New Delhi: Bharat Biotech said on Friday that the timeline for manufacturing, testing, and release for a batch of Covaxin is approximately 120 days.
In a statement, the company said that manufacturing, testing, release and distribution of vaccines is a complex and multifactorial process with hundreds of steps, requiring a diverse pool of human resources.
For vaccines to result in actual vaccination of people, highly coordinated efforts are required from international supply chain, manufacturers, regulators, and state and Central government agencies, it added.
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The company said production scale-up of vaccines is a step-by-step process, involving several regulatory SOPs of GMP (Standard Operating Procedures of Good Manufacturing Practices). There is a four-month lag time for Covaxin to translate into actual vaccination.
"The timeline for manufacturing, testing and release for a batch of Covaxin is approximately 120 days, depending on the technology framework and regulatory guidelines to be met. Thus, production batches of Covaxin that were initiated during March this year will be ready for supply only during the month of June," the company clarified.
Based on Central Drugs Standard Control Organisation (CDSCO) guidelines, all vaccines supplied in India are mandated by law to be submitted for testing and release to the Central Drugs Laboratory, of the Centre. All batches of vaccines supplied to state and Central governments are based on the allocation framework received from the Centre.
"The timeline for vaccine supplies to reach the depots of the state and Central Governments from Bharat Biotech's facilities is around two days. The vaccines received at these depots have to be further distributed by the state governments to various districts within their respective states. This requires additional number of days," the company added.
It said pandemic vaccines are distributed by respective governments equitably across all sections of the population. Vaccines once available at the vaccination centres are then administered to recipients over a period of time, based on demand.