Search For "drug regulator"
Zydus Cadila gets DCGI nod for Phase-3 clinical trials for Covid-19 vaccin
Updated : 5 years, 4 months ago IST
New Delhi [India], January 4 (ANI): The drug regulatory body Drugs Controller General of India (DCGI) has approved Ahmedabad based drug firm Zydus Cadila to initiate Phase III clinical trials of its Covid-19 vaccine ZyCoV-D.
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Whenever India achieves something, Cong comes up with wild theories to rid
Updated : 5 years, 4 months ago IST
New Delhi [India], January 3 (ANI): Bharatiya Janata Party (BJP) national president JP Nadda on Sunday slammed the Congress and other opposition parties for questioning India's drug regulator's approval to two COVID-19 vaccines for restricted emergency use in the country.
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Germany expects to get 15.5 million doses of Moderna COVID-19 vaccine, say
Updated : 5 years, 5 months ago IST
Berlin [Germany], December 28 (ANI/Sputnik): Germany plans to receive 15.5 million doses of Moderna's coronavirus vaccine as soon as it is approved by the European Union's drug regulator, a health ministry spokeswoman said Monday.
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Indigenous mRNA vaccine candidate supported by DBT gets Drug Controller no
Updated : 5 years, 5 months ago IST
New Delhi [India], December 11 (ANI): In a major development in the fight against COVID-19, India's first indigenous mRNA vaccine candidate has received approval from Indian Drug regulators to initiate Phase I/II human clinical trial.
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Drugs regulator refuses application of Dr Reddy's Lab for marketing author
Updated : 5 years, 6 months ago IST
New Delhi [India], November 2 (ANI): The top drug regulator has refused Dr Reddy's Laboratories' application, for full marketing authorization of anti-viral drug Remdesivir, for treatment of COVID-19 patients in India.
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Submit previous trial data for Covaxin before rolling out phase III: Drug
Updated : 5 years, 7 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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Serum Institute says will adhere to DCGI instructions after show cause ove
Updated : 5 years, 8 months ago IST
New Delhi [India], September 9 (ANI): Hours after the Drugs Controller General of India (DCGI) issued a show-cause notice Serum Institute of India (SII) asking for an explanation as to why the ongoing clinical trial of Covishield vaccine candidate has not been suspended till doubts about
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COVID-19: Subject Expert Committee seeks DCGI's nod to use hepatitis injec
Updated : 5 years, 9 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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DCGI nod to Serum-Oxford COVID19 vaccine for phase 2, 3 clinical trials in
Updated : 5 years, 9 months ago IST
New Delhi, [India], Aug 3 (ANI) India's top drug regulator-- Drugs Controller General of India (DCGI) has granted permission to Serum Institute of India (SII) to conduct phase 2 and 3 human clinical trials in India on the potential COVID19 vaccine, a senior government official said.
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Drug regulator gets committee approval for nod to clinical trials by Serum
Updated : 5 years, 9 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 : 5 years, 10 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 : 5 years, 10 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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