More on drug quality: India

By Nicholson Price

The New York Times had a troubling piece this weekend about major problems in drug quality in India, where FDA Commissioner Margaret Hamburg is visiting to discuss safety issues. India makes 40% of the U.S.’s generic prescription and over-the-counter drugs.

Quality issues seem to be unfortunately common (though of course there are many top-quality manufacturers and plants as well).  Half of all the FDA’s drug-related warning letters last year were issued to Indian plants, and recently popular drugs (including Neurontin and Cipro) have been banned from the United States if they’re manufactured in India.  Part of the explanation is differing standards for different markets; manufacturing standards are higher for the U.S. than for India, but the same companies are doing the manufacturing, sometimes at the same plants. Problems aren’t just about quality control in the plants – there are also major concerns with fraud.  In a particularly harrowing situation, “One widely used antibiotic was found to contain no active ingredient after being randomly tested in a government lab. The test was kept secret for nearly a year while 100,000 useless pills continued to be dispensed.”

(If you’re interested in pharmaceutical counterfeiting and are in New England, there’s what promises to be a terrific conference on pharmaceutical counterfeiting at UNH School of Law in Concord, NH on February 19 and 20; details are here.)

The article also highlights similar quality concerns with Chinese drugs.  But where FDA has been able to beef up its Indian inspection staff, the Chinese government has not yet provided the necessary visas, so inspections remain infrequent.  I’ll note that I’m not quite convinced about the article’s final paragraph:

The United States has become so dependent on Chinese imports, however, that the F.D.A. may not be able to do much about the Chinese refusal. The crucial ingredients for nearly all antibiotics, steroids and many other lifesaving drugs are now made exclusively in China.

It’s true that China makes lots of active pharmaceutical ingredients (APIs) which are what make drugs work.  But others could make them too, and have; they’re essentially fairly-difficult commodity chemicals.  Would it be pain if push came to shove and FDA banned the importation of Chinese-made APIs from un-inspected factories?  Yes, a big one, especially in the short term.  But it could be dealt with; I don’t think the current locus of API manufacturing is the trump card the article makes it out to be.

W. Nicholson Price

Nicholson Price is an Assistant Professor of Law at the University of Michigan Law School. Previously, he taught law at the University of New Hampshire. He holds a PhD in Biological Sciences and a JD, both from Columbia, and an AB from Harvard. He clerked for Judge Carlos T. Bea on the Ninth Circuit, and was then appointed as an Academic Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard. Nicholson teaches patents and health law and studies life science innovation, including big data and artificial intelligence in medicine. He recommends reading Bujold, Jemisin, and Older. His work has appeared in Nature, Science, Nature Biotechnology, the Michigan Law Review, and elsewhere. Nicholson is cofounder of Regulation and Innovation in the Biosciences, co-chair of the Junior IP Scholars Association, and a Core Partner at the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.