Bharat Biotech is facing a surge in deman of Covaxin.
Amid rising demand for COVID vaccines, Bharat Biotech on Friday said production and supply of Covaxin is a time-consuming process as various procedures and approvals need to be in place before it is made available for vaccination.
The Hyderabad-based vaccine major noted the timeline for manufacturing, testing and release for a batch of Covaxin is around 120 days, depending on the technology framework and regulatory guidelines to be met.
The company's statement comes amid the shortage of Covid jabs in the country and demand from various states to enhance the production of vaccines.
"Thus, production batches of Covaxin that were initiated during March this year will be ready for supply only during the month of June," it said in a statement, adding that manufacturing, testing, release and distribution of vaccines is a complex and multi-factorial process with hundreds of steps, requiring a diverse pool of human resources.
For vaccines to result in actual vaccination of people, the company said highly coordinated efforts are required from international supply chains, manufacturers, regulators, and state and central government agencies.
"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," it noted.
The company said that 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.
All batches of vaccines supplied to state and central governments are based on the allocation framework received from the central government, the company said, adding that the timeline for vaccine supplies to reach the depots of the state and central governments from the company'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 and thus requires an additional number of days, it noted.
"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," it added.
With the increase in demand, Bharat Biotech has already taken steps to produce additional 200 million (20 crore) doses of Covaxin at its subsidiary's Gujarat-based facility. This will take the overall production volume to about 1 billion (100 crore) doses per annum.
From May 1, the government started Covid-19 vaccination drive for population above 18 years of age. The procurement of vaccines for those between 18 and 44 years has been left to states and private hospitals. This has led to state after state rushing to Bharat Biotech and Serum Institute of India (SII) for supply of vaccines.