Biosimilars & Vaccines Regulatory Support
Step 1: Regulatory Pathway Selection
Identify the appropriate approval route:
Comparative Development Pathway (preferred)
Individual Development Pathway
New Drug Pathway (if first-time approval in India)
Step 2: Scientific Advice Meetings
Optional pre-submission meeting with CDSCO and DBT
Review development plan, reference biologic, study designs
Step 3: Reference Biologic Selection
Choose a licensed Indian or foreign-approved reference product
Justify structural and clinical similarity
Step 4: Quality (CMC) Development
Detailed analytical comparability data
Manufacturing process and validation
Stability studies and batch-to-batch consistency
Step 5: Preclinical Studies
Conduct toxicity studies (if required)
Often waived with strong comparability data
Regulatory Pathways for Registration of Biologicals in India
Navigate India's evolving biosimilar and biologics landscape with clarity and confidence.
How RGInsight Can Help
Our team provides expert guidance through all three regulatory pathways, ensuring compliant and efficient market entry. Whether you are developing a novel biologic or a biosimilar, we assist with:
Strategic regulatory planning
Scientific advice meeting support
Dossier compilation and submission
Clinical trial application and management
Post-approval lifecycle support
Step 6: Clinical Studies
Phase I: PK/PD equivalence
Phase III: Pivotal efficacy, safety & immunogenicity trial
Clinical trial waivers considered on case-by-case basis
Step 7: Submission to CDSCO
Submit Form CT-21 (clinical trial) and/or Form 44 (marketing authorization)
Dossier in CTD format, including RCGM/GEAC approvals
Step 8: Review by SEC (Biologics)
Application evaluated by Subject Expert Committee
Includes dossier review, site inspections, and clarification rounds
Step 9: Grant of Approval
CDSCO grants marketing authorization post-SEC recommendation
Step 10: Post-Marketing Surveillance
Conduct Phase IV studies within 2 years of approval
Submit PSURs as per regulatory timelines
Step-by-Step Registration Process
India’s regulatory environment for biological products is governed by the Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT), in accordance with the "Guidelines on Similar Biologics." Depending on the type of product and development approach, manufacturers can choose from three distinct regulatory pathways.
