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Drug regulator suspends manufacturing and selling of Entod pharma's eye drops over unapproved claims
3 months, 1 week ago

Drug regulator suspends manufacturing and selling of Entod pharma's eye drops over unapproved claims

India TV News  

The DCGI has halted the authorization given to Mumbai-based Entod Pharmaceuticals to produce and market its novel eye drops, citing the company's assertions that it can assist individuals with presbyopia in becoming less reliant on reading glasses. In response to the claim "first eye drop in India designed to reduce the need for reading glasses", the order stated that the …

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DCGI panel recommends ban on 14 cocktail drugs
2 years, 2 months ago

DCGI panel recommends ban on 14 cocktail drugs

Hindustan Times  

The apex advisory board of the drugs controller general of India has recommended banning 14 of the 19 cocktail drugs — in fixed dose combinations category — citing a lack of therapeutic rationale, people familiar with the matter said. The apex advisory board of the drugs controller general of India has recommended banning 14 of the 19 cocktail drugs DCGI, …

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SEC seeks more data from Serum Institute of India over COVID vaccine 'Covovax' for 7-12 age group: Sources
2 years, 7 months ago

SEC seeks more data from Serum Institute of India over COVID vaccine 'Covovax' for 7-12 age group: Sources

India TV News  

Highlights DCGI subject expert committee on April 29 sought more data from SII on Covovax vaccine SEC has sought more data for Covovax vaccine for 7-12 years age group Covovax has already been recommended by DCGI for children above 12 years of age Coronavirus vaccine: The Drugs Controller General of India's subject expert committee on Friday sought more data from …

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Biological E's ‘Corbevax’ gets DCGI approval for two clinical trials
3 years, 3 months ago

Biological E's ‘Corbevax’ gets DCGI approval for two clinical trials

Hindustan Times  

The Drugs Controller General of India has given approval to Biological E for two clinical trials of its Covid-19 vaccine candidate Corbevax, the ministry of science and technology announced Friday. The Hyderabad-based pharmaceutical company received approval for Phase 3 comparator safety and immunogenicity trial in adults after a review of Phase 1 and 2 clinical trials data by a subject …

Biological Vaccine Dcgi Clinical Biological E Corbevax Received Approval
Proposal to study mixing of Covaxin, Covishield approved by DCGI
3 years, 4 months ago

Proposal to study mixing of Covaxin, Covishield approved by DCGI

India TV News  

The Drugs Controller General Of India, India's drug regulator, has approved a proposal for a study to be conducted on the mixing of two COVID-19 vaccines -- Covishield and Covaxin. The aim of the study will be to assess the feasibility on whether a person can be given two different vaccine shots -- one each of Covishield and Covaxin -- …

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DCGI eases norms for clearing foreign-made COVID-19 vaccines to bolster availability of shots
3 years, 6 months ago

DCGI eases norms for clearing foreign-made COVID-19 vaccines to bolster availability of shots

Firstpost  

These exemptions have been made in light of the huge vaccination requirements in India in the wake of the recent surge of COVID-19 cases and the need for increased availability of imported vaccines to meet national requirements India’s apex drug regulator has waived the requirement of testing every batch of foreign-made COVID-19 vaccines by the Central Drugs Laboratory, Kasauli and …

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Moderna, Pfizer a step closer as India exempts foreign Covid vaccines from bridging trials
3 years, 6 months ago

Moderna, Pfizer a step closer as India exempts foreign Covid vaccines from bridging trials

India Today  

In a move to pave the way for the availability of vaccines like Pfizer and Moderna in India, the Drugs Controller General of India has exempted foreign Covid-19 vaccines approved by specific nations or health bodies from post-approval bridging trials in the country. DCGI chief VG Somani said the decision to waive trials will only apply to the vaccines that …

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Dealing with fake drugs
3 years, 6 months ago

Dealing with fake drugs

The Hindu  

THE Indian pharmaceutical industry has a domestic turnover of more than Rs.20,000 crore and exports over Rs.10,000 crore. The Hathi Committee Report of 1975, for example, had recommended measures to strengthen and streamline the Central and State Drug Control Organisations. The upper limit is from a report in the medical journal Lancet in 2001 by an Indian journalist, ostensibly based …

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Enough Covid jabs for inoculation of priority groups: Niti Aayog member
3 years, 11 months ago

Enough Covid jabs for inoculation of priority groups: Niti Aayog member

Live Mint  

India has enough stockpile of the COVID-19 vaccine for inoculation of priority groups, including healthcare workers and frontline workers, in the first phase, Niti Aayog member V K Paul said on Monday. India's drug regulator DCGI on Sunday approved the Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use …

India Vaccination Covid Paul Vaccine Niti Aayog Bharat Biotech
Coronavirus updates | January 3, 2021
3 years, 11 months ago

Coronavirus updates | January 3, 2021

The Hindu  

India has approved two COVID-19 vaccines — Serum Institute of India's 'Covishield' and Bharat Biotech's 'Covaxin' — for emergency restricted use, regulatory body DCGI said on Sunday. Vaccine approved Covishield, Covaxin approved for emergency use India's drug regulatory body has approved the use of Oxford's COVID-19 vaccine 'Covishield' and Bharat Biotech's 'Covaxin' for restricted emergency use. "The Subject Expert Committee …

