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Guidelines for International Collaboration/Research Projects in Health Research: MoUs and HMSC Procedure

International Health Division

An Indo-Foreign Cell (IFC) was set up in the Indian Council of Medical Research in the early 1980s to coordinate collaboration in biomedical research between India and other countries/ international agencies. The IFC was upgraded to the Division of International Health (IHD) in the year 2000.

International Collaboration & Partnerships

The International collaborations are sought under bilateral, multilateral and/or regional collaborative framework for facilitating and strengthening interactions among governments, academia, institutions and industries in the research areas of mutual interest. Currently, India has several bilateral Science & Technology (S&T) cooperation agreements with other countries to facilitate cooperation in the areas of biomedical research between India and foreign countries. ICMR operates in close cooperation with the Indian Ministry of Health & Family Welfare, Ministry of Science & Technology, Ministry of External Affairs, Indian missions abroad and foreign missions in India for the international collaborations.
By and large, biomedical research / health sciences prominently figures in all bilateral agreements in the field of Science & Technology. In addition, there are few specific agreements signed by the Ministry of Health and Family Welfare with other countries as well as those signed directly by ICMR with its counterpart International organizations/ Institutions.
The purpose of these agreements has been for: (i) exchange of scientific information; (ii) exchange of scientists/technicians for training under the projects (iii) joint execution of scientific projects, including support in the procurement of scientific equipments; and (iv) organization of joint scientific meetings, seminars, workshops, symposia in identified subjects of cooperation.

MoU/Joint Statements/LoI between ICMR and various global bodies

  1. The Indo-German programme has been running in pursuance of Indo-FRG Agreement on Science & Technology signed in January/March, 1974 (Co-ordinated by DST) and subsequently under ICMR-GSF (now taken over by DLR, BMBF), Special Arrangement for cooperation in biomedical sciences signed in January/February, 1976. The ICMR- GSF cooperation was renewed in May, 1990 and further strengthened by signing of an addendum in November, 2005 at New Delhi/Bonn. The areas of cooperation under this agreement cover infectious diseases including AIDS, oncology, family planning and reproduction with special emphasis on birth control, health for mother and child, prenatal medicine, research on scientific basis of traditional medicine with emphasis on composition and pharmacological properties of natural products, environmental toxicology, drug development related to tropical diseases/infectious diseases, bioethics, Antimicrobial Resistance and other biomedical research aspects related to human health.
     
  2. An MoU between ICMR and Helmholtz Association (HGF), Germany for cooperation in Medical Research was signed in April, 2006 at Hannover, Germany during the visit by the then Prime Minister of India to Germany. ICMR and Helmholtz Association are distinguished research organizations in their home countries with outstanding scientific resources and technical facilities at their disposal. The areas of interest identified for cooperation, were infectious diseases, oncology & biomedical research related to health. Under this MoU, a virtual Indo-German Science Centre for Infectious Diseases (IG-SCID) was established in April, 2007 which was located at the Council’s Headquarters and slated to promote research in identified areas of infectious diseases through joint research projects with Indian and German funding. The IG-SCID was in operation till 31st December, 2013. The organization of joint workshops, exchange of scientists/ researchers and execution of twinning projects were the modes of cooperation. Five areas of collaborative priority namely Genetic susceptibility, Vaccines & anti-infectives, Viral diseases (HIV/HCV), Animal models of infectious diseases and Zoonoses were identified under this programme. (pdf)

    The MoU between ICMR and HGF was renewed in May, 2011 at New Delhi in the presence of the then Prime Minister of India and H. E. Chancellor of Germany towards active translational efforts to advance the fight against infections in biomedical research with long-term capacity building for researchers and scientists, in both the countries. The MoU was further renewed in May, 2017 at Berlin during the visit of Hon’ble PM of India to Germany for joint research in areas of Chronic Viral Diseases and Antimicrobial Resistance.

  3. An MoU between ICMR and French National Institute of Health and Medical Research (INSERM) was initially signed in 1989 and renewed in 2000. A Letter of Intent (LOI) between ICMR and INSERM for setting up of an International Associated Laboratory (IAL) in the field of Immunology/Haematology was signed in December, 2010 at New Delhi between the then Secretary, DHR, MOH&FW, GOI & DG, ICMR and CEO, Chairman, INSERM during the visit by delegation of His Excellency, the then President of France to India. (pdf)

    The ICMR-INSERM MoU was renewed on 10th March, 2018 at New Delhi during the visit of Hon’ble President of France to India. Joint research will be collaborated in identified mutual areas of interest –Diabetes and Metabolic disorders; Bioethics with focus on regulatory issues of gene editing and Rare diseases.

