US-based company Gilead Sciences may announce voluntary license agreements with Indian medicine manufacturers. This will allow them to produce generic versions of Remdesivir.
India is hoping that the California-based Gilead Sciences Inc. India will issue generic licenses for the manufacture of antiviral drug Remdesivir. It is believed to be the most promising drugs tested to treat COVID-19 till date.
Drug undergoing clinical trials
The drug is still undergoing clinical trials globally and is yet to be approved for COVID-19 treatment. Indian Council of Medical Research (ICMR) hinted that if the medicine proves effective and if cost-effective versions of the medicine can be made available through Indian generic companies, and then it can be considered for treating COVID-19 patients in India too.
The drug is also being tested under the Solidarity Trial by the World Health Organization. Another major trial is jointly supported by the Bill & Melinda Gates Foundation, the Wellcome Trust and Mastercard.
On April 10, Daniel O’ Day, chairman and CEO, Gilead stated that seven clinical trials are undergoing. It will determine whether Remdesivir is a safe and effective treatment for COVID-19. The company hopes that by May, the initial data from the placebo-controlled NIAID trial as well as data from the Gilead study of patients with moderate symptoms of COVID-19 will be available.
Seeking for voluntarily issue licenses
Indian government is hoping Gilead to issue voluntarily licenses for its patented drug in the same way it did for the hepatitis C drug, Sovaldi, in 2015.
“We do not plan to get the drug under compulsory licensing. If you look at Gilead’s history, they have gone for voluntary licensing before with their hepatitis C drug, Sovaldi. They may give voluntary license for this product also,” said a government official.
India is not asking Gilead to issue the compulsory license. The reason is a past issue over patents for its novel drug Sovaldi, which led to tensions between India and the US in 2015, the report said.
Compulsory licensing issued by the company allows generic drug makers to produce a patented product without having to take permission from the patent holder. Such moves give governments the power to confront emergency health challenges, the report suggested.
Remdesivir is one of the most promising candidates
According to experts, Remdesivir is the most promising candidates for treating COVID-19. Also, in terms of safety, it is better than hydroxychloroquine. But still, a large-scale clinical trial is yet to be completed.
Gilead is supplying Remdesivir free of charge for all clinical trials. The medicine is only available to patients who are part of a clinical trial or for compassionate use.
