Alkem Labs Gets CDSCO Panel Nod for conducting Phase III study of Semaglutide tablet Susmita Roy14 Oct 2025 5:23 PM ISTNew Delhi: Alkem Laboratories has got the go-ahead from the Subject Expert Committee (SEC), functioning under the Central Drug Standard Control...
Reliance Life Sciences Gets CDSCO Panel Nod for Phase I/III Trial of Biosimilar Nivolumab Parthika Patel14 Oct 2025 5:09 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has granted approval to Reliance Life...
SEC Asks Enzene Biosciences to Revise Phase III Trial Protocol for Nivolumab Biosimilar Parthika Patel12 Oct 2025 10:30 AM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has asked Enzene Biosciences Ltd to revise...
Ongoing Sale of Covid-Era Liposomal Amphotericin B Challenged, SC Seeks Response from Top Pharma Firms, DCGI Susmita Roy11 Oct 2025 11:39 PM ISTNew Delhi: The Supreme Court has sought responses from the Union of India, the Drug Controller General of India (DCGI), and several leading...
CDSCO Orders Nationwide Audit of Cough Syrup Makers After Fatal Toxic Syrup Scare Susmita Roy11 Oct 2025 9:53 PM ISTNew Delhi: Amid a chilling surge in child deaths linked to contaminated cough syrups, the Central Drugs Standard Control Organization (CDSCO) has...
CDSCO Panel seeks clarifications from Novo Nordisk on IcoSema phase IIIb clinical study protocol Susmita Roy11 Oct 2025 9:46 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has opined that Novo Nordisk India should...
CDSCO Panel Seeks More Safety Data from Raptim Research on Lenalidomide Patch Parthika Patel11 Oct 2025 1:41 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has asked Raptim Research Pvt Ltd to...
AstraZeneca Gets SEC Nod for New Trastuzumab Deruxtecan Indication in HER2-Positive Solid Tumors Parthika Patel10 Oct 2025 8:09 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has recommended approval for an additional...
No Entry Without Notice: CDSCO Directs All Drug Shipments Through Notified Ports via ICEGATE Susmita Roy10 Oct 2025 4:59 PM ISTNew Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued a directive reminding stakeholders that the import of drugs into India...
Fludrocortisone 0.2 mg Study Rejected by CDSCO Panel Over Potential Adverse Effects Susmita Roy9 Oct 2025 11:02 PM ISTNew Delhi: Noting the possible risk of expected adverse effects in healthy subjects, the Subject Expert Committee (SEC), functioning under the Central...
Unequal Trials in New Drug Approvals: CDSCO Seeks Feedback for Policy Reform Susmita Roy9 Oct 2025 9:17 PM ISTNew Delhi: With an aim to address the existing disparity between the first applicant who conducts full-scale clinical and bioequivalence (BE) studies...
After Cough Syrup Deaths, CDSCO Tightens Oversight on Drug Testing Compliance Susmita Roy8 Oct 2025 8:06 PM ISTNew Delhi: In the wake of the tragic child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups, the Central Drugs...
