Policy | September 09, 2021
New law to regulate drugs and medical devices soon
The panel is headed by DCGI Dr VG Somani with representatives from various state drug regulators and health ministry
The panel is headed by DCGI Dr VG Somani with representatives from various state drug regulators and health ministry
Hetero’s drug is a biosimilar version of Roche’s Actemra/RoActemra and will be available at the end of this month
The bioequivalence study was conducted by Accutest Research India, one of the preferred CRO players in India
The trial will be conducted across eight sites in Maharashtra
The trial will be conducted across 10 sites in India
The drug has been granted permission by DCGI for emergency use as an adjunct therapy for Covid-19
The company has to approach the DCGI for approval to commence the trials
This is the world’s first Covid=19 DNA vaccine developed in partnership with DBT-BIRAC
The company has also applied to DCGI for Emergency Use Authorization (EUA) for ZyCoVD, the world's first Plasmid DNA Vaccine
Filing for WHO Emergency Use Authorisation this month
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