Starting March 11, 2024, the process for submitting Periodic Safety Update Reports (PSURs) regarding Marketing Authorization of New Drugs, Subsequent New Drugs (SND), Fixed Dose Combinations (FDC), Biologicals, and Veterinary products must be made online via the Sugam portal at www.cdscoonline.gov.in.   

Offline submissions in hard copy or any other mode will no longer be available after this date.

This online system aims to streamline the regulatory submission procedure, making it easier and more convenient for all stakeholders.  

Access the official notification from here.

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