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.
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:
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.
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