Import of pharmaceutical products into India is regulated under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945. Overseas manufacturers intending to market drugs in India must obtain the appropriate import registration and import licence through CDSCO. Vaayath provides complete regulatory support from documentation and dossier preparation to regulatory submissions and post approval compliance.
What we deliver
- Import Registration Certificate — Support for obtaining Registration Certificates for foreign manufacturing sites and products.
- Import Licence — Preparation and filing of import licence applications with CDSCO.
- Documentation Review — Review of technical documents before submission.
- Dossier Preparation — Preparation of complete regulatory dossiers.
- Power of Attorney Review — Preparation and legalization support.
- GMP Documentation Review — Review of GMP certificates and inspection documentation.
- Product Permission Strategy — Assessment of applicable regulatory pathway.
- CDSCO Query Response — Preparation of technical responses.
- Post Approval Support — Amendments, Additional products, Renewals and Variations.
Our Approach
Regulatory Assessment
Evaluate product category, applicable provisions and licensing requirements.
Documentation
Prepare regulatory dossiers, technical documents and application forms.
Submission
Electronic filing and regulatory coordination with CDSCO.
Post Approval Compliance
Import licence amendments, renewals and ongoing compliance support.
Who this is for
Our Expertise Covers
We support regulatory import approvals across a broad spectrum of pharmaceutical products:
Why Choose Vaayath
- 20+ Years Regulatory Experience
- Import Registration Specialists
- Technical Documentation Support
- Query Management
- Lifecycle Compliance