Page 3 - Drug Controller General Of India

AstraZeneca Pharma gets DCGI nod for lung cancer treatment drug

AstraZeneca Pharma India on Wednesday said it has received marketing approval from the Drugs Controller General of India (DCGI)for its product for the treatment of non-small cell lung cancer.

A bitter pill: Domestic pharma market growth slides to 1.1% in February

Recovery slow, top drug firms post muted growth in February

Healing a weak regulator

Weaknesses in India's drug regulatory regime and the constraints and questionable decisions of the drug regulator could mar the country's reputation in global markets

AstraZeneca's Dapagliflozin tablets get DCGI nod for chronic kidney disease

AstraZeneca Pharma India on Saturday said it has received approval from the Drugs Controller General of India (DCGI) for Dapagliflozin

V G Somani: The DCGI chief, a man known by his actions, 'not of words'

To the media, Somani may be a man of few words but among peers he's known for quick responses

Govt clears air on Bharat Biotech's vaccine, says relied on safety data

Minutes of expert panel meeting made public

A shot at transparency

Approval to Covaxin raises many questions

India gets Covid-19 vaccine: DCGI nod for Serum Institute, Bharat Biotech

Health Minister Harsh Vardhan termed it a 'watershed moment in India's battle against Covid-19'

India likely to approve AstraZeneca vaccine by next week: Sources

This could be the first country to give the regulatory green light for the British drugmaker's vaccine as the British medicine regulator continues to examine data from the trials

India's first mRNA vaccine for Covid-19 heads for human trials

mRNA-based vaccines are scientifically the ideal choice to address a pandemic because of their rapid developmental timeline

Proactive regulator

Credibility of an approved vaccine should be ensured

Provide more safety data on Covid-19 vaccine: SEC to Serum, Bharat Biotech

The application submitted by the Pfizer was not discussed at the SEC meeting as the company has requested for more time for giving its presentation

Gennova Pharma gets conditional permission for human trial of Covid vaccine

DCGI granted conditional permission for phases 1 and 2 human clinical trial of the COVID-19 vaccine candidate developed by Gennova Biopharmaceuticals Ltd in collaboration with HDT, USA

Trust DCGI to ask for enough data before vaccine approval: Gagandeep Kang

Having achieved the first goal of seeing whether the vaccines work, we can be more ambitious and design studies to assess whether and how much they reduce transmission, says Kang

Bharat Biotech applies for emergency use authorisation for Covaxin

The company is conducting a 26,000 subjects phase 3 efficacy trial in India to determine the efficacy of its candidate

Decoded: What emergency use authorisation of Covid vaccine means for us

After the Indian arm of US pharmaceutical giant Pfizer, the Serum Institute of India has applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation

Decoding Feluda: The test that detects Covid-19 quickly, cheaply and easily

Named after Detective Feluda, a character created by filmmaker and writer, Satyajit Ray, the test based on the CRISPR technology is easy to use, gives faster results at a lower cost

DCGI issues guidelines for pharma giants manufacturing Covid-19 vaccine

The DCGI has issued a new set of guidelines, focusing on safety, immunogenicity and efficacy parameters for pharma giants who are developing Covid-19 vaccines

Serum Institute gets DCGI nod to resume clinical trial of Oxford vaccine

DCGI gave permission to Serum Institute to resume clinical trial of the Oxford Covid-19 vaccine candidate in the country

DCGI aks Serum Institute to suspend recruitment for Oxford vaccine trials

DCGI has directed Serum Institute of India to suspend till further orders new recruitment in phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine candidate