India Coronavirus Emergency Cases State Covid Phase
Coronavirus | Data on Covaxin phase-3 trials submitted to DCGI: Bharat Biotech
3 years, 11 months ago

Coronavirus | Data on Covaxin phase-3 trials submitted to DCGI: Bharat Biotech

The Hindu  

Bharat Biotech in a statement issued on Saturday said the publication of its COVID vaccine ’s phase II trial data is undergoing the peer review process and that as a part of the regulatory guidelines all data has been submitted to the DCGI and CDSCO. The firm said that product development and clinical trial data for Covaxin has so far …

India Trial Vaccine Bharat Biotech Covaxin Phase
Coronavirus | Covaxin gets central drugs authority panel approval for restricted use
3 years, 11 months ago

Coronavirus | Covaxin gets central drugs authority panel approval for restricted use

The Hindu  

India’s first indigenously developed COVID-19 vaccine, Covaxin, has been recommended for “restricted use in emergency situation, subject to multiple regulatory conditionalties” by the Subject Expert Committee of Central Drugs Standard Control Organisation, here on Saturday. Coronavirus | ‘Covaxin Phase-III trials nearing 20k volunteers’ The Health Ministry in its statement said the SEC has made three recommendations for the consideration and …

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Expert Panel Gives Nod To Bharat Biotech’s Covaxin For Restricted Emergency Use
3 years, 11 months ago

Expert Panel Gives Nod To Bharat Biotech’s Covaxin For Restricted Emergency Use

ABP News  

#COVID19Update Subject Expert Committee of @CDSCO_INDIA_INF makes recommendations in respect of accelerated Approval Process request of @SerumInstIndia, @BharatBiotech & Phase-III Trials of M/s Cadila Healthcare Ltd.https://t.co/hwNyTYqSJM pic.twitter.com/9uLOrjV7cQ — Ministry of Health January 2, 2021 In what comes as a significant relief for India, the Subject Expert Committee on Saturday gave nod to the Bharat Biotech’s vaccine candidate 'Covaxin' for restricted …

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Coronavirus | After SII, Bharat Biotech seeks DCGI approval for Covaxin
4 years ago

Coronavirus | After SII, Bharat Biotech seeks DCGI approval for Covaxin

The Hindu  

After pharma majors Pfizer and Serum Institute of India, Hyderabad-based Bharat Biotech International Ltd on Monday sought emergency use authorisation from the Drugs Controller General of India for its COVID-19 vaccine, Covaxin. Earlier in the day SII CEO Adar Poonawalla tweeted stating: “As promised, before the end of 2020, SII has applied for emergency use authorisation for the first made-in-India …

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Dr Reddy’s seeks DCGI nod to conduct phase-3 clinical trial of Russian COVID-19 vaccine Sputnik V
4 years, 2 months ago

Dr Reddy’s seeks DCGI nod to conduct phase-3 clinical trial of Russian COVID-19 vaccine Sputnik V

Live Mint  

The Hyderabad-based Dr Reddy's Laboratories has applied to the Drugs Controller General of India for permission to conduct phase-3 human clinical trials of the Russian vaccine Sputnik V against COVID-19 in India, sources said. The Indian pharma giant has collaborated with The Russian Direct Investment Fund to conduct clinical trials of Sputnik V as well as its distribution. "The Dr …

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AIIMS panel gives nod to begin human clinical trial of COVID-19 vaccine Covaxin from 20 July
4 years, 5 months ago

AIIMS panel gives nod to begin human clinical trial of COVID-19 vaccine Covaxin from 20 July

Firstpost  

Covaxin, Bharat Biotech’s COVID-19 vaccine candidate, has been developed in collaboration with the ICMR and NIV New Delhi: The AIIMS Ethics Committee on Saturday gave its nod for a human clinical trial of the indigenously developed COVID-19 vaccine candidate Covaxin following which the premier hospital is likely to begin the exercise by enrolling healthy volunteers from Monday. “The AIIMS Ethics …

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India's first indigenous pneumonia vaccine developed by Serum Institute get DCGI nod for market
4 years, 5 months ago

India's first indigenous pneumonia vaccine developed by Serum Institute get DCGI nod for market

Firstpost  

Serum Institute conducted a three-phase clinical trial of the vaccine in India along with trials in the West African nation of The Gambia. Serum Institute conducted Phase I, Phase II and Phase III clinical trials of the Pneumococcal Polysaccharide Conjugate Vaccine in India and was successful. Ltd, Pune has been granted permission to manufacture domestically developed first Pneumococcal Polysaccharide Conjugate …

India Trial Sec Institute Phase Vaccine Gambia
Coronavirus India lockdown Day 109 updates | July 11, 2020
4 years, 5 months ago

Coronavirus India lockdown Day 109 updates | July 11, 2020

The Hindu  

A novel coronavirus vaccine will take at least 12 months to be commercially available and a realistic deadline for it would be some time next year, a group of government officials informed the Parliamentary Panel on Science and Technology headed by Congress leader Jairam Ramesh at a meeting held in the Parliament House complex on Friday. Here are the latest …

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