Concept Note: Pharma Bulk Drug Manufacturing Summit
India’s role as the "Pharmacy of the World" is closely tied to its robust bulk drug (API) manufacturing sector. With the Government of India’s focus on API self-reliance through schemes like the PLI and Bulk Drug Parks, the landscape is rapidly evolving. However, to truly achieve global leadership, there’s a need to address key areas like process innovation, supply chain resilience, quality standards, sustainability, and regulatory harmonization.
The Pharma Bulk Drug Manufacturing Summit 2025 aims to bring together top industry leaders, technocrats, regulatory authorities, and innovators to share insights, explore challenges, and unlock new opportunities for sustainable and globally competitive API manufacturing.
Who Should Attend
Why Attend
✔️ Understand regulatory trends impacting API production locally and globally
✔️ Explore innovations in green chemistry, continuous processing, and automation
✔️ Network with key buyers, suppliers, and decision-makers
✔️ Get updated on the Bulk Drug Parks Scheme and PLI incentives
✔️ Benchmark best practices for cost-efficiency, EHS compliance, and quality control
✔️ Discover new technologies and vendor solutions
Agenda
Ø Driving Self-Reliance in API Manufacturing: Policy, Potential & Progress
Ø Reducing dependence on Chinese imports
Ø Bulk Drug Parks & PLI Scheme: Updates & Opportunities
Ø Infrastructure & logistics as enablers
Ø Flow chemistry, enzymatic synthesis
Ø Continuous vs batch processing
Ø Energy and cost efficiencies
Ø Tackling USFDA/EDQM audit challenges
Ø Building data integrity and QA culture
Ø Role of digitization in regulatory compliance
Ø Continuous Manufacturing vs. Batch: What’s the Future?
Ø Adopting Process Intensification and PAT (Process Analytical Technology)
Ø Cost Optimization Without Compromising Quality
Ø Green Chemistry Practices in Bulk Drug Manufacturing
Ø Effluent Treatment & Zero Liquid Discharge: Regulatory Outlook
Ø How ESG is Impacting CDMO Partnerships and Licensing
Ø Meeting USFDA, EU-GMP, and WHO-GMP Requirements
Ø Addressing Regulatory Gaps in Exporting APIs
Ø Audit Readiness for Global Markets
Ø Digital Twins, IoT, and Automation for Plant Optimization
Ø Equipment Innovation for Scale and Energy Efficiency
Ø Smart Plant Equipment & Digital Solutions for APIs
Ø Global positioning & export competitiveness
Ø Technology partnerships & talent building
Ø Integrating ESG goals into manufacturing
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