The monthly vaccine production capacity of Covishield is planned to be increased from 11 crore doses to more than 12 crore doses per month and of Covaxin from 2.5 crore doses to around 5.8 crore, the Lok Sabha was informed on Friday.
From January 16 to August 5, 44.42 crore doses of Covishield were supplied by Serum Institute of India and 6.82 crore doses of Covaxin by Bharat Biotech for the National COVID-19 Vaccination Programme, Minister of State for Health Bharati Pravin Pawar said in a written reply.
“As communicated by the manufacturers, the monthly vaccine production capacity of Covishield is planned to be increased from 11 crore doses per month to more than 12 crore doses per month and the production capacity of Covaxin is planned to be increased from 2.5 crore doses per month to around 5.8 crore doses per month,” she said in response to a question on the total capacity of vaccine manufacturing or production in the country.
Elaborating on the steps taken to increase the production of COVID-19 vaccines in the country, Pawar said Central Drugs Standard Control Organisation has taken various steps for fast track approval of vaccines.
A system is in place for fast track processing of application for clinical trial and approval for COVID-19.
According to a CDSCO notice dated April 1, Covid vaccines already approved by CDSCO for restricted use in emergency situation in India, and proposed to be fill finished at a site within the country different from the manufacturing site, by receiving bulk of the approved vaccine, will be approved by CDSCO based on inspection and CDL release, Pawar said in the reply.
Additionally, if such a vaccine is manufactured in India from basic drug substance stage to the fill-finish stage, it will also be given manufacturing licensee, based on inspection, for stock piling and CDL release.
The CDSCO has granted permission for manufacturing of Gam-COVID-Vac Combined vector vaccine (SPUTNIK-V) using ready to fill bulk to M/s Ra (biologicals) Panacea Biotec Ltd., New Delhi for restricted use in emergency situation on July 2 and manufacturing licence was issued on July 5.
The CDSCO has granted permission to Indian Immunological Limited, Hyderabad for manufacturing of Whole Virion Inactivated Corona Virus (COVAXIN) Bulk Vaccine on March 26 for examination, test and analysis purpose.
Further, the Department of Biotechnology under the Ministry of Science and Technology has launched ‘Mission COVID Suraksha- the Indian COVID-19 Vaccine Development Mission’, the reply stated.
The Mission is being implemented by Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Undertaking (PSU) of Department of Biotechnology.
Under the mission, facility augmentation of Bharat Biotech and one state public sector enterprise and two central public sector enterprises (PSEs) — Haffkine Biopharmaceutical Corporation Ltd, Mumbai; Indian Immunologicals Limited (IIL), Hyderabad and Bharat Immunologicals Biologicals Limited (BIBCOL), Bulandshahr — for production of Covaxin have been supported.
In addition, technology transfer of Covaxin production to Gujarat COVID Vaccine Consortium (GCVC), including Hester Biosciences and OmniBRx Biotechnologies Pvt Ltd, led by Gujarat Biotechnology Research Centre (GBRC), Department of Science and Technology, government of Gujarat has also been facilitated.
Further, the Centre has also extended financial assistance to one of the domestic manufacturers for ‘At-risk manufacturing’, advance payment against the supply orders placed with Serum Institute of India and Bharat Biotech, and streamlining of regulatory norms for approval of vaccines, the reply added.