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Cipla gets Gujarat FDCA approval to manufacture generic remdesivir for COVID-19 under loan licensing pact with BDR Life Sciences
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Shardul Nautiyal, Mumbai
June 27 , 2020
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In order to meet the demand for critically ill COVID-19 patients, Cipla Limited has received approval from Gujarat Food and Drug Control Administration (FDCA) to manufacture generic remdesivir under a loan licensing agreement with BDR Life Sciences. Cipla was recently granted regulatory approval by the Drug Controller General of India (DCGI) for restricted emergency use in the country as part of the accelerated approval process considering the urgent and unmet medical need in the wake of COVID-19 scenario.
Informed Gujarat FDCA Commissioner Dr H G Koshia, “Following DCGI approval, Gujarat FDCA approved loan license agreement between Cipla Ltd and BDR Life Sciences. As per the agreement, Cipla has given the contract of manufacturing remdesivir to the facility of BDR Life Sciences in Vadodara. This will soon be marketed in Cipla Ltd name.”
DCGI on June 20 had granted permission to manufacture and market the same injectable formulations of the drug to the indigenous manufacturers for the same indication, restriction and conditions for use as stipulated for innovator’s product. This will ensure early access of remdisivir for treatment of severe COVID patients in the country under the Restricted Emergency Use.
Cipla Limited recently announced the launch of generic version of remdesivir under its brand name Cipremi. The US FDA issued an emergency use authorization (EUA) to Gilead Sciences Inc. for emergency use of remdesivir for the treatment of hospitalized COVID-19 patients.
It is the only US FDA approved Emergency Use Authorisation (EUA) treatment for adult and paediatric patients hospitalized with suspected or laboratory confirmed COVID-19 infection.
As part of a risk management plan, Cipla will provide training on use of the drug, informed patient consent documents, conduct post marketing surveillance as well as conduct a phase IV clinical trial on Indian patients.
In May 2020, Gilead Sciences Inc. extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla's generic version of remedisvir called Cipremi.
According to a preliminary report from the ACTT-1 (Adaptive COVID-19 Treatment Trial 1) study1, a randomized clinical trial conducted with remdesivir in 1063 patients over 60 centres across US, Europe and Asia demonstrated a faster time to clinical recovery in hospitalised patients as compared to placebo.
Most of these patients were on oxygen therapy of which some were receiving high flow oxygen or non-invasive ventilation, and some were on a mechanical ventilator. The mortality rates in the study were 7.1% in those given remdesivir and 11.9% in those who were given placebo.
As part of its efforts to enable speedy and equitable access to this treatment and in anticipation of demand, Cipla will be commercialising remdesivir through its own facilities and partnered sites. The drug will be supplied through government and open market channels to ensure equitable distribution.
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