Boehringer Ingelheim Told to File Separate Phase IV Trial Plan for Empagliflozin Written By Susmita Roy1 Nov 2025 5:42 PM ISTNew Delhi: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has directed Boehringer Ingelheim India to...
MSN Labs Gets SEC Go-Ahead to Conduct Phase IV Clinical Trial on Elagolix for Endometriosis Written By Parthika Patel1 Nov 2025 5:25 PM ISTNew Delhi: Hyderabad-based MSN Laboratories Pvt Ltd has received a recommendation from the Subject Expert Committee (SEC) under the Central Drugs...
CDSCO Panel Seeks Anesthesiology Expert Review for AIIMS Raipur Trial on Gabapentin, Melatonin, Clonidine FDC Written By Susmita Roy31 Oct 2025 7:26 PM ISTNew Delhi: After reviewing a clinical trial proposal submitted by Dr Pratibha R Mudgal from AIIMS Raipur, involving a fixed-dose combination of...
No More Offline Filings: CDSCO Mandates Submission of Post-Approval Changes for Cell and Gene Therapy Trial via SUGAM Portal Written By Susmita Roy30 Oct 2025 1:18 PM ISTNew 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 Written By Parthika Patel30 Oct 2025 12:28 PM ISTNew 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 Written By Susmita Roy29 Oct 2025 2:46 PM ISTNew 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 Written By Parthika Patel29 Oct 2025 2:45 PM ISTMumbai: 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 Written By Susmita Roy28 Oct 2025 8:13 PM ISTPunjab: In a decisive move to safeguard public health, the Punjab Government has banned the sale of 112 medicines declared "substandard" by the...
Principal Investigator Must Be Psychiatry-Trained, MADRS-Certified: CDSCO Panel Asks Exemed to Revise Bupropion-Dextromethorphan PMS Study Written By Susmita Roy28 Oct 2025 7:41 PM ISTNew 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 Written By Susmita Roy27 Oct 2025 7:00 PM ISTNew 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 Written By Parthika Patel27 Oct 2025 6:38 PM ISTNew 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 Written By Susmita Roy26 Oct 2025 4:00 PM ISTNew Delhi: In a significant regulatory move, the Ministry of Health and Family Welfare (MoHFW) has proposed amendments to the Drugs Rules, 1945, to...
