NEW DELHI, India
India will soon market and distribute the domestically produced Remdesivir drug for “restricted emergency use” for the treatment of coronavirus patients, according to statements from Indian companies.
Indian drugmakers CIPLA and Hetero Pharma launched the generic Remdesivir drugs production late Sunday, a month after signing the deal with the US-based patent-holder Gilead Sciences.
With total confirmed cases of COVID-19 soaring at 425,282, the companies will be making the generic drugs available in the capital Delhi and the financial capital Mumbai first, the two worst-hit cities in the country, via hospital channels. The drug will not be available on counters.
The Indian Health Ministry recently re-issued its COVID-19 clinical management protocol, calling Remdesivir an “investigational therapy on coronavirus patient.”
“At present, use of these therapies is based on limited available evidence. As the situation evolves, and when more data become available, the evidence will be accordingly incorporated, and recommendation upgraded,” according to the protocol.
CIPLA has launched the drug under the brand name “Cipremi”, while Hetero under the brand name “Covifor”.
Both companies have already received approval from the country’s Drug Controller General, as part of their agreement with Gilead Sciences.
“As part of the risk management plan, CIPLA will provide training on the use of the drug, informed patient consent documents, conduct post-marketing surveillance as well as to conduct a Phase IV clinical trial on Indian patients,” said a statement by the drugmaker.
In a 52-week high, CIPLA’s shares climbed over 9% in Monday’s trade after it announced the launch of Cipremi.
The Mumbai-based drugmaker said that it will be marketing and supplying the drug through both government and open market channels. Though it has not yet made public the details on the pricing of the generic drug, confirmed their spokesperson.
Hetero Pharma, on the other hand, said it plans to make 100,000 dosages of Remdesivir available across the country over the next three-four weeks for treatment of severe COVID-19 patients.
Remdesivir trials and situation in India
In May, the US Food and Drug Administration authorized the emergency use of the drug for adult and pediatric patients hospitalized with suspected or laboratory-confirmed COVID-19 infection, particularly those on oxygen support.
After the authorization, Gilead had entered a non-exclusive licensing agreement with one Pakistani and four Indian firms for the manufacturing and distribution of Remdesivir to 127 countries. The company had also said the licenses are royalty-free until the World Health Organization (WHO) declares the end of the public health emergency or a vaccine is approved.
A report from a randomized clinical trial was conducted with the drug on 1,063 patients over 60 centers across the US, Europe, and Asia. Most of these patients were on oxygen support, receiving high flow oxygen or non-invasive ventilation.
The mortality rates in the study were 7.1% in those given Remdesivir and 11.9% in those given placebo.
New Delhi recently decided to discontinue the hydroxychloroquine (HCQ) arm of the Solidarity Trial at its 22 trial sites after the WHO said the HCQ was not helping the treatment of COVID-19 patients.
The South Asian nation on Monday recorded 14,821 new cases and 445 deaths in the last 24 hours as the death toll has touched 13,700, continuing upward trend of daily count.
The western state of Maharashtra, which includes Mumbai, remains the worst-hit state. The state’s death toll hit 6,170 while the total number of patients reached 132,075 including 60,161 active cases.
Delhi announced the availability of Oximeter to all home quarantines. The state has reported 2,175 fatalities so far, while the total infections rose to 59,746, including 24,558 active cases.