Major Generic Drug Manufacturer Ranbaxy Faked Tests for FDA

December 5, 2013

Uncategorized

ranbaxy FDA import banMost of the prescriptions that doctors write for patients in the United States are for generic drugs. A significant portion of these drugs are manufactured overseas in countries like China and India.

These drugs are only available to the American public after having been approved by the FDA after undergoing rigorous product safety tests. Unfortunately, there are times when this system is unable to catch problems with how a medication is approved or manufactured until it is too late.

For example, it came to light that a number of years ago that a major manufacturer of generic drugs, Ranbaxy, had faked results for some of the drug tests required by the FDA. A whistleblower from the company by the name of Dinesh Thakur is responsible for exposing the massive fraud and bringing knowledge of the problems at Ranbaxy to the public.

What kinds of tests were faked by Ranbaxy?

Thakur first became aware of problems with testing at Ranbaxy in 2004 as part of his responsibilities working as an executive at the company.

Generic drug manufacturers are required to provide evidence that their products are the “bioequivalent” of their brand name equivalents. This is proven by testing the drugs to ensure that they have the same effects as the brand name drugs.

In the course of his investigation, Thakur discovered that the actual data used to back claims that some drugs manufactured by Ranbaxy were bioequivalent didn’t actually exist. In some cases, it had even been faked.

Exposure of the fraud led to a Ranbaxy FDA import ban

Thakur brought the matter to the attention of the FDA in 2005. After auditing the company’s records, the FDA discovered that Ranbaxy had engaged in a persistent pattern of submitting untrue data to the agency. As a result, the FDA placed a ban on 30 different drugs manufactured by Ranbaxy from entering the United States in 2008.

The issues involved in the Ranbaxy scandal underscore some of the main safety concerns the many people have when it comes to drugs manufactured both at home and abroad. Patients rely upon medical professionals, drug manufacturers and federal regulators to ensure the safety and efficacy of their medications.

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If you’ve been severely injured due to someone else’s fraudulent or negligent actions, Abrahamson & Uiterwyk may be able to fight for your rights. Call us today at 1-800-753-5203 for a free case evaluation and initial consultation.

Because of the fact that cases involving defective and dangerous drugs may be highly complex and exceedingly specific, our law firm commonly works with other law firms who have considerable experience in each particular case type. Thus, we may be referring these types of cases to a separate firm, with whom we typically associate and work with on a co-counsel basis.