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

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

Shots:

  • 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