How likely is someone to get Ranbaxy psychiatric meds?

A mental health colleague of mine in Massachusetts asked a reasonable enough question:

I understand it’s big, but the drug market is huge. Does this affect a high percentage of US generic drugs?

Since I know he works in mental health, I focused my attention on the psychiatric medications on the list. This is what I learned, and wrote to him:


Ranbaxy is one of very many manufacturers of generics. I went through the list of meds they make, and the ones I recognized as psychiatric, I found out how many other manufacturers made it (at least per FindACode.com).

Total number of manufacturers for the US market apparently:
Continue reading

Things that are Ranbaxy

Another useful thing to be gleened from the State of Connecticut’s Settlement Agreement is this useful list of who all Ranbaxy is:

Ranbaxy Laboratories Limited is a public company incorporated under India law with headquarters in Gurgaon, India.

Ranbaxy, Inc., incorporated in Delaware, is the United States subsidiary of Ranbaxy Laboratories Limited.

Ohm Laboratories, Inc., incorporated in New Jersey; Ranbaxy Pharmaceuticals, Inc., incorporated in Florida; Ranbaxy Laboratories, Inc., incorporated in Delaware; and Ranbaxy USA, Inc., incorporated in Florida, are all subsidiaries of Ranbaxy, Inc.

Well, then.
Ranbaxy Laboratories Ltd’s NDC Labeler Code is 54907.
Ohm Laboratories’ NDC Labeler Code is 51660.
Ranbaxy Pharmaceuticals Inc.’s NDC Labeler Code is 63304.
Ranbaxy Laboratories Inc’s NDC Labeler Code is 10631.

I didn’t turn up NDC codes for Ranbaxy, Inc or Ranbaxy USA, Inc

Where did Ranbaxy’s meds go in the US?

I just discovered the State of Connecticut’s Settlement Agreement with Ranbaxy. Thank you to Google and the CT Attorney General’s office. It says:

On or about April 13, 2007, Dinesh S. Thakur (“RelatorThakur”) filed a qui tam action in the United States DistrictCourt for the District of Maryland (“Court”) captioned UnitedStates of America and the States of Arkansas, California, Delaware, Florida, Hawaii, Illinois, Louisiana, Massachusetts, New Hampshire, New Mexico, Nevada, Tennessee, Texas, Utah, Virginia and the Districtof Columbia, ex rel. Dinesh S. Thakur v. Ranbaxy USA, Inc., et al., Civil Action No. 1:07-00962-JFM (D. Md.). On or aboutFebruary 26, 2010, Relator Thakur filed a First Amended Complaintadding additional counts under the false claims statutes for the States of Georgia, Indiana, Michigan, Montana, New Jersey, New York, Oklahoma and Wisconsin. On or about June 12, 2012, Relator Thakur filed a Second Amended Complaint adding additional counts under thefalse claims statutes for the States of Colorado, Connecticut and Iowa (hereinafter collectively referred to as “Civil A ction”).

I used my fingers but that sounds like 27 states and the District of Columbia.

I do not know that the list is exhaustive.

Wockhardt forbidden to sell in US by FDA

From Reuters:

The U.S. Food and Drug Administration imposed an “import alert” on a plant operated by generic drugmaker Wockhardt Ltd(WCKH.NS), sending its shares down 20 percent on Thursday to their lowest level in seven months.

An “import alert”, effectively a ban, results in detention without physical examination of drugs from firms that have not met so-called good manufacturing practices, according to the FDA website.

[...]

In April, Wockhardt said that the FDA had carried out an inspection at its injectables plant in Aurangabad in Maharashtra, and had issued form 483s to the company. A form 483 is issued when inspectors see conditions that they believe may violate U.S. rules, according to the FDA.

Most of the article concerns itself with the consequences to Wockhardt’s revenue, prospects, and stock price.

It does not specify, nor I have yet been able to find any discussion of, just what the FDA inspectors found in the manufacturing conditions that caused them to say, in effect, “You know what? We aren’t even going to bother inspecting your products; we’re just going to seize them at the border if you try to bring them into our country.”

This article at the Economic Times has these remarkable sentences:

The facility concerned currently does not materially contribute to revenues. It does not include Toprol XL, Flonase or any high value product.

It has nothing more to say about what, precisely, the facility concerned was doing for Wockhardt if not materially contributing to revenues, nor what was made there. Those sentences comprise a stand-alone paragraph in an article otherwise entirely concerned with the business consequences for Wockhardt and its investors.

How To Discover the Manufacturer of a Medication in Hand (in the USA)

So there you are, staring at a bottle of generic pills, trying to figure out who actually made them.  What to do?

First thing to know about finding the manufacturer, is that it is more likely printed on the bottle than on the additional packaging materials or anything additional ephemera you were handed by the pharmacy.  So be sure to pull the bottle out of its box and examine it closely.

Sometimes, it just says right on it.  Sometimes not, in which case, read on.

