Zydus Cadila gets DGCI nod for diabetes drug Saroglitazar Magnesium Farhat Nasim4 Feb 2020 10:30 AM IST"Zydus Cadila has received the approval from the Drug Controller General of India (DCGI) for use of Saroglitazar Mg in the treatment of type II...
DCGI releases list of Reference Products for conduct of BE Study, details Medical Dialogues Bureau25 Jan 2020 2:25 PM ISTNew Delhi: Through a recent notice, Drug Controller General of India has released the List of Products Permitted by DCG(I) and considered as Reference...
Wockhardt gets DCGI nod for 2 new antibiotics Medical Dialogues Bureau17 Jan 2020 1:57 PM IST 'DCGI has approved Wockhardts 2 new antibiotics, EMROK (IV) and EMROK O (Oral), for acute bacterial skin and skin structure Infections including...
CDSCO declares 450 FDCs as rational, issues directions for manufacturers Farhat Nasim15 Jan 2020 1:27 PM ISTNew Delhi: Apex drug regulator, Central Drugs Standard Control Organization (CDSCO) has recently declared 450 more Fixed-Dose Combination (FDC)...
FIRST: Roche wins DCGI nod for Atezolizumab to treat small-cell lung cancer Medical Dialogues Bureau22 Nov 2019 12:25 PM IST"Atezolizumab is the first cancer immunotherapy to receive approval from DCGI in India for the first-line treatment of extensive-stage small-cell lung...
With questions about safety of Meril's Made in India BVS stent, NPPA defers its appeal for price exemption Medical Dialogues Bureau21 Nov 2019 12:09 PM ISTNew Delhi: With an industry association raising health and safety concerns about the flagship Sirolimus-Eluting BioResorbable vascular scaffold system...
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...
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...
AstraZeneca India bags DCGI marketing nod for QTERN-once-daily anti-diabetes drug Medical Dialogues Bureau27 Sept 2019 11:54 AM IST26 September 2019: AstraZeneca Pharma India Limited (AstraZeneca India) announced that it has received Import & Market permission for QTERN®...
CDSCO warns against Cancer Causing Impurities in anti-acidity drug Ranitidine, writes to state drug controllers Farhat Nasim25 Sept 2019 1:19 PM ISTNew Delhi: To ensure patient safety, the country's apex drug regulatory body, Central Drugs Standard Control Organisation (CDSCO) has ordered an...
Meril Life Sciences gets European Conformity mark for Bioresorbable Scaffold MeRes100 Medical Dialogues Bureau9 Aug 2019 9:45 AM ISTMeril Life Sciences MeRes100 has received both Drug Controller General of India(DCGI) and CE (European Conformity) marketing approval. New Delhi:...
Six bodies registered with CDSCO to audit medical device manufacturing sites as per new MD Rules Farhat Nasim4 Aug 2019 3:29 PM ISTNew Delhi: Through a recent public notice, the apex drug regulatory body, Central Drugs Standard Control Organisation(CDSCO) has notified six bodies...