US To Withdraw Allegations Against Ranbaxy?
1 CommentBy Ed Silverman // July 29th, 2008 // 10:20 am
That’s what Malvinder Singh, the generic drugmaker’s ceo, is saying today about a probe by federal prosecutors into allegations Ranbaxy falsified records that resulted in the production and sale of generic meds that didn’t meet FDA standards. And those may be dropped by August 3, according to NewIndiaPress.
“We have received a written communication and we have also been given to understand during discussions that once we complete filing all the information sought by the US FDA, the motion against us will be withdrawn,” Singh says after announcing Ranbaxy’s earnings results.
“All the information sought from us has either already been filed or is being filed so that we expect the motion against us to be withdrawn by August 3. We have enough evidence to believe that some negative elements were behind all this controversy and we will soon take a decision on what appropriate action can be taken against these elements.”
The feds allege officials at 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, according to court documents. The allegations under investigation include fabricating bioequivalence and stability data to support AIDS drugs to be paid for by the President’s Emergency Plan for AIDS Relief program (PEPFAR) and distributed to foreign countries. (Back story).
UPDATE: Ranbaxy’s Singh may be getting ahead of himself. The feds filed their allegations as part of a motion to force Ranbaxy to submit audits of its plants, which the drugmaker refused to do until last week, although sticking points remain. Now, the feds asked the court to place their request ”in abeyance for a reasonable period of time” to see if Ranbaxy follows through, but will only withdraw the motion when complete audits have been submitted, according to court documents.
We have reached out to the US Attorney’s office in Maryland and will update you with any reply.
Singh adds today that the $4.6 billion deal to be purchased by Japan’s Daiichi-Sankyo is on track and once regulatory approvals come in, Daiichi will announce its open offer slated to be made August 8. “There is no change in the timeline as there are no issues as far as getting regulatory approvals are concerned,” Singh says.
Sudhakar Safaya
Dear Ed
Greetings to you.
This is regarding the report filed by you today “ US to withdraw charges against Ranbaxy”
I would like to clarify to you, that there are no charges filed against Ranbaxy in the US , there was only a motion filed by Department of Justice, which will be withdraw upon submission of all documents by Ranbaxy.
Which Mr. Malvinder Singh, CEO & MD, Ranbaxy had also commented.
Given below is his quote in which he talks about the Motion being withdrawn, which has been incorrectly put as charges in the headdline of your story.
“We have received a written communication and we have also been given to understand during discussions that once we complete filing all the information sought by the USFDA, the motion against us will be withdrawn,” Malvinder Mohan Singh, Ranbaxy”
You had put the story based on the IANS report filed today, which had the incorrect headline, since then they have corrected it and put the updated version on their website.
Kindly request you to please correct the story filed on your web site immediately.