Indian Immunologicals ramping up Covaxin drug substance production
Output of Covaxin drug substance will be adequate for 3 to 4 million doses a month and from December it will increase to 10 million doses a month
Hyderabad: In order to ramp up the Covid-19 vaccine production, Hyderabad-based vaccine makers Indian Immunologicals Ltd (IIL) and Bharat Biotech International Limited (BBIL) joined hands in April 2021 to produce drug substance for Covaxin, and IIL has enhanced capacities since then.
Dr K Anand Kumar, MD, IIL handed over the first batch of Covaxin drug substance to Dr Krishna Ella, CMD, Bharat Biotech on Friday. IIL in a short period of time has performed several activities including signing of four agreements with BBIL, repurposing its manufacturing facility in Hyderabad, procurement of key raw materials and consumables, procurement of key equipment for the process, technology transfer, trials at R&D scale, and training.
IIL said, these activities were all done at breakneck speed and production commenced in July 2021. The batches produced at IIL’s manufacturing facility have been tested at BBIL and IIL and meet the quality specifications for the drug substance. The yields are more than expected.
Speaking on this occasion, Dr K Anand Kumar, MD, IIL said, “This is Team India at work. It could not have been possible without the coming together of several stakeholders to achieve a common goal. Our capable and competent team worked tirelessly round the clock to ensure that the committed timelines and product quality are met. 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.”
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 speed up Covaxin inoculation drive. The loan licence agreement by CDSCO for IIL 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,” Dr Anand Kumar added.
Under Atmanirbhar Bharat 3.0 Mission Covid Suraksha was announced by the Government of India, to accelerate the development and production of indigenous Covid vaccines. This is being implemented by the Department of Biotechnology. The Indian Immunologicals Limited (IIL), Hyderabad has been sanctioned a grant of Rs 60 crore towards enhancing production capabilities.
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