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CDSCO (Central Drugs Standard Control Organisation) News

No More Offline Filings: CDSCO Mandates Submission of Post-Approval Changes for Cell and Gene Therapy Trial via SUGAM Portal

No More Offline Filings: CDSCO Mandates Submission of Post-Approval Changes for Cell and Gene Therapy Trial via SUGAM Portal

Susmita Roy30 Oct 2025 1:18 PM IST
New Delhi: In a major regulatory development aimed at strengthening transparency and efficiency in India's clinical trial oversight, the Central Drugs...
Zydus Lifesciences Told To Revise PMS Study For Tofacitinib ER Tablets

Zydus Lifesciences Told To Revise PMS Study For Tofacitinib ER Tablets

Parthika Patel30 Oct 2025 12:28 PM IST
New Delhi: Zydus Lifesciences Ltd. has been directed by the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization...
Pulse Pharma Gets CDSCO Panel Nod to Manufacture, Market Aripiprazole Oral Solution

Pulse Pharma Gets CDSCO Panel Nod to Manufacture, Market Aripiprazole Oral Solution

Susmita Roy29 Oct 2025 2:46 PM IST
New Delhi: In a recent development, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has...
Maha: Rs 14-Crore Mephedrone Unit Busted Near Police Station, Cop Suspended for Negligence

Maha: Rs 14-Crore Mephedrone Unit Busted Near Police Station, Cop Suspended for Negligence

Parthika Patel29 Oct 2025 2:45 PM IST
Mumbai: In a case of alleged negligence, a massive illegal mephedrone (MD) manufacturing unit valued at around Rs 14 crore was busted in Nalasopara...
Punjab Bans 112 Substandard Drugs After CDSCO Warning

Punjab Bans 112 Substandard Drugs After CDSCO Warning

Susmita Roy28 Oct 2025 8:13 PM IST
Punjab: In a decisive move to safeguard public health, the Punjab Government has banned the sale of 112 medicines declared "substandard" by the...
Exemed Pharma

Principal Investigator Must Be Psychiatry-Trained, MADRS-Certified: CDSCO Panel Asks Exemed to Revise Bupropion-Dextromethorphan PMS Study

Susmita Roy28 Oct 2025 7:41 PM IST
New Delhi: After reviewing the active post-marketing surveillance (PMS) protocol for Bupropion Hydrochloride (As Extended Release) IP 105 mg plus...
After DEG Contamination Scare, CDSCO Launches ONDLS Digital Monitoring System for High-Risk Solvents

After DEG Contamination Scare, CDSCO Launches ONDLS Digital Monitoring System for High-Risk Solvents

Susmita Roy27 Oct 2025 7:00 PM IST
New Delhi: In the wake of recent reports of cough syrup contamination with Diethylene Glycol (DEG), the Central Drugs Standard Control Organisation...
Abbott Told to Provide Prescribing Details, Supporting Data for Triamcinolone Hexacetonide Pre-Filled Syringe

Abbott Told to Provide Prescribing Details, Supporting Data for Triamcinolone Hexacetonide Pre-Filled Syringe

Parthika Patel27 Oct 2025 6:38 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has directed Abbott Healthcare Pvt. Ltd....
India to Regulate Cell and Gene Therapies Under Drug Licensing Rules: Health Ministry Issues Draft Amendment

India to Regulate Cell and Gene Therapies Under Drug Licensing Rules

Susmita Roy26 Oct 2025 4:00 PM IST
New Delhi: In a significant regulatory move, the Ministry of Health and Family Welfare (MoHFW) has proposed amendments to the Drugs Rules, 1945, to...
Knee Pain

Modi Mundipharma Gets SEC Approval to Study Cingal, a Hyaluronic Acid-Steroid Device for Osteoarthritis Knee Pain

Susmita Roy26 Oct 2025 12:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Modi...
CDSCO Panel Rejects Troikaa Pharmas High-Strength Paracetamol Injection Citing Safety Concerns

CDSCO Panel Rejects Troikaa Pharma's High-Strength Paracetamol Injection Citing Safety Concerns

Parthika Patel25 Oct 2025 5:12 PM IST
New Delhi: Ahmedabad-based pharma firm, Troikaa Pharmaceuticals Limited has been refused approval by the Subject Expert Committee (SEC) under the...
CDSCO Flags Besto-Cof Cough Syrup as Spurious, Raipur Drug Lab Claims Batch Not Made by Listed Firm

CDSCO Flags Besto-Cof Cough Syrup as Spurious, Raipur Drug Lab Claims Batch Not Made by Listed Firm

Susmita Roy25 Oct 2025 4:25 PM IST
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued a warning after the State Drug Testing Laboratory (SDTL) in Raipur,...
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Editorial

Indian Study Finds Vildagliptin SR Effective and Safe in Type 2 Diabetes Patients Uncontrolled on Metformin: PRIME-Vilda Trial

Indian Study Finds Vildagliptin SR Effective and Safe in Type 2 Diabetes Patients Uncontrolled on...

Advancements in Antifungal Treatment: Insights from In vitro Trials with Selenium Sulfide

Advancements in Antifungal Treatment: Insights from In vitro Trials with Selenium Sulfide

The Betami-Danblock Trial: Randomized Discontinuation Of Beta-Blockers After Myocardial Infarction

The Betami-Danblock Trial: Randomized Discontinuation Of Beta-Blockers After Myocardial Infarction

Reperfusion Therapy for STEMI in LMICs: A Clinical Consensus Discussion with Dr Thomas Alexander

Reperfusion Therapy for STEMI in LMICs: A Clinical Consensus Discussion with Dr Thomas Alexander

Importance of Identifying High-Risk Node-Positive Patients in EBC

Importance of Identifying High-Risk Node-Positive Patients in EBC

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Journal Club Today

Understanding Chest Acne - The Overlooked Breakouts Explained by Dermatologist Dr Ishad Aggarwal

Understanding Chest Acne - The Overlooked Breakouts Explained by Dermatologist Dr Ishad Aggarwal

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Health News Today

Health Bulletin 30/October/2025

Health Bulletin 30/October/2025

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