E X P E R T I N S I G H T S
and funding , enabling Indian companies to accelerate their R & D efforts and bring innovative products to market more efficiently
Regulatory Support
Regulatory agencies have been playing a crucial role in facilitating the development and approval of biosimilars , implementing pathways that streamline the approval process while ensuring safety and efficacy standards are met . This regulatory support provides confidence to companies investing in biosimilar development , further fuelling interest in the biopharma space .
Over the past decade , Indian regulatory guidelines for biosimilars have evolved significantly , with over 100 biosimilars approved for 35 reference products . Efforts toward global harmonization continue , allowing Indian biosimilars to gain acceptance in international markets . Notably , biosimilars from India have
received USFDA approval and been launched in the US . Despite progress , challenges such as low awareness and lengthy approval timelines persist . However , efforts by Department oif Biotechnology ( DBT ) -supported institutes and national bodies have contributed to raising awareness . India ' s inclusion in the ICH enhances its international influence . Central Drugs Standard Control Organization ( CDSCO )' s restructuring facilitates regulatory processes , and MoUs with US FDA and other jurisdictions improve information flow and cooperation .
Overall , the growing Indian biopharma R & D sector is driven by a combination of government support , skilled workforce , cost advantages , market opportunities , focus on biosimilars , strategic collaborations , and regulatory reforms . These factors contribute to India ' s emergence as a hub for biopharmaceutical innovation and research excellence .
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BioVoiceNews | May / June 2024