NEW DELHI: Under fire for delayed availability of Covaxin for the vaccination drive, its manufacturer Bharat Biotech on Friday clarified that it takes about 120 days for one batch to complete the process of manufacturing, testing, and release.
A batch, under production in March, for instance will be available for supply only in June.
The government has been claiming that nearly 2 crore doses of this vaccine is now being produced in India now but far lower numbers are available for vaccinating the beneficiaries.
The break-up available on the vaccination dashboard run by the Centre shows that of total 20,43,91,365 Covid vaccine doses administered, only 22,107,737 or just about 10% has been that of Covaxin, country’s only indigenously developed coronavirus vaccine so far.
“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,” said Bharat Biotech 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.
Shortage of Covid vaccines in India have been a major problem but scarcity of Covaxin has drawn even more attention, leading to calls for compulsory licensing to other companies to ramp up its production.
The company, however, insisted that the manufacturing, testing, release and distribution of vaccines is a complex and multifactorial process with hundreds of steps and requiring a diverse pool of human resources.
For vaccines to result in actual vaccination of people, highly coordinated efforts are required from international supply chains, manufacturers, regulators and state and Central government agencies, it said.
Experts, meanwhile, said that the statement by Bharat Biotech may further heighten the confusion around vaccine availability rather than clearing the air.
“The company is saying that it takes 120 days for the vaccine from production to release but how do we know how many doses were being produced in March and how many doses will be manufactured in June?” asked economist R Ramakumar.
He added that in the context of this clarification, the claim by the government earlier that 10 crore doses of Covaxin could be produced from August-September will reach the vaccination centres only December onwards.
The company, on the other hand, maintained that production scale-up of vaccines is a step-by-step process, involving several regulatory SOPs of good manufacturing practices.
The firm also said that all vaccines supplied in India are mandated by law to be submitted for testing and release to the Central Drugs Laboratory under the government and all batches of vaccines supplied to states are based on the allocation framework received from the Centre.
The timeline for vaccine supplies to reach the depots of the state and Centre from Bharat Biotech’s facilities is around two days, the company said adding the vaccines received at these depots have to be further distributed by the state government to various districts within their respective states.
“This requires an additional number of days. Pandemic vaccines are distributed by respective governments equitably across all sections of the population,” the company said.