  4. The Indo-US Joint Statement on HIV/AIDS was signed in 2000 and further renewed in June 2006; October, 2011and in June, 2015 through exchange of letters. The renewed cooperation in the field of STD and HIV /AIDS intends to continue and develop cooperation in the field of basic, clinical, translational, prevention research, training and infrastructure strengthening. (pdf)
     
  5. The Indo-US Joint Statement on Diabetes Research was signed in June, 2012 in USA and renewed in 2017 through exchange of letters. The collaborative research projects are mainly aimed for capacity building through scientific knowledge, technology and training needs, developing tools for disease control and prevention such as vaccine and collaboration on prevention, treatment and elimination of disease. To generate a better understanding of the molecular and biological mechanisms underlying diabetes, to characterize the genetics, social and environmental determinants and to identify innovative approaches for improving prevention and treatment of diabetes, developing cost effective tools and approaches to translate research results into policies and actions to improve public health. (pdf)
     
  6. The Indo-US Joint Statement on Environmental and Occupational Health, , Injury Prevention and Control was earlier signed in 2002 and was renewed in June, 2006. This Joint Statement has been further renewed as MoU in June, 2015 to promote and develop cooperation in the field of Environmental and Occupational Health, injury prevention and control research, education and training, infrastructure development and capacity building. (pdf)
     
  7. The Indo-US MoU for Cooperation on Cancer Research Prevention Control and Management among the NCI (AIIMS), MOH&FW, ICMR (DHR), DBT (Min of S&T) and NCI (NIH), DHHS, Govt. of USAwas signed in June, 2015 at New Delhi for establishment of the general framework of collaboration for promoting and conducting high quality research to strengthen evidence base necessary for cancer prevention, treatment and management. (pdf)
     
  8. The Indo-US Letter of Intent (LoI) between ICMR, New Delhi and Department of Biotechnology, Ministry of Science and Technology of the Republic of India and the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, DHHS, USA was signed in June, 2015 on Antimicrobial Resistance Research. (pdf)
     
  9. The Indo-US Joint Statement for Establishment of International Centre for Excellence Research (ICER) at National Institute for Research in Tuberculosis, Chennai was signed in June, 2003 and extended in May, 2008. The scientific focus was to continue ongoing activities and to expand cooperation in the areas of epidemiology, molecular biology, medical entomology, parasitology, immunology bacteriology, microbiology, virology etc. with emphasis on techniques for the prevention, diagnosis and treatment of tropical infections and allergic diseases. The collaboration was further renewed in January, 2017 through exchange of letters. (pdf)
     
  10. An MoU between ICMR and International AIDS Vaccine Initiative (IAVI), USA was signed in Oct/November 2014 respectively at New York / New Delhi. This MoU between IAVI & ICMR is to collaborate and contribute their experiences and resources on AIDS Vaccine development and evaluation of one or more safe and effective AIDS vaccines primarily for use in, but not limited to, India and other biomedical tools for prevention of AIDS based on mutual agreement. (pdf)
     
  11. An MoU between ICMR and London School of Hygiene and Tropical Medicine London (LSHTM), United Kingdom was signed in February/September, 2009 at London and New Delhi to build upon the synergy of expertise of each party for the promotion and conduct of research in the areas of Public Health; Cardiovascular medicine; Cancer; Infectious diseases including vector borne disease; Metabolic diseases; Obesity/Diabetes; Research support to National Rural Health Mission of India. The collaboration was renewed in December, 2015 at London. Joint research in identified mutual areas of interest -Public Health, including evaluation and health systems research; Disabilities (Prevention and Rehabilitation) and Impact of Environment on Health; Infectious Diseases including vector borne diseases; Maternal and Child Health; Nutrition (under- and over-nutrition), including the role of Agricultural policy and practices; Statistics and methodology; Research support to National Health Mission of India. (pdf)
     
  12. In February, 2010 An MoU between ICMR and Medical Research Council (MRC), United Kingdom was signed at New Delhi to encourage joint research in a range of health areas including persistent, new and emerging infections; Chronic non-communicable diseases; Impacts of environmental change (including climate) on health. The collaboration was renewed at New Delhi in November, 2015 for research on Antimicrobial Resistance, Dementia, Maternal and Child Health, Impacts of environmental change (including climate) on health. (pdf)
     
