New research published today by Roger Bate and me addresses the issue of drug quality in developing and emerging markets by looking at the first point of drug regulation—registration systems—in a variety of countries, including India, Brazil, China, and many African nations.
Not only is drug quality important to the health of citizens of those countries, but—since as much as 80 percent of active ingredients in U.S. drugs are made overseas—Americans should also be concerned about drug regulation abroad.
Looking at 12 countries, our research provides an idea of how stringent authorities are in registering drug products. There are major differences in registration costs, pre-quality testing requirements, evaluation timelines (see chart), and other areas. Such differences are often important: For instance, just how thorough can the review of a new drug be when conducted in seven days, when the process takes at least three months elsewhere?
With a four-fold increase in U.S. drug recalls from 2008 to 2009, there is more pressure on the Food and Drug Administration (FDA) than ever to protect the pharmaceutical supply chain from unsafe or adulterated products. But the FDA only has the capacity to inspect foreign production plants once every 13 years.
Unable to do the job alone, the FDA should put more pressure on foreign regulatory authorities. While a general lack of human and financial resources impacts many foreign authorities’ ability to regulate, not all perform equally badly. Countries with stronger political commitment to regulation stand out from their counterparts. Recent efforts in Nigeria to tighten registration and clarify procedures are in stark contrast to efforts of countries like Uganda, where corruption continues to occur in the open, or Kenya, where huge gaps in product registration exist. But it’s India and China that Americans should watch, as most of our drug ingredients come from there, and in both countries the news is mixed—as we discuss in our report.
Ultimately, many nations may not have the capacity, or even the experience, necessary to adhere to Western regulatory standards. But with the global pharmaceutical supply chain expanding, it is important that regulatory authorities in emerging markets strengthen regulation where they can, and our research highlights an area where they can start that is manageable and makes sense.
Emily Putze is a research assistant at AEI.