Date: 03-Jul-2020

India Poised To Ramp Up Remdesivir Production As Mylan And Jubilant Life Sciences Soon To Launch The Drug

India is poised to ramp up production of antiviral drug remdesivir to fight COVID-19 with two more drugmakers---Mylan and Jubilant Life Sciences--gearing up for the launch of the drug soon, taking the tally of drug units launching remdesivir in the country to four.

Recently, Hetero Labs Ltd and Cipla had introduced remdesivir under the brand name ‘Covifor’ and ‘Cipremi’ respectively following manufacturing and marketing approval from Drugs Controller General of India (DCGI) for "restricted emergency use" on adult and paediatric patients hospitalised with suspected or laboratory-confirmed COVID-19 infection.

Remdesivir, intravenously administered in hospitals, helped shorten hospital recovery times in a clinical trial. Following this, the antiviral drug received emergency use authorization in the United States and full approval in Japan.

The drug is expected to be in high demand as one of the only treatments so far shown to reduce the course of COVID-19.

Jubilant received approval from DCGI for manufacturing and marketing the antiviral drug subject to certain criterion being met. The company is working to make this product available to COVID-19 patients soon, stated Jubilant Life Sciences spokesperson.

Talking about availability of raw material to initiate manufacturing of remdesivir, the company spokesperson said “We will produce API at our own manufacturing facility at Nanjangud. And for API, we will also produce our own key starting material in our Life Science Ingredients business segment.”

Mylan is also set to commercialize remdesivir in India and is in the process of registering the product. It is working closely with the government of India to make remdesivir accessible, stated the company spokesperson.

It is learned that Mylan has imported raw material for manufacturing COVID-19 drugs-- remdesivir and favipiravir from China which got stuck at the Mumbai airport over the last few days due to delay in customs clearance.

Gilead Sciences, the patent holder of remdesivir has signed non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers in India-- Hetero, Cipla, Jubilant Life Sciences, Mylan, Dr Reddy's Laboratories, Syngene, a Biocon company and Zydus Cadila Healthcare Ltd to further expand supply of the antiviral drug.

The agreements allow generic drug makers to manufacture remdesivir for distribution in 127 countries including India.

Under the licensing agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up production more quickly. We are preparing the technology transfer packages and our goal is to make them available as soon as possible. The licenses are royalty-free until the World Health Organization declares the end of the public health emergency of international concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier, stated Gilead Sciences spokesperson.

Gilead Sciences has received DCGI marketing approval for Veklury (remdesivir) for treatment of suspected or laboratory confirmed coronavirus disease in adults and children hospitalised with severe disease.

Replying to a query on supply of remdesivir in India, the company spokesperson said “The timeline to get the drug to the Indian patients that need it will depend on the licensees and a process that Gilead does not control.”

Gilead has priced remdesivir at US$ 2,340 per patient in developed nations.

Shedding light on drug price in India, the spokesperson said, “We are committed to making remdesivir both accessible and affordable to governments and patients around the world. In India generic manufacturers are free to set their own prices. It is our hope and intent that volumes and competition will drive costs down.”

Talking about effectiveness of remdesivir in treating COVID-19 patients, Dr Sudha Kansal, senior consultant pulmonology and chest physician, Indraprastha Apollo Hospitals said “Till today there is no proven therapy for the treatment of COVID 19. Remdesivir has proven to help improve outcomes in terms of faster recovery for people who are moderate COVID pneumonia patients. While 20% of such patients require admission, 5% out these need ICU care. This therapy is basically used for patients who have multiple co-morbidities and need oxygen support. Remdesivir helps improve outcomes in conditions of these patients. But the key here is to start the therapy early and not wait for the patient's condition to worsen where they require ventilator support.”

“Another important aspect while using the remdesivir therapy is checking the steroids given to the patient during the treatment. The common steroid used for COVID patients is dexamethasone that tends to increase the metabolism of this drug, thereby reducing the level of remdesivir. Therefore, if a patient is on remdesivir therapy his line of treatment should be complimented with a different steroid like methylprednisolone, which does not alter the levels of remdesivir,” stated Dr Kansal.

Remdesivir therapy is not advised for patients with renal failures, as there is no data on the amount of permissible dose for patients with this condition, she said.