BIRAC Launches Dedicated Regulatory Affairs & Policy Advocacy Unit at BioNEST Conclave
SciFocus May 24, 2024 -- In a significant move to bolster India's biotech sector, the Biotechnology Industry Research Assistance Council (BIRAC) announced the establishment of a dedicated Regulatory Affairs & Policy Advocacy unit during the BioNEST Conclave on May 17, 2024, at the India International Centre (IIC), New Delhi.
Key Highlights:
- Purpose and Objectives:
- Facilitate the navigation of innovators through complex regulatory approval processes.
- Harmonize global regulations and advocate for policies that support the growth of startups, SMEs, and entrepreneurs.
- Strengthen evidence-based regulatory and policy frameworks in India.
- Key Speakers and Dignitaries:
- Dr. Rajeev Raghuvanshi, DCGI, CDSCO, emphasized regulations as facilitators of innovation.
- Dr. N. Kalaiselvi, Director General, CSIR & Secretary, DSIR, highlighted the importance of regulations in translating research to market-ready products.
- Prof. M. Jagadesh Kumar, Chairman, UGC, underscored the need for regulatory knowledge in universities and academic institutes.
- Dr. Alka Sharma, Senior Advisor, DBT, affirmed the initiative's potential to foster innovation and collaboration.
- Dr. Jitendra Kumar, MD-BIRAC, announced the collaboration with CDSCO, FSSAI, NITI Aayog, and other stakeholders to empower the biotech community.
- Unit’s Role and Impact:
- Aimed at driving innovation by navigating regulatory complexities.
- Expected to play a pivotal role in ensuring the smooth execution of BIRAC's innovation-focused objectives.
- Designed to bring various stakeholders together on a single platform for regulatory knowledge generation.
- Inaugural Remarks:
- Dr. Sonia Gandhi , Head of Regulatory Affairs & Policy Advocacy, BIRAC, concluded that the unit will be instrumental in navigating the intricate regulatory landscape.
This new division signifies a strategic step towards creating an enabling and empowering ecosystem for the biotech industry in India.
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