Search For "central drugs standard control organisation"

DCGI's expert panel recommends Phase 3 clinical trial nod for Bharat Biote
Updated : 2 years, 5 months ago IST
New Delhi [India], October 22 (ANI): The expert panel at Central Drugs Standard Control Organisation (CDSCO) has recommended the top drugs regulator to grant permission to Bharat Biotech to conduct phase III clinical trial using indigenous covid19 vaccine--Covaxin, with subject to the condit
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Submit previous trial data for Covaxin before rolling out phase III: Drug
Updated : 2 years, 5 months ago IST
New Delhi [India], October 10 (ANI): The expert panel at Central Drugs Standard Control Organisation (CDSCO) has asked drug maker Bharat Biotech to submit safety and immunogenicity data from ongoing phase II trial in order to conduct phase III clinical trial of indigenous COVID-19 vaccine, C
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Drugs control organisation issues guidelines for trial, marketing of vacci
Updated : 2 years, 6 months ago IST
New Delhi [India], September 18 (ANI): The Central Drugs Standard Control Organisation (CDSCO) said the requirements and guidelines to conduct clinical trial or grant of permission for the marketing of new drugs including vaccines are prescribed under New Drugs and Clinical Trials Rules, 201
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COVID-19: Subject Expert Committee seeks DCGI's nod to use hepatitis injec
Updated : 2 years, 7 months ago IST
New Delhi [India], Aug 19 (ANI): The Subject Expert Committee (SEC) at the Central Drugs Standard Control Organisation (CDSCO) has recommended that the country's top drug regulator grant permission for phase 3 clinical trial using Thymosin @-1 injection 1.6 mg on moderate to severe COVID-19
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Drug regulator gets committee approval for nod to clinical trials by Serum
Updated : 2 years, 7 months ago IST
New Delhi [India], July 31 (ANI): The Subject Expert Committee at Central Drugs Standard Control Organisation (CDSCO) has recommended to the top drug regulator to grant permission to Serum Institute of India (SII) to conduct phase two and three clinical trials in India on a potential COVID-1
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Drug Regulator asks Serum Institute to furnish revised protocol for COVID-
Updated : 2 years, 7 months ago IST
New Delhi [India], July 29 (ANI): The Central Drugs Standard Control Organisation (CDSCO) has advised the Serum Institute of India (SII) to submit a revised protocol to perform the clinical trials in India for potential COVID-19 vaccine.
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Top drug regulator suspends import license of 19 firms for their COVID-19
Updated : 2 years, 8 months ago IST
New Delhi [India], July 25 (ANI): The Central Drugs Standard Control Organisation (CDSCO) has suspended the import licenses of at least 19 firms for their respective COVID-19 test kits after USFDA removed the manufacturer from their list of the product of serology test kits for coronavirus.
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Top drug regulator CDSCO suspends import license of Mumbai-based firm for
Updated : 2 years, 8 months ago IST
New Delhi [India], July 24 (ANI): The Central Drugs Standard Control Organisation (CDSCO) has suspended the import license of Mumbai-based company--Transasia Bio-Medicals which is providing COVID-19 IgG ELISA kit.
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CDSCO approves 60 firms for RT-PCR testing kits
Updated : 2 years, 10 months ago IST
New Delhi [India], May 1 (ANI): About 60 Indian firms have got approval from the Central Drugs Standard Control Organisation (CDSCO) for RT-PCR testing kits for COVID-19. Out of the 60 companies, five firms got approval for indigenously manufactured kits and 55 others for imported kits.
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ICMR receives 99 applications to study efficacy of convalescent plasma to
Updated : 2 years, 11 months ago IST
New Delhi [India], April 20 (ANI): The Indian Council of Medical Research (ICMR) has received 99 applications for participation in "Randomized controlled study to assess the safety and efficacy of convalescent plasma to limit COVID-19 associated complications".
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CDSCO approves institutes to conduct clinical trial with convalescent plas
Updated : 2 years, 11 months ago IST
New Delhi [India], April 18 (ANI): The Central Drugs Standard Control Organisation (CDSCO) has given a green signal to interested institutes to conduct the clinical trial with convalescent plasma in COVID-19 patients, as per the protocol developed by Indian Council of Medical Research (ICMR)
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Exclusive Vertical in CDSCO will check 'Garage Manufacturing': MTaI
Updated : 3 years, 10 months ago IST
New Delhi [India] April 29 (ANI/NewsVoir): Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies having a large footprint in manufacturing, R&D and healthcare training in India, today said that creation of a separate verti
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