Lupin gets CDSCO panel nod to bioavailability study of Remdesivir Oral Solution for COVID 19
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has opined for the grant of permission to drug maker Lupin to conduct the bioavailability study of Remdesivir Oral Solution 100 mg/5ml.
However, the permission comes with a condition that the study should be conducted in male human subjects in fasting condition only.
The recommendation came in the wake of the proposal presented by the firm along with the animal study data of pharmacokinetics of the proposed Remdesivir formulation and Absolute bioavailability study protocol.
Remdesivir is an inhibitor of the viral RNA-dependent, RNA polymerase. It possesses an in vitro inhibitory activity against SARS-CoV-1 and the Middle East respiratory syndrome (MERS-CoV). It was identified early as a promising therapeutic candidate for Covid-19 because of its ability to inhibit SARS-CoV-2 in vitro.
Remdesivir was approved by the Drug Controller General of India (DCGI) for restricted emergency use in India for the treatment of Covid-19 patients hospitalized with severe symptoms.
The SEC committee in its 148th meeting held on 23.03.2021 & 24.03.2021 at CDSCO, HQ New Delhi, reviewed the proposal regarding Remdesivir Oral Solution 100 mg/5ml.
Responding to the proposal presented by the firm, after detailed deliberation, the SEC committee recommended for grant of permission to conduct of the bioavailability study, as per the protocol presented, subject to the condition the study should be conducted in male human subjects in fasting condition only. Further, it was suggested to submit the revised protocol as per the committee's recommendation to CDSCO for approval.