Ranbaxy Laboratories, which is operating under an extensive consent decree with U.S. regulators, has now run afoul of authorities in India, which reportedly slapped it with a four-day suspension for "flouting" rules on product storage.The suspension, issued by the Maharashtra Food and Drug Administration, was prompted by a complaint by the Maharashtra Chemists & Distributors Federation (MCDF), reports Pharmabiz. Narendra Jain, general secretary of the MCDF, tells the publication he thinks Ranbaxy is getting off too easy for practices that expose products to potential contamination. A Ranbaxy spokesman told Pharmalot that the company was checking into the accuracy of the report.While this appears to be a local fight, even the hint of a suggestion of any manufacturing or handling shortcomings is sensitive for the drugmaker. It has only recently gotten FDA approval to ship products from three of its Indian plants and is under unprecedented scrutiny as part of a 5-year, 55-page consent decree announced earlier this year. In 2008, regulators uncovered a list of issues, including faked drug quality data, and banned 30 products from the U.S. Among other provisions, the decree requires the company to set up an independent oversight group that can take in complaints from employees and elsewhere. The auditors are to report all of their findings and recommendations to the FDA as well as the company. Ranbaxy has taken full advantage of its ability to ship products from its upgraded plants to the North American market. As a result of the FDA approval for Ranbaxy's generic of Pfizer's ($PFE) Lipitor, the company has seen its sales here surge. In its first full quarter selling copycat Lipitor, the Indian genericsmaker reported sales in North America doubled to $375 million.- check out the Pharmabiz story
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Friday, 22 June 2012
Ranbaxy Laboratories-Consent Decree-Indian Plants-Regulators
Saturday, 12 May 2012
Consent Decrees-Fda Compliance
Abbot Laboratories ($ABT) has shed the smell of a consent decree more than a decade after its imposition and just before it splits itself up for the public markets.The FDA compliance order dates to 1999 and was issued after its diagnostics division for 6 years came up short on manufacturing practices, reports Pharmalot. The FDA relented after Abbott demonstrated its ability to practice current good manufacturing practices, the FDA tells the website."Many consent decrees that FDA enters with firms allow the firms, under defined circumstances, to seek court termination of the decrees following extended periods of compliance. That is the case with this one," an FDA spokeswoman explains.The company paid a $100 million fine at the time the decree was ordered, but of course there are all of the expenses of upgrading facilities and paying consultants to help get facilities up to snuff and back in the good graces of the agency.There also is the need to continually report in financial filings that the company is operating under a consent decree. Now that language can be erased from financial disclosures, and now is the time for that, as the company divides itself. One piece, to be called AbbVie, will focus on the portfolio of existing drugs and those in the pipeline. The other will be spun off to be a device- and diagnosticsmaker and will sell branded drugs outside the U.S.- read Pharmalot's storyRelated Articles:
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