DCGI rejects DRL's proposal, denies full marketing rights for Remdesivir

Emergency use authorisation to continue; recently, WHO had raised doubts about efficacy of drug in treatment of Covid-19 patients

After the US drug regulator approved Gilead's antiviral drug remdesivir (Veklury) as treatment for Covid-19 amid reservations from the World Health Organization, the Indian regulator on Monday turned down a proposal by Dr Reddy's Laboratories for full marketing authorisation of remdesivir for Covid-19 patients. 

The Drug Controller General of India (DCGI) has said that the emergency use authorisation of the drug will continue. 

Recently, WHO had noted that the Recovery Trial led by them showed that remdesivir along with drugs like Hydroxychloroquine and Interferon had not significant benefits for hospitalised Covid-19 patients. 

The Covid-19 subject expert committee (SEC) of the Central Drugs Standards Control Organisation (CDSCO) noted, "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 meeting was held on October 29. 

Dr Reddy's had presented the proposal along with clinical data for change in regulatory approval status for remdesivir injection from restricted emergency use to full marketing authorisation. 

 

Restricted Emergency Use basically implies that any drug is not an approved therapy to treat a disease. Basically, there is not enough data to support the claim that the drug works to cure or treat the disease. In such a case, as against a full marketing authorisation, the patients' consent in writing is of key importance. 

India's National Covid19 Clinical Management Protocol advices the use of drugs like remdesivir and Hydroxychloroquine to treat Covid-19 patients. 

Doctors have, however, maintained that the drug does work on patients despite the WHO trial data. 

Exlaining the clinician’s experience, Satyanaryana Mysore, head of department of interventional pulmonology at Manipal Hospitals, said, “As part of the task force of remote medical guidance to hospitals across Karnataka, I have seen the difference the drug made. Prior to July 15, when the drug was not available here, morbidities and the severity of cases in government hospitals were much higher. Remdesivir definitely helped doctors to manage the disease well,” he said, adding that while it was no magic bullet, the timing of administering the drug could make all the difference.