The Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services (DGHS) on February 25, 2026 reiterated the adoption of a guidance document on dossier-based licensing of drugs for grant of manufacturing licenses across India. The guidance aims to ensure uniformity in product licensing and had earlier been shared with State/UT authorities in February 2024.
The document was discussed and agreed upon in principle during a meeting of State Regulatory Authorities held on August 29, 2023 under the chairmanship of the Secretary, Health & Family Welfare. It provides a structured checklist divided into Part A (administrative information) and Part B (technical information) required for drug approval applications. This checklist has already been integrated into the Online National Drugs Licensing System (ONDLS) portal.
The circular reiterates the need for all State/UT Licensing Authorities to adopt this standardized framework to ensure consistency and efficiency in drug licensing processes nationwide and requests confirmation of compliance and action taken.
[Notification No.: DC-DT-15011(11)/20/2026]
