Bharat Biotech which is facing criticism for not being able to scale up production of its COVID-19 vaccine Covaxin on May 28 said the manufacturing, testing, release and distribution of vaccines is a complex and multifactorial process with hundreds of steps, requiring a diverse pool of human resources.
The company said that there is a four-month lag time for Covaxin to translate from manufacturing to final 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," the company said in a statement.
"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 said.
Bharat Biotech statement comes at a time when the company said it has the capacity to produce 10-12 million doses of vaccine, but there were reports in media that the actual supplies was far less than what was being announced. Bharat Biotech said it is ramping up capacities to 700 million doses by December.
The company further 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, Government of India.
All batches of vaccines supplied to state and central governments are based on the allocation framework received from the Government of India.
"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 an additional number of days," the company said.
