Panel Discussion: Quality and compliance: Powering global leadership in biopharma

Panellists in this video:
• Mr Prasun Guha, Head and VP – Regulatory Affairs, Biologics, Dr Reddy’s Laboratories (MODERATOR)
• Dr Yashwant Chavan, MD, geneOmbio Technologies
• Dr Shuvankar Ballav, Manager and Lead – Regulatory Affairs (ABL), Ipca Laboratories
• Mr Jayachandran Ramalingam, DGM- Biosimilars QC, Serum Institute of India

Key Highlights:
[1] Quality is India’s key to global markets. Consistent adherence to international standards is key to build trust with regulators and partners

[2] 483s are not the end of the world. It’s a checkpoint, not a verdict. Regulatory observations should be seen as opportunities for improvement

[3] Indian regulators are harmonising with global standards to strengthen global trust in Indian biopharma

[4] Without a robust compliance system, data integrity is compromised

[5] Compliance is evolving from obligation to opportunity. Companies that ensure compliance into their culture gain a competitive edge

[6] The quality of any product depends on how effectively compliance is ensured across every stage of manufacturing

[7] We need to strengthen how we generate and manage data, and ensure we are always prepared and inspection-ready