Umesh K Vice President & BU Head – Antivirals Challenges & Opportunities in the development, registration & uptake of New Formulations and Combinations Umesh K Vice President & BU Head – Antivirals

Product Development Registrations Uptake

No Objection Certificates (NOC) Marketing Authorization NOC Product Development DCGI Indian FDA No Objection Certificates (NOC) Bioequivalence NOC Marketing Authorization NOC BE NOC is critical for the product development Delays in NOCs for new combinations force companies to conduct BE studies abroad resulting in increasing the PD cost & the timelines MA NOC is compulsory to get CoPP (Certificate of Pharmaceutical Product) CoPP is mandatory for dossier filing with most NRAs DCGI’s requirement for Phase 3 Clinical Trials with Indian subjects can substantially delay the process Delays in adoption of new HIV formulations in India HIV Program

Dossier Filing with National Regulatory Agencies Registrations Country Level Dossier Filing with National Regulatory Agencies National Guidelines Lack of Clarity on registration timelines & harmonization Ranges from 6 months to 3 years Absence of Fast Track mechanisms in many countries for HIV products Affects Capacities planning for the Procurement Agencies & Suppliers Varying Adoption Timelines Lag in alignment with WHO Guidelines Affects in aggregation of forecasts for new HIV formulations & supply planning

Uptake of New Formulations DCGI Drug Controller General of India Country Registrations Forecast BE NOC MA NOC CoPP Dossier Filing with CoPP Registration timelines Adoption of WHO Guidelines into the National Guidelines Budget Allocations Increasing timelines for Commercialization of New Formulations

Opportunities to Bridge Gaps DCGI’s approach to a New Regulatory Pathway for new HIV drugs & Combinations Identifying rational combinations through WHO guidelines & EOI List Facilitating fast track “Clinical Trial Waiver Process” Registration Harmonization across High Disease Burden Countries Fast track registration by NRAs for products with SRA / WHO PQ approvals. Alignment of National Therapy Guidelines with WHO Guidelines which can lead to faster and timely adoption Forecasting/Budgeting and Funding decisions to be aligned accordingly

Thank You For updates and specific queries, please visit our website www. aurobindo.com Umesh K Phone: +91-40-66721414 +91 995110067 Email: umesh@aurobindo.com Corporate Office: Water Mark Building, Level-3, Plot No.11, Survey No. 9, Kondapur, Hitech City, Hyderabad – 500084