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  • CDSCO (Central Drugs...

CDSCO (Central Drugs Standard Control Organisation) News - Page 17

Ropanicant Phase-2b trial for Major Depressive Disorder achieves 100 percent enrollment ahead of schedule: Suven Life Sciences

One Death a Day: 1,705 Lives Lost in India's Clinical Trials Since 2021, RTI Reveals

Susmita Roy31 Aug 2025 2:00 PM IST
New Delhi: In a grim reality, from 2021 till July 2025, clinical trials in India have seen 1,705 deaths and more than 7,000 serious adverse events,...
AstraZeneca Pharma India Slapped Rs 11.88 Cr Tax Adjustment for FY23, to Move ITAT

AstraZeneca Faces Setback as CDSCO Panel Rejects Seloken XL Prescribing Update

Susmita Roy31 Aug 2025 1:00 PM IST
New Delhi: Rejecting the proposal of AstraZeneca Pharma for the update of prescribing information (PI) of Metoprolol Succinate Prolonged Release...
Sun Pharmas Dementia Drug Rivastigmine Banned in China

Sun Pharma Gets CDSCO Panel Nod for Phase IV Trial of Esomeprazole Dual Release Tablets 80 mg

Parthika Patel30 Aug 2025 9:00 PM IST
New Delhi: Sun Pharma has received approval from the Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), to...
CDSCO Panel Defers Biospheres Colloidal Nano Silver Gel Trial, Seeks Full Data

CDSCO Panel Defers Biosphere's Colloidal Nano Silver Gel Trial, Seeks Full Data

Parthika Patel29 Aug 2025 10:44 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) has deferred further action on...
Vitamin D3 Tablets, Heparin Sodium Injection Fail Quality Test, 2 Drugmakers Blacklisted by CGMSC

State Drug Alert: Ciprofloxacin, Lorazepam, Albendazole Among 97 NSQ Samples Flagged in July

Susmita Roy29 Aug 2025 5:12 PM IST
New Delhi: Reflecting ongoing concerns around drug quality in India's pharmaceutical supply chain, the Central Drugs Standard Control Organisation...
CDSCO Declares 74 Medicines, APIs and Devices Samples Not of Standard Quality in December

46 Drug Batches Fail CDSCO Quality Test In July, Details

Susmita Roy28 Aug 2025 9:03 PM IST
New Delhi: The Central Drugs Standard Control Organization (CDSCO) has declared 46 batches of medicines as "Not of Standard Quality" (NSQ) after drug...
CDSCO Flags 7 Batches of Popular Medicines as Purportedly Spurious in December

CDSCO Flags 8 Batches of Spurious Medicines, Including Popular Brands Augmentin, PAN 40

Susmita Roy28 Aug 2025 8:53 PM IST
New Delhi: In a disclosure that raises serious concerns over drug safety, the Central Drugs Standard Control Organisation (CDSCO) has flagged eight...
Sun Pharma Names Sana Shaikh as Head of Marketing

Sun Pharma Wins CDSCO Panel Approval for Phase III Vitiligo Trial of Ruxolitinib Cream

Susmita Roy26 Aug 2025 12:00 PM IST
New Delhi: Based on the justification presented by the pharmaceutical major Sun Pharmaceutical Industries, the Subject Expert Committee (SEC)...
No More Offline Filings: CDSCO Mandates Submission of Post-Approval Changes for Cell and Gene Therapy Trial via SUGAM Portal

CDSCO Panel Asks Unique Biotech to Submit Approval Status of Bacillus coagulans Unique IS-2 2 Billion CFU

Susmita Roy25 Aug 2025 4:00 PM IST
New Delhi: In line with the proposal regarding the combination of an osmotic laxative and a probiotic, which is Lactulose 10 gm plus Bacillus...
Health Ministry Proposes Perpetual Validity for Medical Device Licences

Mandatory Excipients Disclosure on Drug Labels from March 2026: Health Ministry

Parthika Patel24 Aug 2025 5:33 PM IST
New Delhi: All drug labels will now be required to clearly disclose the qualitative details of excipients along with the date of expiry, as the Union...
CDSCO Panel Declines to Consider ACME Generics Phase IV Trial Results for Liothyronine Tablets

CDSCO Panel Rejects Phase III Trial of QL2107 Injection Proposed by Syneos Health

Parthika Patel24 Aug 2025 4:20 PM IST
New Delhi: In a setback to Syneos Health India Private Limited, the Indian arm of the global contract research organization Syneos Health, the Subject...
Ravenbhel Bilastine, Montelukast FDC Under Review, CDSCO Panel Seeks Pediatric Expert Opinion

Ravenbhel's Bilastine, Montelukast FDC Under Review, CDSCO Panel Seeks Pediatric Expert Opinion

Dr. Divya Colin22 Aug 2025 6:38 PM IST
New Delhi: In response to a proposal submitted by Ravenbhel Healthcare of the fixed dose combination (FDC) pulmonary drug Bilastine 10 mg plus...
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Editorial

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

U.S. FDA Grants Approval for Ranitidine Comeback

U.S. FDA Grants Approval for Ranitidine Comeback

Dapagliflozin and Sitagliptin FDC in T2D with Heart Failure: 2025 Indian Practice Review

Dapagliflozin and Sitagliptin FDC in T2D with Heart Failure: 2025 Indian Practice Review

Importance of Early Aggressive Glucose Control - Approach in 2026

Importance of Early Aggressive Glucose Control - Approach in 2026

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Journal Club Today

Lowering Sodium in Everyday Foods Could Help Prevent Heart Disease, Stroke: Study

Lowering Sodium in Everyday Foods Could Help Prevent Heart Disease, Stroke: Study

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Health News Today

Health Bulletin 28/January/2026

Health Bulletin 28/January/2026

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