Indian Manufacturer of Generic Drugs Acquired FDA Approval Through Faked Test Results

Of all the prescription drugs that are prescribed to American patients each year, 80% are generic drugs. A recent report indicated that Ranbaxy, a leading generic drug manufacturer in India, allegedly skipped required steps in the approval process for its drugs. Ranbaxy produces drugs that treat illnesses including AIDS, infections, and heart ailments.

Upon responding to a supervisor’s request to produce documents that are required for FDA approval, a Ranbaxy executive discovered that the documents did not exist. Absence of the required documents suggests that the company received drug approvals based on information that was absent or fraudulent.

The original employee notified the FDA of his discovery, and the FDA launched an investigation. Results of the investigation suggested that Ranbaxy had a pattern of submitting untrue statements. On at least 15 drug applications that were examined, 1,600 errors were found. FDA officials concluded that the drugs were potentially unsafe and illegal to sell. Ironically, while one branch of the FDA was in the process of pursuing criminal charges against the manufacturer, another division of the regulation agency was in the process of approving Ranbaxy to produce a generic version of Lipitor, a decision that helped the company earn $600 million within the first six months of production.

Ranbaxy was purchased by Japanese owners in 2008. The new owners have reportedly invested more than $300 million in infrastructure upgrades and have indicated an interest in implementing new training procedures in order to keep the company in full compliance with all regulations.

The employee who was first to discover and report the regulation violations to the FDA was awarded $49 million by a U.S. court. When asked in an interview, he indicated that he would not have been comfortable taking a Ranbaxy drug if he had been aware of the violations that were taking place. He also added that he would still not advise consumers to take Ranbaxy drugs today. Nevertheless, the