In this space in our June issue (bit.ly/19hF4Wd), I wrote about Fortune magazine’s L-O-N-G article on Ranbaxy’s . . . compliance problems . . . at several of its facilities in India. I cited the potential for xenophobic ranting about “how they do things over there” and was, I thought, careful to point out that serious quality issues arise in U.S. facilities, too: Fort Washington, anyone?

Still, I can’t exactly say I was surprised when another Ranbaxy facility in Mohali, India, was hit with an import ban by the FDA in September. After all, I did tie that previous editorial to a horror-story theme and Halloween is coming up shortly. One pharma company recently told me that it had lost out on a few high-value generic products after learning that — unbeknownst to them — Ranbaxy was embedded in the products’ supply chains. Frightening stuff!

However, Ranbaxy doesn’t have a monopoly on scary pharma stories and supply chain woes in the subcontinent. In September, a reporter for the Hindustan Times filed an article (bit.ly/1b99xNG) about how the National Pharmaceutical Pricing Authority (NPPA) is surveying the prices of bulk drugs in order to revise its medicine-pricing schedule. The overall Drug Price Control Order (DPCO), initiated in May 2013, will use average pricing of 652 drug formulations of 348 bulk drugs to bring down prices by 20% or so for nearly a third of India’s drug market.

Some of you might consider the policy of capping drug prices by government fiat to be a big horror story, but that’s not the scariest element of this process.

No, see, by July, the NPPA was having trouble getting data on prices for 100 of those bulk drugs, so it elected to contact the companies directly. What has it found out since then? Here’s what Himani Chandna Gurtoo’s article in the HT reported:

“There is no information available for 55 random formulations and we may exclude them from the list of price fixation,” CP Singh, chairman, NPPA told HT. “We are unable to trace most of the manufacturers.”

That means that makers of 55 bulk drugs . . . are ghosts! Only 45 drugmakers responded to the NPPA request, meaning more than half have vanished into thin air! That’s right; a highly publicized order to lower drug prices in India has revealed that some drugs are made by ghosts! Spooooky . . .

Or is it?

Now that I think about it, maybe employing ghosts to make drugs might not be a bad idea. They probably present fewer sterility issues than the FDA found at that Ranbaxy Mohali site. Ghosts aren’t likely to have arm-hairs that fall into tablet presses, and the lack of water in Mohali’s washing and rest-room facilities — next to a raw material storage space, no less! — wouldn’t pose a problem for them. Sure, the pressurized airflow in a cleanroom might cause them to get sucked up by a floor vent, but no one said drugmaking should be risk free.

It’s scary when the real risk is for the patients taking these drugs. Happy Halloween!

Gil Roth, Editor
[email protected] / twitter.com/contractpharma

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Retraction

The column “Changing Models,” in our September 2013 issue contained substantial portions of an article published in the January 2012 issue of Life Science Leader. We sincerely regret that this occurred and have removed that column from our archives. To read the original article in LSL, “New Global Pharmaceutical Outsourcing Trends” by Jim Zhang, please visit bit.ly/1fWhCEU

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What I’m Reading
Pharma
With a Name Like Xalkori . . .
David Schultz, Slate • slate.me/16Cgxki
Comment: Primer on how drugs get their names, including the FDA’s approval process and the rise in computer programs that generate near-random assemblies of letters as potential names. Nice read, but I seriously doubt that one of the mistakes he cites — accidentally prescribing, fulfilling and taking Lunesta instead of Neulasta — is really an issue.

Non-Pharma
A Month in the Country
JL Carr • amzn.to/18EoFx7
Comment: A beautiful short novel about a WWI vet hired to restore a mural in an ancient church in the north of England in 1920. The narrator, an old man recollecting that month he worked on the restoration, relates a sad and gorgeous story about the horrors of war, the importance of art, the clashes of class and religion in England, and the ways in which we try to redeem our souls.

Why don’t you tell us what you’re reading? Write us at [email protected], www.goodreads.com/groth, www.linkedin.com/groups?gid=1775433 or www.facebook.com/contractpharma — and the first respondent wins a prize!