Dr Santosh Indraksha, Deputy Drugs Controller (India), CDSCO, DGHS, MoH&FW, Government of India

Speaker in this video:
Chief Guest Address by Dr Santosh Indraksha, Deputy Drugs Controller (India), CDSCO, DGHS, MoH&FW, Government of India

Key Highlights:
[1] Quality failures in pharma products directly impact patient safety and product efficacy. So, they must be eliminated completely.

[2] AI should be integrated across the drug development lifecycle, from API characterisation to clinical modeling and scale-up.

[3] India is strengthening its innovation ecosystem with faster clinical trial approvals (reduced from 90 to 45 days) and supportive regulations.

[4] Formulation R&D (FR&D) is a critical function for managing process changes, alternate vendors, and maintaining product quality.

[5] The industry must work toward zero quality defects, with stronger CAPA systems and collaboration to support MSMEs.