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.

1. PMDSM Division of CDSCO monitors all post-licensure activities of drugs, medical devices, and in-vitro diagnostics (IVDs) related to Adverse Events Following Immunization (AEFI), Adverse Drug Reactions (ADRs), Periodic Safety Update Reports (PSUR), and any other data on adverse reactions.
2. Conducting Subject Expert Committee meetings for Periodic Safety Update Reports of Human Vaccines and Drugs.
3. Conducting Pharmacovigilance (PV) inspections of Marketing Authorisation Holders (Manufacturers and Importers) of Human Vaccines for the audit of Pharmacovigilance sites.
4. Ensuring compliance with regulatory actions based on the recommendations of the National AEFI Committee, the Signal Review Committee of the AEFI Secretariat, and the PSUR Expert Committee.
5. Sharing line listings provided by the AEFI Secretariat with Marketing Authorisation Holders of Human Vaccines on a fortnightly and monthly basis.
6. Reviewing and processing applications for Periodic Safety Update Reports of Biologicals, Subsequent New Drugs (SND), New Drugs (ND), Fixed Dose Combinations (FDC), Imports, Medical Devices (MD), and in-vitro diagnostics (IVDs).
7. Ensuring compliance with regulatory actions based on the recommendations of the Signal Review Panel of NCC-PvPI, IPC Ghaziabad.
8. Sharing Individual Case Safety Reports (ICSRs) received from Marketing Authorization Holders (MAHs) of Drugs and Vaccines and forwarding them to the concerned Pharmacovigilance partners.
9. Conducting investigations of AEFI/ADR cases and drawing samples for testing, if required.
10. Coordinating with the AEFI Secretariat, Ministry of Health and Family Welfare (MoHFW), and the National Coordination Centre – Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission, Ghaziabad.
11. Providing all other technical assistance, including the preparation and submission of replies to RTI applications, redressal of public grievances, and execution of other activities pertaining to the division.

1. Step 1: Initial Screening

   Each PSUR submitted through the SUGAM Portal is screened against predefined risk-based criteria.

2. Step 2: Risk Categorization
   1. Low-Risk Criteria:

      A low-risk categorization indicates that the drug has an established safety track record and that no new safety signal has emerged to challenge its known benefit-risk balance.

      PSUR applications classified as Low Risk are reviewed as per the standard procedures prescribed under the Fifth Schedule of the New Drugs and Clinical Trials Rules, 2019. Upon satisfactory verification of all stipulated documents as per the PSUR Checklist, the PSUR submission may be closed without referring it to the PSUR Expert Committee. A system-generated acknowledgement email is sent to the Marketing Authorization Holder (MAH) after the application is closed by the Licensing Authority (LA).

   2. High-Risk Criteria:

      A high-risk PSUR contains data indicating a new or serious safety concern that could potentially outweigh the drug's benefits for certain patients.

      PSUR applications classified as High Risk are reviewed as per the standard procedures prescribed under the Fifth Schedule of the New Drugs and Clinical Trials Rules, 2019. Upon satisfactory verification of all stipulated documents as per the PSUR Checklist, the PSUR submission is referred to the PSUR Expert Committee for detailed review. The recommendations of the PSUR Expert Committee are communicated to the concerned MAH for compliance and closure of the application. A system-generated acknowledgement email is sent to the MAH after the application is closed by the Licensing Authority (LA).

3. Step 3: Documentation

   Any recommendations regarding regulatory actions shall be uploaded to the SUGAM Portal.

4. Step 4: PSUR Expert Committee Review
   • The PSUR submissions made by Marketing Authorization Holders (Importers/Manufacturers) through the SUGAM Portal are reviewed based on the prescribed risk-based criteria.
   • The Post Marketing Drug Safety Monitoring (PMDSM) Division convenes the PSUR Expert Committee meeting, where the MAH presents the PSUR data/report before the committee members.
   • Following detailed deliberations, the recommendations of the Committee, if any, are communicated to the MAH for compliance and subsequent closure of the PSUR application.
5. Step 5: Subsequent Regulatory Action
   • Follow-up regulatory actions are monitored and tracked until final closure.

• Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products (Version: 2.0)
• Guidance For Industry on Pharmacovigilance Requirements for Human Vaccines Version 2.0
• Guidance Document for Marketing Authorization Holders
• SUGAM Portal User Manual for PSUR Submission
• SUGAM Portal User Manual for PSUR Historical Data Submissions
• Online System for Medical Devices User Manual for PSUR Submission
• PSUR Submission Checklist
• Cioms Form