India’s central drug regulator has rejected Dr Reddy’s Laboratories’ application seeking approval for full marketing authorisation of anti-viral drug remdesivir which has so far been allowed restricted emergency use on COVID-19 patients in the country. The Hyderabad-based pharmaceutical company had applied to the Drugs Controller General of India (DCGI) seeking permission for full marketing authorisation of remdesivir injection after it recently became the first drug to get formal clearance from the US Food and Drug Administration (FDA) for treating hospitalised COVID-19 patients.
The subject expert committee (SEC) on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) deliberated on the application on October 29. “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 authorisation.
“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 recommended. The interim results of the WHO Solidarity Trial indicate that four repurposed drugs for COVID-19, including remdesivir, appeared to have little or no effect on reducing mortality, initiation of ventilation and duration of hospital stay.
During the trial, conducted from March 22 to October 4, remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon regimens were tested in 405 hospitals across 30 countries covering 11,266 adults. Responding to a question over the interim results of the WHO Solidarity Trial, ICMR chief had at a press conference on October 20 said discussion was ongoing at the National Task force and the Joint Monitoring group, and advisories regarding the outcome of the trial would be issued accordingly.
“Debate and discussion is going on at the National Task force and Joint Monitoring group and we will take into cognizance the results of this trial and issue advisories accordingly,” ICMR Director General Dr Balram Bharagav had said. The Union health ministry in its ‘Clinical Management Protocols for COVID-19’ has recommended the use of remdesivir in COVID-19 patients in the moderate stages of the illness. The drug has been included as an “investigational therapy” and recommended only for restricted emergency use purposes. The drug, which is administered in the form of an injection, has been allowed for restricted emergency use for a maximum five-day period for treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children hospitalised in moderate stage of the illness, subject to several safeguards. Several companies in India, such as Dr Reddy’s, Hetero and Cipla among others have been granted permission by the DCGI to manufacture and market remdesivir for “restricted emergency use” on hospitalised COVID-19 patients.
Written informed consent of each patient is required before the use of the drug and results of additional clinical trials, active post-marketing surveillance data and reporting of serious adverse events have to be submitted.