Govt Panel Makes This Approval Mandatory For New Drug Licenses Farhat Nasim5 July 2025 4:44 PM ISTNew Delhi: Raising serious regulatory concerns, the apex statutory body under the Central Drugs Standard Control Organisation (CDSCO), the Drugs...
CDSCO Panel Asks Glenmark To Justify BE Waiver for FDC Inhalation Suspension With Scientific Evidence Dr. Divya Colin5 July 2025 3:36 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has advised Glenmark...
Sun Pharma Gets SEC Nod to Begin Phase III Trial of Cough Drug Gefapixant Dr. Divya Colin5 July 2025 3:21 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended granting...
Pfizer Told To Conduct Phase IV Trial of Abrocitinib in Indian Adolescents with Atopic Dermatitis Parthika Patel4 July 2025 3:00 PM ISTNew Delhi: In a recent regulatory development, the Subject Expert Committee (SEC) under the Dermatology and Allergy division of the Central Drugs...
Submit Full Adverse Event Data from Lenvatinib Phase IV Liver Cancer Trial: CDSCO Panel To Eisai Pharma Parthika Patel4 July 2025 1:00 PM ISTNew Delhi: In a recent regulatory review, the Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control...
High-Alcohol Medicinal Preparations to Come Under Schedule H1: Govt Panel Approves Rule Change Farhat Nasim4 July 2025 12:00 PM ISTNew Delhi: The Drugs Consultative Committee (DCC) has agreed to amend the Drugs Rules, 1945 to regulate the alcohol content in tinctures and other...
Delhi HC Flags Off-Label Use of Diabetes Drugs for Weight Loss, Seeks CDSCO Report Farhat Nasim3 July 2025 9:27 PM ISTNew Delhi: The Delhi High Court has directed the Central Drugs Standard Control Organisation (CDSCO) and the Drug Controller General of India (DCGI)...
Sun Pharma Gets CDSCO Panel Go-Ahead to Manufacture, Market Relugolix, Estradiol, Norethindrone Acetate FDC Parthika Patel2 July 2025 5:01 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Reproductive division of the Central Drugs Standard Control Organization (CDSCO) has...
DCC Recommends Licensing, Labelling Restrictions on Anti-TB Drugs to Curb Private Market Misuse Farhat Nasim1 July 2025 11:07 PM ISTNew Delhi: In a move to curb potential misuse of critical tuberculosis medications, the Drugs Consultative Committee (DCC) has recommended that...
Hetero Labs' Acarbose-Sitagliptin-Metformin FDC Rejected by CDSCO Panel Over GI Risk Dr. Divya Colin30 Jun 2025 5:45 PM ISTNew Delhi: In a setback to Hetero Labs Limited, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation...
CDSCO Clears Abbott's phase IV Trial Of Dydrogesterone MR Tablet Parthika Patel30 Jun 2025 2:53 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Reproductive division of the Central Drugs Standard Control Organization (CDSCO) has approved...
Intas Gets SEC Nod to Import, Market Anti-Cancer Drug Serplulimab, Phase IV Trial Mandated Dr. Divya Colin29 Jun 2025 1:00 PM ISTNew Delhi: Intas Pharmaceutical has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
