A “confusing, inconsistent and arbitrary” regulatory environment has seen the number of industry-sponsored clinical trials conducted in India fall by 66% from 256 in 2010 to 86 in 2013, says the US-based Association of Clinical Research Organizations (ACRO).
Citing data from the clinicaltrials.gov registry at a hearing on trade, investment and industrial policies in India organised by the United States International Trade Commission in Washington, John Lewis, ACRO’s vice president of public affairs, called for a regulatory framework that “is reasonable and rooted in science, not politics”.
He also warned that research “can be relocated to more hospitable countries to mitigate the direct economic damage”.
The real loss, Lewis added, was to “the global research environment that is critical to the efficient development of new treatments and therapies for patients in need, in the US, in India and around the world”.
The Indian authorities have been under pressure both politically and publicly to clamp down on clinical trials, amid allegations that industry has exploited impoverished patients for research without proper consent or oversight.
Recent developments have included a new regime of trial-site inspections; reported barriers to clinical-study approvals; a temporary freeze imposed by the Supreme Court on clinical trials of some 157 new chemical entities; disputed financial-compensation arrangements for study participants; and draft guidelines requiring audio-visual recording of all informed-consent procedures.
The more controversial of these policies have drawn criticism from industry both outside and inside India, with local companies such as Biocon and Lupin saying they have moved some trials abroad.
US$100 million commitment
According to ACRO, the association’s members have been operating in India since 1999 and have invested more than US$100 million there in “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, it notes.