RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Feature ArticlesFeature Articles

    Data Integrity in the FDA-Regulated Laboratory

    "Data integrity problems break trust. In the time between inspections, we trust you to do the right thing. And if we finish an inspection and that trust has been broken, then we need to go through a few exercises to build that trust [again] before we can go forward and trust you until the next inspection."-FDA Center for Drug Evaluation and Research (CDER) Office of Compliance Senior Policy Advisor Karen Takahashi To assure the quality of raw materials, in process mate...
  • DOJ Says Corporate Integrity Agreements Are Cornerstone of New Compliance Approach

    The pharmaceutical industry's reputation has been heavily battered over the course of the last two decades, in part because of a seemingly endless stream of massive multibillion-dollar settlements over charges of off-label marketing claims. Those fines, which have seemingly done little to curb illicit behavior, have been seen by at least some industry analysts as cost of doing business-not a deterrent. But the Department of Justice (DOJ) seems poised to change that dyn...
  • Global Networks Lead to Global Scandal as MHRA Defends Against Questionable Ranbaxy Practices

    For years, regulators around the globe have been touting the challenges and benefits of globalization, explaining that a globally diverse product supply chain means needing to rely on regulatory partners to ensure that products are safe for consumption. Now UK regulators are learning a related lesson: A scandal that affects products intended for one country may well affect more than just one regulatory authority. Background On 13 May 2013, Ranbaxy Laboratories pled gui...
  • Ranbaxy Pleads Guilty to Felony Charges in Largest False Claims Case Ever

    The US Department of Justice (DOJ) has announced that Indian generic pharmaceutical manufacturer Ranbaxy has pleaded guilty to three felony charges, including lying to the US Food and Drug Administration (FDA), that will result in the company paying US authorities $500 million in penalties. Background The announcement , made 13 May 2013, comes as the result of a long-running investigation into the practices of Ranbaxy, which markets several pharmaceutical products in t...
  • Citing Consent Decree, Ranbaxy Withdraws Dozens of Generic Drug Registrations

    Indian generic drug manufacturer Ranbaxy announced 22 January that the US Food and Drug Administration (FDA) has, per its request, withdrawn 27 Abbreviated New Drug Applications (ANDAs) for products as part of a Consent Decree signed in January . The Consent Decree , more formally known as a Consent Decree of Permanent Injunction, was the end result of an investigation by FDA into data integrity deficiencies at a number of the company's India- and US-based manufactur...
  • Reeling from Regulatory Hit, Ranbaxy Takes Q4 Loss

    Indian drug manufacturer Ranbaxy Laboratories, still reeling from a $500 million fine paid for regulatory violations, announced on 24 February that it would suffer a $607 million loss despite increased sales.  Ranbaxy had announced on 26 January that it would settle with the US Department of Justice after US regulators found manufacturing and data integrity deficiencies at numerous Ranbaxy facilities located in India and the US. The settlement required them to pa...
  • DOJ Files 'Groundbreaking' Consent Decree Against Ranbaxy, Company Agrees to 'Remedy Deviations'

    The US Department of Justice (DOJ) filed a Consent Decree of Permanent Injunction against Ranbaxy, an Indian generic drug manufacturer, with the US District Court of Maryland on 25 January. The action was taken on behalf of the US Food and Drug Administration (FDA), which had found manufacturing and data integrity deficiencies at numerous Ranbaxy facilities located in India and a US-based Ranbaxy subsidiary's facility in New York. The consent decree requires Ranbaxy to c...
  • Risk Aversion in Indian Deal-Making the Result of Regulatory Compliance Concerns

    Global pharmaceutical companies-and in particular western pharmaceutical companies-are shying away from buying or partnering with Indian generics manufacturers because of quality and compliance issues , write WSJ journalists Namrate Nandakumar and C.H. Unnikrishnan. Companies, including Pfizer, Sanofi-Aventis, and Daiichi Sankyo have been hit with fines, delays, or both after acquiring or partnering with Indian generics manufactures.  Daiichi Sankyo, for instance...