CDSCO Alert: 64 Drug Batches Including Metformin, Paracetamol Declared Not of Standard Quality in November Written By Susmita Roy20 Dec 2025 6:36 PM ISTNew Delhi: In a strong reminder of persistent quality concerns in India's pharmaceutical supply chain, 64 batches of drugs and medical products have...
CDSCO Expert Panel Backs Akums' Faropenem Dispersible Tablets, Grants CT, BE Waivers Written By Parthika Patel19 Dec 2025 8:30 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to...
Novo Nordisk Gets CDSCO Panel Nod to Conduct India-Specific PMS Studies on Somapacitan Written By Susmita Roy17 Dec 2025 9:04 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Novo Nordisk India...
Sun Pharma Asked to Resubmit Revised Phase III Protocol for Delafloxacin CABP Trial Written By Parthika Patel16 Dec 2025 8:00 PM ISTNew Delhi: In a significant regulatory decision, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO)...
Wockhardt Gets Expert Panel Nod for Phase III Study of Recombinant Insulin Aspart Written By Susmita Roy15 Dec 2025 2:45 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to...
CDSCO Panel Seeks Revised Phase IV Study for Zydus' Empagliflozin, Metformin FDC Written By Susmita Roy15 Dec 2025 1:30 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), has asked Zydus Healthcare...
Novo Nordisk Gets CDSCO Panel Nod to Update Wegovy Label With New Safety, Pharmacodynamics Data Written By Susmita Roy14 Dec 2025 12:43 AM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended granting approval to Novo...
Govt Panel Proposes Separate Licensing System for Bulk Drugs and Excipients Wholesalers Written By Susmita Roy11 Dec 2025 2:07 PM ISTNew Delhi: In a move aimed at improving regulatory oversight of bulk drugs and excipients, the Drugs Consultative Committee (DCC) has agreed to...
CDSCO Panel Flags Gaps in Serum Institute's rBCG Vaccine Data, Calls for Stronger Trial Written By Parthika Patel10 Dec 2025 5:20 PM ISTNew Delhi: Serum Institute of India's proposal for its Recombinant BCG (rBCG) Vaccine for Tuberculosis has hit a regulatory hurdle, as the Special...
CDSCO Committee Seeks Efficacy-Focused Redesign of Intas' Pembrolizumab Clinical Trial Written By Susmita Roy9 Dec 2025 6:45 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has advised Intas Pharmaceuticals to...
CDSCO Panel Rejects Hetero Lab's Plea for Lenacapavir Approval Without Local Trials Written By Parthika Patel9 Dec 2025 3:12 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has declined the proposal submitted by...
Sun Pharma Told to Revise Delafloxacin Phase III Trial Protocol Written By Parthika Patel8 Dec 2025 7:01 PM ISTNew Delhi: The Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), has directed Sun Pharma Laboratories...
