US pharma giant seeks marketing authorisation from India for remdesivir - (The Economic Times via NewsPoints Desk)

  • According to sources, Gilead Sciences has the complete data about the pre-clinical and clinical studies for remdesivir for COVID-19, as reportedThe Economic Times

  • "The company has applied seeking marketing authorisation for its anti-viral drug remdesivir to India's Central Drugs Standard Control Organisation (CDSCO). The CDSCO will examine the application with the help of the expert committee. It will take a final decision based on the recommendations of the expert committee," a source said.

  • Meanwhile, Cipla and Hetero Labs are applying to the drug regulator seeking permission to manufacture and sell remdesivir in India.

  • The Indian companies have also sought a clinical trial waiver for remdesivir so that the drug can be made available for the patients faster, an official said.

  • Gilead Sciences has entered into non-exclusive licensing agreements withdrugmakers, including three Indian companies Cipla, Jubilant Life Sciences and Hetero, for manufacture and distribution of remdesivir.

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