New Delhi: Jubilant Life Sciences, an integrated global pharmaceutical and life sciences company, is exploring the possibility of launching remdesivir injections in tablet form to treat Covid-19 patients.
Remdesivir, which is one of the most sought-after experimental drugs for the treatment of Covid-19 infection, is currently administered through an intravenous injection.
The firm has presented its proposal to the Narendra Modi government’s expert panel — the subject expert committee (SEC) — for evaluation during a meeting held on 25 August.
The SEC functions under the Central Drugs Standard Control Organisation (CDSCO), an arm of the health ministry, which regulates the quality of drugs and vaccines in the country. It is led by the Drugs Controller General of India.
According to the minutes of the meeting, uploaded on the CDSCO website, the proposal has been listed as “remdesivir sublingual tablets 20 mg”.
Sublingual administration involves placing a drug under one’s tongue so it dissolves and gets absorbed into blood through the tissues there.
ThePrint reached the Jubilant Life Sciences via email and text messages but the firm refused to comment on the development.
The company’s move comes within a month of launching its ingenuously-manufactured remdesivir vials in the Indian market.
On 3 August, Jubilant Life Sciences had announced the launch of remdesivir injections under the brand name ‘JUBI-R’, at a price of Rs 4,700 per vial of 100 mg. This came nearly three months after it had signed a ‘non-exclusive‘ agreement with US drugmaker Gilead to manufacture generic versions of remdesivir.
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How sublingual administration works
According to Healthline, an American health information website, the cheek and area under our tongues have many capillaries or tiny blood vessels. “There, drugs can be absorbed directly into the bloodstream without going through your digestive system,” it explained.
Medicines such as sorbitrate used for angina (chest pain that can hint at a heart attack) are administered through the sublingual route.
This route helps drugs get into a patient’s system quickly. It is also used when a medication doesn’t absorb very well through the stomach or when a drug’s effect decreases in the process of digestion.
It is also a patient-friendly method given that a drug can be administered outside of a hospital setting.
Expert panel asks for ‘clear justification’
The firm, according to the minutes of the meeting, has submitted its proposal along with a bioavailability protocol before the committee. A bioavailability protocol shows to what extent a drug becomes completely available to its intended destination(s) in a body.
“After detailed deliberation, the committee recommended that the firm should submit clear justification for use of the drug through sublingual route supported by evidence or literature including animal PK data generated with the drug through sublingual route,” the SEC has told the company, according to the minutes.
Animal PK studies — known as pharmacokinetic (PK) — are done on a new drug by collecting several blood samples time to time from the body of an animal to determine how it is handling the substance.
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