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  Drug regulator suspends manufacturing and selling of Entod pharma's eye drops over unapproved claims

  Health | September 12, 2024 11:00 IST

  The drug regulator stated that the company had failed to respond to the queries and tried to justify the claims for the product for which no approval was granted.

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  DCGI orders withdrawal of AstraZeneca's anti-cancer drug 'Olaparib tablets' for certain treatments

  India | May 23, 2024 8:36 IST

  The Drug Controller General of India said that the drug may continue to be marketed for other approved indications.The communication noted that the company provided clinical evidence supporting the withdrawal of the indication for Olaparib tablets.

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  Blood not for sale, only processing fee to be charged: DCGI tells blood banks

  Health | January 05, 2024 16:57 IST

  The Drug Controller General of India (DCGI) has recently made an important decision regarding blood donations and the functioning of blood banks in the country. To regulate and monitor the sale of blood, the DCGI has directed all blood banks to strictly adhere to the policy of not selling blood.

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  DCGI asks states to keep vigil on sale of falsified versions of 2 drugs following WHO alerts

  India | September 10, 2023 15:54 IST

  Adcetris (Brentuximab Vedotin) is a CD30-directed antibody-drug conjugate indicated for the treatment of patients with Hodgkin's lymphoma after the failure of an autologous stem cell transplant and systemic anaplastic large cell lymphoma.

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  Digene gel recalled by Abbott India after DCGI issues advisory

  Health | September 06, 2023 18:48 IST

  The DCGI said the impugned product manufactured at the Goa facility may be unsafe and its use may result in adverse reactions.

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  Gennova Biopharmaceuticals' mRNA vaccine gets DCGI approval for emergency use

  India | December 17, 2022 13:22 IST

  GEMCOVAC-19 is the first mRNA vaccine that has been developed in India.

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  Serum Institute's Covovax gets DCGI's nod for emergency use in children aged 7-11 years

  India | December 17, 2022 13:24 IST

  The DCGI's nod came after the subject expert committee on COVID-19 of the CSDCO last week recommended granting emergency use authorisation to Covovax for the age group of 7 to 11 years.

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  Serum Institute seeks regular marketing authorisation from DCGI for Covishield

  India | October 25, 2021 21:51 IST

  If the DCGI grants regular marketing authorisation, Covishield will be the second vaccine in the world to receive such approval. Pfizer-BioNTech's COVID-19 vaccine has received full US FDA approval for use in individuals 16 years of age and older.

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  Sputnik's single-dose vaccine gets DCGI nod for phase-III trials in India

  India | September 15, 2021 14:20 IST

  CDSCO in July had refused to grant emergency-use authorisation to Sputnik-Light, ruling out the need for the conduct of the phase III trial of the Russian vaccine in the country.

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  COVID: Phase 3 trial of Biological E underway

  News | September 02, 2021 22:05 IST

  The Drug Controller General of India (DCGI) on Wednesday informed that the Phase 3 trial of Hyderabad-based Biological E Limited for its anti-COVID shots is underway. Member-Health, NITI Aayog, Dr VK Paul said, "Phase 3 trial work of Biological E going on. Stockpile being produced. We should wait for results, we hope it'll be in next month or 2

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  SII chairman Cyrus Poonawalla says third dose desirable; warns against mix-and-match

  India | August 14, 2021 9:12 IST

  Cyrus Poonawalla on Friday strongly affirmed that mixing two different vaccines of COVID-19 is a very risky decision and it is must be discouraged.

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  VIDEO: Cipla gets DCGI nod to import Modernas COVID vaccine

  News | June 30, 2021 8:15 IST

  Drugs Controller General of India (DCGI) granted permission to Mumbai-based pharmaceutical firm Cipla to import Moderna COVID-19 vaccine for India.

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  Zydus Cadila vaccine for 12-18 age group soon: Centre informs SC

  India | June 27, 2021 7:55 IST

  Zydus Cadila has concluded its clinical trials for the 12 to 18 age group, and the vaccine may be available in near future, subject to the statutory permissions.

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  Biophore applies to DCGI for emergency-use approval for COVID treatment drug

  Business | June 11, 2021 11:36 IST

  Biophore India Pharmaceuticals on Friday said it has applied to the Drugs Controller General of India (DCGI) for obtaining emergency-use approval for Aviptadil, used in the treatment of moderate to severe cases of COVID-19.

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  Serum Institute of India gets DCGI nod to manufacture Sputnik V COVID-19 vaccine in India

  News | June 05, 2021 7:44 IST

  The DCGI has granted permission to the Serum Institute of India (SII) to manufacture the Sputnik COVID-19 vaccine in India for examination, test and analysis with certain conditions.

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  Serum Institute gets nod to manufacture Russian Sputnik V vaccine in India

  India | June 05, 2021 0:06 IST

  Pune-based SII has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia for developing Sputnik V at its licensed Hadapsar facility.

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  Norms for clearing foreign-made COVID-19 vaccines eased by DCGI

  India | June 02, 2021 13:02 IST

  The decision by the Drugs Controller General of India (DCGI) comes in the backdrop of Pfizer and Cipla putting forth similar demands during negotiations to supply imported vaccines to India.

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  2-DG: How and when to use DRDO's anti-Covid drug? Guidelines

  India | June 01, 2021 13:37 IST

  2-DG is an oral anti-viral drug for Covid-19 patients. It has been developed by the DRDO in collaboration with Dr Reddy's Laboratories. It reduces dependence on supplemental oxygen.

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  DCGI approves anti-COVID drug developed by DRDO for emergency use

  India | May 09, 2021 0:05 IST

  The drug has been developed by Institute of Nuclear Medicine and Allied Sciences (INMAS), a leading laboratory of Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy's Laboratories in Hyderabad.

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  Bharat Biotech seeks DCGI's nod to extend shelf life of Covaxin

  India | April 25, 2021 17:01 IST

  Bharat Biotech has written to India's drug regulator seeking extension of the shelf-life of its indigenously developed COVID-19 vaccine Covaxin from six to 24 months, sources said on Sunday.