Lok Sabha Question No. 3044 (UNSTARRED), answered on 2019-12-06
Subject: Medical Research by ICMR
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Jugal Kishore Sharma, Riti Pathak

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

LOK SABHA UNSTARRED QUEST ION NO. 3044 TO BE ANSWERED ON 6 TH DECEMBER, 2019

## MEDICAL RESEARCH BY ICMR

## 3044. SHRI JUGAL KISHORE SHARMA:

## SHRIMATI RITI PATHAK:

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

- (a) the details of major research projects started by Indian Council of Medical Research during the last three years and the current year;
- (b) whether the shortage/vacant posts of scientists and experts in ICMR has adversely affected it functioning and the progress of various projects initiated by it;
- (c) if so, the details thereof; and
- (d)  the reformative  measures  taken/  proposed  to  be  taken  by  the  Government  for  capaci building and strengthening of ICMR and streamlining its functioning?

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

- (a):     Details are annexed.
- (b)  &  (c):        No.  However  30  scientists  have  been  recruited  recently  and  process  to - up remaining vacant posts, has been undertaken.
- (d):       The knowledge and skills of scientific personnel are being regularly update through their  participation  in  various  national  and  international  level  trainings,  worksh conferences. Upgradation of National Institute of Virology (NIV) unit at Gorakhpur has done to a full fledged centre - Regional Medical Research Centre (RMR C), Gorakhpur. As part of streamlining  of  ICMR,  number  of  institutes  under  ICMR,  have  been  brought  down  from 32 to 26.

………………..

## M ajor research projects undertaken by ICMR during 2016- 2019

## Outbreak/Epidemic Investigations

The  network  of  VRDLs,  duly  supported  by  National  Institute  of  Virology  (NIV),  Pune  with  BSL - 4 facility, tackles outbreak investigations in the country. ICMR was instrumental in timely detec successful containment of the recent Zika (ZiV) and Nipah Virus (NiV) outbreaks. In an effort to keep the country bio - secure and establish itself as a leader among South East Asia in tackling crisis inves DHR -ICMR  has established  'RESEARCH -Regional Enabler  for South East Asia Research Collaboration for Health'  in  collaboration  with  9  countries  of  South - Asian region. The platform will work to effectively combat emerging and re - emerging infectious diseases in South East Asia region.

## Affordable Health Technology

ICMR is working on various indigenously developed medical technologies/devices/kits which are cost effective and applicable in primary health care system. During the last 3 years following innovat place:

- Shigella Vaccine: Technology transferred to Hilleman Laboratories.
- MIP Vaccine ag ainst Leprosy: Validated the Made in India vaccine and is being implemented i National Leprosy Elimination Programme
- Point of Care Diagnostic Test for Blood Disorder: INR 50 test developed for detection of disorders, Haemophilia A & von Wilerbrand disease.
- Six diagnostic technologies which include, ELISA based diagnostic tests for detection of di viz. Hepatitis  E  virus,  Kyasanur  Forest  disease  (KFD),  Crimean - Congo  haemorrhagic  fever (CCHF),  Chandipura  virus  (CHPV)  and  Japanese  encephalitis,  h ave  been  transferred  to  M/s Cadila Healthcare through execution of license agreement. Three of which have been launched the market.
- ICMR in collaboration with IIT, Kharagpur is associated with its Imprint programme to work collaboration  for  designing health  technologies  and  finding  better  technological  solutions  fo human health.
- Four fertility assessment kits (InduLISA, CorpuLISA, LuteLISA and FolliLISA) developed an technology licensed to HLL Healthcare, Thiruvananthapuram
- Resazurin reduction test o assess sperm quality and functional ability has been filed. Kits h been prepared and the test is being commercialized by ICMR.
- A sensitive and specific PCR method developed to detect Chlamydia trachomatis (CT) infection in cervical samples is ready for commercialization.
- A sensitive and specific ELISA has been developed for the estimation of human intact Osteca (OC) for assessment of bone health especially in conditions such as osteoporosis. Second validation has been carried out.

