Wockhardt Gets Expert Panel Nod for Phase III Study of Recombinant Insulin Aspart 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 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 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 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 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 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 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 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...
No Ads for High-Risk Medicines: Govt Panel Recommends Major Amendments to Drugs Rules 1945 Susmita Roy8 Dec 2025 12:15 PM ISTNew Delhi: In a significant move aimed at tightening regulatory control over the promotion of high-risk medicines, the Drugs Consultative Committee...
MSD Pharma Gets Conditional SEC Approval to Begin Phase III Trial of Sacituzumab Tirumotecan Susmita Roy7 Dec 2025 11:08 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to MSD...
WHO Alert Spurs India's Probe Into Deadly Cough Syrup, Licence Cancelled, 700 Plus Units Audited, Parliament Informed Susmita Roy6 Dec 2025 11:22 PM ISTNew Delhi: In response to the World Health Organization's alert of 13 October 2025 on contaminated cough syrups linked to child deaths, the Union...
CDSCO Panel Seeks Protocol Revisions in Levim Lifetech's Teriparatide Biosimilar Study Susmita Roy6 Dec 2025 11:02 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has opined that LevimLifetech revise the...
