IIL begins supply of Covaxin drug substance to Bharat Bio

Our Bureau Hyderabad | Updated on August 13, 2021

This will enable biotech firm to ramp up output of vaccine

Indian Immunologicals Limited (IIL) has begun the supply of the Covaxin drug substance to Bharat Biotech, which will enable the latter to step up output of the vaccine.

IIL initially expects to supply input material to produce 3-4 million doses a month and ramp it up to 10 million by December.

Deal with Bharat Bio

Following government approval, IIL and Bharat Biotech International Limited joined hands in April 2021 to produce the drug substance.

After IIL signed up with Bharat Biotech, it repurposed its manufacturing facility in Hyderabad; procured key raw materials and consumables and key equipment for the process; concluded technology transfer, trials; and scaled up research and development. These activities were done at breakneck speed and production commenced in July.

The batches produced at IIL’s manufacturing facility have been tested at Bharat Biotech and IIL, and meets the quality specifications for the drug substance. The yields are more than expected, the note said.

Dr K Anand Kumar, MD, IIL, handed over the first lot of Covaxin drug substance to Dr Krishna Ella, CMD, Bharat Biotech. “This is Team India at work. Our capable and competent team worked tirelessly round the clock to ensure that the committed timelines and product quality are met,” said Anand Kumar.

“This would have not been possible without the constant support provided by Niti-Aayog, BIRAC, DBT, Mission Covid Suraksha Team, Central and State drug control authorities,” he added.

Dr Renu Swarup, Secretary, DBT, and Chairperson, BIRAC, said: “The government has worked relentlessly to provide all possible support for ramping up Covaxin production in the country and to speed up Covaxin inoculation drive.

“The loan licence agreement by CDSCO for Indian Immunologicals Ltd to produce Covaxin drug substance is a major milestone, achieved in a very short span of time. The DBT-BIRAC support under Mission Covid Suraksha aims to meet the Covid-19 vaccine requirement of our country.”

“IIL is also working on another Covid-19 vaccine and the animal trials are underway currently, and is expected to come out by next year for human vaccination,” Anand Kumar said.

Under Atmanirbhar Bharat 3.0, Mission Covid Suraksha was launched to accelerate the development and production of indigenous Covid Vaccines. This is being implemented by DBT.

IIL has been sanctioned a grant of ₹60 crore towards enhancing production capabilities. Headquartered in Hyderabad, IIL is one of the largest producers of vaccines in Asia.

Published on August 13, 2021

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