For Indonesian pharmaceutical companies seeking to export products to India, obtaining approval from the Central Drugs Standard Control Organisation (CDSCO) is mandatory. The registration process involves several steps:
1. Online Application: Applicants must register on the CDSCO's online portal, providing details about the company and the products intended for import.
2. Document Submission: Essential documents include a Certificate of Pharmaceutical Product (COPP) from the country of origin, a Good Manufacturing Practice (GMP) certificate, and a free sale certificate.
3. Review and Approval: CDSCO reviews the submitted documents to ensure compliance with Indian standards. This may involve site inspections and additional documentation requests.
4. Import License Issuance: Upon successful evaluation, CDSCO issues an import license, authorizing the company to import and distribute the pharmaceutical products in India.
The entire process can take several months, depending on the completeness of the application and the nature of the products.