## Annexure

- ICMR  has  signed  an  MoU  with  Federation  of  Indian  Chambers  of  Commerce  and  Industry (FICCI)  for  commercialization  of  ICMR  technologies  under  the  program  'Health  Technology Acceleration and Commercialization (HTAC).
- The  Indian  Council  of  Medical  Research  (IC MR)  and  the  Department  of  Health  and  Family Welfare of the Ministry of Health and Family Welfare (MOHFW), GOI signed a Memorandum of  Understanding  (MOU)  with  the  International  Vaccine  Institute  (IVI),  South  Korea collaborate on vaccine research and deve lopment.
- Two MoUs were signed between ICMR and Emami Healthcare Ltd, Kolkata on 'Development of Standardized Phytopharmaceutical Formulation for Preventing or Delaying the Development o Type- 2  Diabetes  in  Subjects  with  Pre -Diabetes'  and  on  'Development  of Standardized Herbal/Ayurvedic formulation for the Treatment of Sleep disorders'.

## Supporting Ayushman Bharat

- DHR - ICMR  is  supporting  Ayushmann  Bharat  and  ensuring  a  sustainable  and  cost - effective model through its ongoing programmes like health technology assessment, standard treatment work flows and national list of essential medicines and diagnostics. These programmes wo serve  as  an  important  tool  in  prioritizing  national  health  spending  and  providing  a  u guideline to ensu re quality healthcare services across the nation.
- National essential diagnostics list has been prepared to ensure that quality diagnosis is p all levels of healthcare facilities.
- Health  Technology  Assessment  India  (HTAIn)  :  To  facilitate  the  proc ess  of  transparent  and evidence informed decision making in the field of health, Health Technology Assessment in I (HTAIn) has been set up to evaluate appropriateness and cost effectiveness of the availab new health technologies in India, so that maximum people can have access to quality healthcare at minimum cost in the country. Health Technology Assessment have been initiated for topic Intra ocular Lenses for Cataract Surgery, Screening for Breast Cancer, Screening for Ce Cancer, Non I nvasive Hemoglobinometers, Safety Engineered Syringes, Implants that can be part of Family planning Programme, Screening for Diabetes, Bempu Neonatal Hypothermia device, SOHUM Neonatal Hearing Device, Real time PCR for H1N1, Screening for Hypertension and Intrauterine  balloon  tamponades  for  post - partum  Hemorrhage.  Currently,  it  is  conducting  a national Costing Study of Health Care Systems in 14 states.
- Standard Treatment Workflows (STW): The first volume has been released on 17th November 2019  that  includes 50  diseases  across  9  specialities.  They  will  serve  as  uniform  treatme guideline  for  doctors  in  primary  and  secondary  healthcare  settings.  About  300  experts  a India's government and private hospitals have been roped in to prepare STWs for 100 common illnesses, ranging from kidney diseases, infections in children to cardiac diseases.

## Flagship Programmes

- The India TB Research Consortium: ICMR took a lead and initiated a new flagship Programme to establish  India  TB  research  and  development  Consortium  t hat  aims  to  bring  together  all  major national players (with international collaborators) to address overarching scientific question TB in a mission mode.
- TB Diagnostic Initiative: TruNAT Rif, an indigenous, cost effective, rapid molecular diagnostic k for  TB/MDR - TB has  been  developed  in  collaboration  with  ICMR,  DBT  and  the  industry. The

feasibility  study  of  TruNAT  at  100  microscopy  centres  at  50  districts  across  10  states  ha completed and the report has been reviewed by ICMR expert committee and International Scienti Advisory Group. In view of the above recommendations, it has been recommended for roll out un RNTCP  at  Primary  Health  Centres  (DMCs)  in  a  phased  manner.  Also,  ac tive  c se  finding  pilot project has been initiated in five states for bridging gap in last mile delivery of services a populations.

