THE DRUG CONTROLLER GENERAL OF INDIA

SII, Bharat Biotech gift India the most-awaited Covid vaccine, but here's where the problem starts

Even though clinical trials take several years, WHO allows companies and regulators to skip the usual process to grant emergency approval i...

AIIMS director hails DCGI approval of 'India-made' COVID vaccine

"It is a great moment for India and for our fight against COVID-19. Bharat Biotech's Covaxin is a vaccine that has been made in India. A ma...

AstraZeneca vaccine set to become first to get approval in India: Sources

The decision would pave the way for the vaccine's rollout in the world's second-most populous country which, after the United States, has t...

Zydus Cadila receives DCGI nod for NAFLD drug Saroglitazar Mg in India

Non-Alcoholic Fatty Liver Disease (NAFLD) is a progressive disease of the liver, which starts with fat accumulation in the liver in patient...

1,000 volunteers prepare for second dose of Covaxin

Dr JS Kushwaha, principal investigator at Prakhar hospital, said: "The second dose of Covaxin would also be administered to these 1,000 vol...

Emami to expand ayurvedic product export under Zandu

Emami plans to export its healthcare portfolio under Zandu into several newer markets with the company receiving the WHO-GMP and Certificat...

AstraZeneca gets DCGI nod for asthma drug

The company has received approval from the DCGI for Fasenra (Benralizumab solution for injection in a single dose prefilled syringe30 mg/ml...

Give vaccine emergency use authorisation after trials on sufficient sample size: Parliamentary Panel

In a report submitted Monday to Rajya Sabha chairman and Vice President M Venkaiah Naidu, the Parliamentary Standing Committee on Home Affa...

AstraZeneca Pharma gets DCGI nod to market asthma drug

AstraZeneca Pharma said the receipt of this permission paves way for the launch of Benralizumab (Fasenra) in India, subject to the receipt ...

US FDA nod may help speed up Pfizer vaccine rollout in India

“India will have to give approval if it has to secure free doses of Pfizer vaccine from the Covax facility,” an official said. “Without giv...

Covid-19: India's first indigenous mRNA vaccine gets DCGI nod for human trial

India's first indigenous mRNA vaccine candidate has received approval from the Drug Controller General of India to initiate Phase I/II huma...

Gennova Biopharmaceuticals granted conditional permission for human clinical trial of its COVID-19 vaccine

The recommendations of the Subject Expert Committee (SEC) on COVID-19, which deliberated upon the proposal submitted by the firm for grant ...

Zydus Cadila gets permission from DCGI for phase-1 clinical trial of novel molecule ZYIL1

Drug firm Zydus Cadila on Monday said it has received permission from Drugs Controller General of India (DCGI) to initiate phase-1 clinical...

Covid-19: Serum Institute seeks emergency authorisation for Oxford vaccine Covishield in India

The Serum Institute of India on Sunday became the first indigenous company to apply to the Drugs Controller General of India (DCGI) seeking...

Initial findings into 'adverse event' did not necessitate halting of trials: Govt

A 40-year-old man who was a volunteer in the third phase of the ''Covidshield'' vaccine trial in Chennai has alleged serious side effects, ...

Cabinet nod for inking MoU between India, UK for cooperation in medical product regulation

The main areas of cooperation between the two regulatory authorities include exchange of safety information, including pharmacovigilance wh...

Dr Reddy’s gets nod for phase-3 Covid trials of cancer drug

The drug, 2-Deoxy-D-Glucose oral powder, also called 2-DG, works by blocking the supply of glucose molecules to cancerous cells. Without gl...