Over the next two posts, we’ll explore a growing international problem involving the safety of generic drugs produced overseas. Namely, generic medications produced in India – including those manufactured by False Claims Act offender Ranbaxy – are becoming more and more problematic, due in part to the alleged falsification of clinical testing data relied upon by other nations to ensure patient safety. Moreover, when challenged by whistleblowers and others within the medical community, international regulators engage in unproductive political maneuvers and other avoidance tactics as opposed to conducting transparent investigations to get to the root of the issue.
In a recent article published in the Hindu Business Line, Ranbaxy whistleblower Dinesh Thakur discusses this growing trend, how it could affect patient care in the U.S. and elsewhere, and how the Indian pharmaceutical company uses its lobbying power to shield itself from the repercussions of manufacturing sub-par, dangerous generic drugs.[1. Thakur, Dinesh, “Beware of ‘Made in India’ medicine.” August 12, 2015. http://www.thehindubusinessline.com/opinion/columns/beware-of-made-in-india-medicine/article7531267.ece#comments]
In today’s post, we will introduce details of the problems within the Indian generic pharmaceutical trade.[2. Mathur, Aparna; Bate, Roger; and Zhe Jin, Ginger, “India Must Fix Its Drug Quality Problem.” September 17, 2014. http://www.forbes.com/sites/theapothecary/2014/09/17/india-must-fix-its-drug-quality-problem/] In a follow-up post, we will explore the various problems raised by Mr. Thakur’s article, which was recently highlighted by the whistleblower advocacy group known as Taxpayers Against Fraud (TAF).
Indian generic drugs raise major safety concerns
From the New York Times to other publications worldwide, there have been many recent discussion surrounding the Indian generic drug trade.[3. Harris, Gardinier, “Medicines Made in India Set Off Safety Worries.” February 14, 2014. http://www.nytimes.com/2014/02/15/world/asia/medicines-made-in-india-set-off-safety-worries.html] In 2014, the National Bureau of Economic Research published a study revealing that nearly 10 percent of the Indian drugs it reviewed contained insufficient levels of active ingredients,[4. “Poor Quality Drugs and Global Trade: A Pilot Study.” http://www.nber.org/papers/w20469.pdf] which is an alarming and life-threatening fact that could place patients in danger of the deadly effects of unresolved infections. More specifically, the shipment of these drugs to patients in Africa has further aggravated the continent’s struggle with drug-resistant disease and has caused international concern regarding the evolution of infections like tuberculosis.
Closer to home, Indian drug giant Ranbaxy paid a half-billion dollars in penalties and fines to the Department of Justice after admittedly shipping ineffective medications to the U.S. for use by patients suffering from a variety of ailments. During the investigation, regulators uncovered over 1,600 errors in 15 drug applications. Nonetheless, Ranbaxy’s irreverent CEO reiterated that its fraud scheme was simply a “competitive advantage [used] to build and grow.”
Falsification of data
Mr. Thakur explains the various methods used by Indian drug makers to essentially circumvent medical regulations and profit exponentially from the sale of cheaply-made pharmaceuticals. In most instances, national drug safety regulators rely on data from centralized clinical research laboratories when determining whether to approve a drug for use by patients in that particular country. One such laboratory, known as GVK Biosciences, has been accused of falsifying the results of patient information obtained during human trials for “an extended period of time.” In other words, GVK Biosciences had falsified the results of patient trials in order to advance the approval of drugs and, ultimately, grow profit margins.
Also of concern are the lax safety protocols within many Indian drug factories. According to emerging data, national regulators tasked with ensuring the safety of India-based pharmaceutical production have failed to conduct the regular inspections required under both Indian law and the settlement agreement between the U.S. Department of Justice and Ranbaxy (as well as potentially several other settlement agreements).
As a result of these very public issues with health and safety, several nations, including Ghana, Nigeria, and a number of European countries, have refused to accept shipments of generic Indian medications for use by patients.
In tomorrow’s post, we will examine the political climate surrounding this deadly phenomenon, how and why companies like Ranbaxy are able to continue participating in the drug market, and how the American False Claims Act applies to this type of fraudulent misconduct.
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If you are aware of fraud in the healthcare industry, or would like to speak to a reputable whistleblower attorney, please contact Berger Montague today.