Hyderabad-based Indian Immunologicals Ltd (IIL) has started supplying basic drug raw material to Bharat Biotech International Limited (BBIL) to produce more doses of the indigenously developed Covaxin. The development is significant since the country is trying to augment Covid-19 vaccine production capacity to meet its vaccination target.
Dr K Anand Kumar, MD, IIL, handed over the first lot of Covaxin drug substance to Dr Krishna Ella, CMD, Bharat Biotech today in Hyderabad, IIL said today.
India currently gets about 2 crore doses of Covaxin and 10 crore doses of Covishield from the Pune-based Serum Institute of India. Covaxin supplies were projected to increase to around 2.5 crore doses in August. Additionally, 2 million doses of Covaxin are expected to be delivered between August and September. The Covishield production, too, is expected to increase by another 2 crore vaccine doses.
The Central government had directed the IIL and Bharat Biotech to join hands in April, as Bharat Biotech was struggling to augment its capacity. IIL also received a grant of Rs 60 crore towards enhancing production capabilities. IIL was set up by the National Dairy Development Board (NDDB) in 1982.
IIL said in a short time, it has performed several activities, including the signing of four agreements with Bharat Biotech, 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.
These activities were all done at a breakneck speed, and the production started in July. The batches produced at IIL's manufacturing facility have been tested at Bharat Biotech and IIL, and meet the quality specifications for the drug substance. The yields are more than expected, said IIL.
"It could not have been possible without the coming together of several stakeholders to achieve a common goal. Our capable team worked tirelessly round the clock to ensure the committed timelines and product quality are met," said Dr K Anand Kumar, MD, IIL.
He said 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.
According to Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC, ''The loan licence agreement by CDSCO for Indian Immunologicals Ltd to produce Covaxin Drug Substance is a major milestone, achieved in a very short time".
Dr K Anand Kumar said IIL is also working on another COVID-19 vaccine. Currently, animal trials are underway, and the jab is expected to be rolled out for human vaccination by next year.
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