The Subject Expert Committee (SEC) on Antimicrobial & Antiparasitic has asked M/s Emcure Pharmaceuticals Limited to revise its proposed Active Post-Marketing Surveillance (PMS) protocol for Liposomal Amphotericin B Injection 50 mg/vial (Lyophilized) before it can be considered further.
The recommendation was made during the 6th SEC (Antimicrobial & Antiparasitic) meeting of 2026, held on June 11, 2026, at the Central Drugs Standard Control Organization (CDSCO) headquarters in New Delhi.
During the meeting, Emcure Pharmaceuticals presented an amended Active PMS protocol, Protocol No. CT/22/010, Version 1.0 dated February 24, 2026, for evaluation by the committee. The proposed surveillance study is intended to collect real-world safety and effectiveness data on the company's Liposomal Amphotericin B Injection marketed under the brand name TRASPOR®.
After reviewing the proposal in detail, the committee identified several areas requiring modification and recommended key changes to the study design.
According to the SEC, the second inclusion criterion should be revised to ensure that only patients enrolled prospectively are included in the study. The committee emphasized that patients who are already receiving treatment with Liposomal Amphotericin B Injection should not be enrolled retrospectively.
The committee also recommended changes to the fourth exclusion criterion. The existing criterion proposed exclusion of patients who had received Amphotericin B formulations other than TRASPOR® within the previous six weeks. However, the SEC advised that the protocol should be revised to exclude all patients who are already undergoing treatment with any Amphotericin B preparation, irrespective of the brand or formulation used.
In addition, the expert panel noted that the proposed study indication should be aligned with disease burden and epidemiological data available from the National Centre for Disease Control (NCDC). Based on such data, the committee further recommended increasing the study sample size to ensure the surveillance program generates robust and meaningful evidence.
Following these observations, the SEC concluded that the protocol requires substantial revision before it can be assessed further. The committee directed Emcure Pharmaceuticals to submit a revised Active PMS protocol incorporating all recommended changes for re-evaluation in a future meeting.
