For Japanese pharmaceutical companies aiming to export products to India, obtaining approval from the Central Drugs Standard Control Organisation (CDSCO) is mandatory. The process involves several key steps:
1. Application Submission: An authorized Indian agent must submit the application on behalf of the Japanese manufacturer through the CDSCO's online portal, SUGAM. This includes providing detailed information about the product and manufacturing processes.
2. Documentary Requirements: Essential documents include a Power of Attorney from the manufacturer, a Site Master File detailing the manufacturing facility, a Plant Master File, and a Free Sale Certificate from the country of origin.
3. Review and Approval: CDSCO reviews the application and may conduct inspections to verify compliance with Indian standards. Upon satisfactory evaluation, a registration certificate is issued, authorizing the import and sale of the product in India.
The timeline for this process can vary, but it typically ranges from several months to a year, depending on the complexity of the product and the completeness of the application.