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Gujarat will soon start production of a drug substance which is used for manufacturing of COVAXIN

Friday, 28 May 2021 (11:13 IST)
In the current situation of covid-19, it is required to accelerate the production of vaccine which can be made available to the people of Gujarat and India. This is possible by expanding the production of current vaccine through contract manufacturing. 
Considering this, GBRC (Gujarat Biotechnology Research Centre), an autonomous society established under Department of Science and Technology, Government of Gujarat, along with Hester Bioscience Ltd. and Omni BRx Technologies has today entered into MoU with Bharat Biotech Ltd. for contract manufacturing of drug substance for COVAXIN manufacturing. 
The manufacturing of vaccine is a complicated procedure and is highly regulated. It requires to build BSL3 GMP facility i.e. Biosafety Level 3 and bio containment facilities. According to CDC and WHO guidelines, Biosafety Level 3 is applicable to laboratories where work with indigenous or exotic agents may cause serious disease because of exposure by inhalation route.
However, if everything goes as per the plan, then bulk production of this drug substance equivalent to 20 Million doses per month will begin from August, 2021. This will be then supplied back to Bharat Biotech Ltd. for producing vaccine doses.
Under the guidance of Chief Minister Shri Vijay Rupani, GBRC and Government of Gujarat  are acting as mentor, advisor and facilitator for the technology transfer from BBIL. HBL will build the BSL3 facility suitable for manufacturing drug substance for COVAXIN and shall obtain necessary regulatory approvals whereas Omni BRx will act as technology support partner.
This agreement between GCVC and BBIL will enhance the bulk drug substance production in Gujarat and this will enable BBIL to produce more number of doses which will be made available to not only population of Gujarat but India also.
At present there is no financial support from Govt. of Gujarat to any private party. GoG at suitable point of time will enter into buy back agreement with BBIL for required doses of COVAXIN as per the rate and policy of Government of India. 
It is to be noted that GBRC has been contributing to the prevailing pandemic situation in the state by conducting various translational researches on Novel Corona virus. During the epidemic, COVID-19 genome sequencing projects was initiated by GBRC to understand the origin of corona virus, its evolution, efficacy, potential drug target and vaccine development. After NIV (Pune), GBRC become the second lab in India by completing the first COVID-19 genome sequencing on April 17, 2020.
With the foresights of Government of Gujarat, GBRC had last year signed MoU with three companies, namely Hester Biosciences Pvt. Ltd., Supratech Laboratory and Vekaria Healthcare LLP to develop a COVID-19 vaccine and diagnostics.
Government of India has facilitated this entire process whole heartedly. Department of Biotechnology from Government of India has also played key role in facilitating this entire process.
The institute has been accredited by ICMR for the diagnosis of COVID-19, under which more than 10,000 samples have been tested by GBRC till date. As of now, more than 1100 SARS-CoV-2 genomes have been sequenced by GBRC. Apart from this, GBRC has also conducted research on Host-pathogen interaction in COVID and waste water-based epidemiology for early warning of cases.
From the recommendation of the Ministry of AYUSH, GBRC has checked the in-silico effectiveness of more than 200 Ayurveda herbs as well as herbs against COVID-19.

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