The document outlines the pharmaceutical business development process, detailing activities related to idea generation, regulatory approvals, financial and technical feasibility, and marketing demands. It discusses the stages of API sourcing, testing, dossier preparation, and product registration, culminating in product launch and distribution. Overall, it emphasizes a systematic approach to developing generic pharmaceutical products.

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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