AstraZeneca Gets SEC Nod for New Trastuzumab Deruxtecan Indication in HER2-Positive Solid Tumors Parthika Patel10 Oct 2025 8:09 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has recommended approval for an additional...
No Entry Without Notice: CDSCO Directs All Drug Shipments Through Notified Ports via ICEGATE Susmita Roy10 Oct 2025 4:59 PM ISTNew Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued a directive reminding stakeholders that the import of drugs into India...
Fludrocortisone 0.2 mg Study Rejected by CDSCO Panel Over Potential Adverse Effects Susmita Roy9 Oct 2025 11:02 PM ISTNew Delhi: Noting the possible risk of expected adverse effects in healthy subjects, the Subject Expert Committee (SEC), functioning under the Central...
Unequal Trials in New Drug Approvals: CDSCO Seeks Feedback for Policy Reform Susmita Roy9 Oct 2025 9:17 PM ISTNew Delhi: With an aim to address the existing disparity between the first applicant who conducts full-scale clinical and bioequivalence (BE) studies...
After Cough Syrup Deaths, CDSCO Tightens Oversight on Drug Testing Compliance Susmita Roy8 Oct 2025 8:06 PM ISTNew Delhi: In the wake of the tragic child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups, the Central Drugs...
Exemed Pharma's Empagliflozin-Vildagliptin Combo Rejected by CDSCO Panel Over Questionable Clinical Use Susmita Roy8 Oct 2025 8:04 PM ISTNew Delhi: In a setback to Exemed Pharmaceuticals, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO)...
Ravenbhel Gets SEC Nod to Market Bilastine, Montelukast FDC, Phase IV Trial Mandated Susmita Roy8 Oct 2025 7:45 PM ISTNew Delhi: Waiving the requirement for bioequivalence (BE) and Phase III clinical trials, the Subject Expert Committee (SEC) functioning under the...
Ajanta Pharma Told to Revise BE Study Protocol for Cilnidipine, Metoprolol FDC Parthika Patel7 Oct 2025 8:30 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has reviewed the proposal by Ajanta Pharma...
Zydus Gets CDSCO Panel Nod to Market Sodium Chloride Nebuliser Solution Parthika Patel7 Oct 2025 6:21 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has recommended granting permission to...
Zydus Gets CDSCO Panel Nod for Phase III Trial of Dextromethorphan, Phenylephrine Cough Syrup FDC Susmita Roy6 Oct 2025 7:59 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has granted permission to Zydus Healthcare...
Zydus Lifesciences Secures CDSCO Panel Approval for Usnoflast Capsule Interaction Study Parthika Patel5 Oct 2025 9:30 AM ISTNew Delhi: The Subject Expert Committee (SEC) on Investigational New Drugs under CDSCO has recommended approval for Zydus Lifesciences Limited to...
CDSCO Flags MSD Pharma's Cancer Drug Trial Over Indian Representation, Control Arm Parthika Patel4 Oct 2025 4:11 PM ISTNew Delhi: The Subject Expert Committee (SEC) on Oncology under the Central Drugs Standard Control Organization (CDSCO) has raised critical concerns...
