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Dr Kiran Kumar Karlapu, deputy secretary, Department of Health and Family Welfare, stated in an official order that the competent authority has concurred approval for Dr VG Somani to continue to hold the charge of Drugs Controller (India) under FR49(v) for a further three months beginning November 16, 2022, or until further order, whichever is earlier

DCGI Approves First Indigenous mRNA Covid-19 Vaccine For Emergency Use In Adults

BW Online Bureau

Healthcare

The DCGI had approved Covovax for restricted use in emergency situations in adults on December 28 and in the 12 to 17 years age group subject to certain conditions on March 9

DCGI Gives Emergency Use Nod To SII's Covovax For 12-17 Years Age Group

BW Online Bureau

National

It is the fourth vaccine to receive the regulator's nod for use among those below 18 years

Natco Pharma Signs Agreement With MPP To Sell Molnupiravir Capsules

BW Online Bureau

Companies & Markets Sector Reports

Natco Pharma Ltd said it has signed a non-exclusive license agreement with the Medicines Patent Pool (MPP), Switzerland to manufacture and sell Molnupiravir capsules 200 mg for treatment of COVID-19.

Govt Expert Panel Recommends Regular Market Approval For Covishield, Covaxin

BW Online Bureau

Health

Pharma companies Serum Institute of India (SII) and Bharat Biotech had submitted applications to the Drugs Controller General of India (DCGI) seeking regular market authorisation for their respective COVID-19 vaccines Covishield and Covaxin.

Stempeutics Gets DCGI Nod For Phase 3 Trial For COVID Treatment

BW Online Bureau

Economy

The company will be using its stem cell product, Stempeucel, for conducting the label extension Phase 3 clinical trial.

After Serum, Bharat Biotech Seeks Regular Marketing Approval For Covaxin

BW Online Bureau

Health

DCGI had asked for some more information following which Singh last week submitted a response along with all desired data and information to DCGI.

Pharma Firms To Roll Out Anti-Covid Pill As DCGI Approves Emergency Use

BW Online Bureau

Health

They plan to market the capsules under their respective brands and make them available at all leading pharmacies and COVID-treatment centres across the country.

Cadila Healthcare Gets DCGI Nod To Conduct Phase III Trials For Two-Dose COVID Vaccine

BW Online Bureau

Health

Shares of Cadila Healthcare Ltd were trading at Rs 563.95 per scrip on BSE, up 0.29 percent from their previous close

Novavax, SII Apply To WHO For Emergency Use Listing Of COVID Vaccine

BW Online Bureau

Health

The application to WHO is based on the companies' previous regulatory submission to the Drugs Controller General of India (DCGI), Novavax Inc said in a statement.

Mankind Pharma Gets DRDO Nod To Manufacture, Market Covid Drug 2-DG

BW Online Bureau

Health

The clinical trials for 2-DG were conducted by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of DRDO, in association with Dr Reddy’s Laboratories

Johnson & Johnson Exploring Ways To Accelerate Delivery Of Its COVID Vaccine In India

BW Online Bureau

Health

The company also said as per a recent announcement by the Indian drug regulator, there is no longer a need to conduct bridging clinical trials of COVID-19 vaccines in India.

Sun Pharma To Launch Complete Range Of Generic Anti-Epilepsy Drug

BW Online Bureau

Health

Brivaracetam belongs to the class of anti-epileptic drugs (AEDs) which have a unique or different mechanism of action compared to the existing treatment options. It has fast onset of action and promising efficacy.