The pharmaceutical company has sought permission of the Drugs Controller General of India (DCGI) to launch remdesivir in a tablet form. In a meeting held on August 25, the company had presented its proposal to the DCGI.
The company has given bioavailability protocol to the subject expert committee (SEC), which has been set up to evaluate proposals related to Covid-19, according to the minutes of the meeting, a copy of which was seen by ET.
According to the proposal, the company is exploring the possibility of launching 20 mg sublingual tablets. Sublingual administration involves placing a drug under the tongue so that it gets dissolved and absorbed into the blood through the tissues.
The SEC, which functions under DCGI, asked for more clarity from the company on the proposal. “The firm presented their proposal along with bioavailability protocol before the committee. After detailed deliberation, the committee recommended that the firm should submit clear justification for use of the drug through sublingual route supported by evidence/literature including animal pharmacokinetic (PK) data generated with the drug through sublingual route,” said the minutes of the meeting.
“The matter will be taken up again, once the company submits its response,” said a senior official, who did not wish to be identified.
The company refused to comment on the development.
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