DCGI seeking more data for authorization will not impact Covid-19 vaccine roll-out timeline: Govt Ruchika Sharma17 Dec 2020 6:46 PM ISTThese applications filed with the Drugs Controller General of India (DCGI) are being examined by the subject expert committee on COVID 19 of CDSCO for...
CDSCO panel to review Serum Institute, Bharat Biotech, Pfizer COVID vaccine applications on December 9 Medical Dialogues Bureau8 Dec 2020 4:55 PM ISTThe decision was taken late on Monday evening after the Hyderabad based Bharat Biotech became the third pharmaceutical firm to apply to the Drugs...
Clinical trial participants paid over Rs 12 crore compensation in last 3 years for adverse events: DCGI Ruchika Sharma6 Dec 2020 11:00 AM ISTAddressing a webinar, ''Regulatory Pathways for COVID19 Vaccines, Clinical trials, Rolling Reviews and Adverse Event Monitoring'', Drugs Controller...
CDSCO grants medical device registration to three GOQii wearables Farhat Nasim4 Dec 2020 7:54 PM ISTNew Delhi: California-based fitness technology company, GOQii recently received medical device registration from the Central Drugs Standard Control...
Initial findings into Serum Institute 'adverse event' did not necessitate halting of trials: Govt Farhat Nasim2 Dec 2020 5:23 PM IST"We have been given to understand that there is a court case so we would not want to comment on the specifics of the case," Union Health Secretary...
Serum Institute plans Rs 100 crore case against Covishield Trial Participant who sought Rs 5 crore alleging serious side effect Farhat Nasim30 Nov 2020 3:21 PM ISTNew Delhi: Brewing controversy a man, who was administered 'Covishield' shots in a vaccine trial in Chennai alleged serious "neurological and...
CDSCO nod to CoSara Diagnostics for manufacturing COVID-19 test with two target genes Farhat Nasim27 Nov 2020 7:29 PM ISTThe Saragene test kit approved by the CDSCO uses the Company's patented CoPrimer technology and is based on a test originally designed by Co...
PM Modi to visit Serum Institute on November 28 Ruchika Sharma27 Nov 2020 11:41 AM ISTPune: Prime Minister Narendra Modi will on Saturday visit the Pune-based Serum Institute of India, which has partnered with global pharma giant...
CDSCO Flags 8 Drug Samples As Not Of Standard Quality Farhat Nasim14 Nov 2020 11:00 AM ISTNew Delhi: The apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 8 drug samples as 'Not of Standard Quality'...
Macleods Pharma proposes chewable Faviparavir, gets rejected by CDSCO panel Farhat Nasim12 Nov 2020 4:57 PM ISTNew Delhi: In a major setback to Mumbai-based drugmaker Macleods Pharmaceuticals Ltd, the Subject Expert Committee (SEC) functional under the Central...
Cabinet nod to CDSCO, UK MoU for cooperation in medical product regulation Medical Dialogues Bureau8 Nov 2020 10:45 AM ISTThe MoU will help in establishing a framework for fruitful cooperation and exchange of information between the Central Drugs Standard Control...
Approval of FDCs: NPPA flags prospects of over medication, profiteering Farhat Nasim2 Nov 2020 3:46 PM ISTNew Delhi: The National Pharmaceutical Pricing Authority (NPPA) has recently expressed its concern over approving Fixed Dose Combinations (FDCs) of...
