The government of India is hoping for the issuance of voluntary licence for the antiviral drug remdesivir by California-based Gilead Sciences Inc like it did for the hepatitis C drug, Sovaldi in 2015, Mint has reported citing senior Indian government officials.
Remdesivir, originally developed to treat Ebola more than a decade ago, is said to be one of the more promising drugs being tested to treat COVID-19.
The Indian government is not keen on asking Gilead to compulsorily issue the generic licence of its novel drug, an official told the publication, adding that the government is hoping Gilead will voluntarily issue licences for its patented drug.
Moneycontrol could no tindependently verify the report.
A reason behind India not being keen on asking Gilead to issue compulsory licence is an issue over patents for its novel drug Sovaldi, which led to tensions between India and the US in 2015, the report said.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
At that time, the Indian patent office rejected the company’s patent application filed in July 2014 for the drug on the grounds that it was not a significant improvement over an earlier compound developed by another firm, as per the report.
When a company issues compulsory licensing, it allows generic drug makers to produce a patented product without having to take permission from the patent holder. Such moves give governments the firepower to confront emergency health challenges, the report suggested.
Currently, about half-a-dozen clinical trials of remdesivir is underway across the globe, said the report.
Before taking any final decision on how to procure the drug, India will wait until the drug is found to be effective and production continues, said the report quoting another official.
However, waiting for Gilead to issue a voluntary licence could be risky, as it may create uncertainty over its supply, especially if the trials are successful, the report said.
Gilead is supplying the antiviral drug remdesivir free of charge to all clinical trials, but it is only available to patients who are part of a clinical trial or for compassionate use, said the report citing an official at the drugmaker.
The interest in Gilead's remdesivir has been high as there are currently no approved treatments or preventive vaccines for COVID-19, and doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can shut down other organs in extremely severe cases.Follow our full COVID-19 coverage here.