DCGI grants conditional market approval for Covishield and Covaxin
Published By : Prameya News Bureau | January 27, 2022 IST
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New Delhi, Jan 27: Drugs Controller General of India (DCGI) has granted conditional market approval for Covishield and Covaxin. The approval has been granted under the New Drugs and Clinical Trials Rules, 2019. The vaccines will not be available in medical stores. The hospitals and clinics can purchase the vaccines. Vaccination data has to be submitted to DCGI every six months. Data to be updated on CoWIN app also. The Central Drugs Standard Control Organisation (CDSCO) has now upgraded the permission for COVAXIN and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions, said Union Health Minister Dr Mansukh Mandaviya. The conditions include supply for programmatic settings including registration on the CoWin platform and to continue to submit safety data on a six-monthly basis, he added.
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