Drugs regulator refuses application of Dr Reddy's Lab for marketing authorisation of Remdesivir for COVID-19 treatment

New Delhi [India], November 2 : The top drug regulator has refused Dr Reddy's Laboratories' application, for full marketing authorization of anti-viral drug Remdesivir, for treatment of COVID-19 patients in India.
So far, the central government in its national clinical management protocol for COVID-19 has approved the Remdesivir drug only for restricted emergency use as investigational therapy on coronavirus patients with the moderate illness.
On October 29, the Subject Expert Committee (SEC) of the drugs controller thoroughly evaluated Dr Reddy's application. "The firm presented the proposal along with clinical data for change in regulatory approval status for Remdesivir injection from restricted emergency use to full marketing authorization," SEC recommendation stated.
"After detailed deliberation, the committee did not recommend for grant of full marketing authorisation and opined that approval for Restricted Emergency use of the drug should continue," the SEC recommendation stated.
It is pertinent to note that the interim analysis of WHO's Solidarity Trial has revealed that 4 repurposed drugs for COVID-19--remdesivir, hydroxychloroquine, lopinavir/ritonavir, and interferon regimens appeared to have little or no effect on reducing mortality, initiation of ventilation, and duration of hospital stay, stated medRxiv in its recent preprint server which is under review for publication in a medical journal.
The aim of the study was to see the effects of treatment for COVID-19 by using these drugs on overall mortality, initiation of ventilation, and duration of hospital stay in hospitalised patients.
The trial was conducted from March 22 to October 4 and the trial was undertaken in 405 hospitals in 30 countries on 11,266 adults who were randomly enrolled.