CDSCO Import Licensing
Strategic Drug & Cosmetics Regulatory Support by Kafka Consultings LLP — designed to secure CDSCO approvals smoothly, ensure compliant imports, and safeguard your business from regulatory actions, shipment holds, and market access barriers.
- CDSCO Applicability & Product Classification
- Import License & Registration Application Filing
- Documentation & Dossier Preparation
- Coordination with CDSCO & Testing Authorities
- Post-Approval Compliance & Renewal Advisory
- Free Consultation with a Pharma Regulatory Expert
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Imports of drugs, cosmetics, medical devices, diagnostics, and notified health products into India are regulated under a highly controlled statutory framework. Any lapse in approval, registration, or documentation under CDSCO leads to immediate customs hold, testing orders, rejection, or re-export.
At Kafka Consulting LLP, CDSCO compliance is handled as a pre-import regulatory architecture, ensuring your products are legally admissible, port-ready, and audit-defensible before shipment dispatch.
CDSCO approvals are documentation-intensive and coordination-heavy, involving overseas manufacturers, Indian importers, testing norms, and port health authorities.
Product classification under CDSCO schedules & device rules
Applicability assessment (drug vs cosmetic vs device)
Overseas manufacturer documentation coordination
Dossier & technical document structuring
Online filing via CDSCO / SUGAM portal
Label compliance advisory (India-specific requirements)
Coordination for clarifications & deficiency responses
Import readiness advisory post-approval
Documents Required
Typical documentation includes:
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