CDSCO Panel Flags Inadequate Data, Withholds Pilot Study Nod for BPH Pulse Field Ablation Device Parthika Patel11 Sept 2025 1:51 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO), has withheld permission for a proposed...
CDSCO Criminal Prosecution Against IndiaMART Put on Hold by Delhi HC Till Sept 17 Susmita Roy10 Sept 2025 9:51 PM ISTNew Delhi: The Delhi High Court has directed the Central Drugs Standard Control Organisation (CDSCO) not to enforce its order initiating criminal...
Novo Nordisk Gets CDSCO Panel Nod for Rybelsus Label Update, Aligned with EMA Parthika Patel10 Sept 2025 9:36 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has recommended approval of an updated...
CDSCO Eases Rules for Biopharma Research, Will Accept Lab Biosafety Committee Approvals Susmita Roy10 Sept 2025 8:31 PM ISTNew Delhi: With the aim of streamlining the regulatory process for biopharmaceutical manufacturers engaged in vaccine, recombinant DNA, and other...
Sun Pharma Fails to Secure CDSCO Nod for BE, Phase III Waiver on Sitagliptin, Glimepiride, Metformin FDC Susmita Roy7 Sept 2025 3:30 PM ISTNew Delhi: Citing the absence of supporting data for the proposed strength of the fixed-dose combination (FDC) of Sitagliptin phosphate monohydrate,...
Drug Safety Alert: IPC Flags Adverse Reactions linked to Tranexamic acid and Metoclopramide Susmita Roy7 Sept 2025 1:30 PM ISTNew Delhi: The Indian Pharmacopoeia Commission (IPC), in its latest drug safety alert for August, has reported safety signals indicating that the...
Virchow Biotech gets CDSCO panel nod to study Semaglutide for chronic weight management Susmita Roy7 Sept 2025 12:30 PM ISTNew Delhi: Recommending modifications in the protocol, the Subject Expert Committee (SEC), functional under the Central Drugs Standard Control...
CDSCO Panel Rejects Theon Pharma's Proposal for Empagliflozin, Linagliptin, Metformin FDC Susmita Roy6 Sept 2025 2:34 PM ISTNew Delhi: Raising doubts over the rationality of the fixed-dose combination (FDC) in the proposed strength and its significant benefits, the Subject...
Virchow Biotech Gets CDSCO Panel Nod for Semaglutide BE, Phase III Trials Parthika Patel6 Sept 2025 2:12 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has recommended granting permission to...
Novo Nordisk to Discontinue Multiple rDNA Insulin Products in India Parthika Patel4 Sept 2025 3:03 PM ISTThe CDSCO's expert panel consented for firm's proposal for discontinuation of products noting that alternative therapies are available in Indian...
Sun Pharma Gets CDSCO Panel Nod to Manufacture, Market Enzalutamide for Prostate Cancer Susmita Roy3 Sept 2025 1:20 PM ISTNew Delhi: The pharmaceutical major Sun Pharmaceutical Industries has received approval from the Subject Expert Committee (SEC), functional under the...
Health Ministry Drafts Rule Change to Halve Drug Trial Approval Time from 90 to 45 Days Susmita Roy2 Sept 2025 9:15 PM ISTNew Delhi: With an aim to ease the processes for preclinical and analytical drug testing, the Ministry of Health and Family Welfare has released draft...
