DCGI starts rolling reviews of Covid-19 vaccine candidates for speedy approval

The Drugs Controller General of India (DCGI) has initiated rolling reviews for the vaccine candidates that are in advanced stages to ensure their fast approval and speedy availability to the Indian people. DCGI VG Somani has said the Central Drugs Standard Control Organisation will facilitate analysis of interim clinical trial data at pre-defined stages. "For candidates that have been developed outside of India, the regulator will also consider pre-clinical or clinical data generated outside of the country along with data from bridging studies in India before giving approval," the DCGI said, reported Times of India.

Also read: India awaits results of five candidates; Moderna to produce 125 million doses

Rolling review means the drug regular will check the clinical trial data on a real-time basis rather than waiting for final data to be made available for evaluation.

Notably, Prime Minister Narendra Modi, during a virtual all-party meeting yesterday, said India's first coronavirus vaccine may be ready in a few weeks. He said nearly eight vaccine candidates, out of which three are indigenously developed, are undergoing trials. "Experts believe that COVID vaccine will be ready in the next few weeks. As soon as scientists give a green signal, vaccination will start in India. Healthcare, frontline workers & elderly people suffering from serious diseases will be given priority in vaccination," he said.

Also read: COVID-19 vaccine will be ready in few weeks: PM Modi cites experts

Modi also said that Centre and states will work together for vaccine distribution. He said that they plan on fully exploiting India's experienced network in the field of vaccination.  

The centre is presently conducting extensive backend preparation for the COVID-19 immunisation drive. The government expects to receive and utilise 400-500 million doses and cover approximately 20-25 crore people by July 21. The Prime Minister also visited the Zydus Biotech Park in Ahmedabad, Bharat Biotech in Hyderabad and Serum Institute of India in Pune recently.

Meanwhile, AIIMS director Dr Randeep Guleria has also pinned hopes on five coronavirus vaccine candidates -- SII-AstraZeneca, Pfizer-BioNTech, Sputnik V, Covaxin, Zydus Cadila and Biological E -- that are in varying stages of trials. He said at least one of the vaccines, which is being locally tested, could get emergency use approval from the DCGI to be administered to the public beginning with priority groups.

Also read: Zydus Cadila's biotech drug to treat COVID-19 gets DCGI nod for Phase III trials