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Tag: new drugs

You Searched For "new drugs"
DCGI Told to Act Against Unapproved Antibiotic FDCs

DCGI Told to Act Against Unapproved Antibiotic FDCs

Farhat Nasim14 May 2025 7:48 PM IST
New Delhi: The Drugs Technical Advisory Board (DTAB), India's apex drug advisory body, has taken a firm stance on curbing the irrational use of...
No Free Pass: CDSCO Mandates Registration, Import License for SEZ Drugs Sold in India

CDSCO issues Revised Export NOC Guidance document for Manufacture of Unapproved, Approved New Drugs

Susmita Roy9 May 2025 6:00 PM IST
New Delhi: Through a recent notice, the Central Drugs Standard Control Organisation (CDSCO) has issued revised guidance documents for the issuance of...
Only Licensed Importers Can Overprint Labels Under Rule 104A, Clarifies CDSCO

Gastro-Resistant, Delayed-Release Drugs Now Under 'New Drug' Category

Farhat Nasim27 Feb 2025 7:55 PM IST
New Delhi: The Central Drugs Standard Control Organization (CDSCO) has directed all State and Union Territory (UT) Drugs Controllers to uniformly...
Drug alert: CDSCO flags 60 formulations as not of standard quality

CDSCO Moves Clinical Trial Site Addition, PI Change Applications to Online Platform

Farhat Nasim2 Jan 2025 2:08 PM IST
New Delhi: The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, has announced a streamlined...
Usnoflast Phase II(b) clinical trial

CDSCO Waives Local Clinical Trials for Drugs Approved in Select Countries: Health Minister

Farhat Nasim9 Dec 2024 5:19 PM IST
New Delhi: All new drugs are approved by the Central Drugs Standard Control Organization (CDSCO) without local clinical trials on case to case basis...

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