Milind Antani
Nishith Desai Associates, India
Title: Similar biologics in India – Legal and regulatory perspective
Biography
Biography: Milind Antani
Abstract
Biologics sector in India has seen significant growth in last few years with many players entering this sector aggressively to meet the global demands. The similar biologics are regulated in India through various acts and guidelines. The Department of Biotechnology (DBT) that comes under the Ministry of Science and Technology is the main regulatory body that is responsible for approval of ‘similar biologics’ in India. DBT operates through its Review Committee on Genetic Manipulation (RCGM) and the Central Drugs Standard Control Organization that comes under the Ministry of Health and Family Welfare). Though there are regulations that govern similar biologics, there is a need to have more robust legislation that is conducive for the industry players. The talk will explain existing legal and regulatory landscape for similar biologics in India and way to navigate through the same.