Express Healthcare

IIL produces covaxin drug substance in record time

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Output of Covaxin drug substance will be 3 to 4 million a month and from December will increase to 10 million a month

In order to augment the Covid 19 vaccine production capacity in our country so that a significant percentage of the population can get vaccinated at the earliest, the Central Government requested that Indian Immunologicals Ltd (IIL) and Bharat Biotech International Limited (BBIL) join hands in Apr 2021. IIL in a short period of time has performed several activities including signing of 4 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, training etc. These activities were all done at breakneck speed and production at commenced in July 2021. The batches so produced at IIL’s manufacturing facility have been tested at BBIL and IIL and meets the quality specifications for the drug substance. The yields are more than expected.

In a simple handing over function, Dr. K. Anand Kumar, MD, IIL handed over the first lot of Covaxin Drug Substance to Dr Krishna Ella, CMD, Bharat Biotech on the 13th of August 2021.

Speaking on this occasion, Dr K Anand Kumar said that “This is TEAM India at work. It could not have been possible without the coming together of several stake holders 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. It is a proud moment for IIL to have played a vital role in supporting our Nation’s interest during this unprecedented time. 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”.

Speaking on this achievement 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 license 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. I congratulate the team for the efforts put in for this achievement”.

“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,” said Dr K Anand Kumar

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 Department of Biotechnology. The Indian Immunologicals Limited (IIL), Hyderabad has been sanctioned grant of Rs. 60 crores towards enhancing production capabilities

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