The India Sterile Injectable Summit 2025 was held on April 11 in Ahmedabad, Gujarat, focusing on “Advancing Sterile & Injectable Manufacturing: Innovation, Compliance & Market Growth.” As India strengthens its global leadership in complex injectables, this summit brought together industry experts, regulators, and innovators to discuss trends shaping the future of sterile drug development and manufacturing.
Key discussions revolved around regulatory compliance with USFDA, EMA, and global GMP standards, alongside the integration of aseptic processing, single-use systems, Qbd principles, and cold chain logistics to ensure sterility, safety, and operational efficiency.
The summit also highlighted the rising role of India in contract manufacturing, tech transfer, and biosimilars, particularly under Make in India and Pharma Vision 2047. Innovation in facility design, automation, and cleanroom technology took centre stage, promoting global competitiveness.
A special focus was given to intellectual property (IP) strategies for injectables. LexOrbis, represented by Neha Ramani and Ankit Patel, engaged with key stakeholders on securing innovations in formulations, delivery systems, and biologics. They also emphasised the importance of robust patent portfolios, trade secret protection, and freedom-to-operate strategies to support commercialisation.
The event further touched on ESG goals for MSMEs and encouraged sustainable manufacturing practices as part of a broader strategy for industry resilience and global relevance. India’s sterile injectable sector stands at the cusp of transformative growth. This summit helped define a strategic path forward, powered by innovation, compliance, and collaboration.