India’s drug regulator grants Gilead Sciences marketing authorization for remdesivir, Health News, ET HealthWorld


By Payal Banerjee

New Delhi: India drug regulator have you given us pharma huge Gilead Sciences marketing authorization for its antiviral drug strap desivir for “limited emergency use“in hospitalized COVID-19 patients, given the pandemic crisis.

The remediation approval process was accelerated given the emergency and unmet need for medication in light of coronavirus outbreak, a source of knowledge of the told developments.

The drug has been allowed for limited emergency treatment to treat suspected or laboratory-confirmed cases of COVID-19 in adults and children suffering from severe symptoms, subject to several protective measures, the source said.

“The drug, administered in the form of an injection, is approved to be sold in retail on prescription by specialists for hospital or institutional use only,” the source said.

“The remdesivir approval process was expedited by invoking special provisions under the new Drug and Clinical Trials Rules, 2019, which allow for the waiver of clinical trials in special circumstances,” the source said.

On May 29, Gilead Sciences had applied for marketing authorization for remdesivir in India. The drug is being touted as a potential treatment for COVID-19.

The approval was granted after consulting the subject matter committee of the Central Drugs Standard Control Organization (CDSCO).

“The drug is given in the form of an injection and that is why it should be administered under the supervision of a doctor in a hospital,” the source said.

Gilead Sciences, the proprietor of the drug, has the complete data on the pre-clinical and clinical trials for remedies, the source added.

The drug has been issued by a US Food and Drug Administration (FDA) as an Emergency Access Use (EUA) permit to treat hospitalized coronavirus-infected patients.

Meanwhile, applications from two Indian pharmaceutical companies – Cipla and Hetero Labs – seeking permission to manufacture and sell remdesivir in India are still pending.

Gilead Sciences Inc has entered into non-exclusive licensing agreements with pharmaceutical companies, including three domestic protagonists Cipla, Jubilant Life Sciences and Hetero, for the manufacture and distribution of remdesivir.

The Indian Medical Research Council had previously said that antiviral drug remesivir used during the Ebola outbreak could possibly inhibit SARS-CoV-2 replication, and research into its efficacy in the treatment of COVID-19 of the WHO’s ‘Solidarity Trial’.

According to a recent study published 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 given remedies.

All new drugs must undergo trials before getting approval for marketing them in India.

However, the new drug and clinical trial rules, 2019, contain certain clauses under which the provision for waiver of local Phase III clinical trials of the drug is approved and marketed in certain countries (which have been notified from time to time) subject to certain conditions such as national emergencies or epidemics in the public interest.


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