Lok Sabha Question No. 909 (UNSTARRED), answered on 2021-07-23
Subject: Vaccines Approved for use in India
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Uttam Kumar Nalamada Reddy, Ranjeetsingh Naik Nimbalkar, P.P. Chaudhary, Balak Nath, Sumedhanand Saraswati

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

LOK SABHA U NSTARRED QUES TION NO. 909 TO BE ANSWERED ON 23 RD JULY, 2021

## VACCINES APPROVED FO R USE IN INDIA

## 909. SHRI UTTAM KUMAR RED DY NALAMADA:

SHRI RANJEETSINGH HINDURA O NAIK NIMBALKAR:

SHRI P.P. CHAUDHARY:

SHRI BALAK NATH:

SHRI SUMEDHANAND SAR ASWATI:

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

- (a) the details of the COVID vaccines which have been approved for use in India alon g with the chronologicla account of approval granting process followed for these vaccines;
- (b) the number and details of vaccines that are currently in the process of getting approval for use in the  country  along with the steps being taken by the Governmen t to speed up the approval process for vaccines in the country;
- (c) the percentage of rural population that has got vaccination doses, State/UT - wise;
- (d)  the  details  of  orders  placed,  price  quoted  and expenditure  made  by  the  Government  to procure COVID-19 vaccines, nationally and internationally as on date;
- (e) the details chronological account of COVID vaccine supplies received by the Government and their dispatch to different states for inoculation along with the data collected post monitoring by the Government regarding inoculation carried by public or private, central sponsored or state sponsored, vaccine/dose/age/month/ State/UT - wise; and
- (f) whether the Government has studied the efficacy of various vaccines against new variants of COVID present in the country and if so, the details thereof?

## ANSWER

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

(a):  As  per  the  provisions  of  New  Drugs  and  Clinical  Trials  Rules,  2019  under  Drugs Cosmetics Act, 1940 a nd in light of urgent need due to COVID pandemic in the country, Centra Drugs Standard Control Organisation (CDSCO) has granted permissions to following COVID - 19 vaccines for prevention of COVID - 19 for restricted use in emergency situation:

## 1. ChAdOx1 nCoV - 19  Corona  Virus  Vaccine  (Recombinant)  manufactured  by  M/s Serum Institute of India Pvt., Ltd., Pune

CDCSO had granted permission to M/s Serum Institute of India Pvt., Ltd. Pune to conduct P II/III clinical trial of ChAdOx1 nCoV -19 Corona Virus Vaccine (Recombinant) on 02.08.2020.

Subsequently,  M/s  Serum  had  submitted  its  application  on  06.12.2020  for  grant permission  to  manufacture  ChAdOx1  nCoV - 19  Corona  Virus  Vaccine  (Recombinant).  The Subject  Expert  Committee  (SEC)  of  CDSCO  reviewed  the  pr oposal  in  its  meetings  dated 09.12.2020, 30.12.2020 and 01.01.2021 as well as reviewed continuously the data as and w received.  The  MHRA  approval  for  AstraZeneca  vaccine  dated  30.12.2020  along  with  it conditions/restrictions was also reviewed by the co mmittee.

The committee  recommended for  grant of permission for restricted  emergency use of t vaccine subject to various regulatory provisions including with various conditions/restric

CDSCO accepted the recommendations of the Expert Committ ee and accordingly, the permission was granted to M/s Serum Institute on 03.01.2021 to manufacture ChAdOx1 nCOV -19  Corona  Virus  Vaccine  (Recombinant)  (COVISHIELD)  for  restricted  use  in  emergency situation with various conditions/restrictions.

## 2. Whole  Virion Inactivated  Corona  Virus  Vaccine  manufactured  by  M/s  Bharat Biotech International Limited, Hyderabad .

CDCSO  had  granted  permission  to  M/s  Bharat  Biotech  International  Limited,  Hyderabad  t conduct  Phase  I/II  clinical  trial  of  Whole  Virion  Inactivated  Coron a  Virus  Vaccine  on 29.06.2020 & Phase III clinical trial of on 23.10.2020.

Subsequently M/s Bharat Biotech International Limited, Hyderabad submitte  its application on 07.12.2020  for  grant  of  permission  to  manufacture  Whole  Virion  Inactivated  Corona  Vi Vaccine. The data was reviewed by CDSCO in consultation of Subject Expert Committee (SEC) in meetings dated 09.12.2020, 30.12.2020, 01.01.2021 & 02.01.2021. The committee recommended for grant of permission for restricted use in emergency situation in pub lic interest as  an  abundant  precaution,  in  clinical  trial  mode,  to  have  more  options  for  vaccin especially in case of infection by mutant strains.

Further, the firm shall continue the on -going Phase III clinical trial and submit data emerging from the trial as and when available.

CDSCO  accepted  the  recommendations  of  the  Expert  Committee  and  accordingly,  the permission  was  granted  to  M/s  Bharat  Biotech  on  03.01.2021  to  manufacture  Whole  Virio Inactivated  Corona  Virus  Vaccine  (COVAXIN)  for  restricted  use  in  emergency  situation clinical trial mode with various conditions/restrictions.

## 3. Gam -COVID - Vac  Combined  vector  vaccine  [SPUTNIK - V]  imported  by  M/s  Dr. Reddy's Laboratories Ltd, Hyderabad on 12.04.2021.

CDSCO had granted permission to M/s Dr. Reddy's Laboratories Ltd., to conduct Phase II/III clinical of Gam - COVID -Vac Combined vector vaccine [SPUTNIK - V] on 22.10.2020.

