Central Drugs Standard Control Organization (CDSCO) has issued a notice on 26.Feb.2024 stating that the stakeholders can submit applications for PSURs (Period Safety Update Reports) in relation to Marketing Authorization for New Drugs/Subsequent New Drugs(SND)/ Fixed Dose Combinations(FDC)/ Biologicals/Veterinary by using the Sugam portal at www.cdscoonline.gov.in online system.
It is now possible to submit applications for PSURs (Period Safety Update Reports) in relation to Marketing Authorization for New Drugs/Subsequent New Drugs(SND)/ Fixed Dose Combinations(FDC)/ Biologicals/Veterinary by using the Sugam portal at www.cdscoonline.gov.in online system. PSURs must be submitted online as per the checklist on the Portal. Applications can be submitted offline in hard copy or in any other format, but they will not be processed after 11.03.2024.