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CDSCO (Central Drugs Standard Control Organisation) News

CDSCO Panel Flags Ethnic Variability, Seeks More Data from Takeda for Fruquintinib Hard Capsule Approval

CDSCO Panel Flags Ethnic Variability, Seeks More Data from Takeda for Fruquintinib Hard Capsule Approval

Susmita Roy3 Feb 2026 1:45 PM IST
New Delhi: Following a detailed evaluation of global Phase III clinical data and safety findings of Fruquintinib 1 mg and 5 mg Hard capsule, the...
CDSCO Clears Eyestems Phase II Trial for Stem Cell Therapy Eyecyte-RPE in Dry AMD

CDSCO Clears Eyestem's Phase II Trial for Stem Cell Therapy Eyecyte-RPE in Dry AMD

sheeba farhat28 Jan 2026 5:11 PM IST
New Delhi: Eyestem Research Pvt Ltd, a biotechnology company developing advanced scalable cell therapy solutions for blindness caused by dry...
From Teriparatide to Pembrolizumab: CDSCO Clears Import of r-DNA Drugs via CT-18 Route

From Teriparatide to Pembrolizumab: CDSCO Clears Import of r-DNA Drugs via CT-18 Route

Susmita Roy26 Jan 2026 1:58 PM IST
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has granted multiple CT-18 approvals between January 2020 and December 2025 for...
CDSCO Panel Grants Go Ahead for Levim Lifetechs Phase I/III Teriparatide Trial

CDSCO Panel Grants Go Ahead for Levim Lifetech's Phase I/III Teriparatide Trial

Susmita Roy26 Jan 2026 1:46 PM IST
New Delhi: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended grant of permission to Levim...
Macleods Gets CDSCO Panel Nod to Conduct BE Studies for Semaglutide Prefilled Pens

Macleods Gets CDSCO Panel Nod to Conduct BE Studies for Semaglutide Prefilled Pens

Susmita Roy25 Jan 2026 11:36 PM IST
New Delhi: Accepting the toxicity data submitted by Macleods Pharmaceuticals, the Subject Expert Committee (SEC) functioning under the Central Drugs...
CDSCO Finds 93 Medicines Samples Substandard, Key Antibiotics, Chronic Drugs Affected

CDSCO Finds 93 Medicines Samples Substandard, Key Antibiotics, Chronic Drugs Affected

Susmita Roy25 Jan 2026 3:00 PM IST
New Delhi: Highlighting continuing concerns over drug quality in India's pharmaceutical supply chain, the Central Drugs Standard Control Organisation...
CDSCO Clears Over 100 rDNA Drugs and Biologics Between 2020-25, Boosting Access to Advanced Therapies

CDSCO Clears Over 100 rDNA Drugs and Biologics Between 2020-25, Boosting Access to Advanced Therapies

Susmita Roy23 Jan 2026 5:09 PM IST
New Delhi: India's drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has approved a wide range of recombinant DNA...
CDSCO Flags 7 Batches of Popular Medicines as Purportedly Spurious in December

CDSCO Flags 7 Batches of Popular Medicines as Purportedly Spurious in December

Susmita Roy23 Jan 2026 3:51 PM IST
New Delhi: In a disclosure that raises serious concerns over drug authenticity and patient safety, the Central Drugs Standard Control Organisation...
CDSCO Declares 74 Medicines, APIs and Devices Samples Not of Standard Quality in December

CDSCO Flags 74 Drugs, Devices Samples as NSQ in December: Zerodol-SP, Defcort, Telmisartan, Amikacin Among Failed Products

Susmita Roy22 Jan 2026 7:18 PM IST
New Delhi: As part of a nationwide quality surveillance drive, the Central Drugs Standard Control Organisation (CDSCO) has flagged 74 drugs,...
CDSCO to Reject Long-Pending SUGAM Applications After 30 Days for Non-Response to Queries

CDSCO to Reject Long-Pending SUGAM Applications After 30 Days for Non-Response to Queries

Susmita Roy18 Jan 2026 5:58 PM IST
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has announced that it will dispose of and reject long-pending applications...
Johnson and Johnson Gets CDSCO Panel Nod for Talqetamab in Relapsed Multiple Myeloma, Phase IV Trial Mandated

Johnson and Johnson Gets CDSCO Panel Nod for Talqetamab in Relapsed Multiple Myeloma, Phase IV Trial Mandated

Parthika Patel15 Jan 2026 10:56 PM IST
New Delhi: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended grant of permission to...
CDSCO, DoP Told to Find Workable Solution on Revised Schedule M GMP Concerns

Health Ministry Appoints Two New Drug Inspectors Under Drugs and Cosmetics Act

Susmita Roy14 Jan 2026 10:30 AM IST
New Delhi: The Union Ministry of Health and Family Welfare has appointed two new inspectors under the Drugs and Cosmetics Act, 1940, authorizing them...
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Editorial

Efficacy and Safety of Dapagliflozin-Vildagliptin in Indian T2DM Patients with CV Risk Factors

Efficacy and Safety of Dapagliflozin-Vildagliptin in Indian T2DM Patients with CV Risk Factors

SURPASS-2: Superior HbA1c and Weight Reduction With Tirzepatide vs. Semaglutide

SURPASS-2: Superior HbA1c and Weight Reduction With Tirzepatide vs. Semaglutide

Regulatory Approval Granted for Reformulated Ranitidine

Regulatory Approval Granted for Reformulated Ranitidine

Robust Glycemic Control & Cardio-Renal Protection: Meeting the Advanced Needs of Indian Uncontrolled T2D with Empagliflozin, Sitagliptin, Metformin

Robust Glycemic Control & Cardio-Renal Protection: Meeting the Advanced Needs of Indian Uncontrolled...

Evaluation of Biologic Efficacy and Cost per NNT in Moderate-to-Severe Psoriasis: Indian Analysis

Evaluation of Biologic Efficacy and Cost per NNT in Moderate-to-Severe Psoriasis: Indian Analysis

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Journal Club Today

Prior Ischemic Stroke More Than Doubles Risk of Recurrence During Pregnancy and Postpartum: Study Finds

Prior Ischemic Stroke More Than Doubles Risk of Recurrence During Pregnancy and Postpartum: Study...

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Health News Today

Health Bulletin 03/February/2026

Health Bulletin 03/February/2026

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