Dr Reddy's Told to Justify Patient Numbers in Vonoprazan Phase IV Trial, Revise Protocol Parthika Patel16 Nov 2025 11:15 AM ISTNew Delhi: Noting that the sample size was "too small" for a Phase IV study of Vonoprazan Tablets 10 mg and 20 mg, the Subject Expert Committee (SEC)...
CDSCO Panel Asks Abbott for Proof-of-Concept Study on UDCA for Dengue Hepatic Dysfunction Parthika Patel14 Nov 2025 2:00 PM ISTNew Delhi: Raising key scientific and clinical concerns, the Subject Experts Committee (SEC) has declined to recommend the Phase III clinical trial...
CDSCO Panel Asks Zydus Lifesciences to Revise Phase I Protocol for Inactivated Chikungunya Vaccine Susmita Roy13 Nov 2025 9:01 PM ISTNew Delhi: The Subject Expert Committee (SEC) on Vaccines, under the Central Drugs Standard Control Organisation (CDSCO), has directed Zydus...
Health Ministry Notifies New CDSCO Drugs Inspector Recruitment Rules, 419 Posts Sanctioned for 2025 Susmita Roy13 Nov 2025 3:45 PM ISTNew Delhi: In a major move to strengthen the country's drug regulatory framework, the Ministry of Health and Family Welfare has notified new...
DCGI Orders Nationwide GMP Inspection Drive to Enforce Revised Schedule M Susmita Roy12 Nov 2025 10:43 PM ISTNew Delhi: The Drugs Controller General of India (DCGI) has directed all states and Union Territories to immediately launch a nationwide inspection...
Sanofi's Tetraxim Vaccine Gets CDSCO Panel Nod for Expanded Indication Susmita Roy11 Nov 2025 10:02 PM ISTNew Delhi: The Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organization (CDSCO), has approved an additional...
CDSCO Panel Clears MSN Labs' Abiraterone Acetate 1000 mg, Mandates Phase IV Trial Parthika Patel10 Nov 2025 8:38 PM ISTNew Delhi: The Subject Expert Committee (SEC) on Oncology, under the Central Drugs Standard Control Organisation (CDSCO), has recommended the grant of...
Zenvision Pharma Gets CDSCO Panel Nod to Conduct BE Study on Rifaximin Sachets Susmita Roy9 Nov 2025 12:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to...
Torrent Pharma Gets CDSCO Panel Nod to Manufacture, Market Prucalopride Oral Solution Susmita Roy7 Nov 2025 6:31 PM ISTNew Delhi: In a significant regulatory development, Torrent Pharmaceuticals has got the go-ahead from the Subject Expert Committee (SEC) under the...
Dr. Reddy's Gets CDSCO Panel Nod for BE Study on Resmetirom Tablets for NASH Treatment Susmita Roy6 Nov 2025 3:17 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Dr. Reddy's...
CDSCO Panel Approves Updated Package Insert for Johnson and Johnson's Stelara Susmita Roy5 Nov 2025 4:51 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended approval for the updated...
CDSCO Panel Approves Updated Package Insert for Takeda's Vedolizumab Susmita Roy5 Nov 2025 4:16 PM ISTNew Delhi: In a key regulatory development, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has...
