India Overhauls Drug Regulation: New Guidelines for mRNA, Gene Therapy on Anvil

• India is set to overhaul its drug regulatory system to spur research and innovation, focusing on emerging technologies like mRNA and gene therapies.
• An expert committee's final report has led the Centre to assign specific reforms to CDSCO divisions for implementation.
• Key recommendations include flexible clinical trials, fast-tracking novel biologics, rare disease, and breakthrough therapies.
• The drug regulator will prepare detailed guidelines and SOPs for criteria, timelines, and evaluation frameworks for these reforms.
• Guidelines for mRNA therapeutics, ATMPs, Cell and Gene Therapies will be developed, aligned with international standards.