RSS Affiliate Calls for Clarity on Biosimilar Guidelines

Quick Summary

• Organisation and Appeal: swadeshi Jagran Manch (SJM), affiliated with the RSS, has written to the central Drugs Standard Control Organisation (CDSCO) seeking clarity in its 2025 draft guidelines for biosimilars.
• Concerns Raised: SJM expressed concerns about regulatory provisions that might favor multinational pharma companies and increase costs for Indian firms developing biosimilars.
• appreciative Points: The SJM commended the adoption of modern technologies and ethical practices like in-vitro assays, organ-on-chip models, and computational simulations under the “3Rs principle” (replacement, reduction, refinement).
• Potential Cost Issues: SJM flagged that discretionary clauses allowing CDSCO to mandate additional animal studies could inflate biosimilar progress costs and conflict with global standards followed by authorities like EMA, UK MHRA, Health Canada, and USFDA.
• Positive Measures Noted: Waiving certain clinical trials when laboratory tests confirm high similarity was praised as cost-effective but needs explicit criteria to prevent ambiguity or misuse.

Indian Opinion Analysis

The focus on affordable biosimilars showcases India’s commitment to addressing health challenges related to chronic illnesses such as cancer and diabetes while aligning scientific practices with evolving global norms. However, ambiguity within draft regulatory clauses could create hurdles for domestic pharmaceutical companies striving to innovate at competitive costs.

By highlighting discrepancies between Indian regulations and established international standards-such as eliminating mandatory animal testing-the feedback underscores a demand for greater specificity in guidelines from CDSCO. Addressing these issues could help strike a critical balance between maintaining affordability without compromising safety or encouraging monopolization by multinational corporations.

Ensuring clear processes will strengthen India’s position as an equitable player in global pharma while driving patient-centric advancements at reduced costs domestically.

published July 31, 2025 | Read More