India's clinical trials rebound, but first-in-human testing lags

Key points

• India’s clinical research industry is staging a comeback after a decade of mistrust, regulatory crackdowns and “guinea pig” fears drove global drugmakers away from the country.
• But even as India emerges as the world’s third-largest destination for clinical trials, a key gap remains: first-in-human (FIH) studies, the earliest and most critical stage of testing new drugs on people.
• The hesitation is rooted in a painful past.
• Read Full Story Allegations of unethical trials, weak oversight and inadequate patient protections during the late 2000s and early 2010s, including trials of a vaccine against cervical cancer and cancer drugs, triggered public outrage and judicial scrutiny.
• India responded with sweeping safeguards, but the tightening also made regulators more cautious, especially around Phase 1 and FIH studies where experimental molecules are tested in humans for the first time.