FDA Halts New Applications From Indian Drug Maker's Plant

Agency says Ranbaxy Laboratories facility falsified scientific data

By Steven Reinberg
HealthDay Reporter

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WEDNESDAY, Feb. 25 (HealthDay News) -- U.S. health officials have halted the review of any new drug applications from a Ranbaxy Laboratories plant in India after determining the facility was falsifying scientific data.

Ranbaxy, based in India, is one of the largest suppliers of generic drugs to the United States.

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"We took this action after it became apparent that this facility was submitting falsified scientific data in applications for FDA approval of marketed drugs in the United States," Dr. Douglas Throckmorton, deputy director of FDA's Center for Drug Evaluation and Research, said during a Wednesday teleconference.

Falsifying data in drug applications is a "serious breach of integrity -- a breach that must be quickly addressed and corrected," Throckmorton added.

Throckmorton noted this is the second action against the Paonta Sahib facility in less than six months. "No other Ranbaxy facilities are directly affected by this action," he said.

Until these problems are resolved, the FDA will stop review of drug applications from the Paonta Sahib plant and the agency will not accept any new applications from this plant, Throckmorton said.

These applications fall into three categories, drugs made in the plant for the U.S. market, drugs not marketed in the United States pending FDA approval, and drugs made in the United States that relied on data from the Paonta Sahib plant.

Last September, the FDA denied U.S. entry of 30 generic drugs made at the Paonta Sahib plant and a sister facility in Dewas, India, for problems related to the manufacturing process. At that time, FDA officials also recommended denying any new drug applications from those two plants.

Some of the false data supplied from the Paonta Sahib plant involved the shelf life of products, Deborah Autor, director of the FDA's Office of Compliance at the Center for Drug Evaluation and Research, said during the teleconference. In addition, the company falsified data about production practices, she said.

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