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Ranbaxy Prosecuted Over Generic Drugs

Ranbaxy has been prosecuted for selling adulterated generic drugs. If you have been a victim of impure generic drugs it would be a good idea to consult a personal injury attorney.


Ranbaxy USA Inc. is a subsidiary of India’s largest pharmaceutical company. On Monday, May 13, 2013, federal prosecutors said that Ranbaxy has pled guilty to criminal charges. Ranbaxy has agreed to pay a record $500 million in fines and penalties for selling adulterated generic drugs in the United States.

This guilty plea by Ranbaxy represents the largest financial penalty against a generic drug company for violations of the Federal Food, Drug and Cosmetic Act. This act does not allow the sale of adulterated drugs in the United States. The case is part of an ongoing crackdown on the quality of generic drugs that are coming into the United States.

Will resolve civil claims

Ranbaxy USA Inc. is a subsidiary of Ranbaxy Laboratories Limited. In pleading guilty to criminal charges, Ranbaxy has also agreed to resolve civil claims with all 50 states and the District of Columbia. Ranbaxy had already set aside $500 million for potential civil and criminal liability.

As a part of the deal, Ranbaxy admitted to selling impure generic drugs that had been manufactured at two development sites in India. Prosecutors said that the batches of impure generic drugs consisted of generic versions of an antibiotic and other medications that are used in the treatment of epilepsy, nerve pain and a severe form of acne.

False statements

Ranbaxy admitted to making false statements to the US Food and Drug Administration (FDA) in 2006 and 2007 annual reports in regard to dates of tests for the purpose of determining appropriate storage conditions and detecting drug impurities. In some instances, tests were actually performed weeks or months after Ranbaxy said they had been done, or the tests were performed on the same day or within days of each other instead of months apart as they were supposed to be.

The company admitted to far reaching deficiencies. These included:

Delaying a voluntary recall of medication that it knew would not maintain its expected shelf life
Improperly storing drug samples that were waiting to be tested
Continuing to sell a medication in the United States even after if had failed purity tests.

This concludes a federal investigation into the manufacturing deficiencies of Ranbaxy that has lasted for a full year. The FDA had earlier barred the company from importing 30 different generic drugs that had been manufactured at factories in India. In 2011, the FDA had made a deal with Ranbaxy that the company would ensure that data on its products are accurate, its drug-making procedures would be improved and undergo extra oversight from a third party.

Ranbaxy said that if fully cooperated with the investigation that involved actions from several years ago. The company also added that it expects “future growth in the U.S. and around the world with a robust pipeline of important products.”

Again, if you believe that you have been a victim of impure drugs from Ranbaxy or any other drug company, the best thing to do is to contact a personal injury attorney and discuss your case with him or her.
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