- Malaria Elimination  Research  Alliance  (MERA)  India : MERA  India  (Malaria  Elimination Research Alliance) has been established to bring multiple stakeholders (national and internation under one umbrella to achieve the aim of disease elimination.
- India Cancer Research Consortium:

## Enhancing Outreach/Establishing new Centres in deficit/un -served areas

- ICMR has established Samrat Ashok Tropical Disease Research Centre at RMRI, Patna which will focus on research on various tropical diseases. The other development in the area of infras development  is  the  expanding  outreach  of  ICMR  in  far  flung  and difficult  areas  like  Keylong  in Lahaul & Spiti district of Himachal Pradesh, establishment of satellite centre of National In Immunoheamatology (NIIH), Mumbai at Chandrapur, Maharashtra for screening and management of sickle cell disease and fiel d station of NIV Pune at Alappuzha (Allepy) and RMRC, Port Blair in Car Nicobar &Nancowry islands aimed at providing necessary health facilities. Process has also s for establishment of new Regional Medical Research Centre (RMRC) at Gorakhpur, UP for human public  health  related  problems  of  eastern  part  of  UP  as  well  as  Biomedical  Research  Cent Guwahati, Assam. National  Animal  Resource  Facility  for  Biomedical  Research  is  being  set  up  a Hyderabad. This will be first of its kind Institute for basic and appl ed biomedical research nd will provide  support  to  academic  and  private  R&D  groups  for  preclinical  testing. NIIH- C n re  for Research, Management and Control of Haemolglobinopathies, Chandrapur will cater to the needs entire Vidarbha region es pecially in the area of sickle cell anaemia. There are around 4,00,000 Si cell  disease  patients  in  this  region  along  with  approximately  40,00,000  sickle  cell  carri Foundation Stone of was laid by Hon'ble Prime Minister in February, 2019. All these Centres will be further strengthened and made fully functional in the coming year.

## E-Health/M- Health and Promoting Use of Space Technology Tools

- With the changing time,ICMR is focusing its efforts on using E - Health/M - Health and promote the use of Space Technology tools. ICMR has developed -a mobile based disease surveillance system for  malaria  (MosQuit)  using  mobile  platform.  This  technology  has  been  developed  by  RMRC, Dibrugarh  in  collaboration  with  CDAC,  Pune,  which  has  been  deployed  in  Tengag hat  PHC  of Assam.  ICMR  has  also  developed  various  e - learning  programmes  in  Health  Research  as  well  as prepared databases like TB - DRUGS, DDRTB, Food and Nutrition Database, etc .
- To address the impact of climate change on human health and promote use of spac e technology tools ICMR has developed an early warning system of JE for Upper Assam, initiated studies on mappi of malaria and mosquito - genic conditions, developed models for predicting filariasis. These effo will be up - scaled for larger use in the co ming year.
- PBIT an online webserver for identification of drug targets for infectious diseases has been developed.
- ICMR - NIMR (National Institute of Malaria Research), Delhi has signed and MoU with ISRO - IIRS (Indian Institute of Remote Sensing), Dehradun fo r development of geospatial solution for disease

surveillance particularly vector - borne diseases and work in the area of Health and GIS for disease modeling.

## Regulatory Issues in Research/deal with strong ethical dimensions

- Regulatory issues are also important for protecting public and patients and ICMR has develo various Bills/Guidelines which help to take care of the patients enrolled for research. The important among these are The Biomedical and Health Research Regulati on Bill (Ethical Issues pertaining to Biomedical Research) , Assisted Reproductive Technology Bill, Guidelines for Stem Cell Research, revised Bioethics guidelines and Bioethics guideline for health research inv children, National Guidelines for Gene Therapy Product Development & Clinical Trials (in collabor ation with Department of Biotechnology (DBT)), guidelines for evaluation of nano -pharmaceuticals (in collaboration with DBT and Central Drugs Standard Control Organisation (CDSCO)). A white paper was released on use of e - Nicotine products that led to the b an of ENDS (Electronic Nicotine Delivery System) by MoHFW. The Prohibition of Electronic Cigarettes Bi 2019 for the same has been passed.

## Nutrition

- Mobile  App  on  'Dietary  Guidelines  For  Indians: The  App  is  based  on  the  Recommended Dietary Allowances ( RDAs) for Indians prescribed by NIN.
- Fortified Food to Fight Malnutrition :  ICMR  has  come  up  with  a  micronutrient  mix  that  is being considered by government for its flagship programmes.
- Release  of  Indian  Food  Composition  Tables :  The  new  'Indian  Food  Composi tion  Tables -2017',  comprising  of  data  of  586  varieties  of  Indian  foods  and  their  nutritive  values,  was released.
- ICMR has taken up a project involving Nutrition Interventions in adolescent girls . 18 Navodaya Schools  have been identified
- ICMR in collaboration with DBT and ICAR is working on ,  'Establishment of nutri -smart villages and backyard nutrigardens'. 3 nutrition deficient districts have been identified.
- Development of a community based IEC intervention module for dietary salt restrict n and reduction of blood pressure .

