Over 200 tests for every batch: Bharat Biotech on Covaxin quality concern

Each batch of the vaccine was subjected to more than 200 quality control tests at its facilities, followed by submission samples to CDL. Only based on approval by CDL are batches released commercially

Bharat Biotech on Thursday said all batches of their Covid-19 vaccine till date have been manufactured and released only from the Genome Valley in Hyderabad, which are fully audited and approved by regulatory authorities.

 

“We wish to put to rest any concerns on the quality of Covaxin,” the company said, adding each batch of the vaccine was subjected to more than 200 quality control tests at its facilities, followed by submission samples to Central Drugs Laboratory (CDL). Only based on approval or release by CDL are batches released commercially.

 

“Since early June, manufacturing of Covaxin has commenced at our sites at Malur in Karnataka, and Ankleshwar in Gujarat, prior to which engineering batches were also executed to study equipment functionality. Products manufactured from these facilities will be available for supplies during September. This is based on our 120-day timeline for manufacturing, testing, release, regulatory approvals, and distribution,” it clarified.        

 

Some media reports had earlier suggested that the batches from the Bengaluru plant have had quality issues. So far, 70 million doses of Covaxin have been supplied.  On Tuesday, the company also claimed that Covaxin received a certificate of Good Manufacturing Practices compliance from Hungarian authorities.