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CDSCO (Central Drugs Standard Control Organisation) News - Page 13

CDSCO Panel Approves GSKs Proposal to Double Indian Patient Pool in Dostarlimab Trial

CDSCO Panel Approves GSK's Proposal to Double Indian Patient Pool in Dostarlimab Trial

Parthika Patel15 July 2025 7:34 PM IST
New Delhi: In a recent regulatory development, the Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control...
Health Ministry Proposes Notification-Based Approval for Pharma Export BE Studies Instead of Central Licensing Authority Nod

Do Not Issue Licenses Without New Drug Permission from DCGI, Govt Panel Tells States

Farhat Nasim14 July 2025 11:28 PM IST
New Delhi: In a move to reinforce coordination between central and state drug regulatory bodies, the Drugs Consultative Committee (DCC) has called on...
Pfizer

Pfizer Gets CDSCO Panel Nod To Conduct Phase III Trial of RSV Vaccine in India, Told to Clarify Subject Criteria

Dr. Divya Colin13 July 2025 1:00 PM IST
New Delhi: Pfizer has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation...
After Cough Syrup Deaths, CDSCO Tightens Oversight on Drug Testing Compliance

Unreadable Expiry Dates, Generic Mix-Ups: Govt Panel Proposes Forming Sub-Committee on Medicine Labelling

Farhat Nasim12 July 2025 8:25 PM IST
New Delhi: In a move responding directly to widespread consumer grievances, the Drugs Consultative Committee (DCC), a statutory body under the Central...
Child Given Wrong Injection at Government Hospital

SEC Flags Safety, Efficacy Gaps in Troikaa's Rapid IV Paracetamol Bolus Proposal, Seeks More Data

Parthika Patel12 July 2025 7:59 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has declined to approve Troikaa...
Cipla Bommasandra facility gets VAI classification from USFDA

Cipla Secures CDSCO Panel Nod to Manufacture Amantadine Oral Solution with Trial Waiver

Dr. Divya Colin10 July 2025 7:05 PM IST
New Delhi: Drug major Cipla has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO Panel Recommends Phase IV Trial for Acne FDC Gel by Precise Biopharma

CDSCO Panel Recommends Phase IV Trial for Acne FDC Gel by Precise Biopharma

Parthika Patel9 July 2025 11:37 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Dermatology and Allergy division of the Central Drugs Standard Control Organisation (CDSCO)...
CDSCO Panel Asks Dr Reddys to Submit Indian Data for Triptorelin Pediatric Use

CDSCO Panel Asks Dr Reddy's to Submit Indian Data for Triptorelin Pediatric Use

Parthika Patel8 July 2025 1:45 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Endocrinology and Metabolism division of the Central Drugs Standard Control Organisation...
Madras HC Flags Licensing Gap, Says Ayurvedic Imports Must Meet Indian Drug Standards

Madras HC Flags Licensing Gap, Says Ayurvedic Imports Must Meet Indian Drug Standards

Farhat Nasim7 July 2025 7:42 PM IST
Chennai: Observing that "it is necessary for the rule-making authority to modify existing rules, prescribe standards and prepare appropriate forms in...
AstraZeneca Koselugo recommended for approval in EU for plexiform neurofibromas in adults with neurofibromatosis type 1

Expert Panel Approves Post-Marketing Surveillance Study of Eculizumab (Soliris) by AstraZeneca in India

Dr. Divya Colin6 July 2025 3:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to...
Braille Labels, QR Code Voice Assistance on Drugs? CDSCO Seeks Stakeholder Comments

Govt Panel Proposes Braille Cards, Voice-Enabled QR Codes on Medicine Packs to Aid Visually Impaired

Farhat Nasim6 July 2025 11:30 AM IST
New Delhi: In a move aimed at improving accessibility for the visually impaired, the Drugs Consultative Committee (DCC) has recommended placing the...
Pfizers Abrocitinib Phase III Data Accepted by CDSCO Expert Committee

Pfizer's Abrocitinib Phase III Data Accepted by CDSCO Expert Committee

Parthika Patel6 July 2025 10:00 AM IST
New Delhi: The Subject Expert Committee (SEC) under the Dermatology and Allergy division of the Central Drugs Standard Control Organisation (CDSCO)...
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