Dr. M. Kalaivani is Principal Scientific Officer and Officer-in-charge, Biologics Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Govt. of India. She holds a PhD in Pharmaceutical Sciences from The TN Dr. MGR Medical University, Chennai, India. She is working with IPC since year 2010 and has been instrumental in establishing a separate division and laboratory facility for biologics at IPC. Biologics division at IPC develops IP monographs for rDNA therapeutic products, Vaccines and immunosera for human and veterinary use, Blood and blood related products and activities related to implementation of Alternatives to animal methods in Indian Pharmacopoeia. She is closely associated with National and International Organizations Such as National Institute of Biologicals (NIB), Central Drugs Standard Control Organization (CDSCO)/Central Drugs Laboratory (CDL), World Health Organization (WHO), United States Pharmacopoeia (USP) etc in various activities related to Biological derived therapeutics. She is certified assessor for compliance of ISO/IEC 17025:2017 by National Accreditation Board for Testing and Calibration Laboratories (NABL), Quality Council of India. She authored more than 65 scientific papers in journals, books and conference proceedings. Dr. Kalaivani also contributed in National Formulary of India (NFI), 2011, NFI 2016 and responsible for publication of NFI, 2021.