Subsequently  M/s  Dr.  Reddy's  Laboratories  Ltd.,  had  submitted  application  fo r  grant  of permission  for  import  of  Gam - COVID - Vac  Combined  vector  vaccine  [SPUTNIK - V]  on 19.02.2021

The proposal of restricted emergency use was reviewed by CDSCO in consultation of Subje Expert Committee (SEC) including data reviewed continuously as an d when received.

The committee recommended grant of permission for restricted use in emergency situati subject to various regulatory provisions.

CDSCO  accepted  the  recommendations  of  the  Expert  Committee  and  accordingly,  the permission  was  granted to  M/s  Dr.  Reddy's  Laboratories  Ltd  on  12.04.2021  to  import  Gam -COVID - Vac Combined vector vaccine [SPUTNIK - V] for restricted use in emergency situation with various conditions/restrictions.

## 4. mRNA - 1273  COVID - 19  vaccine  (Moderna)  imported  by  M/s  Cipla  Limite d, Mumbai.

M/s Cipla has submitted application for grant of permission for import of mRNA - 1273 COVID 19 vaccine (Moderna) in the country on 28.06.2021. CDSCO has reviewed the application a granted  permission  to  M/s  Cipla  Limited,  Mumbai  for  import  of  mRN A - 1273  COVID - 19 vaccine  (Moderna)  for  restricted  use  in  emergency  situation  on  29.06.2021  in  line guidelines in the force.

## 5. Gam -COVID - Vac  Combined  vector  vaccine  (SPUTNIK - V)  manufactured  by  M/s Ra (biologicals) Panacea Biotec Ltd., New Delhi.

M/s Ra (b iologicals) Panacea  Biotec  Ltd., New Delhi has submitted complete application manufacturing of Gam - COVID - Vac Combined vector vaccine (SPUTNIK -V) using Ready to fill bulk on 29.06.2021.

CDSCO has reviewed the application and granted permission for manuf acture of Gam -COVID - Vac  Combined  vector  vaccine  (SPUTNIK - V)  using  Ready  to  fill  bulk  to  M/s  Ra (biologicals) Panacea Biotec Ltd., New Delhi in line with guidelines in force for restric emergency situation on 02.07.2021.

(b): CDSCO has received 0 4 applications for grant of approval for restricted use in emerge situation, which are under examination & the details are as follows:

1. Novel Corona Virus 2019 - nCoV Vaccine (Recombinant) of M/s Cadila Healthcare Ltd., Ahmedabad :
2. SARS - CoV - 2  rS  Protein  ( COVID - 19)  recombinant  spike  protein  Nanoparticle Vaccine of M/s Serum Institute (Hadapsar and Manjari site):
3. Gam -COVID - Vac  Combined  vector  vaccine  (Sputnik  V)  manufactured  by  M/s Hetero:
4. Sputnik Light Vector vaccine of M/s Dr. Reddy's Laboratories Ltd.:

Various steps have been taken for fast track approval of COVID - 19 Vaccines, as below:

- a) A system is in place for fast track processing of application for clinical trial & for COVID- 19 Vaccines by CDSCO.
- b) The manufacturers were encouraged to share the safety, immunogenicity and effica data  with  the  regulators  as  and  when  it  was  generated  instead  of  waiting  fo

completion of the clinical trial, so as to enable continuous assessment/rolling re r educing the processing time.

- c) To  facilitate  quick  development  of  vaccines,  manufacturing  site  inspections conducted during the clinical batches development phase instead of initial developm
- d) Approvals  of  combined  phases  of  clinical  trials  like  phase I/II  or  phase  II/III  were granted in consultation with SEC to reduce the timeline of development of COVID - 19 Vaccines to ensure its early availability.
- e) The meetings of the Subject Expert Committee (SEC) evaluating the applications f conduct of clinical trials and approval of new drugs pertaining to COVID -19 drugs and vaccines are being held frequently. More than 150 meetings of the Committee have be held till date since COVID - 19 was declared as a pandemic.
- f) As  perCDSCO  notice  dated  15.04.2021, the  COVID  Vaccines  already  approved  by CDSCO  for  restricted  use  in  emergency  situation  in  India,  and  proposed  to  be finished at a site within the country different from the manufacturing site, by r bulk of the approved vaccine, will be approved by CDS CO based on inspection & CDL release.  Additionally,  if  such  a  vaccine  is  manufactured  in  India  from  basic substance  stage  to  the  fill - fin sh  stage,  it  will  also  be  given  manufacturing  license based on inspection, for stock piling & CDL release.
- g) Furt her,  notice  was  issued  on  01.06.2021  on  regulatory  pathways  for  approval COVID - 19 Vaccines in India for restricted use in emergency situation which are al approved for emergency use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Eme rgency Use Listing (EUL) providing for exemptions from conduct of post approval parallel local bridging trials and each batch testing of the vaccin CDL, Kasauli subject to condition that it is approved by the National Control Labor of the coun try of origin, and released by CDL, Kasauli based on such certificate summary lot protocol, to further expedite the approvals of imported vaccines.

(c): The location of the residence of the beneficiary is not recorded on CoWIN portal. H between 1stApril 2021 to 20th July 2021, approximately 56% of the total COVID - 19  vaccine doses were administered in Rural COVID - 19 Vaccination Centres (CVCs).

(d):  Government  of  India  has  placed  orders  for  supply  of  100.6  crore  doses  up  to December 2021. A tota l of INR 8071.09 crore have been spent on purchase of COVID - 19 vaccines out of the budget outlay of Rs. 35,000 crore (as of July 2021).

(e): Till 20th July 2021, a total of 42.51 crore doses have been supplied to States/UTs throug sources of which 40 .36 crore doses have been utilized during the ongoing vaccination drive.

(f): The data available so far suggest that all currently used vaccines are effective in hospitalization and deaths due to COVID - 19.