The Subject Expert Committee (SEC) on Antimicrobial & Antiparasitic has asked 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 meeting of 2026 held on June 11 at the Central Drugs Standard Control Organization (CDSCO) headquarters in New Delhi.
During the meeting, Emcure Pharmaceuticals presented an amended Active PMS protocol, identified as Protocol No. CT/22/010 Version 1.0 dated February 24, 2026. The surveillance study has been designed to generate real-world data on the safety and effectiveness of the company’s Liposomal Amphotericin B Injection marketed under the brand name TRASPOR®.
After reviewing the proposal, the expert committee identified several areas that require modification. One of the key observations was related to patient enrollment. The SEC recommended revising the second inclusion criterion to ensure that only patients enrolled prospectively are included in the study. According to the committee, patients who have already started treatment with Liposomal Amphotericin B should not be enrolled retrospectively, as this could affect the quality and reliability of the data collected.
The committee also proposed changes to the fourth exclusion criterion. The existing protocol suggested excluding patients who had received Amphotericin B formulations other than TRASPOR® within the previous six weeks. However, the SEC advised broadening this criterion to exclude all patients already receiving treatment with any Amphotericin B formulation, regardless of the brand or product type. This change is intended to ensure that study outcomes accurately reflect the safety and effectiveness profile of TRASPOR® without interference from prior or ongoing antifungal therapies.
In addition, the committee emphasized the need to align the study indication with disease burden and epidemiological data available from the National Centre for Disease Control (NCDC). Such alignment would help ensure that the surveillance program reflects real-world treatment patterns and addresses areas of significant clinical need.
The SEC further noted that the proposed sample size should be increased. A larger study population would provide more robust evidence regarding the safety and effectiveness of the product and strengthen the overall value of the surveillance program. Adequate sample size is particularly important in post-marketing studies, where data generated can support clinical decision-making and ongoing pharmacovigilance efforts.
Liposomal Amphotericin B is an important antifungal therapy used in the treatment of serious fungal infections, including invasive fungal diseases. Given its critical role in managing severe infections, comprehensive post-marketing monitoring is essential to evaluate its performance in routine clinical practice.
Following its review, the committee concluded that the protocol requires substantial revisions before further consideration. Emcure Pharmaceuticals has been directed to submit a revised Active PMS protocol incorporating all recommended changes for re-evaluation in a future SEC meeting.
The decision highlights CDSCO’s continued focus on ensuring scientifically robust post-marketing studies that generate reliable real-world evidence to support patient safety and effective use of medicines in India.
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