Massachusetts Personal Injury Library
Firm Fakes Generic Drug Tests
A recent article in The Washington Post indicates that the Federal Food and Drug Administration (FDA), announced that India’s largest drugmaker has falsified laboratory tests for generic drugs that were approved for sale in the US.
According to the article, the FDA identified problems at the Ranbaxy Laboratories plant in Paonta Sahib where evidence shows they falsified data and test results in approved and pending drug applications for 25 drugs that were approved by the FDA. They don’t believe any of those medications are on the shelves of any US pharmacies because Ranbaxy has been prevented from exporting more than two dozen drugs in the US.
The FDA has not ordered a recall because they don’t believe the drugs pose a health risk, but is concerned about the falsified testing. The affected drugs include medications for high cholesterol and an antihistamine, but the FDA has not provided a specific list. The FDA is also not suggesting that patients using the drugs should stop. 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.
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.
The article indicates that since 2006, FDA investigators at the Paonta Sahib plant have turned up laboratory tests that were inaccurate or missing information. In some cases, the drugs that were supposed to be tested at room temperature were refrigerated, while other tests that were supposed to take 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.
The FDA warned Ranbaxy in a letter that these incidents reflect a pattern of wrongful conduct. According to the article, Ranbaxy has said it will cooperate with the FDA. It is India’s biggest pharmaceutical company and one of the biggest producers of generic drugs in the world.
The FDA also blocked the company last September 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 production of generic drugs in India and China has increased in recent years and public health advocates and lawmakers have grown increasingly concerned about the safety of imported drugs and the FDA’s ability to police them.
A congressional Committee on Energy and Commerce has been investigating Ranbaxy. Some members of Congress have been concerned about the ability of the FDA to adequately police these companies around the world.
