CDSCO Issues Revised Guidance on Common Submission Format for Import and Registration of Bulk Drugs and Finished Formulations in India

The Central Drugs Standard Control Organization (CDSCO) has released a revised guidance document governing the import and registration of bulk drugs (APIs) and finished formulations for human use in India. The document aligns existing regulatory requirements under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945 with the current online SUGAM submission system. It outlines procedures for obtaining Registration Certificates (Form 41), Import Licenses (Form 10/10A), and Post Approval Changes (PACs), along with comprehensive documentation requirements, fee structures, timelines, stability data expectations, labeling requirements, and compliance obligations. The guidance also clarifies procedures for special situations such as imports with residual shelf life below 60%, overprinting/stickering permissions under Rule 104A, further packing permissions under Rule 37, and charitable hospital imports under Rule 36A. The document is intended to improve transparency, consistency, and regulatory compliance for stakeholders involved in drug importation into India.