Ranbaxy expects probe to be dropped soon
The statement was made by Malvinder Singh follwing the publication of Ranbaxy’s results for the second quarter, which saw operating profit stay the same at $39m. Sales of active pharmaceutical ingredients (API) for the quarter rose by 31 per cent to $32m.
Cessation of the investigation into the alleged sale of “adulterated and misbranded products” by Ranbaxy would be a relief for the generics company, which saw its share price plummet upon instigation of the court proceedings.
Singh said: “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during discussions that once we complete filing all the information sought by the FDA, the motion against us will be withdrawn.”
“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sought from us has either already been filed or is being filed so that we expect the motion against us to be withdrawn by August 3.”
However, documents filed with the court on July 28 suggest that Singh’s assertions may be somewhat premature.
According to the attorneys involved in the case the government is yet to receive all the Parexel files and until July 22 Ranbaxy was maintaining that it had privilege over certain audit documents.
Consequently the attorneys are requesting that the court waits “for a reasonable period of time” to allow Ranbaxy to produce the documents.
It goes on to say: “The government intends to withdraw the Motion upon full and complete production of the Parexel documents.”
Running parallel to the US Department of Justice’s investigation into Ranbaxy is the Indian company’s own probe into the parties it believes are responsible for creating the controversy.
Singh commented: “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.”
Hunter becomes the hunted
The investigation into Ranbaxy has also drawn attention to the FDA’s role in the controversy, with Representatives Bart Stupak and John Dingell signaling their intent to investigate how the agency acted.
According to documents filed with the court the FDA was aware of allegations of fraudulent conduct by Ranbaxy for 18 months before action was taken.
Consequently they are trying to discover if the FDA "knowingly allowed drugs suspected of being fraudulently approved and manufactured in violation of good manufacturing practices (GMP) to continue being sold by Ranbaxy in the United States”.
