Central Drugs Standard Control Organisation- CDSCO

Key Responsibilities

• Prepare, review, and submit applications for product registrations, import licenses, manufacturing licenses, and other regulatory approvals through the CDSCO portal.
• Coordinate with CDSCO officials and relevant authorities regarding approvals, queries, and compliance requirements.
• Maintain and update regulatory documentation, licenses, certificates, and approval records.
• Monitor changes in CDSCO regulations, notifications, and guidelines and ensure timely implementation.
• Prepare technical dossiers and supporting documents as per regulatory requirements.
• Track application status and ensure timely follow-up for approvals and renewals.
• Coordinate with clients, manufacturers, laboratories, and internal departments for documentation and compliance activities.
• Review product labels, packaging, and technical documents for regulatory compliance.
• Support audits, inspections, and regulatory assessments.
• Ensure compliance with applicable rules under the Drugs and Cosmetics Act and related regulations.