CDSCO granted restricted emergency use of Favipiravir tablets to Glenmark Pharmaceuticals; and Remdesivir injectable formulations to Cipla and Hetero Drugs
India’s Central Drugs Standard Control Organisation (CDSCO) has approved restricted emergency use of Favipiravir tablets and Remdesivir injectable formulations for the treatment of Covid-19.
The drug regulator has allowed Glenmark Pharmaceuticals to manufacture and market the oral antiviral drug Favipiravir (FabiFlu) for the treatment of mild to moderate Covid-19 patients in India.
Glenmark said that the CDSCO approval is based on evaluation of data and in consultation with the subject expert committee, as part of the accelerated approval process, considering the emergency and unmet medical need of the Covid-19 outbreak.
Also, the approval is for restricted emergency use, involves responsible use of medication, and signed consent of every patient before the start of treatment.
Hetero Drugs and Cipla to produce and sell Remdesivir under brand names Covifor and Cipremi, respectively
CDSCO has approved the manufacture and sale of the generic version of investigational antiviral medicine Remdesivir, under the brand name Covifor by Hetero Drugs, and Cipremi by Cipla.
Hetero chairman B Partha Saradhi Reddy said: “In the light of increasing COVID-19 cases in India, the approval of ‘Covifor’ (Remdesivir) can prove to be a game-changer given its positive clinical outcomes. Backed by strong backward integration capabilities, we can ensure that the product is immediately made available to patients across the country.
“We are prepared for ensuring enough stocks required to cater to the present needs. We will continue to work closely with the government and medical community to make a difference in the fight against Covid-19. This product is made indigenously in line with ‘Make in India’ campaign as envisioned by our Hon’ble Prime Minister.”
Cipla has launched the product under a licensing agreement with Gilead Sciences to expand access to Covid-19 treatment in low and middle-income countries.
The company said that a preliminary report from the Adaptive COVID-19 Treatment Trial 1 (ACTT-1 study), a randomised clinical trial of Remdesivir in 1063 patients over 60 centres across the US, Europe and Asia, has shown faster clinical recovery in hospitalised patients as compared to placebo.
Also, Cipla is planning to commercialise Remdesivir through its own facilities and partnered sites, as part of its efforts to enable quick access to the treatment and in anticipation of demand.
Cipla Global CEO Umang Vohra said: “Cipla appreciates the strong partnership with Gilead to bring Remdesivir to patients in India. We have been deeply invested in exploring all possible avenues to save millions of lives impacted by Covid-19 pandemic, and this launch is a significant milestone in that direction.
“We will continue to collaborate with all stakeholders in the healthcare ecosystem towards providing access to such promising treatments in furtherance with our belief that no patient should be denied access to life-saving treatments.”