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  • CDSCO (Central Drugs...

CDSCO (Central Drugs Standard Control Organisation) News - Page 7

AstraZeneca Koselugo recommended for approval in EU for plexiform neurofibromas in adults with neurofibromatosis type 1

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 Pharma exposed to some headline risk amid US tariff move, but with limited earnings impact

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

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...
94 Drug, Medical Product Batches Fail CDSCO Quality Tests in August

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...
Spurious Drugs Alert: Diazepam, PAN 40, and PAN-D Capsules Under Investigation

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 Halol facility gets OAI status from USFDA

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

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

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...
Fludrocortisone 0.2 mg Study Rejected by CDSCO Panel Over Potential Adverse Effects

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...
CDSCO Digitisation Cuts Post-Approval Change Timelines in CGTs from 218 to 98 Days: DCGI

CDSCO Digitisation Cuts Post-Approval Change Timelines in CGTs from 218 to 98 Days: DCGI

Parthika Patel22 Aug 2025 6:12 PM IST
New Delhi: The Drug Controller General of India (DCGI), Central Drugs Standard Control Organisation (CDSCO), Dr Rajeev Raghuvanshi, has recently...
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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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