Recently on May 18, Generic drug maker Ranbaxy Laboratories filed a corrective action plan to take steps to rectify the current FDA ban on some of its generic drugs and allegations falsifying new drug applications. In September of 2008, the FDA barred some of Ranbaxy's drugs from import to the U.S because of violations found during inspections of the Dewas and Paonta Sahib Facilities in India. The Paonta Sahib plant was cited in February of 2009 for falsifying data on new and approved drug applications.

While the details of the corrective plan have not been released, “The FDA is working very closely with the firm to ensure that all the Ranbaxy products currently in the U.S. market are safe and effective,” FDA spokesman Christopher Kelly said in an e-mail to Bloomberg.com yesterday. “The next steps will be dependent on the actions identified” in the plan, he said. A corrective plan of action includes, but is not limited to, conducting a third-party independent audit of applications associated with Paonta Sahib.

Based in India and operating in the United States since 1995, Ranbaxy is one of the 10 largest generic-drug producers in the world. Several scandals have surround Ranbaxy this past year. In July of 2008, US prosecutors alleged that Ranbaxy forged documents relating to an investigation into the quality of the company’s drugs sold in the United States. Allegations included that Ranbaxy concealed violations of good manufacturing practice regulations from FDA and made weak or adulterated HIV drugs dispensed in Africa.

In February the FDA also said the plant in Paonta Sahib falsified data and test results in approved and pending drug applications. An inspection in 2006 revealed the problem which included incorrectly storing drug samples in refrigerators though stability testing required the drugs be stored at room temperature. Logbooks even did not identify which samples were in the refrigerator or how long they had been there.

To address the falsified data, the FDA has invoked its Application Integrity Policy (AIP) against the Paonta Sahib facility. The AIP is invoked when a company's actions raise significant questions about the integrity of data in drug applications. This AIP covers applications that rely on data generated by the Paonta Sahib facility only.

The FDA halted the review of drug applications made at Ranbaxy’s Paonta Sahib plant in India because of the issue. To date, the FDA has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products.

The affected applications are for drugs that fall into three categories:

• Approved drugs made at the Paonta Sahib site for the U.S. market;
• Drugs pending approval at the FDA that are not yet marketed; and
• Certain drugs manufactured in the United States that relied on data from the Paonta Sahib facility.

In the meantime, the FDA recommends that patients not disrupt their drug therapy because this could jeopardize their health. Individuals who are concerned about their medications should talk with their health care professional.

For more information:

• For drug safety information, read: FDA's Drug Safety Initiative
• Read the FDA's 2008 Warning Letters to Ranbaxy and the Import Alert
• Read the redacted AIP letter to Ranbaxy
• Read about the Application Integrity Policy
• Read the FDA’s News Release announcing Ranbaxy Paonta Sahib AIP

Labels: ban, corrective, FDA, Generic, Ranbaxy, tonight show