Search For "drug controller"
Bharat Biotech gets SEC approval for phase 3 clinical trials of COVID boos
Updated : 4 years, 2 months ago IST
New Delhi [India], January 5 (ANI): The Subject Experts Committee (SEC) of the Drug Controller General of India (DCGI) on Wednesday granted approval to Bharat Biotech for conducting intranasal phase 3 trials and heterologous trials for COVID-19 booster intranasal vaccine for those who hav
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SEC to hold meeting on Bharat Biotech's Nasal vaccine booster dose
Updated : 4 years, 2 months ago IST
New Delhi [India], January 4 (ANI): The Subject Expert Committee (SEC) of the Drug Controller General of India (DCGI) is expected to meet on Tuesday afternoon to discuss Bharat Biotech's application for clinical trials of its intranasal Covid vaccine as a booster or a third dose.
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Dr Dangs Lab as central lab conducted tests in all three trial phases of C
Updated : 4 years, 2 months ago IST
New Delhi [India], December 29 (ANI): With the Drug Controller General of India (DCGI) approving two new COVID-19 vaccines and one anti-viral drug for emergency use on Tuesday, Dr Arjun Dang, CEO, Dr Dangs Lab, welcomed the announcement and said they feel immensely proud "to have been a p
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Biological E gets approval to conduct trials of Corbevax as booster dose
Updated : 4 years, 2 months ago IST
New Delhi [India], December 29 (ANI): The Drug Controller General of India (DCGI) has given approval to the Hyderbad-based pharmaceutical company Biological E to conduct phase 3 clinical trials of its COVID-19 vaccine Corbevax as a booster dose, said sources.
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DCGI grants Cipla emergency use authorisation for COVID-19 drug Molnupirav
Updated : 4 years, 2 months ago IST
Mumbai (Maharashtra) [India], December 28 (ANI): Drug Controller General of India (DCGI) on Tuesday granted Emergency Use Authorisation (EUA) to Cipla for the launch of Molnupiravir in the country for COVID-19 treatment.
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Zydus seeks DCGI nod for 'Desidustat' oral pill to treat anaemia in kidney
Updated : 4 years, 3 months ago IST
Ahmedabad (Gujarat) [India], November 23 (ANI): Pharmaceutical company Zydus Cadila on Tuesday announced that it has submitted its first "New Drug Application (NDA)" to the Drug Controller General of India for its oral pill "Desidustat" to treat anaemia in kidney patients.
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Approval to Covaxin for children aged between 2-18 years awaited after eva
Updated : 4 years, 5 months ago IST
New Delhi [India], October 12 (ANI): After the evaluation of data Covaxin is yet to get approval by the Drugs Controller General of India (DCGI) for children between 2-18 years old, according to official sources.
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Sputnik Light Covid vaccine gets permission for Phase 3 trials in India
Updated : 4 years, 6 months ago IST
New Delhi [India], September 15 (ANI): The Drug Controller General of India has given its approval to the single-dose COVID-19 vaccine version of the Sputnik V vaccine 'Sputnik Light' to conduct trials on the Indian population to check whether the vaccine gives a similar immune response i
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DCGI approves Hetero's Tocilizumab for treatment of COVID-19 in hospitalis
Updated : 4 years, 6 months ago IST
Hyderabad (Telangana) [India], September 6 (ANI): Hetero announced on Monday that the Drug Controller General of India (DCGI) has approved Emergency Use Authorization (EUA) for its generic version of Tocilizumab in India for the treatment of COVID-19 in hospitalised adults.
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Biological E gets drug regulator's approval to conduct phase 2/3 trials on
Updated : 4 years, 6 months ago IST
New Delhi [India], September 2 (ANI): The Drug Controller General of India (DCGI) on Wednesday granted permission to Hyderabad-based Biological E Limited to conduct Phase 2 & 3 clinical trials for its anti-COVID shots called Corbevax on children between 5 and 18 years of age with certain
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Enzene Biosciences Ltd. obtains a Marketing Authorization for its Denosuma
Updated : 4 years, 6 months ago IST
Pune (Maharashtra) [India], August 27 (ANI/PRNewswire): Enzene Biosciences Ltd. "Enzene" announces a successful Marketing Authorization (MA) from the Drug Controller General of India (DCGI) for its third biosimilar drug 'Denosumab', indicated for the treatment of osteoporosis in adults.
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Enzene Biosciences Ltd. obtains Marketing Authorization for its Romiplosti
Updated : 4 years, 6 months ago IST
Pune (Maharashtra) [India], August 20 (ANI/PRNewswire): Enzene Biosciences Ltd. "Enzene" announces a successful Marketing Authorization (MA) from the Drug Controller General of India (DCGI) for its second biosimilar drug "Romiplostim", indicated for the treatment of chronic Immune Thrombocyt
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