Cipla and hetero seek clinical trial waiver for Remdesivir - (The Economic Times via NewsPoints Desk)

  • According to people familiar with the matter, Cipla and Hetero Labs have sought a clinical trial waiver for remdesivir from the Drug Controller General of India (DCGI), reported The Economic Times.

  • "The matter will be taken to the subject expert committee, which will decide on the marketing authorisation and if clinical trials can be waived in an emergency situation of a pandemic," the people added.

  • Earlier, DCGI VG Somani said India will allow remdesivir to be sold only if it shows "meaningful benefit" in treating COVID-19.

  • Somani had said the regulator had taken note of the caveats that remdesiver developer Gilead Sciences had disclosed while launching the drug in Japan.

  • Gilead said it was not yet known if remdesivir was "safe or effective" for the treatment of COVID-19 and there was a possibility of "unfavourable" results emerging from additional clinical trials, the news source said.

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