For Ethiopian companies aiming to export pharmaceutical products to India, obtaining registration with the Central Drugs Standard Control Organisation (CDSCO) is mandatory. The process involves several key steps:
1. Application Submission: Companies must register on the CDSCO SUGAM portal, providing details about the applicant and the products intended for import.
2. Document Submission: Essential documents include the Certificate of Pharmaceutical Product (COPP), Good Manufacturing Practice (GMP) certificate, free sale certificate, and a power of attorney.
3. Review and Approval: CDSCO reviews the application and may conduct inspections to ensure compliance with Indian standards.
4. License Issuance: Upon successful evaluation, CDSCO issues the necessary import license, authorizing the company to export pharmaceutical products to India.
The entire process can take several months, depending on the completeness of the application and the efficiency of the review process.