CDSCO committee tells Roche to submit Phase III clinical trial data of blood cancer combo drug Farhat Nasim27 Oct 2019 11:30 AM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), recently recommended drugmaker,...
Dr Reddys gets CDSCO Committee recommendation for approval for additional indications of Desosumab Farhat Nasim26 Oct 2019 2:38 PM ISTRecently, the Hyderabad-based Dr Reddy's Labs presented its proposal before the CDSCO Committee for an additional indication for Denosumab 120...
Medical Devices classified as Drugs: CDSCO releases Amendment Rules for registeration of 36 devices Medical Dialogues Bureau25 Oct 2019 4:29 PM ISTNew Delhi: Through a recent Gazette Notification, Central Drugs Standard Control Organisation (CDSCO) has recently released Draft Medical Devices...
Drug Alert: CDSCO declares 28 samples including Soframycin, Ranitidine as sub-standard in quality; Details Farhat Nasim24 Oct 2019 2:22 PM ISTNew Delhi: Apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has declared batches of 28 drugs made by certain...
DCGI nod to Lincoln pharma Diclofenac Rectal Spray for reducing types of pain Medical Dialogues Bureau23 Oct 2019 4:24 PM ISTThe patent has been awarded by the Government of India for "a novel liquid rectal spray dosage form containing diclofenac and its pharmaceutically...
CDSCO directs drug regulators to strictly monitor end-use of dual-use APIs Medical Dialogues Bureau22 Oct 2019 5:32 PM ISTNew Delhi: Through a recent Office Memorandum, Central Drugs Standard Control Organisation (CDSCO) has directed drug regulators to strictly monitor...
Parliamentary panel to now examine regulation, control of medical devices Medical Dialogues Bureau21 Oct 2019 2:20 PM ISTNew Delhi: A parliamentary panel has decided to examine regulation and control of medical devices in the country to ensure that they meet certain...
Ultrasound Equipment now classified as DRUGS, under purview DCA: Gazette notification Farhat Nasim20 Oct 2019 11:41 AM ISTNew Delhi: Through a recent notification, apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has notified Ultrasound...
Health Ministry to bring all Medical Devices under CDSCO regulations, Invites comments Farhat Nasim19 Oct 2019 5:38 PM ISTOnce finalized, the medical device makers will have to get licences from the Drug Controller General of India (DCGI) while CDSCO will be the nodal...
Cipla acquires novel anti-infective Elores to further antimicrobial stewardship in critical care in India Medical Dialogues Bureau18 Oct 2019 1:50 PM ISTMumbai: Cipla Limited announces the acquisition of a novel and patented anti-infective product, Elores, from Venus Remedies Limited ("VRL") for the...
Illegal renting of licences to Chemists: 241 Gujarat Pharmacists lose Registration Medical Dialogues Bureau17 Oct 2019 12:19 PM IST"This is the first time in India when such large number of pharmacists have been penalised. We have also issued warnings to around 3,000 pharmacists...
Mylan moves application with DCGI to launch new TB drug Pretomanid in India Medical Dialogues Bureau16 Oct 2019 4:10 PM IST"We have submitted the new drug application to the office of DCGI. We are in an advanced stage of discussion and are working with the office of...