Indian Firm Falsified Tests on Generic Drugs, FDA Says

By Lyndsey Layton
Washington Post Staff Writer
Thursday, February 26, 2009

India's largest drugmaker has falsified laboratory tests for generic drugs that had been approved for sale in the United States, officials at the Food and Drug Administration say.

The FDA cited the fraudulent laboratory tests yesterday as it took the unusual step of stopping its review of all pending applications from Ranbaxy Laboratories. Federal investigators said the problems centered on the company's plant in Paonta Sahib, which has produced 25 drugs that have been approved by the FDA. Most of those medications are not thought to be on U.S. pharmacy shelves; since September, Ranbaxy has been prevented from exporting more than two dozen drugs to the United States.

The FDA is not seeking a recall, because regulators do not believe the drugs pose a health risk.

"There is no concern about the safety or efficacy of Ranbaxy's drugs on the U.S. market," said Deborah Autor, director of compliance at the FDA. The affected drugs include medications for high cholesterol and an antihistamine, but the FDA would not provide a specific list.

Patients using the drugs should not stop, said Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research.

But federal officials said they were concerned enough by their investigation into Ranbaxy's Paonta Sahib plant that they decided to halt approvals of any new or pending applications from the company. The agency will resume approvals if Ranbaxy improves its manufacturing processes, Autor said.

Since 2006, FDA investigators at the Paonta Sahib plant have turned up reams of laboratory tests that were inaccurate or missing information. In some cases, the company refrigerated samples of drugs that were supposed to be tested after being stored at room temperature or higher to demonstrate their shelf life, Autor said. Other tests that were supposed to be performed over a period of months to measure whether a drug lost potency over time were taken on the same day or within days.

Investigators also discovered laboratory records signed by employees who were not present when testing took place, she said.

"These and other findings indicate a pattern and practice of submitting untrue statements of material fact and other wrongful conduct," the FDA wrote in a letter to Ranbaxy.

In a written statement, Ranbaxy said it is reviewing the FDA letter and would "respond appropriately in a timely manner." It pledged continued cooperation with the FDA.

Ranbaxy is India's biggest pharmaceutical company and one of the biggest producers of generic drugs in the world.

Yesterday's move is the second FDA sanction against Ranbaxy in six months. In September, officials blocked the company from importing 28 drugs made at its plants in Paonta Sahib and Dewas. The agency cited manufacturing problems including "inadequate sterile processing operations"; failure to prevent cross-contamination with compounds that can cause allergic reactions; and inadequate record-keeping.

The FDA had previously sent the company two warning letters, the first in 2006, noting that inspectors had found numerous deviations from good manufacturing practices.

As pharmaceutical manufacturing has burgeoned in countries such as India and China, public health advocates and lawmakers have grown increasingly concerned about the safety of imported drugs and the FDA's ability to police them.

"For the past three years, FDA possessed credible information that Ranbaxy had engaged in a pattern of fraudulent behavior, but they continued to drag their feet while American lives were at risk," said Rep. John D. Dingell (D-Mich.) of the Committee on Energy and Commerce, which has been investigating Ranbaxy. "The Ranbaxy case is yet another example of the need for significant reform at the FDA."


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