Lupin Secures CDSCO Panel Clearance for Phase III COPD Inhaler Trial Parthika Patel19 Sept 2025 3:00 PM ISTNew Delhi: Lupin Limited has received recommendations from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization...
CDSCO Cancels Registration Certificate of G3 Medical Systems for Import of Allergan Cosmetics Susmita Roy19 Sept 2025 11:00 AM ISTNew Delhi: The Central Drugs Standard Control Organisation (CDSCO) has confirmed the cancellation of Registration Certificate (RC) No. RC/COS-002850,...
Lupin Secures CDSCO Panel Nod for Phase IV Trial of Budesonide-Based COPD Inhaler Parthika Patel18 Sept 2025 6:45 PM ISTNew Delhi: Lupin Limited has received recommendations from the Subject Expert Committee, under the Central Drugs Standard Control Organization (CDSCO)...
CDSCO Launches Separate Online Provision for Subsequent Importers of Medical Devices, IVDs Susmita Roy18 Sept 2025 3:00 PM ISTNew Delhi: With an aim to streamline the regulatory process for the import of medical devices and in vitro diagnostics (IVDs), the Central Drugs...
Cocrystals of Approved APIs to Be Treated as New Drugs, Clarifies CDSCO Susmita Roy17 Sept 2025 5:22 PM ISTNew Delhi: The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, has issued a clarification...
Intas Pharma Secures CDSCO Panel Approval for Post-Marketing Study of Tacrolimus Enema Susmita Roy17 Sept 2025 4:06 PM ISTNew Delhi: With the recommendation to include kidney function test (KFT) and blood pressure monitoring in the study volunteers to assess the safety,...
CDSCO Panel Asks Wockhardt to Revise Phase III Study Protocol for Nafithromycin, Seeks Dosing, Control Arm Changes Susmita Roy16 Sept 2025 8:01 PM ISTNew Delhi: The Subject Expert Committee (SEC), which functions under the Central Drugs Standard Control Organisation (CDSCO), has recommended...
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...
AstraZeneca's Proposal to Increase Sample Size in Zibotentan-Dapagliflozin Global Trial Gets SEC Nod Parthika Patel14 Sept 2025 3:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended approval of a protocol...
CDSCO Panel Nod To Phase I Clinical Trial of Anticancer Drug Bevacizumab by Jeevan Scientific Susmita Roy14 Sept 2025 11:30 AM ISTNew Delhi: Noting that the drug product is approved in the country of origin, the Subject Expert Committee (SEC), functional under the Central Drugs...
Fixed Dose Combination of Metformin-Voglibose Now CDSCO Approved Susmita Roy13 Sept 2025 6:20 PM ISTNew Delhi: The Central Drugs Standard Control Organisation (CDSCO) has clarified that the fixed-dose combination (FDC) of Voglibose 0.2 mg and...
Insufficient Efficacy, Safety Data: CDSCO Panel Rejects Zydus' Phase III CT Waiver Request for Voclosporin Susmita Roy13 Sept 2025 6:13 PM ISTNew Delhi: Citing lack of sufficient efficacy and safety data to prove that the dose requirement in the Indian population is adequate, the Subject...
