Lok Sabha Question No. 3045 (UNSTARRED), answered on 2021-08-06
Subject: COVID-19 Vaccine Production
Ministry: HEALTH AND FAMILY WELFARE
Asked by: P. C. Mohan, Dr. T. Sumathy (a) Thamizhachi Thangapandian

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO.3045 TO BE ANSWERED ON 6 th  AUGUST, 2021

## COVID-19 VACCINE PRODUCTION

## 3045.   SHRI P.C. MOHAN:

## DR. T. SUMATHY (A) THAMIZHACHI THANGAPANDIAN:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) the total capacity of vaccine manufacturing/ production in the country;
- (b) the details of COVID-19 Vaccines produced in the country during the last one year;
- (c)  whether  the  Government has taken effective steps to increase the production of COVID-19 vaccines in the country; and
- (d) if so, the details thereof?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (DR. BHARATI PRAVIN PAWAR)

- (a)  &  (b):  ChAdOx1  nCoV-  19  Corona  Virus  Vaccine  (Recombinant)  (COVISHIELD)  is manufactured  by  M/s  Serum  Institute  of  India  Pvt.,  Ltd.,  Pune,  while  the  Whole  Virion Inactivated  Corona  Virus  Vaccine  (COVAXIN)  is  manufactured  by  M/s  Bharat  Biotech International Limited, Hyderabad.

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.

From  16 th January,  2021  to  5 th August,  2021,  44.42  crore  doses  of  Covishield  have  been supplied by M/s Serum Institute of India and 6.82 crore doses of Covaxin have been supplied by M/s Bharat Biotech International Limited for the National Covid Vaccination Programme.

- (c) & (d): Central Drugs Standard Control Organisation, Ministry of Health and Family Welfare has taken various steps for fast track approval of COVID-19 Vaccines, as below:
- (i) A system is in place for fast track processing of application for clinical trial & approval for COVID-19

(ii)  As  per  CDSCO notice dated 15.04.2021, the 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 & CDL release. 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 & CDL release.

(iii)  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  02.07.2021  and  manufacturing license was issued on 05.07.2021.

(iv) CDSCO has granted permission to M/s Indian Immunological Limited, Hyderabad for manufacturing  of  Whole  Virion  Inactivated  Corona  Virus  (COVAXIN)  Bulk  Vaccine  on 26.03.2021 for examination, test and analysis purpose.

Further, Department of Biotechnology under the Ministry of Science & Technology has launched 'Mission COVID Suraksha- the Indian COVID-19 Vaccine Development Mission'. 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 01 State Public Sector Enterprise and 02 Central Public Sector Enterprises (PSEs) including 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, Govt. of Gujarat has also been facilitated.

Further,  Government  of  India  has  also  extended  financial  assistance  to  one  of  the domestic manufacturers for 'At-risk manufacturing', advance payment against the supply orders placed with M/s Serum Institute of India and M/s Bharat Biotech, and streamlining of regulatory norms for approval of vaccines.

*******