CDSCO Panel Seeks Revised Protocol for Green Signal's BCG Vaccine PMS Study
Written By : Dr. Kamal Kant Kohli
Published On 2025-06-05 05:15 GMT | Update On 2025-06-05 05:15 GMT
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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.
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