Back to today’s briefing

Story perspectives

India's 2025 Guidelines Cut Animal Testing, Modernize Regulations

5/21/2025

31 4

Summary

Story summary

The 2025 CDSCO draft guidelines aim to modernize India's regulatory framework by aligning with global standards, significantly reducing animal testing and permitting waivers for efficacy trials under certain conditions. However, to truly enhance clarity and consistency in biosimilar oversight, further refinement in statistical testing, biomarker validation, and justification for extrapolation is essential.

1 of 1

Story summary

The 2025 CDSCO draft guidelines aim to modernize India's regulatory framework by aligning with global standards, significantly reducing animal testing and permitting waivers for efficacy trials under certain conditions. However, to truly enhance clarity and consistency in biosimilar oversight, further refinement in statistical testing, biomarker validation, and justification for extrapolation is essential.