Lok Sabha Question No. 1111 (UNSTARRED), answered on 2021-12-03
Subject: Manufacturing of COVID-19 Vaccines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Dr. T. Sumathy (a) Thamizhachi Thangapandian, D. M. Kathir Anand

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

## LOK SABHA UNSTARRED QUESTION NO. 1111 TO BE ANSWERED ON 03 rd  DECEMBER, 2021

## MANUFACTURING OF COVID-19 VACCINES

## 1111:    DR. T. SUMATHY (a) THAMIZHACHI THANGAPANDIAN: SHRI D.M. KATHIR ANAND:

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

- (a)  whether  the  Government  has  ascertained  that  the  two  approved  COVID-19  vaccine manufacturers of Covishield and Covaxin have achieved the optimum production capacity, if so, the details thereof;
- (b) whether the Government or Indian Council of Medical Research has approved any other companies  other  than  the  said  two  companies  to  manufacture  and  produce  COVID-19 vaccines in India;
- (c) if so, the details thereof and if not, the reasons therefor;
- (d) whether the Central Drugs Standard Control Organisation (CDSCO) has granted import permission/  license  for  importing  and  manufacturing  of  COVID-19  Vaccines  to  meet  the demand in the country; and
- (e) if so, the details of the permission granted and the total number and quantum of vaccines expected through this arrangement?

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

- (a) 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  M/s  Serum  Institute  of  India,  the  current  monthly  vaccine production capacity of Covishield is approx. 250-275 Million doses per month.

Further, as communicated by M/s Bharat Biotech International Limited, Hyderabad, the current monthly vaccine production capacity of Covaxin is approx. 50-60 Million doses/month. Both companies have achieved close to 90% of present production capacity.

(b) to (e): As per the provisions of New Drugs and Clinical Trials Rules, 2019 under Drugs and Cosmetics Act, 1940 and in light of urgent need due to COVID pandemic in the country, CDSCO has granted permissions to following COVID-19 vaccines other than COVAXIN & COVISHIELD for prevention of COVID-19 for restricted use in emergency situation:

## Permission For Manufacture of COVID-19 vaccines :

1. Gam-COVID-Vac Combined vector  vaccine  [SPUTNIK-V]  manufactured  by  M/s  Ra (biologicals), Panacea Biotec Ltd., New Delhi using imported Ready to Fill (RTF) bulk from M/s Generium JSC, Russia on 02.07.2021.
2. Novel  Corona  Virus  2019-nCoV  vaccine  [ZyCoV-D]  manufactured  by  M/s  Cadila Healthcare Limited, Ahmedabad on 20.08.2021.
3. Ad26.COV2-S (recombinant)  COVID-19  Vaccine  manufactured  by  M/s  Biological  E limited,  Hyderabad  using  imported  bulk  of  M/s  Johnson  &  Johnson  Pvt.  Ltd  on 18.08.2021.
4. Gam-COVID-Vac Combined vector vaccine [Sputnik-V] manufactured under technology  transfer  from  M/s  RDIF,  Russia  by  M/s  Hetero  Biopharma  Limited, Hyderabad on 07.10.2021.

## Permission For Import of COVID-19 Vaccines :

1. Gam-COVID-Vac  Combined  vector  vaccine  [SPUTNIK-V]  to  M/s  Dr.  Reddy's Laboratories Ltd, Hyderabad on 12.04.2021.
2. mRNA-1273  COVID-19  vaccine  (Moderna)  to  M/s  Cipla  Limited,  Mumbai  on 29.06.2021.
3. Ad26.COV2-S (recombinant) COVID-19 Vaccine to M/s Johnson & Johnson Pvt. Ltd., Mumbai on 07.08.2021.

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