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DCGI approves “Conditional Market Authorisation” of Covaxin and Covishield ExpressPharma
January 28, 2022
The approval pathways through this route are fast-tracked with certain conditions to enhance the access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines
Bharat Biotech seeks full marketing approval from DCGI for Covaxin ExpressPharma
January 17, 2022
The company, however, is yet to submit the full follow up data of clinical trial of Covaxin to DCGI, a source said.
Enzene Biosciences Ltd. obtains Marketing Authorization for its Romiplostim Biosimilar drug in India firstwordpharma
August 26, 2021
Enzene Biosciences Ltd. "Enzene" announces a successful Marketing Authorization (MA) from the Drug Controller General of India (DCGI) for its second biosimilar drug "Romiplostim", indicated for the treatment of chronic Immune Thrombocytopenic Purpura.
Novavax and Serum Institute of India Announce Submission to Regulatory Agencies in India, Indonesia, Philippines for Emergency Use Authorization of Novavax' Recombinant Nanoparticle COVID-19 Vaccine prnasia
August 06, 2021
Novavax, Inc. today announced that the companies have filed regulatory submissions for emergency use authorization of Novavax' recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant.
Working with Moderna to see make its COVID vaccine available in India: Govt expresspharma
July 12, 2021
The government said that it is working actively with COVID-19 vaccine manufacturer Moderna to see how its vaccine can be imported and made available in the country.
Laurus Labs gets DRDO nod to make and market 2-Deoxy-D-glucose (2DG) in India expresspharma
July 05, 2021
Laurus Labs announced that it has received the licence from Defence Research & Development Organisation (DRDO) to manufacture and market of 2-Deoxy-D-Glucose (2DG).
Zydus applies to DCGI for EUA to launch ZyCoV-D expresspharma
July 02, 2021
The COVID-19 vaccine has been tested in adolescent population in the 12-18 years age group in India as well.
Cipla gets permission from DCGI to import Moderna’s COVID-19 vaccine expresspharma
June 30, 2021
The company has to submit seven days safety assessment of the vaccine in the first 100 beneficiaries before rolling out the vaccine for further immunisation programme.
DCGI allows PNB Vesper Life Science to conduct phase-III clinical trials on PNB 001/GPP-BALACOVIN to treat COVID-19 expresspharma
June 25, 2021
PNB Vesper has received permission from the Drugs Controller General of India (DCGI) to enter into the phase-III clinical trials of PNB 001/GPP-BALACOVIN, the company said in a statement.
Govt is taking steps to boost availability of Amphotericin B, allots 6.67 lakh vials to states, UTs expresspharma
June 18, 2021
The existing manufacturers have also been called upon to increase the production of Liposomal Amphotericin-B, informed Chemicals and Fertilisers Ministry.

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