Articles for Market Authorisation

DCGI Approves Market Authorisation for SII's Covid Vaccine Covovax as Heterologous Booster Dose
1 year, 11 months ago

DCGI Approves Market Authorisation for SII's Covid Vaccine Covovax as Heterologous Booster Dose

News 18  

The Drug Controller General of India has approved market authorisation to COVID-19 vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin, official sources said on Monday. Prakash Kumar Singh, Director of Government and Regulatory Affairs at the Serum Institute of India, had recently written to the DCGI for the approval …

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SII Seeks Drug Regulator's Nod for Market Authorisation of Covovax Vaccine as Covid-19 Booster Dose
2 years ago

SII Seeks Drug Regulator's Nod for Market Authorisation of Covovax Vaccine as Covid-19 Booster Dose

News 18  

The Serum Institute of India has sought the drug regulator’s approval for market authorisation of its COVID-19 vaccine Covovax as a booster dose for those aged 18 years and above who have been administered two doses of Covishield or Covaxin, official sources said on Thursday. Prakash Kumar Singh, director, government and regulatory affairs, SII, submitted a market authorisation application for …

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Govt Panel Recommends Market Authorisation for SII's QHPV Vaccine Against Cervical Cancer
2 years, 6 months ago

Govt Panel Recommends Market Authorisation for SII's QHPV Vaccine Against Cervical Cancer

News 18  

An expert panel of India's central drug authority on Wednesday recommended granting market authorisation to the Serum Institute of India to manufacture indigenously-developed India's first Quadrivalent Human Papillomavirus vaccine against cervical cancer, official sources said. Prakash Kumar Singh, director at SII had applied to the Drugs Controller General of India on June 8 for market authorisation of qHPV after completing …

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A dose of science in the vaccination strategy
2 years, 10 months ago

A dose of science in the vaccination strategy

The Hindu  

Six weeks after the Indian government announced ‘precaution shots’ or the ‘third dose’ of COVID-19 vaccines for select populations, there have been four relevant developments. Two, given that COVID-19 vaccines currently in use in India have limited evidence about their role in reducing transmission, nasal vaccines, through mucosal antibodies, are likely to perform better in reducing transmission. The role of …

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How conditional market authorisation to Covishield and Covaxin will change India’s COVID-19 vaccine drive
2 years, 10 months ago

How conditional market authorisation to Covishield and Covaxin will change India’s COVID-19 vaccine drive

Firstpost  

Highly-placed sources have said that the conditional market authorisation will now allow the two vaccines to be made available at private hospitals and clinics at pre-decided costs India’s COVID-19 vaccination drive is about to witness a change after the drug regulator on Thursday granted a conditional market authorisation for Covishield and Covaxin, the two coronavirus vaccines widely used in the …

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Covishield, Covaxin get conditional market nod
2 years, 10 months ago

Covishield, Covaxin get conditional market nod

Hindustan Times  

The Drugs Controller General of India, India’s pharmaceuticals regulator, granted a conditional market authorisation for Covishield and Covaxin, the two coronavirus vaccines widely used in the country, officials said on Thursday. “The @CDSCO_INDIA_INF has now upgraded the permission for Covaxin and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions,” …

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Panel pitches full market nod for Covaxin, Covishield
2 years, 11 months ago

Panel pitches full market nod for Covaxin, Covishield

Hindustan Times  

The subject expert panel of the national drugs regulator on Wednesday recommended full market authorisation for both Covaxin and Covishield under certain conditions, according to people familiar with the developments. Serum Institute of India and Bharat Biotech International Ltd, manufacturers of Covishield and Covaxin respectively, separately applied to the central drugs standard control organisation to seek full market authorisation stating …

India Market Cdsco Vaccine Covaxin Covishield Full Market Authorisation
SEC recommends Covaxin, Covishield for full market authorisation: Report
2 years, 11 months ago

SEC recommends Covaxin, Covishield for full market authorisation: Report

Hindustan Times  

The subject expert committee of the Central Drugs Standard Control Organisation on Wednesday recommended regular market approval for Covaxin and Covishield, the two most widely used jabs in the national vaccination drive against Covid-19, news agency PTI has reported, citing official sources. The development comes just days after the SEC, on January 14, sought more data from the two manufacturers--Hyderabad-based …

India Sec Vaccine Serum Institute Covishield Eua Full Market Authorisation
Give full authorisation to Covishield: Serum Institute of India
2 years, 11 months ago

Give full authorisation to Covishield: Serum Institute of India

Hindustan Times  

NEW DELHI: Pune-based Serum Institute of India on Friday announced it has applied to India’s drugs regulator for full market authorisation to Covishield, its anti-Covid vaccine, citing adequate availability of the required data. The government of India now has enough data for full market authorisation, and therefore @SerumInstIndia has applied to the @CDSCO_INDIA_INF and @MoHFW_INDIA for this permission,” Adar Poonawalla, …

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Serum Institute of India applies to Indian authorities for full market authorisation of Covishield
2 years, 11 months ago

Serum Institute of India applies to Indian authorities for full market authorisation of Covishield

Firstpost  

SII had partnered with the developer of Covishield, AstraZeneca, for the supply of the vaccine to the Indian government, which had in January this year granted emergency use authorisation in the country. New Delhi: Serum Institute of India CEO Adar Poonawala on Friday said the vaccines major has applied to Indian authorities for full market authorisation of Covishield, stating supplies …

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Covishield could soon be available at medical stores as SII seeks full market authorisation nod
2 years, 11 months ago

Covishield could soon be available at medical stores as SII seeks full market authorisation nod

India TV News  

Pune-based Serum Institute of India has applied for full market authorisation for the COVID-19 vaccine Covishield with the drug regulator. SII CEO Adar Poonawala confirmed that the institute has applied for full market authorisation of the drug, stating supplies of the COVID-19 vaccine have exceeded 125 crore doses. The institute had earlier this month sought the drug regulator's approval for …

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Bharat Biotech's Covaxin recommended by Subject Expert Committee on Covid-19 for children aged 2-18 years
3 years, 2 months ago

Bharat Biotech's Covaxin recommended by Subject Expert Committee on Covid-19 for children aged 2-18 years

India TV News  

An expert panel of the Central Drug Authority has recommended granting emergency use authorisation to Bharat Biotech's Covaxin for children in the 2 to 18 years age group with certain conditions. Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of Covid vaccine Covaxin for use in children aged between 2 and 18 years, had submitted the data to the …

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Vaccines Demystified: Emergency Use vs Conditional Market Authorisation; Tracking Covaxin and Covishield
3 years, 9 months ago

Vaccines Demystified: Emergency Use vs Conditional Market Authorisation; Tracking Covaxin and Covishield

News 18  

In part-I of Vaccines Demystified, we had a close look at Pfizer-BioNTech, Moderna, Johnson and Johnson, and Oxford-AstraZeneca vaccines against Covid-19. In yet another signal of intent of significant departure from previously established policy, the European Medicines Agency of the European Commission is considering if it should start granting “Emergency Use Authorisation ” to Covid-19 vaccines for member states of …

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