DCGI approves Hetero Labs proposal to manufacture and market Favipiravir combi pack

The DGCI permitted Hetero Labs to manufacture and market combi pack of Favipiravir tablets 800 mg (16 tabs) and Favipiravir tablets 200 mg (2 tabs). Favipiravir which was basically designed for influenza got much attention in India for the management of Covid19.

New Delhi: The Drug Controller General of India (DCGI) has permitted Hetero Labs to manufacture and market combi pack of Favipiravir tablets 800 mg (16 tabs) and Favipiravir tablets 200 mg (2 tabs). Favipiravir which was basically designed for influenza got much attention in India for the management of Covid19. The subject expert committee (SEC) of DCGI on Thursday gave the permission for the manufacture and marketing of Favipiravir.

The SEC, however, did not give approval to Mylan for manufacture and marketing for combi pack of Declatasvir and sofosbuvir 60mg and 400mg tablets as well as Nitazoxanide 500mg tablets due to lack of data.

The SEC, on the other hand, gave permission to Mylan to conduct phase II clinical trial of Declatasvir Dihydrochloride IP with certain conditions which include upper age limit of volunteers should not be more than 65 years of age.

Read: Bharat Biotech gets final nod to conduct Phase 3 trails of COVAXIN

On the usage of Hydroxy-chloroquine tablets, the SEC said that CDSCO should communicate to the PvPI to further examine if any other reported ADR have been received by then for taste disorder and urinary incontinence. "If so, details should be obtained for further considerations," the SEC said.

On Tuesday, the SEC has approved Bharat Biotech's proposal to conduct phase III clinical trial of its Covid19 vaccine candidate BBV152.

The firm presented its data from Phase I and II trial along with animal challenge data in two species including NHP on the inactivated Coronavirus vaccine along with the proposal to conduct event-driven phase III clinical trial to assess the efficacy of the vaccine.

The committee after detailed review gave permission to conduct Phase III clinical subject to the condition that the primary efficacy endpoint for symptomatic cases should be amended.

Meanwhile, the Serum Institute of India (SII) has entered into an agreement with German pharmaceutical giant Merck and New York-based non-profit health research organisation IAVI to develop a treatment for people infected by Covid19.

The trio aims to develop SARS-CoV-2 neutralizing monoclonal antibodies (mAbs) that could help keep people healthy after being infected by the virus.

Read: 'Next 3 months decisive in determining India Covid trajectory'