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The FDA Calls for Consent Decree for Permanent Injunction of Ranbaxy

Author: Lauren Cohrs
Posted on Oct 26, 2012 in bad-drug-blog

Ranbaxy drugs and logo On January 25, 2012, the Department of Justice for the U.S. Food and Drug Administration took measures to end drug manufacturing malpractice by ordering a consent decree for permanent injunction of Ranbaxy Laboratories Ltd. This generic medicine manufacturer based in India with sites also in the United States has been accused of falsely and incorrectly reporting data and experiments, producing medicines in conditions that do not meet standards and errors with testing methods for drugs. To protect the rights of consumers, filing this order will implement stricter regulations against poor procedures used by medicine manufacturers which do not adhere to the guidelines of current good manufacturing practice.

What are the Current Good Manufacturing Practices?

The current good manufacturing practice or cGMP are a set of standards and regulations which have been put in place by legislation to ensure high quality, safe products. The current good manufacturing practices include guidelines that protect consumers through:

consistent, secure, precise and controlled manufacturing of products
clear documentation of processes and tests
a traceable history of products and procedures during the manufacturing
records of all medicines produced for future reference in the event of recalls or adverse reactions
an organized team in charge of assessing complaints and documenting manufacturing procedures

Organizations such as the FDA require that manufacturers be inspected at an unannounced time to observe adherence to these principles. If these practices are not followed, the U.S. Food and Drug Administration may call for stricter procedures in the manufacturing system or may mandate that manufacturing be stopped until administration makes necessary changes.

How will the Consent Decree for Permanent Injunction Affect Ranbaxy?

As of the mandate requested by the U.S. Food and Drug Administration, Ranbaxy must make sufficient changes to its plants in both the United States and India in order to meet standards. The FDA has prohibited certain manufacturing plants of Ranbaxy from further producing medicine until making these changes. To prevent obstructions of these principles in the future, the FDA will require Randbaxy to have their tests, data and procedures examined by an outside source to enforce integrity.

Learn about the latest recalls, drug facts and medicine health by reading more at bad-drug.net.

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