Notification / Circular No.: F. No. DC-DT-15011(11)/20/2026 dated February 25, 2026
Applicable Act / Rule: Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945
This communication refers to the earlier guidance document on dossier-based licensing of drugs circulated vide email dated February 12, 2024 for uniform product licensing across the country. The guidance was also presented in the meeting of State Regulatory Authorities held on August 29, 2023, at CDSCO (HQ), where States/UTs agreed in principle to adopt the same for ensuring uniformity in licensing practices.
The Central Drugs Standard Control Organisation has reiterated adoption of the “Guidance Document for submission of application for obtaining Manufacturing License by the Applicant based on Dossier based licensing of Drugs” for uniform implementation across all States/UTs.
The guidance document provides a structured checklist-based approach for grant/renewal of manufacturing licences, divided into:
The checklist has been incorporated in the Online National Drugs Licensing System (ONDLS) portal for processing manufacturing licence applications.
All State/UT Licensing Authorities are advised to adopt and implement the guidance document to ensure:
Authorities are requested to acknowledge receipt and update action taken in this regard.
Disclaimer: The information contained in this Article is intended solely for personal non-commercial use of the user who accepts full responsibility of its use. The information in the article is general in nature and should not be considered to be legal, tax, accounting, consulting or any other professional advice. We make no representation or warranty of any kind, express or implied regarding the accuracy, adequacy, reliability or completeness of any information on our page/article.