CDSCO Guidelines for Biosimilars Explained: Ultimate Guide to India’s Regulatory Pathway Mastering CDSCO Guidelines for Biosimilars: Compliance-Ready Guide for India’s Regulatory Affairs Introduction to CDSCO Biosimilars Guidelines and Their Importance CDSCO guidelines for biosimilars govern the approval of biosimilar medicines in India, one of the fastest-growing markets for biologics. The Central Drugs Standard Control Organization (CDSCO), along with the Review Committee on Genetic Manipulation (RCGM) and the Department of Biotechnology (DBT), jointly regulate biosimilars through a framework introduced in 2012 and revised in 2016. These guidelines define requirements for quality, preclinical, and clinical comparability studies. By 2025, India has become…