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Gilead Plans to Submit MAA to CDSCO for its Remdesivir to Treat COVID-19 in India

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Gilead Plans to Submit MAA to CDSCO for its Remdesivir to Treat COVID-19 in India

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  • Gilead seeks CDSCO’s MAA for its anti-viral therapy remdesivir for the treatment of COVID-19. The company had a discussion with Union Health Ministry and Drugs Controller General of India (DCGI) prepare a road map for introducing remdesivir in India
  • Following the US FDA’s approval- CDSCO can approve the therapy by waiving off clinical trials in special circumstances in accordance with the provisions of the New Drug and Clinical Trial Rules 2019
  • Remdesivir is one of the four treatments that are being evaluated WHO's solidarity trial to find an effective treatment for COVID-19 across multiple countries. Additionally- Gilead has entered into non-exclusive licensing agreements with pharma firms including Cipla- Jubilant Life Sciences and Hetero for manufacture and distribution of remdesivir

Click here to­ read full press release/ article 

Ref:  The Economic Times | Image: Gilead


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