DCGI endorsed Hetero Pharmaceuticals for the supply of drug Covifor (Remdesivir) to various states where the many suspected or laboratory-confirmed COVID cases are hospitalized because of drastic symptoms of the Corona virus.
Hetero stated that Covifor (Remdesivir) will be provided in a 100 mg vial (injectable) and must be administered intravenously in a hospital or intensive care unit under the supervision of a healthcare practitioner.
The chairman of the Hetero Group also stated that “with the rising number of COVID-19 cases in the nation, the endorsement for the supply of Covifor (Remdesivir) drug can prove to be a game-changer because clinical results are positive and satisfactory”.
What is Covifor?
Covifor is a generic version of Remdesivir drug which can be used in emergency conditions of Corona cases
It is a drug whose first batch will be supplied to Delhi, Maharastra, Gujrat etc.
The company is sure about enough stock to provide to the present requirements of the drug.
COVID-19 therapy by Covifor will cost less than 30,000 per patient. Six doses of the drug will be provided in the aforementioned timeframe.
Dr. M. Srinivasa Reddy stated that “Covifor is Remdesivir’s first generic brand. With this Covifor drug, we hope to lessen the treatment time of patients within the hospital, decreasing the increasing pressure on the medical foundation that’s currently overburdened because of a sudden acceleration in COVID- 19 infection rates”.
He further said that we are working closely with the government and the medical community so that public and private medical institutions across the country can quickly access the “COVIFOR” drug.
In May, the Supreme Drug Regulatory Authority allowed the manufacturing authorization of the antiviral drug Remdesivir to Hetero, Cipla, and other pharmaceutical companies, only for “restricted emergency use” COVID-19 patients with moderate disease (especially those on oxygen).
Now, domestic pharmaceutical giant Hetero has begun to provide 20,000 bottles of Covifor (Remdesivir) generic drugs nationwide. The cost of the product is Rs 5,400 per bottle.
A Hetero spokesperson said: “The first batch of 20,000 bottles, divided into two equal parts, each batch of 10,000, one of which will be immediately provided to Maharashtra, Delhi, Gujarat, Hyderabad, Tamil Nadu, Mumbai and other parts of Maharashtra.”
A Hetero spokesperson said that another batch will be provided to Indore, Kolkata, Lucknow, Bhopal, Patna, Bhubaneswar, Vijayawada, Ranchi, Cochin, Trivandrum and Goa to meet emergencies.
The Union Ministry of Health has explained the use of Remdesivir as an investigational treatment antiviral drug in its latest clinical administration for COVID-19 patients.
The patient will be given an intravenous injection of 200 mg on the first day and then 100 mg IV 5 days a day. This drug should not be prescribed to pregnant or nursing mums and minors under 12 years old. The Ministry of Health documents stated that patients should also not have liver disease and kidney complications.
Agreement with Gilead
The product was launched under a licensing agreement with Gilead Sciences Inc.The goal is to expand access to COVID-19 treatment in low- and middle-income countries. The investigational drug of Gilead Ramdesivir had also received an Emergency Use Authorization (EUA) from the US Food and Drug Administration (USFDA) for the treatment of critical COVID-19 hospitalized patients.
In addition to Hetero, many other pharmaceutical manufacturers including Jubilant Lifesciences, Mylan, Dr. Reddy’s Laboratories, Biocon Company Syngene, and Zydus Cadila Healthcare have entered into a non-exclusive voluntary license agreement with Gilead under which they will distribute manufactured products at 127 Countries.
In May, the US National Institutes of Allergies and Infectious Diseases stated that the recovery time of Covid-19 patients given Remdesivir rallied from 15 to 11 days.
Last month, DCGI’s Office of the Central Drug Control Standards Organization (CDCSO) allowed the manufacturing and marketing authorization to its US-based Gilead Sciences’ antiviral drug Remdesivir in India, which may be adopted for “limited emergency use” on the sufferers who are hospitalized because of COVID-19 infection within the wake of coronavirus pandemic.
The DGCI endorsement for Hetero’s product comes close on the heels of Glenmark Pharmaceuticals, who received the drug regulator’s nod to market its antiviral drug Favipiravir for treatment of mild to moderate COVID-19 patients in India.
It is expected that the “COVIFOR” drug for coronavirus treatment will play an important role in reducing the mortality caused by COVID-19, given its proven positive clinical results, the company said.