The second thing to know is what a NDC number is.  Continue reading

A list of medications manufactured by Ranbaxy Laboratories for sale in the USA

Below the fold is a list of all the pills manufactured by Ranbaxy Laboratories that I could find through use of Google and drugs.com.

Note that it only contains pills; it doesn’t contain sprays, salves, IV solutions, or any other sort of preparation.

The links take you to the page at drugs.com which show a photograph of the pill (both sides) and give a written description of the marks on it, so you can check visually that a pill is the one indicated.

The list is alphabetical by drug name, then by dose. After the dash is the “imprint” – the letters or numbers marked on the pill to identify it.

The List

Dirty Medicine: Vast Fraud at Generic-Drug Manufacturer Ranbaxy Laboratories

From Dirty Medicine by Katherine Eban for Fortune Blogs:

[Ranbaxy] CEO Tempest had assured Kumar that the company would do the right thing. So on an evening in late 2004, several months after assigning Thakur to dig up the truth, Kumar found himself before five members of the scientific committee of the board of directors, including Tempest and the chairman of the board.

Kumar had a PowerPoint presentation of 24 slides. It made clear that Ranbaxy had lied to regulators and falsified data in every country examined in the report. “More than 200 products in more than 40 countries” have “elements of data that were fabricated to support business needs,” the PowerPoint reported. “Business needs,” the report showed, was a euphemism for ways in which Ranbaxy could minimize cost, maximize profit, and dupe regulators into approving substandard drugs.

No market or type of drug was exempt, including antiretrovirals purchased by the U.S. and WHO as part of a program to fight HIV in Africa. In Europe, for example, the company used ingredients from unapproved sources, invented shelf-life data, tested different formulations of the drug than the ones it sold, and made undocumented changes to the manufacturing process.

In entire markets — including Brazil, Kenya, Ethiopia, Uganda, Egypt, Myanmar, Thailand, Vietnam, Peru, and the Dominican Republic — the company had simply not tested the drugs and had invented all the data. Noting Ranbaxy’s agreement to manufacture brand-name drugs, a slide stated, “We have also put our partners (Bayer & Merck (MRK) in Mexico and in South Africa) at risk by using suspect data.”

Kumar proposed a drastic course: pull all compromised drugs off the market; repeat all suspect tests; inform regulators of every case of switched data; and create a process for linking the right data to the right drugs. As the PowerPoint stated, “A short-term loss of revenue is better than a long-term losing proposition for the entire business.”

Kumar completed the presentation to a silent boardroom. Only one director, a scientist, showed any surprise about the findings. The others appeared more astonished by Kumar’s declaration that if he was not given full authority to fix the problems, he would resign.

The silence told Kumar everything he needed to know.

Within two days of the board meeting, he submitted his resignation: “… given the serious nature of the issues we discussed,” he wrote, his only choice was to withdraw “gracefully but immediately.” He had been at Ranbaxy less than four months.

Katherine Eban of Fortune has written an epic investigative report on fraud, world-wide, by Ranbaxy Laboratories, manufacturer predominantly of generic medications.  More:

In August, the WHO restored the company’s ARVs [Anti-retrovirals, for treating AIDS] to its prequalified list.

Thakur knew the drugs weren’t good. They had high impurities, degraded easily, and would be useless at best in hot, humid conditions. They would be taken by the world’s poorest patients in sub-Saharan Africa, who had almost no medical infrastructure and no recourse for complaints. The injustice made him livid.

Ranbaxy executives didn’t care, says Kathy Spreen, and made little effort to conceal it. In a conference call with a dozen company executives, one brushed aside her fears about the quality of the AIDS medicine Ranbaxy was supplying for Africa. “Who cares?” he said, according to Spreen. “It’s just blacks dying.”

More:

The congressional inquiry into the FDA petered out over the years. But under the direction of David Nelson, investigators interviewed the FDA inspectors who went to Paonta Sahib and asked them a simple question: Would they feel comfortable taking Ranbaxy drugs? “Every single inspector that went to India said they would never take a Ranbaxy drug,” says Nelson, “like eight out of eight.”

They were not alone. One by one, each of the former Ranbaxy executives Fortune interviewed had determined, while still at the company, to stop taking Ranbaxy drugs.

Read the whole article: Dirty Medicine by Katherine Eban.

Are your, your family’s or your patients’ medications manufactured by Ranbaxy?  See the following posts for instructions and tools to figure that out.

Ranbaxy Laboratories guilty of 7 counts in US federal court

FORTUNE — Indian generic drug-maker Ranbaxy Laboratories pleaded guilty Monday [May 13, 2013] to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn’t meet specifications, and making intentionally false statements to the government.

As part of the proceedings in Baltimore federal court Monday morning, a whistleblower lawsuit against Ranbaxy was also unsealed. The company will pay a total of $500 million in criminal and civil penalties to resolve the criminal case and the whistleblower suit.

Read the whole article at http://features.blogs.fortune.cnn.com/2013/05/13/ranbaxy-guilty/