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2 min read
India’s regulatory landscape is undergoing a major digital transformation. The Central Drugs Standard Control Organization (CDSCO) has begun a phased shift toward mandatory eCTD (electronic Common Technical Document) submissions — a move aligned with global harmonization efforts in the US, EU, UK, Japan, and other mature markets.
As regulatory authorities worldwide continue to adopt digital submission frameworks to improve quality, transparency, and review efficiency, India is now accelerating its own modernization. For pharmaceutical and biologics companies preparing for product approvals in India, understanding this shift — and getting eCTD-ready — is essential.
1. Why India is Transitioning to eCTD
CDSCO’s move toward eCTD is driven by several factors:
Harmonization with global regulatory standards (ICH / US FDA / EMA / MHRA)
eCTD is now the international standard for dossier submissions. India’s adoption strengthens its alignment with ICH regions and enhances global interoperability.
Improved submission quality
eCTD ensures:
- Consistency
- Version control
- Reduced errors
- Structured data
- Faster communication
This is a significant improvement over traditional paper-heavy processes.
Faster review cycles
Digital submissions enable reviewers to:
- Access data quickly
- Navigate modules easily
- Perform more efficient lifecycle management
This supports India’s efforts to accelerate drug approvals and reduce timelines.
Better lifecycle management
eCTD allows seamless handling of:
- Variations
- Amendments
- Responses to queries
- New data uploads
This streamlines post-approval regulatory operations.
2. Current Status in India (2024–2025)
CDSCO has already:
- Launched pilot programs for eCTD
- Introduced a portal-based eCTD system for select filing categories
- Begun moving new drug applications from physical files toward structured electronic submissions
CDSCO is now working toward a broader adoption model, which is expected to become mandatory in 2026, beginning with high-priority categories such as:
- New Drug Applications (NDA)
- Biologicals
- Vaccines
- Select generic applications
- Post-approval changes
3. What Sponsors Must Prepare Before 2026
1. Convert CTD content into compliant eCTD format
Companies must ensure that:
- Module 1 is fully CDSCO-compliant
- Metadata is correctly assigned
- Dossiers are structured according to the Indian backbone
- PDF granularity and bookmarking meet eCTD standards
2. Strengthen publishing capabilities
eCTD publishing requires:
- Compliance with ICH M2, M4 guidelines
- XML backbone validation
- Sequence management
- Defined submission numbering practices
3. Upgrade document management systems
Sponsors must evaluate:
- DMS compatibility
- Version control practices
- Document readiness workflows
4. Train internal RA teams
eCTD requires specialized:
- Technical understanding
- Regulatory knowledge
- Publishing capabilities
5. Prepare for lifecycle submissions
India will require:
- Sequences for variations
- Replacements/submissions following ICH formats
- Clear justification and traceability
4. Opportunities for Pharmaceutical Companies
India’s transition to eCTD brings several advantages:
- Faster dossier acceptance
- Fewer deficiencies due to structured data
- Improved communication with CDSCO
- Easier global harmonization across multi-country submissions
- Reduced long-term documentation burden
Companies who begin preparations now will gain a distinct competitive advantage once eCTD becomes mandatory.
Partner with Freyr Solutions to Become Fully eCTD-Ready for India
Freyr Solutions is a global leader in eCTD submissions, publishing, and Regulatory Affairs operations, supporting 120+ countries with 2,400+ regulatory experts.
Our India-focused Regulatory Affairs team helps sponsors achieve complete eCTD readiness through:
Freyr’s India eCTD Support Services
- eCTD publishing and submission
- CTD-to-eCTD conversion and remediation
- Dossier authoring, QC, and validation
- Module 1 (India-specific) localization
- Lifecycle management (variations, renewals, responses)
- Regulatory strategy for CDSCO approvals
- DMS setup, workflow design, and compliance checks
- End-to-end Regulatory Affairs consulting for India
Whether you’re preparing an NDA, biologic, new generic, or variation, Freyr ensures fully compliant, error-free, and high-quality eCTD submissions to CDSCO.
Contact Freyr Solutions today to accelerate your Regulatory Affairs journey and prepare for India’s mandatory eCTD era.
