Ranbaxy refutes DoJ’s adulteration charges

July 15, 2008

Indian drugmaker Ranbaxy Laboratories has refuted the charges levelled against it by the US Department of Justice (DOJ) of not sharing audit information sought by the US authorities to investigate the allegations of document forgery and sale of substandard drugs in the US market.

In an eight-page response filed with the district court of Maryland (US), a copy of which is with ET, Ranbaxy said the DoJ’s legal move was not consistent with the department’s ordinary practice in such investigations, adding that it has already informed the US government of the company’s willingness to share the remaining records sought by them.

“Since Ranbaxy became aware of the investigation it has cooperated fully. The government already has hundreds of thousands of pages of Ranbaxy documents, and as a result of previous privilege waivers and non-assertions of privileges, the government already has over one hundred thousand pages of PAREXEL documents.

While Ranbaxy believes that some of the work done by PAREXEL, are protected by attorney client and work product privileges, Ranbaxy had already informed the government at the time of this motion was filed that it had waived its privileges for all audits conducted by PAREXEL and as a result, and is not now or at the time the motion was filed any dispute requiring adjucdication of the court,” the company said in its reply to the court.

It added that PAREXEL conducted two separate audits in 2006 for stability verification and quality system improvement program of the Paonta Sahib plant. It shared the two documents with the FDA in 2006.

After DOJ conducted raids at its US facilities in 2007, Ranbaxy said that while it was willing to share additional information which the government investigators wanted and told the authorities in July that PAREXEL had done several audits for the company.

DOJ requested the company to produce all the PAREXEL audits. However, in September 2007, DOJ served PAREXEL subpoena for all audits and underlying papers. “Ranbaxy argued to both FDA and DOJ that the government’s request for voluntary audits conducted at the request of the counsel was bad policy,” the paper said.

Ranbaxy said that on July 3, within half an hour of first call from the government counsel informing Ranbaxy of the motion to compel, the company informed the government that it would waive privilege for the remaining audits. At the time this motion was file, it was moot, Ranbaxy said.

In a motion filed at the district court of Maryland on July 3, the DoJ has said there was evidence to suggest that Ranbaxy used active pharmaceutical ingredients (API) from unapproved sources, blended unapproved API with approved API, and used less-than-approved API at its Paonta Sahib (Himachal Pradesh) plant in its drugs, resulting in the sale of ‘subpotent, super potent or adulterated medicines’ in the US market.

The DoJ also said contrary to the stipulation of manufacturers using approved sites, evidence suggests that Ranbaxy manufactures products at other plants and obtains API from unapproved sources.

Source: Economic Times

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Ranbaxy units face FDA heat after inspections

July 2, 2008

TWO manufacturing facilities of Ranbaxy Laboratories are learnt to have come under the scanner of the US Food and Drug Administration (USFDA), the drug regulatory body in the US. All pharma companies have to get USFDA approval for selling medicines in the US. This is in addition to the company’s Paonta Sahib (Himachal Pradesh) plant, which has been the subject of USFDA investigations for the past two years.

USFDA concern:

Sources said that USFDA has given a ‘not approved’ rating to new products manufactured at the facility, although this could not be independently confirmed. In the Batamandi plant, USFDA is learnt to have raised objections over the validation of equipment used to manufacture products at the facility.

For Ranbaxy US is single largest market, and in 2007, its US sales stood at $386 million, accounting for 22.89% of the company’s global sales. It is believed that Ranbaxy’s manufacturing facility in New Jersey is now a major supplier for the US market.

Other companies too like:

Sun Pharma had to withdraw batches of generic metformin tablets, used to treat diabetes, on efficacy grounds. A couple of years ago, USFDA had also asked Wockhardt to correct several deficiencies.

Source: Economic Times