India to Define Biological Drugs Amid Semaglutide Boom, Regulatory Overhaul Expected

• India plans to formally define 'biological drugs' under its medicines law, driven by the rise of therapies like semaglutide.
• The Drugs Technical Advisory Board (DTAB) will deliberate on a proposal for a legal definition, origin-based labeling, and updated Drugs Rules, 1945.
• The move addresses regulatory complexities arising from manufacturers producing both synthetic and biological products at the same facility, especially for peptide-based therapies.
• Current rules lack clarity on core definitions and licensing overlaps for different drug categories manufactured at the same site.
• Proposed changes include incorporating WHO's definition of biological products and mandatory origin-based labeling for transparency.