How Ranbaxy.docx - How\u200aRanbaxy\u200ahurtled\u200atowards\u200aa\u200ameltdown 11 min read Updated 11 Jul 2019 10:13 PM IST Katherine\u200aEban The story of how

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HowRanbaxyhurtled towards a meltdown 11 min read . Updated: 11 Jul 2019, 10:13 PM IST Katherine Eban The story of how India’s largest generics drug maker dealt with the discovery of deep gaps in its drug trial data Share Via Read Full Story Topics Long Reads Ranbaxy Malvinder Singh Pharma Sector The initial disclosure of fraud at Vimta Labs Ltd (in 2004), the company Ranbaxy Laboratories Ltd had hired to test its AIDS drugs, was like a teetering domino, threatening to topple interconnected drug applications approved by regulators around the world. As charitable organizations asked the company for underlying data to support its claims, the problem confronting Ranbaxy executives had become almost unsolvable. Drugs that had never been tested, or whose tests revealed a failing product, were now due to be re-registered in countries around the world. Much of the raw data didn’t match what the company had filed with regulators. Either it didn’t exist, didn’t make sense, or had been fabricated at some point. A refusal to share the data would trigger further suspicion, leaving the company with two bad options: come clean—which would have disastrous business consequences—or lie more. The company needed to start testing drugs properly. But that not only risked exposing past fraud but often required a new set of lies. This catch-22 played out in a torrent of confidential emails in which Dr. Brian Tempest, then-chief executive officer (CEO), and future CEO Malvinder Singh were often cc’d and also weighed in. In mid-July 2004, a Unicef official asked why Ranbaxy had submitted only limited stability data for several of its AIDS drugs. Companies must prove that their drugs will remain stable in a range of temperature conditions. The required tests, which help to establish the shelf life of a drug and measure impurities over time, are conducted in chambers that resemble oversized refrigerators, which can replicate extremes of heat and cold. Unicef’s question prompted a round of panicky internal emails. In one titled “Stability Studies—Urgent", an executive wrote: “According to Unicef, if we fail to furnish the data by Wednesday evening and do not provide the information requested in the mail below, then we can forget about this tender." He added, “this tender is worth $5 million and we cannot take any chances on it." But the only data that Ranbaxy had internally to give Unicef was a nonsensical hodgepodge that would raise more questions. The limited testing that Ranbaxy had done on the HIV drugs showed some impurities remaining constant or even decreasing between nine and twelve months, which was technically impossible. As an executive pointed out, these problems “will certainly raise a doubt in the mind of the reviewer . . . we need to revise this number".
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