Abstract

IRRITABLE BOWEL SYNDROME: REGULATORY PATHWAYS

Dr. Varada Bapat*

ABSTRACT

Irritable bowel syndrome is known to mankind since antiquity; hence every system of medicines has described its treatment options. However, the pathophysiology of the condition is still not well understood. The regulatory guidelines for diagnosis criteria or evaluation of new drugs or bioequivalence requirements for generic drugs for this condition have evolved after 1995 and are still evolving. Present article attempts to review regulatory requirements in different geographies and also identifies some gaps with suggestions for future refinement.

Keywords: Irritable Bowel Syndrome, IBS, Gut-Brain Axis.