The United States filed a consent decree Wednesday for permanent injunction against Indian generic drug manufacturer Ranbaxy Laboratories Ltd., in the U.S. District Court for the District of Maryland.
Ranbaxy – Failures Galore
The U.S. Department of Justice statement said the government uncovered several problems with Ranbaxy’s drug manufacturing and testing in India and at facilities owned by its U.S. subsidiary, Ranbaxy Inc.
These problems allegedly include:
* Failure to keep written records showing that drugs had been manufactured properly
* Failure to investigate evidence indicating that drugs did not meet their specifications
* Failure to adequately separate the manufacture of penicillin drugs from non-penicillin drugs in order to prevent cross-contamination
* Failure to have adequate procedures to prevent contamination of sterile drugs
* Failure to adequately test drugs to ensure that they kept their strength and effectiveness until their expiration date
The U.S. government has also determined Ranbaxy submitted false data in drug applications to the Food and Drug Administration (FDA), including backdating of tests and submitting of test data for which no test samples existed.
The Justice Department filed the consent decree at the request of the FDA.
All of these actions constituted violations of the federal Food, Drug and Cosmetic Act, making many of Ranbaxy’s drugs adulterated, potentially unsafe and illegal to sell in the United States.
The consent decree, which has yet to be approved by the court, requires Ranbaxy to take a wide range of actions to correct its violations and ensure that they do not happen again.
The consent decree:
* Prevents Ranbaxy from manufacturing drugs for the U.S. market at certain of its facilities until those facilities can do so according to U.S. standards
* Requires Ranbaxy to remove false data contained in its past drug applications
* Prevents Ranbaxy from submitting false data to FDA in the future
* Requires Ranbaxy to hire an outside expert to conduct a thorough internal review at the affected facilities and to audit applications containing data from those facilities;
* Requires Ranbaxy to withdraw any applications found to contain false data
* Requires Ranbaxy to set up a separate office of data reliability within Ranbaxy
* Requires Ranbaxy to hire an outside auditor to audit the affected facilities in the future
Once the consent decree is approved by the court, it becomes a court order with which Ranbaxy must comply or face contempt.