Revised rules for biosimilar drugs enter the final stretch

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.

from Healthcare/Biotech-Industry-Economic Times https://ift.tt/kZ5qovn
via IFTTT