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DCGI gives approval to anti-COVID drug ‘Colchicine’ for phase 2 clinical...

Drugs Controller General of India (DCGI) has given approval to a two-arm phase-II clinical trial to assess the safety and efficacy of the drug Colchicine in the improvement of clinical outcomes during the treatment of COVID-19 patients...........................

Biophore applies for DCGI emergency use approval of Aviptadil for COVID-19

Aviptadil has shown significant results in clinical trials against COVID-19. Biophore has developed both the API and the formulation in-house...........................

Sun Pharma to market Ferring Pharmaceuticals’s obstetric drug ‘CARITEC’ in India

As per the company, CARITEC is an innovative obstetric drug for preventing post-partum hemorrhage. It is a Room Temperature Stable (RTS) formulation of Carbetocin and addresses limitations in refrigeration and cold-chain transportation.......................

DCGI green signal to COVAXIN’s Phase II/III clinical trial in 2-18...

Hyderabad based Bharat Biotech to conduct clinical trials in 525 healthy volunteers........................

Roche gets DCGI nod for its investigational antibody cocktail in India

Casirivimab and Imdevimab is indicated for the treatment of mild to moderate Covid-19 in high-risk patients........................

Zydus’s COVID-19 drug ‘Virafin’ gets DCGI nod

91.15% of patients treated with PegIFN were RT PCR negative by day 7. A single dose of the antiviral Virafin administered subcutaneously early on shows significant clinical and virological improvement in moderate COVID-19 adult patients.......................

Sputnik V vaccine authorized in India

India has become the 60th country to approve the Russian vaccine, Sputnik V, one of only three vaccines registered so far in the country.........................

Zydus Cadila vaccine candidate gets nod for Phase III clinical trials

The candidate has been supported by the National Biopharma Mission (NBM) under the aegis of BIRAC and the Department of Biotechnology, Government of India.......................

Wait over as DCGI approves Bharat Biotech & Serum Institute COVID-19...

After adequate examination, Central Drugs Standard Control Organisation decided to accept the recommendations of the Expert Committee, and accordingly, vaccines of Serum and Bharat Biotech are being approved for restricted use in an emergency situation

Enough compliances in place during COVID-19 vaccine development, assures regulator

Drugs Controller General of India has assured that the COVID-19 vaccines being developed and tested in India have followed all the right methodologies as per existing regulatory guidelines........................