FDA: India’s Largest Drug Company Lied About Test Results for Dozens of Generic Drugs

The Food and Drug Administration says the largest pharmaceutical company in India lied about test results for dozens of generic drugs, prompting a sudden halt to FDA approval review of drugs made by the company.

Ranbaxy Laboratories Limited Inc., the firm which has helped propel India into a major player in the global pharmaceutical market, did not properly test the shelf-life of about 25 generic drugs then lied about how they conducted the tests and falsified results to cover up testing irregularities, the FDA said.

The company’s Paonta Sahib plant is accused of falsifying test results. In 2008, the same Ranbaxy plant was at the center of another FDA action banning more than 30 generic drugs made there after manufacturing problems were uncovered during a routine inspection.

The FDA first detected quality and manufacturing problems at Ranbaxy facilities in 2006.

No Harm, No Recall Yet

FDA officials said no harm to patients who took the dozens of Ranbaxy drugs has been detected, there is no evidence that the drugs are dangerous, and no recall of the drugs is necessary. Officials said patients prescribed Ranbaxy drugs should continue to take their medications. All 25 generic drugs made at the Ranbaxy plant now under investigation likely made their way into the U.S., the FDA said.

Years-Long Investigation Uncovered Fraud

The testing problems at Ranbaxy were uncovered following years of inspections at company plants. In one case, company officials refrigerated drugs undergoing testing then lied about how the drugs were stored and reported that they had been stored at room temperature, the FDA said.

Such misreporting of how clinical testing of proposed drugs has been conducted can dramatically skew results and allow dangerous drugs to find their way into medicine cabinets in millions of American homes.

Other Inspections Found No Similar Problems

Ranbaxy operates three other manufacturing plants in India and imports a variety of generic drugs into the United States. The company makes many popular generic cholesterol drugs and antibiotics.

The FDA said it has inspected Ranbaxy’s plants more than 20 times in the past four years and never uncovered similar problems with reporting testing protocols.

It was not known how many proposed Ranbaxy drugs are currently awaiting FDA approvals and have been halted amid the investigation. Ranbaxy’s U.S. headquarters are in Princeton, N.J.

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