CDSCO publishes new draft guidance on pharmacovigilance requirements for vaccines

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance for the pharmaceutical industry on pharmacovigilance requirements for human vaccines. Stakeholders have been invited to submit suggestions, objections, and comments within 15 days. The draft, issued on May 29, 2024, aligns with the New Drugs and Clinical Trial Rules (NDCTR), 2019.

The guidance, titled "Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines, Version 2.0," was developed in consultation with the Adverse Events Following Immunization (AEFI) Secretariat and the Indian Pharmacopoeia Commission's (IPC) Pharmacovigilance Programme of India (PvPI).

It aims to assist stakeholders, including Marketing Authorization Holders, in Vaccine Safety Monitoring, Audits and Inspection, Risk Management Plan (RMP) implementation, and the periodic submission of Risk-Benefit Evaluation Reports to the Licensing Authority.

The document emphasizes the need for effective pharmacovigilance systems to ensure patient safety across the vaccine product lifecycle.