Members of the Association of Clinical Research Organizations (ACRO) have seen their clinical trials activity in India decrease more than 60% since 2010 as a result of a “confusing, inconsistent and arbitrary” regulatory environment, ACRO’s vice president of Public Affairs, John Lewis, testified before the U.S. International Trade Commission. The USITC hearing was held last week in Washington, DC.
“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,” Lewis testified.
ACRO members have been operating in India since 1999 and have invested more than $100 million in the country building out a research infrastructure, training thousands of employees and establishing approximately two dozen facilities around the country. ACRO member companies have conducted an estimated two-thirds of all industry-sponsored clinical trials in India. In 2010, there were 256 industry-sponsored trials being conducted in India, according to clinicaltrials.gov, but this number fell to 86 by last year.
“In reality, research can be relocated to more hospitable countries to mitigate the direct economic damage,” said Lewis. “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.”