Lok Sabha Question No. 423 (STARRED), answered on 2022-04-01
Subject: Research by ICMR on COVID-19
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Dinesh Chandra Yadav

## GOVERNMENT OF INDIA

## MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH RESEARCH

## LOK SABHA STARRED QUESTION NO. 423 TO BE ANSWERED ON THE 1 ST  APRIL, 2022

## RESEARCH BY ICMR ON COVID-19

## †*423. SHRI DINESH CHANDRA YADAV:

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

- (a) the details of the COVID-19 related research carried out by the Indian Council of Medical Research(ICMR);
- (b) the percentage of success of such research activities; and
- (c)  the  amount  spent  on  ICMR  during  the  last  three  years  by  the  Government,  yearwise?

## ANSWER

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

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

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 423* FOR 1 ST  APRIL, 2022

(a) & (b): Indian Council of Medical Research (ICMR), an autonomous body of the Department of Health Research, has been at the forefront in the fight against COVID19. Some of the major research activities undertaken for COVID-19 are as follows:

## I. Testing for COVID-19:

- a. In  January  2020,  ICMR-NIV,  Pune  standardized  the  RT-PCR  based  diagnostic test and was the standalone lab for COVID testing, whereas today there are 3337 labs  with  testing  capacity  close  to  20  lakh  per  day.    These  include  high throughput machines and mobile testing labs deployed in the country.
- b. For remote and rural areas, TrueNat/CBNAAT platform, validated by WHO for TB, have been repurposed for COVID testing.
- c. Rapid antigen testing was approved in last week of June, 2020. This point of care test has tremendously improved access and ease of testing.
- d. Strategy for pooled testing of samples was standardized and disseminated.
- e. 32  validation  centers  have  been  set  up  for  fast  track  validation  of  newer diagnostic commodities. So far, more than 1600 different diagnostics have been evaluated  of  which  770  are  approved.  In  line  with  the  'Atmanirbhar  Bharat' initiative  of  the  Hon'ble  PM,  ICMR  has  approved  600  indigenous  test  kits. Indigenous manufacturers are also being hand-held to improvise their products. This has resulted in drastic cost reduction of a single RTPCR test as compared to March 2020.
- f. A quarterly Quality Control program has been implemented for more than 1700 RTPCR  laboratories.  With  the  help  of  WHO,  External  Quality  Assurance program has also been implemented where more than 1300 laboratories participated.  91%  of  the  laboratories  qualified  this  exercise.  This  effort  is envisaged to improve the quality of testing.
- g. A  uniform  data  entry  portal  is  hosted  by  ICMR.  This  database  carries  India's COVID-19 testing data for more than 78 crore tests.
- h. A common sample referral form (SRF) has been developed and deployed with the help of National Information Centre (NIC) through the RTPCR application.

## II. Nationwide serosurvey to determine the seroprevalence of SARS-CoV-2:

Blood samples from a total of 24000 samples from 71 districts were collected and tested for IgG antibodies against SARS-CoV-2. Three Nationwide serosurveys have been  conducted  from  May  11  to  June  4,  2020;  August  17  to  September  2  and December 17 to January 8. The nationwide adjusted sero-prevalence was found to be 0.73%;  7.1%  and  21.5%  respectively.  The  third  serosurvey  also  included  7000 healthcare  workers.  The  fourth  serosurvey  was  undertaken  in  June-July,  2021 wherein two-third of individuals with the age ≥ 6 years from the general population and 85% of healthcare workers had antibodies.

## III. Isolation of SARS-CoV-2 virus by ICMR-NIV, Pune:

India became the 5 th country to isolate the virus in March 2020.

Afterwards the following variant of concerns (VOCs) were isolated and cultured:

- (i) Alpha variant strain was isolated in January, 2021
- (ii) Gamma variant strain was isolated in February 2021
- (iii) Beta variant strain was isolated in March, 2021
- (iv) Kappa/ Delta/ B.1.617.3 and Delta Derivatives variant strains were isolated in April-June, 2021
- (v) Omicron variant strain was isolated in December, 2021
- a. Virus isolation paved the way for development of following technologies:
- (i) Indigenous  ELISA  IgG  kit  by  NIV,  Pune.  Technology  was  transferred  to  7 Indian companies.
- (ii) Development  of  indigenous  whole  virion  inactivated  vaccine  by  Bharat Biotech International Ltd.
- (iii) Laboratory assays like the gold standard Plaque Reduction Neutralization Test (PRNT) was established.
- (iv) Animal challenge experiments were conducted to understand the efficacy of vaccines and therapeutics.

