Informed Consent — An Analysis from Medico-Legal and Data Privacy Perspectives

In October 2025, reports emerged from Ahmedabad about large-scale irregularities in clinical drug trials conducted on human volunteers. Investigations later revealed that several pharmaceutical companies and intermediary Clinical Research Organisations (CROs) had been running multiple trials simultaneously, often through unauthorised private agents who recruited participants for small payments. Many volunteers were made to undergo repeated trials without medical supervision, using substandard syringes and inadequate safety measures resulting in serious risks to their health. Most participants were unaware of what substances were being tested on them, what side effects could occur, or why the trials were even being conducted.