In Wake of “Double-Dose” Digitek Pills And ETHEX Morphine Tablets Being Recalled, Drugmaker Ranbaxy Faces Allegations About Fake Data As Regards Quality Of Its Generic Drugs

(Posted by Tom Lamb at DrugInjuryWatch.com)

A July 15, 2008 article, “Ranbaxy denies any misconduct”, published by The Star-Ledger put scrutiny on one generic drug manufacturer and raises the concern, more generally, that the FDA has not been monitoring the quality control of generic medications that are used daily by an increasing number of Americans.

We start with the recent allegations being made against the Indian pharmaceutical giant Ranbaxy Laboratories, which manufactures drugs at 11 sites around the globe and had global sales of $1.6 billion last year.  From the July 15 Star-Ledger article we get these points regarding this Ranbaxy generic drug investigation:

• In a July 3 court filing, prosecutors said “reliable sources and supporting documents” show Ranbaxy systematically lied about the makeup of its generic drugs, which include a cheaper version of Merck’s blockbuster cholesterol pill Zocor. The government alleged Ranbaxy used unapproved ingredients and diluted amounts of ingredients in its drugs.

• Prosecutors alleged a “pattern of systemic fraudulent conduct” by Ranbaxy, including the fabrication of test data at a plant in northern India and the destruction of documents in an attempt to conceal the ruse from FDA inspectors.

• Ranbaxy said its internal audits “will demonstrate that no data manipulation, fraud, or dishonesty occurred” in its regulatory filings with the FDA, according to a response filed late yesterday in U.S. District Court in Maryland.

To show how this Ranbaxy investigation fits in the larger picture when it comes to generic drugs, Star-Ledger staff reporter George E. Jordan developed this background for his July 15 article:

“The most important question is credibility. Once that’s lost, its hard to get it back,” said Steve Brozak, senior analysts at WBB Securities in Westerfield. “This is a systemic flaw. I’m not picking on Ranbaxy, but if you have one unethical player, it brings into question to entire system.”

Ranbaxy denied wrongdoing, but the probe highlights growing concerns about generic drugs around the world.

Earlier this year, Actavis Totowa, the U.S. headquarters of the Icelandic generic drugmaker, recalled the heart medication Digitek because it contained “twice the active ingredient.” Actavis and FDA have not explained how the pills landed on the market.

For those of you not familiar with the “double-dose” Digitek pills that were recalled by Actavis Totowa in April 2008, here are some of our past posts about that still-evolving story:

Digitek Digoxin Recall: Tablets May Be Double The Normal Dose

Digitek Update May 2008: When Old News Is Better Than No News At All

Another “Double-Dose” Pill Problem Demonstrates How And Why The Digitek Recall Is So Unusual

Mylan’s Corporate Motto, Actavis On The Meaning Of GMP, And Who Is Ultimately Responsible For The Digitek Fiasco

As you can see from that list, there was not just one but two instances where generic pills were mis-manufactured by different drug company, the first being Digitek by Actavis Totowa and the second being ETHEX Corporation’s June 2008 recall of its generic morphine sulfate extended release tablets.  In both instances those defective pills were dispensed to unsuspecting patients in the U.S. instead of being found upon inspection and destroyed by the company or the FDA.

With a criminal investigation of Ranbaxy underway, one wonders whether federal prosecutors are looking at the conduct of Actavis as regards Digitek and ETHEX for its morphine tablets.  Further, perhaps the existence of such an investigation by prosecutors is the reason why we have heard little in terms follow-up from Actavis and ETHEX about the extent of their “double-dose” pill manufacturing problems in terms of date ranges and estimated number of pills involved.

Given this Ranbaxy – ETHEX – Actavis trilogy, one must ask:  Where is the FDA on taking steps to ascertain that Good Manufacturing Practices (GMP) are being adhered to so that our nation’s supply of FDA-approved generic drugs is safe?