India drug business stumbles

By Derek Lowe

India is a source for a goodly amount of the world's generic drugs - there are some large and serious companies there, with a lot of expertise. And in recent years, they've just been getting larger and more serious all the time, which makes a couple of recent news items very disturbing reading.


First off, Ranbaxy Laboratories has been notified by the FDA that all of their drug applications are all now on hold, because they've found evidence that the company has submitted falsified data. Most of the problems seem to have been with stability tests, where a company takes production batches of their drugs and ages them at room temperature (and in heated chambers) to make sure that they don't break down in any unusual way on storage. Ranbaxy seems to have cut some corners: for one thing, many samples were found to have been stored in refrigerators after their testing period, some of them for extended periods. None of this was disclosed to the FDA, and closer inspection showed many more inconsistencies in the submitted data. Ranbaxy was warned about this in 2006, but followup checks showed things like employee sign-offs from people who weren't there, different test results for what were supposed to be the same samples, and the like. The FDA's letter can be read here (as a PDF), and they're clearly unhappy.

Adding to the bad publicity, another one of the big Indian companies (Dr. Reddy's) has been involved in a very unusual dispute in a well-respected chemical journal. They'd published a new procedure to make an off-patent antidepressant, but the scientists at Lundbeck, the Danish company that developed the original drug, cried foul. The Indian paper included procedures, they said, that they'd already proved were impossible, and they quoted extensive data to back up their claims. The journal took the unusual step of publishing the Lundbeck challenge, a response from the Dr. Reddy's team, and a counter-response from the Lundbeck group. Most chemists who've read the papers agree that Lundbeck won their case handily, and that the Dr. Reddy's team did not come out looking very good at all.

So it wasn't a good week for the Indian chemical industry, not at all - and it wouldn't be a good one for any country that's trying to build its reputation for reliability and quality. How much this is going to hurt India's rise in the pharma world isn't clear yet. But it sure isn't going to help.

This article available online at:

http://www.theatlantic.com/business/archive/2009/03/india-drug-business-stumbles/1089/