Generic Pharmaceutical Product Development - Road Map of Execution of Work from Idea Generation till Launch Of New Product

1. Description of Activities:
Idea Generation
• New approvals from SRA’s
• Literatures
• Magazines
• New domestic launches
• Marketing department
demand
• IMS sales data
• DRB meeting minutes
review
• Vendor Meetings
• KOL’s suggestions
Feasibilities & Proposal
Approval
• Financial feasibility
• Technical feasibility
• Marketing feasibility
• Regulatory Feasibility
• Proposal for Marketing &
Management approval
Description of Activities:
• API sourcing
• API sample arrangement.
• Innovator sample
arrangement
• Initial Testing
• Vendor Qualification
• Code opening
• Trial batch for stability
Description of Activities:
• Design development,
artwork finalization.
• Packaging material
finalization.
• Code opening
Description of Activities:
• Dossier request form
containing information of
molecule, strengths, pack
size, proposed MRP,
innovator brand, local
brand, artworks, leaflet,
clinical studies, SRA
approval forward to
Regulatory for the
preparation of dossiers.
• Technical Development
Data provided by R&D
• Regulatory prepares the
dossier and submit in
DRAP.
• Product approved in DRB
meeting
• If Product is new molecule
then the case move to
DPC
• Registration letter issued
Description of Activities:
• Forecast arrangement
from marketing.
• BOM preparation &
updation
• PR Submission in MM &
Import for material
arrangement.
• Production
• Release
• Distribution
• Marketing Activities
Idea Generation
& Feasibility
Formulation
Development Registration
Packaging
Development
Launch
Pharmaceutical Business Development Process Flow
(Generic Product Development)
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