CDSCO Seeks Feedback On Revised Vaccine Pharmacovigilance Guidelines

The Central Drugs Standard Control Organization (CDSCO) is seeking industry input on a revised version (version 2.0) of its “Guidance for Industry on Pharmacovigilance requirements for Human Vaccines”. A notice to this effect was issued on May 29, 2024.

This draft guidance aims to align with the New Drugs and Clinical Trials Rules, 2019.

The CDSCO has invited stakeholders to submit suggestions, comments, or objections on the draft document.

Important Information On Submissions:

  • Deadline for submissions: June 13, 2024,
  • Submission method: Email to
  • Justification required: All submissions must be accompanied by valid justifications for proposed changes.

The CDSCO will consider all feedback received within the deadline to finalize the draft guidance document.