Clarity Urged in India's Biosimilar Guidelines

The Swadeshi Jagran Manch (SJM) has urged the Central Drugs Standard Control Organisation (CDSCO) to refine its draft guidelines on biosimilars, emphasizing the need for clearer directives to produce cost-effective, high-quality alternatives. The SJM highlighted concerns over international regulations favoring multinational corporations, potentially impacting India's pharmaceutical landscape.

In the proposed 2025 guidelines, the SJM acknowledged advancements in making affordable biosimilars available for critical conditions but noted ambiguities that could increase production costs. They praised the guidelines for adopting the '3Rs principle', a testament to ethical scientific practices aligning with global standards, while suggesting modern testing technologies as humane alternatives to animal studies.

Highlighting discrepancies against international bodies like the USFDA and EMA that have waived animal testing for biosimilars, the SJM advocated for clearer waiver conditions and a standardized process. These measures, they argue, would lower development costs, expedite market entry, and ensure biosimilars are more affordable for Indian patients, preserving the viability of India's generic and biosimilar industry.

(With inputs from agencies.)