Eris Lifesciences Secures CDSCO Panel Nod to Conduct BE Study on Dapagliflozin, Pioglitazone, Metformin FDC Susmita Roy15 Sept 2025 1:14 PM ISTNew Delhi: Eris Lifesciences has got the go ahead from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control...
Health Ministry Proposes Notification-Based Approval for Pharma Export BE Studies Instead of Central Licensing Authority Nod Susmita Roy3 Sept 2025 1:43 PM ISTNew Delhi: The Ministry of Health and Family Welfare has proposed an amendment to the New Drugs and Clinical Trials Rules, 2019 that would allow...
CDSCO Panel Allows Ravenbhel to Conduct BE, Phase III Trial of Dapagliflozin, Sacubitril, Valsartan FDC Susmita Roy1 Sept 2025 1:52 PM ISTNew Delhi: Ravenbhel Healthcare has got the go-ahead from the Subject Expert Committee (SEC), functional under the Central Drugs Standard Control...
Lupin to Conduct BE Study for Synthetic Semaglutide Tablets in 3 Strengths Parthika Patel15 Aug 2025 3:02 PM ISTNew Delhi: Lupin Limited has received the green light from the Subject Expert Committee (SEC) under the Endocrinology & Metabolism division of the...
Abbott to Conduct BE Study for Carbimazole 15 mg, Trial Waiver Granted In India Parthika Patel8 Aug 2025 2:34 PM ISTNew Delhi: Abbott Healthcare Pvt. Ltd has received the green signal from the Subject Expert Committee (SEC) under the Central Drugs Standard Control...
MSN Labs Gets CDSCO Panel Nod to Begin Phase III Trial of Cenobamate Tablets, With Safety Caveat Dr. Divya Colin5 Aug 2025 4:15 PM ISTNew Delhi: Considering the bioequivalence study results of the MSN Labs Cenobamate Tablets 12.5 mg, 25 mg, 50mg, 100 mg, 150 mg & 200 mg, the...
Expert Committee Clears Ravenbhel to Begin Resmetirom Phase 3 Trial, Asks for BE Data First Parthika Patel27 July 2025 4:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Gastroenterology and Hepatology division of the Central Drugs Standard Control Organisation...
CDSCO Panel Seeks Safety Data on 5% Lenalidomide TDS Before Clearing 8% Patch Trial Parthika Patel25 July 2025 4:38 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control Organisation (CDSCO) has not granted...
CDSCO Panel Accepts BE Report, Tells Intas Pharma to Conduct Phase III Trial for Semaglutide Dr. Divya Colin28 May 2025 3:00 PM ISTNew Delhi: In response to a proposal submitted by Intas Pharmaceuticals, the Subject Expert Committee (SEC) under the Central Drugs Standard Control...
Zydus Lifesciences gets CDSCO Panel nod to study Aprepitant powder for Oral Suspension Dr. Divya Colin20 May 2025 6:15 PM ISTNew Delhi: Granting approval for conducting a bioequivalence (BE) study of Aprepitant powder for Oral Suspension 125 mg, the Subject Expert Committee...
CDSCO Panel Rejects Morepen Laboratories' Proposal To Waive local Phase III clinical trial of Resmetirom Tablet Dr. Divya Colin18 May 2025 6:00 PM ISTNew Delhi: Rejecting the proposal for the local Phase III clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug...
Hetero Labs gets CDSCO Panel nod to study Tegoprazan tablet 50 mg Dr. Divya Colin13 May 2025 5:45 PM ISTNew Delhi: Responding to the proposal presented by Hetero Labs, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
