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  • CDSCO (Central Drugs...

CDSCO (Central Drugs Standard Control Organisation) News - Page 9

Setback to Torrent: CDSCO Panel Rejects Phase III Waiver Plea for Prucalopride Over Safety Data Gaps

Setback to Torrent: CDSCO Panel Rejects Phase III Waiver Plea for Prucalopride Over Safety Data Gaps

Susmita Roy14 Aug 2025 9:28 PM IST
New Delhi: Citing that Torrent Pharmaceuticals has not presented adequate safety data on the synergistic effect of added excipients (propylene glycol,...
CDSCO Tightens RTI Appeal Timelines, Division Heads to Face Penalties for Lapses

CDSCO Launches One-Year Online Dual Use NOC System for Bulk Drug Imports

Parthika Patel13 Aug 2025 6:07 PM IST
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has introduced a new online Dual Use No Objection Certificate (NOC) system on its...
CDSCO Panel Approves Emcures Phase III Clinical Trial of Semaglutide, Mandates Govt Trial Sites

Emcure Pharma Gets CDSCO Panel Nod for Phase III Trial of Semaglutide in Chronic Weight Management

Susmita Roy13 Aug 2025 5:39 PM IST
New Delhi: Accepting the bioequivalence (BE) study report, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control...
Sun Pharma Halol facility gets OAI status from USFDA

Sun Pharma's Phase IV Study on Dual Release Pantoprazole for GERD Gets CDSCO Panel Acceptance

Dr. Divya Colin12 Aug 2025 1:46 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has accepted the results of Sun Pharma's...
Precise Biopharma Gets CDSCO Panel Nod To Conduct Phase III Trial of Semaglutide Injection

Precise Biopharma Gets CDSCO Panel Nod To Conduct Phase III Trial of Semaglutide Injection

Susmita Roy12 Aug 2025 12:47 PM IST
New Delhi: Accepting the bioequivalence study report, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control...
CDSCO Cancels Registration Certificate of G3 Medical Systems for Import of Allergan Cosmetics

CDSCO Cancels Cosmetic Import Registration of Indian Agent for Proteos Biotech

Parthika Patel11 Aug 2025 3:45 PM IST
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has cancelled the Cosmetic Registration Certificate No. RC/COS-003595, held by NKG...
No More Physical WHO-GMP Certificate Applications After August 15: DCGI Alerts Pharma Firms

No More Physical WHO-GMP Certificate Applications After August 15: DCGI Alerts Pharma Firms

Susmita Roy11 Aug 2025 5:45 AM IST
New Delhi: Reaffirming that no further extensions will be granted, the Drugs Controller General of India (DCGI), Central Drugs Standard Control...
CDSCO Panel Accepts Glenmarks Apremilast Trial Report, Seeks 2-Year PSUR Data

CDSCO Panel Accepts Glenmark's Apremilast Trial Report, Seeks 2-Year PSUR Data

Parthika Patel10 Aug 2025 1:00 PM IST
New Delhi: Glenmark Pharmaceuticals Limited has received approval from the Subject Expert Committee (SEC), functioning under the Central Drugs...
Sun Pharma Halol facility gets OAI status from USFDA

Sun Pharma Gets CDSCO Panel Nod For Alfuzosin-Tadalafil FDC Post-Marketing Study

Dr. Divya Colin10 Aug 2025 12:30 PM IST
New Delhi: Drugmaker Sun Pharmaceutical Laboratories Ltd has been granted conditional approval by the Subject Expert Committee (SEC), under the...
AMC Flags Human Trial Violations, Refers Case to Gujarat FDCA

Abiogenesis Clinpharm To Conduct Phase III Trial of UTI Drug Phenazopyridine

Susmita Roy10 Aug 2025 11:15 AM IST
New Delhi: The Subject Expert Committee (SEC), functional under the Central Drugs Standard Control Organisation (CDSCO), has granted approval to...
Eli Lilly Inluriyo gets USFDA nod for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer

Eli Lilly Gets CDSCO Panel Nod for Ixekizumab Safety Label Update

Dr. Divya Colin9 Aug 2025 12:30 PM IST
New Delhi: Eli Lilly and Company (India) Pvt Ltd has secured regulatory clearance from the Subject Expert Committee (SEC) under the Central Drugs...
Novo Nordisk

CDSCO Panel Approves New Indications for Novo Nordisk's Semaglutide, Mandates PMS Study

Susmita Roy9 Aug 2025 12:18 PM IST
New Delhi: Recommending to conduct post marketing surveillance (PMS) study in India, the Subject Expert Committee (SEC) functional under the Central...
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Indias Unique CV Risk Profile: How to Decode the Role of Aspirin?

India's Unique CV Risk Profile: How to Decode the Role of Aspirin?

Vildagliptin-Dapagliflozin FDC Effective in High CV Risk Indian T2DM Patients: Findings from Latest DAa-ViNCI Study

Vildagliptin-Dapagliflozin FDC Effective in High CV Risk Indian T2DM Patients: Findings from Latest...

Tirzepatide proves to be more effective than semaglutide- Results of Surmount 5 Trial

Tirzepatide proves to be more effective than semaglutide- Results of Surmount 5 Trial

Pneumococcal Vaccination in Hematological Malignancies (HM)-Indian Hematology Expert Consensus 2025

Pneumococcal Vaccination in Hematological Malignancies (HM)-Indian Hematology Expert Consensus 2025

Negligence vs Misconduct: Where Do Medical Councils Draw the Line?

Negligence vs Misconduct: Where Do Medical Councils Draw the Line?

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Genome Sequencing in Newborns May Identify Life-Threatening Disorders Missed by Traditional Tests: Study Shows

Genome Sequencing in Newborns May Identify Life-Threatening Disorders Missed by Traditional Tests:...

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Health Bulletin 11/October/2025

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