What is the process to obtain an import drug license in India?
What is the process to obtain an import drug license in India?
To obtain an import drug license in India, applicants must submit a completed Form 8 application to the Central Drugs Standard Control Organization (CDSCO) along with required documents, including a manufacturing license, product registration certificates, and labeling details. The CDSCO evaluates the application for compliance with the Drugs and Cosmetics Act. Following a successful review, the license is issued. Additionally, the applicant must pay the requisite fees. Importers must comply with regulatory standards to ensure product safety and efficacy.