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...
Hetero Biopharma Gets CDSCO Panel Nod for Phase IV Trial of Denosumab Injection in Cancer Patients Parthika Patel2 Sept 2025 4:10 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) has recommended granting...
Lupin Gets Expert Committee Nod To Conduct Phase I Trial of Certolizumab Pegol, IGRA TB Test Made Mandatory Susmita Roy1 Sept 2025 4:23 PM ISTNew Delhi: Lupin has got approval from the Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), to conduct a...
CDSCO Panel Allows Ravenbhel to Conduct BE, Phase III Trial of Dapagliflozin, Sacubitril, Valsartan FDC Susmita Roy1 Sept 2025 1:52 PM ISTNew Delhi: Ravenbhel Healthcare has got the go-ahead from the Subject Expert Committee (SEC), functional under the Central Drugs Standard Control...
One Death a Day: 1,705 Lives Lost in India's Clinical Trials Since 2021, RTI Reveals Susmita Roy31 Aug 2025 2:00 PM ISTNew Delhi: In a grim reality, from 2021 till July 2025, clinical trials in India have seen 1,705 deaths and more than 7,000 serious adverse events,...
