Lok Sabha Question No. 4053 (UNSTARRED), answered on 2021-03-19
Subject: COVID Vaccines Developed by Foreign Countries
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Dayanidhi Maran

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

## LOK SABHA UNSTARRED QUESTI ON NO. 4053 TO BE ANSWERED ON 19 TH MARCH, 2021

## COVID VACCINES DEVEL OPED BY FOREIGN COUN TRIES

## 4053. SHRI DAYANIDHI MARAN :

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

- (a) whether the Government proposes to allow the usage, sale and distribution of foreign orgin COVID vaccines developed by foreign countries;
- (b) the regulatory requirements being imposed on foreign manufacturers for approval of their medicines;
- (c) whether the indigenous/local vaccines are also required to furnish the same requirements for regulatory approvals;
- (d) if so, the details thereof; and
- (e) whether the Government has conducted an y consultations, discussions, review of vaccines such as Pfizer, Moderna etc., if so, the details thereof?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

- (a) : The  Central  Drugs  Standard  Control Organization  ( CDSCO )  had  received application s regarding grant of import permission to import (marketing authorization) the foll wing vaccines developed by foreign countries:
- i) M/s  Dr.  Reddy's  Laboratories  Ltd.,  Hyderabad  for  grant  of  import  permission  to import (marketing authorization) from Russia for emergency use of COVID - 19 Vaccine in the country on 19.02.2021. The proposal was deliberated in the Subject Expert Committee ( COVID ) meeting of CDSCO held on 24.02.2021 and as per the recommendation of the committee, the firm has been requested to submit immunogenicity and safety data of Phase II and III trial as per a protocol for further consideration of the Committee.
- ii) M/s Pfizer Limited, Mumbai for grant of permission to import (marketing autho rization) for emergency use ofits COVID- 19 vaccine in the country on 04.12.2020. However, the application was withdrawn by the firm on 05.02.2021.

(b) to (d) :The detailed guidelines and requirements for approval to conduct of clinical tri marketin g  authorization  permission of New Drugs including vaccines are specified in Sec Schedule of the N w Drugs and Clinical Trial ( ND & CT )Rules, 2019.

The approval of new drug or vaccine for manufacturing and market ingis based on the submission  of  adequate  data  including  Chemistry,  Manufacturing  and  Control  (CMC),  non -clinical (animal studies), clinical trial data as per Rules and outcomes of evaluation o in consultation with Subject Expert Committee (SEC) ofCDSCO .

In the case of import from other countries, before approval of such new drug or vaccine in India, local clinical trial may be required to be carried out as per the provisions of and Clinical Trials Rules, 2019 to generate evidence of effi ca y and safety of the vaccine in Indian population .

(e) : CDSCO receivedan  application  from  M/s  Pfizer  for  grant  of  permission  to  import COVID - 19  vaccine  in  the  country  on  04.12.2020.  The  proposal  was  deliberated in  th SEC (COVID) meeting held on 03.02.2021. The committee noted that incidents of palsy , anaphylaxis and other SAE's were reported during post marketing and the causality of the events with vacci ne was under investigation. Also , the firm ha d not proposed a ny plan to generate safety and immunogenicity  data  in  Indian  population.  After  detailed  deliberation,  the  committee did  not recommend for grant of permission for emergency use in the country at th atstage. However, the fi rm on 05.02021 withdrew its applica tion .

CDSCO has not received any application for approval of COVID - 19 Vaccine of M/s Moderna.