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  • CDSCO (Central Drugs...

CDSCO (Central Drugs Standard Control Organisation) News - Page 19

CDSCO Panel Rejects Hetero Labs Plea for Lenacapavir Approval Without Local Trials

Hetero Biopharma Gets CDSCO Panel Nod for Phase IV Trial of Denosumab Injection in Cancer Patients

Parthika Patel2 Sept 2025 4:10 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) has recommended granting...
Lupin Secures USFDA Nod for Epilepsy Drug Brivaracetam in US

Lupin Gets Expert Committee Nod To Conduct Phase I Trial of Certolizumab Pegol, IGRA TB Test Made Mandatory

Susmita Roy1 Sept 2025 4:23 PM IST
New Delhi: Lupin has got approval from the Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), to conduct a...
After Cough Syrup Deaths, IPC Issues Toolkit to Curb DEG, EG Contamination in Liquid Formulations

CDSCO Panel Allows Ravenbhel to Conduct BE, Phase III Trial of Dapagliflozin, Sacubitril, Valsartan FDC

Susmita Roy1 Sept 2025 1:52 PM IST
New Delhi: Ravenbhel Healthcare has got the go-ahead from the Subject Expert Committee (SEC), functional under the Central Drugs Standard Control...
Prior Intimation System Under NDCT Rules Wont Apply to Hormones, Cytotoxics, Beta-Lactams, Certain Biologics: CDSCO

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,...
CDSCO Clears AstraZenecas Imfinzi (Durvalumab) for Additional Cancer Indication in India

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 ILUMYA Gets USFDA Review Nod for Psoriatic Arthritis Indication

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...
Substandard Deworming Medicines Detected

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...
Azithromycin, Ofloxacin Combos Among 3 Drug Batches Flagged as Purportedly Spurious by CDSCO

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 Rules Out Big-Bang Acquisitions, Bets on Organic Growth and Biosimilars

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...
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