Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

PSUR/PV/AEFI

Drugs and Cosmetics Act 1940 & Rules thereunder is amended vide Gazette notification vide G.S.R No. 227 (E) dated 19th March 2019 mandating all manufacturers and importers of Vaccine for setting up of the Pharmacovigilance system within their organization as per Fifth Schedule r/w Rule 77 and 82 of New Drugs and Clinical Trial Rules 2019 of Drugs and Cosmetics Act & amp which states as under -Post Marketing Surveillance-

  • Drugs and Cosmetics Act 1940 & Rules thereunder is amended vide Gazette notification vide G.S.R No. 227 (E) dated 19th March 2019 mandating all manufacturers and importers of Vaccine for setting up of the Pharmacovigilance system within their organization as per Fifth Schedule r/w Rule 77 and 82 of New Drugs and Clinical Trial Rules 2019 of Drugs and Cosmetics Act & amp which states as under -Post Marketing Surveillance-
    The applicant shall have a Pharmacovigilance system in place for collecting, processing and forwarding the report to the licensing authority for information on adverse drug reactions emerging from the use of the drug imported or manufactured or marketed by the applicant in the country.
    • The system shall be managed by qualified and trained personnel and the officer in-charge of collection and processing of data shall be a medical officer or a pharmacist trained in collection and analysis of adverse drug reaction reports.
    • Subsequent to approval of the product, vaccine shall be closely monitored for its clinical safety once it is marketed.
    • The applicant shall furnish Periodic Safety Update Reports (PSURs) in order to-
      • Report all relevant new information from appropriate sources;
      • relate the data to patient exposure;
      • summarise the market authorization status in different countries and any significant variations related to safety; and
      • indicate whether changes shall be made to product information in order to optimize the use of product.
S.no Title Release Date Download Pdf Pdf Size
1 Circular regarding submission of online application of PSURs with respect to the MA of New Drugs/SNDs/FDCs/Biologicals/Veterinary Products 2024-Jun-25 507 KB
2 PSUR committee meeting detail for website updation 2024-May-15 7kb
3 PSUR_Medical device circular 2024-Mar-19 474kb
4 Online application of PSUR submission 2024-Feb-26 262kb