Gilead Sciences has applied to CDSCO seeking marketing authorisation for its anti-viral drug remdesivir, which is being touted as a potential treatment for COVID-19.
“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.
Sources also said that Gilead Sciences has complete data about pre-clinical and clinical studies for remdesivir.
The medicine has been issued an Emergency Use Authorisation (EUA) by the US FDA to treat hospitalised coronavirus 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, informed a source.
Two Indian pharma companies, Cipla and Hetero Labs, have also applied 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. 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 ICMR had earlier said that remdesivir, which was used during Ebola outbreak, might 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 the public interest.