## IV. Drug Trials:

- a. World's largest Plasma Therapy Trial (PLACID): The trial was conducted in a  total  of  464  participants  across  39  hospitals.  A  set  of  clinical  and  laboratory parameters  were  monitored  over  28-day  period.    The  trial  has  revealed  no significant benefit of plasma therapy in terms of reducing severity of disease and mortality.
- b. WHO Solidarity Trial: India:  ICMR-National AIDS Research Institute led the trial which was initiated trial in April 2020 across 26 hospitals and 1048 adults randomized.  The  globa  trial  in  >11000  individuals  concluded  that  Remdesivir, Hydroxychloroquine,  Lopinavir  and  Interferon  -  little  or  no  effect  on  overall mortality, initiation of ventilation and duration of hospital stay in hospitalized.

## V. COVID-19 Vaccine trials supported by ICMR/DHR:

- i. COVAXIN of Bharat Biotech International Ltd (BBIL) - ICMR: Provided virus strain, Characterized vaccine strain, and conducted preclinical studies in hamsters  &  monkeys.  Technical  &  Lab  support  for  phase  1  &  2  trials  and Technical & lab and financial support for phase 3 trials were also provided.
- ii. COVID-19 vaccines manufactured by Serum Institute of India: Phase 2/3 studies of COVISHIELD  (AstraZeneca), Phase 2/3 studies of COVOVAX  (Novavax)  and  Preclinical Hamster studies: indigenous candidates were conducted
- iii. ZyCoV-D of Zydus Healthcare: Preclinical studies in monkeys at ICMRNIV, Pune

In addition to these, ICMR also supported the following activities:

## VI. Other activities:

- a) COVID-19 clinical registry across 40 tertiary medical institutes of eminence has been  established.  Aim  is  to  understand  the  demographic  features,  clinical outcome  and  design  suitable treatment modalities  for  COVID-19  affected patients.
- b) Ten  COVID-19  biorepositories  for  helping  industry/academia  with  appropriate samples of  SARS-CoV-2 for developing indigenous diagnostics etc. have been established.
- c) Sewage surveillance has been standardized to detect presence of SARS-CoV-2 as early warning signal to predict increase in disease prevalence in a particular zone.
- d) ICMR  has  been  issuing  timely  advisories, treatment modalities, discharge guidelines,  testing  advisories  etc.  through  the  National  Task  Force  chaired  by Member Niti Aayog.
- e) More than 100 antiviral drugs/compounds have been screened for their antiviral potential.
- f) Before the establishment of INSACOG,  ICMR  undertook genomic and epidemiological surveillance of the COVID-19 positive samples collected from January, 2020 till August, 2020 across different regions of the country.
- g) To  understand  the  possible  reason  of  breakthroughs  infections  a  study  was undertaken entitled 'Clinical characterization and Genomic analysis of COVID19 breakthrough infections during second wave in different states of India was undertaken in July, 2021'.
- h) i-DRONE' (ICMR's D rone R esponse and O utreach for N orth E ast) assessed the feasibility  of  using  drone  to  deliver  vaccines  and  medical  supply.  This  was carried out in difficult geographical terrains including land, island, foothills and across  the  hills. The  medical  supplies  delivered  under  iDrone  project  included COVID-19 vaccines, vaccines used under routine immunisation program, antenatal care medicines, multi-vitamins, syringes and gloves. A total of 17,275 units of  medical  supplies  were  delivered  through  such  initiatives  in  the  states  of Manipur and Nagaland.
- i) Mobile BSL-3 has been launched by ICMR.
- j) Good  quality  research  projects  with  high  translational  potential  in  areas  of epidemiology  &  surveillance,  laboratory  diagnostics,  clinical  and  operational research have been funded.  There are more than 250 publications of ICMR on COVID-19  and  vaccine  in  major  areas  of  Plasma  Therapy,  Vaccine  Trials, Genome sequencing, variant analysis etc .
11. (c): The expenditure incurred by ICMR with respect to the budget allocated during the last three years is as under:

(Rs. in Crores)

| F.Y     | Actual Expenditure                                                                                   |
|---------|------------------------------------------------------------------------------------------------------|
| 2018-19 | 1447.85                                                                                              |
| 2019-20 | 1479.17                                                                                              |
| 2020-21 | 2886.79 (including Rs. 1275 crores on Covid-19 Emergency Epidemic Preparedness and Response Project. |