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CDSCO committee rejects Dr Reddy’s proposal seeking full marketing authorization of remdesivir

Laxmi Yadav, Mumbai
Tuesday, November 3, 2020, 08:00 Hrs  [IST]

The Subject Expert Committee (SEC) at CDSCO has rejected a proposal of Dr Reddy’s Laboratories seeking change in regulatory approval status for COVID-19 drug remdesivir injection from restricted emergency use to full marketing authorization.

In June this year antiviral drug remdesivir was approved by Drug Controller General of India (DCGI) for restricted emergency use in India for the treatment of COVID-19 patients hospitalised with severe symptoms.

The drug firm has presented clinical data along with the proposal to the committee. Reddy’s clinical data comprises efficacy and safety results with remdesivir treatment.

A significant number of pulmonologists have supported administration of  remdesivir on patients hospitalised with moderate COVID-19 in the country to ensure their fast recovery thus supporting the claim of the drug firm.

Dr Ravindra Mehta, chief of critical care, consultant pulmonologist/sleep medicine specialist, Apollo Hospitals, Bengaluru was among the pulmonologists advocating use of remdesivir in the treatment of moderately sick COVID -19 patients. Remdesivir is effective when it is given at the right time to the right patients, he said.

After detailed deliberation, the CDSCO committee did not recommend for grant of full marketing authorisation and opined that approval for restricted emergency use of the drug should continue.

In September Dr Reddy’s launched remdesivir under the brand name Redyx for Indian markets.

Dr Reddy’s along with Cipla, Hetero Labs, Jubilant Lifesciences, Mylan, Zydus Cadila, Syngene, a Biocon company signed non-exclusive voluntary licensing agreement with Gilead Sciences to manufacture remdesivir for distribution in 127 countries.

Dr Reddy’s has put forward the proposal seeking full marketing authorization of remdesivir after US FDA approved the use of the drug for treatment of hospitalised COVID-19 patients — for adults and paediatric patients (12 years of age and older) and weighing at least 40 kilograms. The drug regulator’s decision was supported by the analysis of data from three randomised, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.

The FDA has said Veklury (drug's brand name) cut the recovery time on average by five days during clinical trials.

Contrary to the US FDA move, WHO Solidarity trial raised concern over safety and effectiveness of remdesivir in treatment of COVID-19 patients. The trial found that the drug failed to reduce the mortality or hospital stay of the patients.

In another development, SEC has approved the proposal of Cadila Healthcare seeking to conduct phase IV clinical trial and post marketing study of remdesivir.

The drug firm introduced remdesivir under the brand name Remdac in August to treat patients suffering from severe symptoms of COVID-19.

Meanwhile, All India Drug Action Network (AIDAN) has appealed to CDSCO to disclose names and designations of all experts appointed or being consulted by it to participate in the 'SEC to examine COVID-19 related proposals under accelerated approval process'.

AIDAN also sought names of experts who participated in the COVID SEC meetings that have taken place to date.

The NGO has urged the apex drug regulatory body to provide a comprehensive and updated list of COVID-related product regulatory approvals that in each case mentions ---  the specific indications for which approval has been granted to any conditions or restrictions attached to the approval and type of approval and legal provisions under which the approval has been granted (such as for restricted emergency use).

“CDSCO has till date not provided the meaning of "restricted emergency use" approval in contrast to full marketing approval. In spite of repeated requests by AIDAN over several months, CDSCO has not provided the list of COVID-related regulatory approvals along with any conditions/restrictions attached to each approval and the legal provision under which it is granted,” said Malini Aisola, co-convenor, AIDAN.


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