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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