CDSCO Panel Seeks Revised Protocol for Green Signal's BCG Vaccine PMS Study
New Delhi: The Subject Expert Committee (SEC) on Vaccines, operating under the Central Drugs Standard Control Organization (CDSCO), has reviewed the post-marketing surveillance (PMS) study protocol submitted by Green Signal Bio Pharma Pvt Ltd for its BCG Vaccine (Freeze-Dried) I.P.
The review was conducted during the SEC meeting held on May 22, 2025, in hybrid mode. The proposed study, titled “An open-label, prospective, multicentre, single-arm, single-treatment, single-dose post-marketing surveillance study to evaluate the safety and tolerability of BCG Vaccine (Freeze-Dried) I.P.” (Protocol No. VAC-11012(11)/1/2025, eOffice E.No 22852), aims to generate real-world safety data to support post-approval pharmacovigilance.
Following detailed deliberations, the committee recommended that the firm submit a revised study protocol with the following key modifications:
Inclusion Criteria: The protocol should be revised to include only individuals who have not previously received the BCG vaccine.
Sample Size: The sample size should be clearly specified across two distinct cohorts—children below 1 year of age, and those 1 year or older.
Tuberculin Testing: The target population for the skin tuberculin test must be clearly defined within the study design.
