Hyderabad-based Natco Pharma Limited on Monday said it has applied to the Central Drugs Standard Control Organisation (CDSCO) for approval of Phase-III clinical trial of Molnupiravir Capsules, to be used for the treatment of Covid-19 positive patients.
The capsule has been developed by American pharma major Merck along with Ridgeback Biotherapeutics.
According to a press release from Natco, pre-clinical data have shown that Molnupiravir has broad anti-influenza activity, including highly potent inhibition of SARS-CoV-2 replication.
“Patients treated with Molnupiravir achieved response within 5 days of therapy indicating that the duration of treatment with Molnupiravir is short, with the additional advantage of being an oral therapy,” it said.
Natco is hoping that CDSCO would give emergency approval of this drug based on “compassionate use” for patients.
“Compassionate use” approval is given for investigational drugs so that a patient with an immediately life-threatening condition can gain access to the drug.
The company is ready to launch the product this month if approval is given.
CDSCO is responsible for approval of drugs, conduct of clinical trials, laying down the standards for drugs, control over the quality of imported drugs in the country and coordination of the activities of state drug control organisations.
If granted approval, the drug will come as a relief in the wake of a raging second wave in India and several states staring at a shortage of Remdesivir.
Recently, Zydus Cadila received restricted emergency use approval from the Drugs Controller General of India (DCGI) VG Somani for the use of ‘Virafin’, a pegylated interferon alpha-2b, to treat moderate Covid-19 infection in adults.
It was originally used in treating Hepatitis B and C, and is administered in a single dose subcutaneous regimen.
When administered early in treating Covid patients, Virafin can help faster recovery and avoid much of the complications, the company said.
It will be available on the prescription of a medical specialist for use in a hospital and institutional setups, it added.
Meanwhile, India reported 3,52,991 Covid-19 cases in the last 24 hours, taking the cumulative caseload to 1,73,13,163, said the Union health ministry on Monday morning.
The figure marks another jump in the daily cases in India, which has been reporting the highest cases in the world.