India tightens regulation of clinical trials to safeguard participants

India has taken steps to clamp down on potentially dangerous or unethical clinical trials to try to prevent enrolment of patients without their consent and to ensure that any participants who experience adverse events are compensated.

The Drugs and Cosmetics (Third Amendment) Rules 2013, issued by the Ministry of Health and Family Welfare this month, include provisions on ethics committees and compensation that seek to tighten the regulatory framework for drug companies that sponsor clinical trials in India.1

The new rules say that “in case of an injury or death during the clinical trial to the subject of the clinical trial, the applicant shall provide complete medical management and compensation in the case of trial related injury or death.”

Arun Panda, a health ministry official, told the BMJ, “The drug controller general of India would decide the amount [of compensation], if …