also investigating whether Ranbaxy committed contract fraud and caused the submission of false claims to Federal health benefit programmes under the False Claims Act," it added.
"We do not comment on an ongoing litigation," an FDA spokesperson at Rockville, Maryland, said when reached over phone.
The Federal prosecutors are investigating if the Indian generic drugmaker falsified records that resulted in the production of generic drugs that did not meet the standards of the FDA.
A comment from Ranbaxy's communications chief Chuck Caprariello was not immediately available.
The Star Ledger of New Jersey reported that authorities were alleging that Ranbaxy���s plant in northern India used raw chemicals from unapproved sources, fabricated in-house test data to meet FDA standards and attempted to conceal the ruse from FDA inspectors.
ADVERTISEMENT
Department of Justice approached the District Court in Maryland on July 3. Meanwhile, Ranbaxy in a statement issued in New Delhi has said it would file on Monday its response denying allegations by US Department of Justice.
According to court papers, "Specific allegations under investigation include fabricating bioequivalence and stability data to supportanti-retrovirals drugs to be paid for by the Presidents Emergency Plan for AIDS Relief program (PEPFAR) and distributed to foreign countries,
"...the government is also investigating whether Ranbaxy committed contract fraud and caused the submission of false claims to Federal health benefit programmes under the False Claims Act," it added.
ADVERTISEMENT
Start a SIP with as low as ₹500 with ET Money App!
Download
The Economic Times News App for Quarterly Results, Latest News in ITR, Business, Share Market, Live Sensex News & More.
The Economic Times News App for Quarterly Results, Latest News in ITR, Business, Share Market, Live Sensex News & More.
ADVERTISEMENT
