The Association of Clinical Research Organizations (ACRO) has testified in a hearing before the U.S. International Trade Commission (ITC) on the decline of clinical trial activity in India, a decrease more than 60% since 2010, as being the result of a “confusing, inconsistent, and arbitrary” regulatory environment.
ACRO’s vice president of public affairs, John Lewis, testified, “To be clear, ACRO members are committed to conducting safe, ethical, high-quality clinical research across the globe. But to do that, researchers and research companies must depend upon a regulatory framework that is reasonable and rooted in science, not politics.”
ACRO members have been operating in India since 1999 and have invested more than $100 million in the country to build research infrastructure, train thousands of employees, and establish approximately 24 facilities in the country. ACRO member companies have conducted an estimated two-thirds of all industry-sponsored clinical trials in India. In 2010, there were 256 sponsored trials being conducted in India, according to clinicaltrials.gov, which fell to 86 in 2013.
“In reality, research can be relocated to more hospitable countries to mitigate the direct economic damage,” Mr. Lewis continued. “The real loss is to the global research environment that is critical to the efficient development of new treatments and therapies for patients in need, in the U.S., in India and around the world.”