Gilead Sciences is likely to apply to India's Central Drugs Standard Control Organisation (CDSCO) soon seeking marketing authorisation for remdesivir to treat COVID-19, reported The Economic Times.
Sources said officials of India's health ministry, along with the Drugs Controller General of India (DCGI), held talks with Gilead representatives recently to prepare a road map for introducing remdesivir in the country.
"On the basis of approvals granted by the FDA or any other reputed regulator, the Indian regulator can approve the drug by waiving off clinical trials in special circumstances in accordance with [certain] provisions," a source said.
According to the news source, the efficacy of remdesivir was discussed at a recent meeting of a technical committee headed by the Directorate General of Health Services, and its use on COVID-19 patients was not approved due to a lack of enough scientific evidence at that stage.
However, a source said that "in a recent meeting, it was decided that since redmdesivir is one among the four treatment protocols that are being evaluated during the randomised controlled clinical trials under the WHO's Solidarity Trial…we may wait for its outcome before deciding inclusion of this drug in national treatment protocol."
Gilead has entered into non-exclusive licensing agreements with pharmaceutical firms, including Indian drugmakers Cipla, Jubilant Life Sciences and Hetero, for the manufacture and distribution of remdesivir.
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