The Indian government is refining biosimilar drug regulations, aligning with global standards to ensure stringent quality in research and manufacturing. These revised 'Guidelines on Similar Biologics' prioritize minimizing animal testing, advocating for in-vitro studies and the 3R principles (replace, reduce, refine). The aim is to balance regulatory rigor with flexibility, potentially waiving animal studies where sufficient clinical data exists.
The government is giving final touches to a revised set of regulations to set stringent quality standards for research and manufacture of biosimilar drugs, which are emerging as a mainstay for treatment of cancers and autoimmune diseases among others. 

Source: The Economic Times - May 6, 2025