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The 11th edition of iPHEX will be held between September 4 to 6, 2025 at Bharat Mandapam, New Delhi, reaffirming India’s position as the “Pharmacy of the World.” The iPHEX 2025 Global Regulatory Conclaves is all poised to spotlight India’s role in shaping global health.
Organized by the Pharmaceuticals Export Promotion Council of India (Pharmexcil) with support from the Union Commerce ministry, Government of India, the platform brings together regulators, policymakers, and industry leaders from across the globe.
This year’s edition will have participation of over 700 Indian exporters showcasing their products and services, 500+ overseas delegates representing more than 120 countries, more than 20,000 domestic visitors and 8,000+ B2B meetings, positioning iPHEX as one of the most business-driven exhibitions globally.
Key highlights of iPHEX 2025 include Global Regulatory Conclave (in collaboration with the Central Drugs Standard Control Organisation (CDSCO), ministry of health & family welfare: A knowledge-sharing platform to enhance international regulatory cooperation and promote the global recognition of Indian Pharmacopoeia.
The Global Regulatory Conclaves will address critical themes that directly influence Indian pharma’s competitiveness and global positioning.
The themes include Access to quality medicines through regulatory convergence and reliance – Reducing duplication, enabling faster approvals, and lowering costs, Good Reliance Practices (GRPs) – Regulatory reliance as a lever for affordable and timely market entry, Bharat Health Vision 2030 & 2047 towards aligning India’s long-term health roadmap with global trade ambitions, Market access to highly regulated markets – Strategies for the US, EU, and Japan, where Indian pharma faces the tightest scrutiny.
It will also discuss ROW Market Opportunities towards expanding footprints in Africa, Latin America, and ASEAN to offset concentration risks and also Pharmacopoeia Convergence (BP, IP, USP) for standard harmonisation as a tool for building trust in Indian-made generics.
The conclaves underscore the sector’s growing influence in both advanced economies and emerging markets. This offers a vantage point into how India’s regulatory roadmap, market access strategies, and export leadership are shaping the future of global healthcare.
According to Bhavin Mehta, vice chairman, Pharmexcil and Chairman of iPHEX 2025, “iPHEX 2025 is more than a trade platform—it is a dialogue on India’s responsibility as the Pharmacy of the World. The 10th edition (2024) of iPHEX had recorded 7,400 meetings. The 11th edition (2025) is set to surpass this benchmark with close to 8,400 meetings — reflecting the event’s scale and rising global traction. Through the Global Regulatory Conclaves, we aim to harmonize standards, build global trust in Indian generics, and accelerate access to affordable medicines. This is where India’s regulatory vision meets the world’s healthcare priorities”.
The Indian Pharmacopoeia (IP) will be a key focus at iPHEX 2025, with an emphasis on showcasing its global recognition, efficacy, and cost advantage.
“Our focus this year is to champion the Indian Pharmacopoeia and reaffirm its global relevance. Already, 12 countries have recognized and accepted the Indian Pharmacopoeia, and in 2025 our goal is to bring another 10–12 nations on board—further strengthening India’s position as a trusted, accessible, and globally aligned healthcare partner,”, Mehta said.
At its core, iPHEX 2025 Powers Healthcare and Connects Markets—serving as a convergence platform where India’s pharmaceutical leadership meets the world’s healthcare future.
On the first day of the event, Session 1.1 will start on the topic Access to Quality Medicines through Regulatory Convergence & Reliance with focus Trust-based partnerships, MRAs, collaborative inspection framework. The speakers for the session will be Dr. Rajeev Singh Raghuvanshi the Drugs Controller General of India (DCGI), James Pound (UK MHRA), Vladislav Shestakov (Russia), Kayleigh Van Winssen (Netherlands), Daniel Meirelles Pereira (ANVISA, Brazil), Nikhil Gajraj, Minsitry of Health and Family Welfare (MoHFW India) and Raja Bhanu (Director General, Pharmexcil with key takeaway as global regulators chart pathways to convergence and reliance.
Session 1.2 will be on topic of Good Reliance Practices (GRPs) as an Enabler to Affordable Medicines with focus on practical frameworks for reliance and collaboration. The speakers for the session are Daniel Meirelles Pereira (ANVISA, Brazil), James Pound (UK MHRA), Yibeltal Abeje Melese (Ethiopia FDA), Margarita Kellermann (Russia), Aman Madan (Australia), Sanjay Shetgar (India) with key takeaway as regulators + industry leaders showcase reliance as a lever for faster approvals and affordability.
Day 2 will start with Session 2.1 with topic of Country Focus: Netherlands with discussions around regulatory pathways, procurement & reimbursement in Netherlands. Speakers will be Kayleigh Van Winssen (Netherlands MoH), buyers from NFU, Amsterdam UMC, BENU, Mosadex, DSW Insurance with key take away as policymakers, buyers & insurers outline compliance and access mechanisms.
Session 2.2 on Day 2 will start with topic of country as United Kingdom with focus of recognition & compliance strategies from MHRA. Speakers will be James Pound & Tasneem Keshav (UK MHRA) with key takeaway as UK insights on global alignment and regulatory trust.
Session 2.3 on Day 2 will have topic of country as Brazil with focus on API, biologics & medicines authorization, reliance models. The speakers will be Raphael Sanches Pereira (API/Drugs, Brazil), Laura Gomes Castanheira (Biologics, Brazil) with key takeaway as Brazil showcases reliance procedures for market entry.
Session 2.4 on Day 2 will have topic as Market Access & India’s Strategic Role in Balancing Exports with focus on diversification across developed, emerging & Global South. The speakers will be Dr. Ye Myint (Myanmar FDA), Prof Ousmane Dembele (Mali), Dayanira Ortega Larrea (Cuba), Dr. Viengsakhone Louangpradith (Laos), Dr. H.G. Koshia (FDCA, Gujarat) with key takeaway as focus on SMEs, trade partnerships, and cutting non-tariff barriers.
Session 2.5 on day will discuss Pharmacopoeia Convergence: IP & USP with focus on harmonisation of monographs, standards, methods. The speakers will be Dr. V. Kalaiselvan from Indian Pharmacopoeia Commission (IPC), Annu Uppal (USP), Dr. H.G. Koshia (India), Gilson Oliveira Lima (São Tomé & Príncipe), and Sangeetha Ganapuram (Hetero Labs) with key takeaway as IPC & USP leaders outline steps to reduce duplication and build global trust in Indian generics.
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