New Delhi: The Subject Expert Committee (SEC) on Oncology under the Central Drugs Standard Control Organization (CDSCO) has raised critical concerns over the Phase III clinical trial proposal of Sacituzumab Tirumotecan submitted by MSD Pharmaceuticals Pvt. Ltd., directing the company to provide detailed justifications regarding its study design and patient representation in India. Ltd., the Indian subsidiary of global biopharmaceutical company Merck & Co., presented its Phase III clinical trial Protocol No. In light of this, the committee requested MSD Pharmaceuticals to substantially increase the Indian sample size to ensure appropriate representation and robust statistical validity. After detailed deliberation, the SEC directed the company to submit comprehensive justifications regarding the control arm choice and provide a revised study plan with an expanded Indian cohort.