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DCGI asks drug controllers to prevent sale, distribution of DEG contaminated cough syrup, Cofset
expresspharma
August 10, 2020
Earlier, the same firms were accused and booked for selling Coldbest cough syrup which contained DEG and caused the death of nine children in Jammu and Kashmir.
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Zenara Pharma, a Biophore subsidiary, gets DCGI nod for favipiravir tablets
expresspharma
August 06, 2020
The company informed that these tablets, to be marketed under brand name Favizen, will be manufactured with in-house API.
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Kokate Committee releases list of 471 rational FDCs
expresspharma
August 05, 2020
The Prof Kokate Committee has declared 471 fixed-dose combinations (FDC) related to vitamin, minerals and micronutrients as rational.
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Serum Institute of India gets DCGI nod for phase 2 and 3 human trials of Oxford vaccine candidate
expresspharma
August 04, 2020
As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals.
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COVID-19 panel recommends DCGI to permit SII to conduct human trials of Oxford vaccine candidate
expresspharma
August 03, 2020
SII had submitted a revised proposal on Wednesday after the expert panel had asked it to revise its protocol for the trials besides seeking some additional information.
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DCGI asks SII to revise protocol for phase 2, 3 trials of Oxford COVID-19 vaccine
expresspharma
July 30, 2020
SII has submitted a revised protocol for conducting the trials to the DCGI.
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Serum Institute seeks DCGI nod for phase2/3 trials of Oxford’s COVID-19 vaccine
expresspharma
July 27, 2020
According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of 'Covidshield' in healthy Indian adults.
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Brinton Pharmaceuticals gets DCGI’s approval to launch favipiravir anti-viral tablets in India
expresspharma
July 24, 2020
Brinton Pharmaceuticals has received approval from Drugs Controller General of India (DCGI) to market favipiravir under the brand name faviton.
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Mylan receives DCGI approval in India for TB drug, Pretomanid
expresspharma
July 23, 2020
Pretomanid is only the third new anti-tuberculosis (TB) drug developed specifically for drug-resistant forms of the disease to be approved in more than 40 years.
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FabiFlu more affordable than other drugs: Glenmark to DCGI
expresspharma
July 22, 2020
The company also sends its justifications and clarifications to allegations of false claims about FabiFlu’s use for COVID-19 patients.