For Turkish pharmaceutical companies aiming to export to India, obtaining registration from the Central Drugs Standard Control Organisation (CDSCO) is mandatory. The process involves several key steps:
1. Application Submission: Companies must register on the CDSCO's SUGAM portal, providing details about the applicant and the products intended for import.
2. Document Submission: Essential documents include the applicant's identity and address proofs, a copy of the site registration for Bioavailability (BA) or Bioequivalence (BE) studies, and an undertaking granted by a government authority for the registration of tests, drugs, or medical devices.
3. Verification and Approval: Upon submission, the application undergoes verification by CDSCO officials. This may involve site inspections and consultations with subject-matter experts to assess the safety and efficacy of the products.
4. License Issuance: If the products meet the required standards, CDSCO grants the necessary licenses, authorizing the import and distribution of the pharmaceutical products in India.
The entire process can take several months, depending on the complexity of the products and the completeness of the submitted documentation.
