US pharma giant Gilead Sciences has applied to India's drug regulator seeking marketing authorisation for its anti-viral drug remdesivir, which is being touted as a potential treatment for COVID-19.
Gilead Sciences, who is the patent holder of the drug, has the complete data about the pre-clinical and clinical studies for remdesivir, sources said.
"The company has applied seeking marketing authorisation for its anti-viral drug remdesivir to India's Central Drugs Standard Control Organisation (CDSCO). The CDSCO will examine the application with the help of the expert committee. It will take a final decision based on the recommendations of the expert committee," a source said.
The medicine has been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) to treat hospitalised coronavirus-infected patients.
Regulatory approval under exceptional pathway was granted by the Japanese Ministry of Health, Labour and Welfare on May 7, on the basis of clinical data from the US, sources said.
On the basis of approvals granted by USFDA or any other reputed regulator, the Indian regulator can approve the drug by waiving off clinical trials in special circumstances in accordance with the provisions of the New Drug and Clinical Trial Rules 2019, a source in the know of the developments said.
This comes in the backdrop of two Indian pharmaceutical companies -- Cipla and Hetero Labs -- applying to the drug regulator seeking permission to manufacture and sell remdesivir in India.
They have also sought a clinical trial waiver for remdesivir so that the medicine can be made available for the patients faster, an official said.
Their applications are still under consideration, the official said.
Gilead Sciences Inc have entered into non-exclusive licensing agreements with pharma firms including three domestic majors Cipla, Jubilant Life Sciences and Hetero for manufacture and distribution of remdesivir.
The Indian Council of Medical Research had earlier said anti-viral medication remdesivir which was used during Ebola outbreak may inhibit the SARS-CoV-2 replication and research on its efficacy in the treatment of COVID-19 is a part of the WHO's 'solidarity trial.'
According to a recently published study in the New England Journal of Medicine, two out of three critically ill coronavirus patients who were on oxygen support showed signs of improvement when they were administered remdesivir.
All new drugs have to undergo trials before getting approval for marketing them in India.
But the New Drug and Clinical Trial Rules, 2019, provide for certain clauses, according to which the provision of waiver of local phase-III clinical trials of the drug is approved and marketed in certain countries (as notified from time to time) subject to certain conditions, like national emergency or epidemics, in public interest.