The enormous US pharmaceutical firm has applied to India’s drug regulator soliciting marketing authorisation for its anti-viral drug remdesivir, which is being touted as a potential cure for coronavirus.
The sources stated that the patent holder of the drug, Gilead Sciences has full data about the pre-clinical and clinical studies for remdesivir.
“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 United States Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the medicine to treat hospitalised coronavirus patients.
The sources stated that on the basis of clinical data from the US, The Japanese Ministry of Health, Labour and Welfare granted the regulatory approval under exceptional pathway on May 7.
As per a source in the know of development stated that 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 on the basis of approvals granted by USFDA or any another reputed regulator.
Cipla and Hetero Labs are the two Indian pharmaceutical companies which are applying to the drug regulator seeking approval to manufacture and sell remdesivir in India.
For remdesivir, they have also sought a clinical trial waiver so that the medicine can be quickly made available for the patients, the official said.
The official stated that their applications are still under review. For manufacturing and distribution of remdesivir, Gilead Sciences Inc have entered into non-exclusive licensing agreements with pharma firms, including three domestic majors Cipla, Jubilant Life Sciences and Hetero.
Earlier, the Indian Council of Medical Research said that anti-viral medication remdesivir, which was used during the Ebola outbreak, might impede the SARS-CoV-2 replication and research on its efficacy in the cure of COVID-19 is a part of the WHO’s ‘solidarity trial’.
As per 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.
Before getting approval, all new drugs will have to undergo trials for marketing them in India. However, the New Drug and Clinical Trial Rules, 2019, provide for certain clauses, as per 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 the public interest.