New Delhi: Amid a shortage of Covid jabs and demands from various states to enhance production, Bharat Biotech responded that the manufacturing 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.
In a statement released on Friday, the Hyderabad-based vaccine major said that the production batches of Covaxin that were initiated during March this year will be ready for supply only during the month of June, adding that 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.
"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 said.
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.
"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.
As the procurement of vaccines for those between 18 and 44 years has been left to states and private hospitals, state after state is seen rushing to Bharat Biotech and Serum Institute of India (SII) for the supply of vaccines.
Meanwhile, to meet the increase in demand, Bharat Biotech has initiated proceedings to produce 200 million (20 crores) doses of Covaxin at its subsidiary's Gujarat-based facility. This will take the overall production volume to about 1 billion (100 crores) doses per annum.