1. 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

2. Product Development
Registrations
Uptake

3. 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

4. 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

5. 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

6. 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

7. Thank You
For updates and specific queries, please visit our website www. aurobindo.com
Umesh K
Phone:
Corporate Office:
Water Mark Building, Level-3, Plot No.11, Survey No. 9, Kondapur, Hitech City, Hyderabad –