While all new drugs must undergo trials before getting marketing approval in India, the regulator can grant exemptions in public interest and in cases of national emergency, extreme urgency and epidemics.
“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 said. “The committee takes into consideration the pros and cons.”
Earlier, DCGI VG Somani had told ET that 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.
The US company 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 US granted emergency approval to use remdesivir for the treatment of critical Covid-19 patients. Japan, too, has granted similar approval for the drug, originally developed to treat Ebola.
The US Food and Drug Administration authorised emergency use for the drug after trials showed that it halved the recovery time for moderately affected patients to five days.
Gilead has so far signed licensing agreements with Cipla, Jubilant Life Sciences, Hetero and Mylan. ET first reported on May 5 that Gilead was in talks with several companies in India for licensing agreements.
Hyderabad-based generic pharma company Hetero Labs told ET earlier that it was working on a “war footing” to make remdesivir available to Covid-19 patients in India.