FDA issues warning letter to Alembic Pharmaceuticals over missing patient consent in clinical study

The U.S. Food and Drug Administration sent a warning letter to Indian generic manufacturer Alembic Pharmaceuticals after it was found to have failed to obtain informed consent from participants in a clinical trial.

The FDA cited the lack of documented consent as a breach of regulatory requirements designed to protect patient rights and ensure ethical conduct of research.

Alembic will need to address the deficiencies identified in the letter and implement corrective actions to bring its study practices into compliance with FDA standards.

The warning highlights the agency's continued focus on enforcing consent procedures, especially as Indian companies expand their presence in global drug development.