To strengthen India's regulatory and policy milieu, Biotechnology Industry Research Assistance Council (BIRAC) announced a dedicated Regulatory Affairs & Policy Advocacy division during the BioNest Conclave on 17^th May 2024 at the India International Centre (IIC), New Delhi.

The aim of this division is to drive innovation through navigation of regulatory complexities, harmonisation of global regulations, and advocate for policies that catalyse the growth of startups, SMEs, and entrepreneurs in the dynamic landscape of regulatory and policy affairs.

Dr Jitendra Kumar, Managing Director, BIRAC highlighted that this division will collaborate with Central Drugs Standard Control Organisation (CDSCO),Food Safety and Standards Authority of India (FSSAI), NITI Aayog and other stakeholders to foster an enabling and empowering ecosystem for the biotech community.

During the launch, Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI), CDSCO spoke about the need of such an initiative and said that the regulations are not a restriction but a facilitation of innovative product development.

Dr N. Kalaiselvi, Director General, Council of Scientific & Industrial Research (CSIR) & Secretary, Department of Scientific and Industrial Research (DSIR), congratulated BIRAC for creating this unit and emphasised the importance of regulations in translation of laboratory research to market ready products.

Further, Prof. M. Jagadesh Kumar, Chairman, University Grants Commission (UGC) stressed upon the regulatory and policy knowledge in the universities and academic institutes of India.

This initiative will foster innovation, drive collaboration, and advance the biotech ecosystem, said Dr Alka Sharma, Senior Advisor, Department of Biotechnology (DBT).

"The unit will play a pivotal role in navigating the intricate regulatory landscape and ensuring the smooth execution of BIRAC's innovation focused objectives", concluded Dr Sonia Gandhi, Head- Regulatory Affairs & Policy Advocacy, BIRAC.