Page 4 - Drug Controller General Of India

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

Covid-19: Indian sites await DCGI nod to restart Oxford vaccine trial

The Drug Controller General of India (DCGI) V G Somani will take a call after he receives data from the Data and Safety Monitoring Board (DSMB) in the UK as well as India

Abbott gets DCGI nod for once-a-day heart failure, angina treatment drug

Global healthcare firm Abbott on Wednesday said it has received approval from the Drugs Controller General of India (DCGI) for its once-a-day formulation, Ivabradine, used for treatment of chronic heart failure and chronic stable angina. The company plans to launch Ivabradine prolonged release tablets in the Indian market in the coming weeks, Abbott said in a statement. This formulation will be more convenient for patients, which will help facilitate treatment adherence with the aim to improve health outcomes, it added. The formulation has been developed at Abbott's innovation & development (I&D) centre in Mumbai, the statement said. "Adherence to therapy is a critical factor to maximize the overall health of people with chronic heart failure or chronic stable angina. We have used the best technology and science to develop this new dosage formulation," Abbott Regional Medical Director Balagopal Nair said. The convenient once-a-day formulation will help improve overall ...

Oxford Covid-19 vaccine trials in India: Serum Institute seeks DCGI nod

Initial results of the first two-phase trials of the vaccine conducted in five trial sites in the UK showed it has an acceptable safety profile and homologous boosting increased antibody responses

Jenburkt Pharma launches Covid-19 drug Favipiravir at Rs 39 per tablet

The company hopes that the easy accessibility and affordable price point of an effective treatment such as Favivent will offer Indian citizens a timely, much-needed therapeutic solution

Cipla gets DCGI approval to sell Covid-19 drug favipiravir in India

Cipla said it would launch favipiravir as "Ciplenza" in the first week of August, priced at 68 Indian rupees (91 cents) per 200 mg tablet

We want to price Covid-19 vaccine below Rs 1,000: Serum Institute CEO

Pune's Serum Institute of India is placing its bets on the Oxford-AstraZeneca vaccine candidate AZD1222

FabiFlu cheaper than other drugs to treat Covid-19, claims Glenmark

The company further claimed that since favipiravir was an oral therapy, patients could be treated on an out-patient basis without incurring additional hospitalisation expenses

Glenmark defends pricing of Covid-19 drug FabiFlu, says it is economical

Glenmark also denies making any claims that "favipiravir alone" is effective in treatment of mild-to-moderate Covid-19 patients

Jubilant Generics gets DCGI nod to manufacture Covid-19 drug Remdesivir

On June 21, Hetero and Cipla and on July 2 Mylan were given permission to manufacture and market the drug on the same conditions