## Disease Burden Estimation/Other Research Studies

- India's State -Level Disease Burden report released (Jointly by the Public Health Foundation of India (PHFI), ICMR & the  Institute for Heath Metrics and Evaluation (IHME) that contained State - Level  Disease  Burden  and  Risk  Factors  estimates  to  improve  health  programmes  and planning in India.
- National  Anti - Microbial  Resistance  Surveillance  Network  (AMRSN) continued  to  en able compilation of National Data of AMR at different levels of Health Care. Pfizer one of the

leaders in anti - infectives and  medical therapy is committed to combat AMR and has partnered with ICMR as part of  its Corporate Social Responsibility (CS R) ac ivity to achieve the unified goal of reducing AMR.

- National Hospital Based Rotavirus Surveillance Network : The study has been carried out at 4 Major referral labs, 7 ICMR's Regional labs and 23 hospital sites t o observe the trend in burden of  rotavir us  diarrhoea  as  well  as  impact  of  Rotavirus  vaccine  under  Universal  Immunizatio Program (UIP).
- ICMR -INDIAB , an epidemiological study on diabetes: The study is a landmark study providing authentic epidemiological data on diabetes, prediabetes , hypertension, dyslipidemia and obesity from the various States of India. The ICMR - INDIAB study gains significance as it is collecting representative data from the various States and Union Territories in India. The study ha completed in 14 states an d one UT and the data obtained has been shared with the State health departments.  Data  provide  a  snap  shot  of  the  existing  burden  of  pre  diabetes,  dia hypertension and obesity in the country.
- National Cancer Registry Programme: Since 1982 providing systematic, continuous data in cancer  Incidence,  burden,  mortality,  trends,  clinical  care  and  survival  through  30  Pop Based Cancer Registries (PBCR)and 27 Hospital Based Cancer Registries(HBCR).
- Baseline serosurvey to assess the prevalence of antibo dies for dengue, chikungunya and JE : This serosurvey is ongoing in 15 States of the country.
- Sentinel surveillance for Congenital Rubella Syndrome (CRS) in India : The study has been initiated at 6 sites. Aim is assess the impact of Measles Rubella vaccin ation in India.
- Hospital based sentinel surveillance for Pneumonia and Invasive Bacterial Diseases (IBD) : The study has been initiated at 6 sites. Aim is to assess the impact of Pneumococcal Con Vcacine (PCV).
- To strengthen South - South collaboration in advancing health sciences research and to enhance local capacity and ownership, an MoU was signed between ICMR and African Union (AU) on 27th March 2019.
- MoU Signed with Population Council : Innovations to Improve & Institutionalize Data Quality & Analyt ics' to strengthen India's health data ecosystem.
- Signed a Declaration of Intent (DoI) with the National Institute of Allergy and Infectiou Diseases (NIAD) of the National Institutes of Health, USA and the Bill & Melinda Gates Foundation (BMGF) . This Decl aration builds on an ongoing collaborative research and training programme between India and the U.S., including enhancement of research capacity.
- Established ICMR - AIIMS Computational Genomics Centre for providing services ; 31 ongoing data analysis
- National Ethics Committee Registry for Biomedical and Health Research has been set up. Ministry of Health and Family Welfare, Government of India had notified the New Drugs an Clinical Trials Rules - 2019 that came into force from 19th March 2019. Under the Rule s, Chapter IV entitled 'Ethics Committee for biomedical and health research' states that Ethics Committees reviewing biomedical and health research should register with the authority designated b Central  Government  in  the  Ministry  of  Health  and  Family Welfare,  Department  of  Health Research (DHR).
- National Biorepository for AMR Bacterial Strains & AMR - Hub at ICMR NICED , Kolkata
- ICMR  funded    Centre for  Advanced  Research  (CARE)  in  the  areas  of  non - communicable diseases like acute myeloid leukemia (AML), young diabetes, intestinal diseases, kidney dis heart failure etc.