Lok Sabha Question No. 93 (STARRED), answered on 2021-12-03
Subject: Shelf life of COVID-19 Vaccines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: D. M. Kathir Anand, Feroze Varun Gandhi

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

## LOK SABHA STARRED QUESTION NO.93 TO BE ANSWERED ON THE 3 RD  DECEMBER, 2021 SHELF LIFE OF COVID-19 VACCINES

## *93. SHRI D.M. KATHIR ANAND: SHRI FEROZE VARUN GANDHI:

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

- (a) the shelf life of COVID vaccines approved in the country and their active period among the vaccinated persons;
- (b)  whether  the  Government  has  taken  stock  of  the  vaccines  lying  unused  in Government and private hospitals and proposes to procure and redistribute the unused vaccines before their dates of expiry and if so, the details thereof;
- (c)  the  preparedness  of  the  Government  on  production  and  distribution  as  well  as administration of booster doses;
- (d) whether the Government is planning to use these unused doses for administering booster shots and if so, the details thereof; and
- (e)  the  effective  steps  taken  by  the  Government  to  ensure  adequate  production  and supply  of  COVID  vaccines  and  booster  doses  in  the  country  along  with  the  total expenses incurred and funds allocated and disbursed in this regard?

## ANSWER

## THE MINISTER OF HEALTH AND FAMILY WELFARE (DR. MANSUKH MANDAVIYA)

- (a) to (e) A Statement is laid on the Table of the House.

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 93* FOR 3 RD  DECEMBER, 2021

(a)  to  (e)  The  National  Regulator  i.e.  Central  Drugs  Standard  Organization,  has approved, the shelf life of 9 months for Covishield vaccine, for Covaxin vaccine it is 12 months and for ZyCoV-D vaccine it is 6 months from the date of manufacture. The COVID-19 vaccines have been developed very recently, therefore, scientific evidence is still evolving globally regarding the duration of protection.

Government of India closely monitors COVID-19 vaccine stocks in States/UTs so as to ensure their Optimal utilization. COVID-19 Vaccine stock which has not been utilised in private hospitals and nearing expiry has been taken up for redistribution by respective  State  Government,  as  advised  by  Government  of  India,  for  its  timely utilization.

Regarding  administration  of  booster  doses,  the  National  Technical  Advisory Group  on  Immunization  (NTAGI)  and  the  National  Expert  Group  on  Vaccine Administration for COVID-19 (NEGVAC) are deliberating and considering scientific evidences related to this aspect.

Under ' Mission COVID Suraksha- the Indian COVID-19 Vaccine Development Mission' , being implemented by Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Undertaking (PSU) of Department of Biotechnology (DBT), efforts have been made to strengthen COVID-19 vaccine manufacturing capabilities of Indian industry, so as to ensure optimal vaccine production.

In this regard, augmentation of manufacturing facilities was supported at Bharat Biotech  International  Limited  (BBIL)  and  Indian  Immunologicals  Limited  (IIL), Hyderabad.  Indian  Immunologicals  Limited  (IIL),  supported  under  the  Mission,  has achieved a production capacity of ~20 lakh doses/month equivalent Drug Substance (DS)  of  COVAXIN®.  The  validation  of  the  BBIL  facility  at  Malur,  Bengaluru  is complete  and  production  of  Drug  Substance  (DS)  started  in  August  2021.  Further, support for facility augmentation at Bharat Immunologicals and Biologicals Corporation Limited (BIBCOL), Bulandshahr; and Haffkine Biopharmaceutical Corporation Ltd (HBPCL), Mumbai; for COVAXIN® production is under consideration.  An  amount  of  Rs.  260  Cr.  has  been  allocated  to  support  facility  upgradation  for  augmented  COVAXIN®  production,  out  of  which,  an  amount  of  Rs. 27.25 Cr. has been disbursed so far. Additionally, DBT along with the PSU BIRAC, is facilitating  expert  advisory  support  for  facility  up-gradation  at  Gujarat  COVID Vaccine Consortium (GCVC), for augmented production of COVAXIN®.

In the current financial year i.e. 2021-22, INR 35,000 crore has been budgeted for  implementation  of  COVID-19  Vaccination  Programme.  As  on  27 th November 2021, an expenditure of INR 19,675.46 crore has been incurred against this allocation which has been utilized for procurement of COVID-19 vaccine for free of cost supply to State/UTs.

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