  13. An MoU between ICMR and Global Alliance for Chronic Diseases (GACD) was signed in April, 2011. Some of the priority areas of collaboration proposed by GACD founding members are prevention of cardiovascular diseases; public health measures for the control of diabetes and obesity; characterization, quantification of risk factors (tobacco and environmental pollution), and development of control measures for chronic obstructive airways disease, cancer cardiovascular disease and other disorders; and implementation research of interventions to address these and other priorities. The programme is reviewed periodically through Strategy Board Meetings. (pdf)
     
  14. An MoU between ICMR and Research Council of Norway (RCN), Norway was signed in October, 2014 at Oslo by Indian Ambassador to Norway and DG, RCN during the visit of Hon’ble President of India to Norway. This MoU is to encourage health research in a range of health areas of mutual interest, which currently include Human Vaccines; Infectious Diseases and Antimicrobial Resistance. (pdf)
     
  15. An MoU between ICMR and the Russian Foundation for Basic Research (RFBR), Russia was signed in December 2014 at New Delhi in the presence of the Hon’ble Prime Minister of India and H.E. the President of Russia. This cooperation in Health Research is in specific areas such as Oncology, Bioinformatics & bio-imaging, Neurosciences, New generation vaccine research and Research in HIV/AIDS. (pdf)
     
  16. A Memorandum of Intent (MoI) between ICMR and Swedish Research Council for Health Working Life and Welfare (FORTE) was signed in June, 2015 at Stockholm, under India -Sweden agreement on cooperation in the field of healthcare and public health during the visit by the then President of India to Sweden. The MoI is to increase bilateral cooperation between Sweden and India in the field of Ageing and Health to enhance the understanding of demographic change and impact of migration on physical and mental health and well-being of the elderly forms and systems of care of the elderly and use of ICT assistive technology and addressing issues related to nutrition in elderly. (pdf)
     
  17. An MoU between ICMR and Drugs for Neglected Diseases Initiative (DNDi), Switzerland was signed in October, 2015 at New Delhi for cooperation in neglected diseases. (pdf)
     
  18. An MoU between ICMR and National Health and Medical Research Council (NHMRC) Australia was signed in January/February 2016 from ICMR and NHMRC respectively. The MoU is to increase bilateral cooperation between Australia and India in the field of infectious diseases, chronic diseases pursued via each party’s membership of the Global Alliance for Chronic Diseases, public health and clinical aspects of chronic diseases, HIV/AIDS, Road traffic injuries, Maternal and child health and Health systems. (pdf)
     
  19. A Letter of Intent (LoI) between ICMR and National Institute of Infectious Diseases (NIID) of Japan was signed on Antimicrobial Resistance Research in April 2016 in Japan. The collaboration is in the area of Development of integrated surveillance program covering epidemiology data and genomic data of antimicrobial resistance in each country and mutual exchange of information of molecular and epidemiological data of antimicrobial resistance by developing of comparable surveillance program in each country. (pdf)
     
  20. A Tripartite MoU between ICMR, Department of Health Research; Ministry of Health and Family Welfare, GoI and International Vaccine Institute, South Korea was signed in August, 2017 at New Delhi in the area of Vaccine development. The programme is reviewed through Board of Trustees meetings periodically. (pdf)
  21. An MoU between ICMR and the African Union (AU) was signed on 27th March, 2019 at ICMR, New Delhi. It is envisioned that the commonalities between Africa and India in disease epidemiology, including communicable & non-communicable diseases and other health-specific issues(such as HIV/AIDS, Tuberculosis, Cancer, Emerging and re-emerging infections, Vector control, Health Systems) can be well-addressed through collaborative research programs focusing on population-based studies and disease specific product development and address the SDGs through generation of research evidence and validation in humans. Efforts will be made to encourage African entrepreneurship in the health sciences through technology transfer, training and hands-on experience. (pdf)
  22. A Tripartite LoI between The Indian Council of Medical Research (ICMR), Department of Health Research, Ministry of Health and Family Welfare of India; the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), Department of Health and Human Services of the United States of America (USA); and, the Bill & Melinda Gates Foundation (BMGF), USA was signed in October/November 2019 and was exchanged during the visit of Mr. Bill Gates, Co-Chair, Bill & Melinda Gates Foundation to ICMR hqrs, New Delhi on 17th November 2019. The collaboration will establish a clinical research fellowship programme for young scientists in India and the USA to expand research that will advance discovery to improve clinical practice and benefit public health in both countries. The initial focus of this fellowship programme is to be for scientists engaging in infectious disease and immunology research, with an emphasis on diseases that affect women and children. (pdf)
  23. A MoU between The Indian Council of Medical Research (ICMR) and the Department of Medical Research (DMR), Ministry of Health and Sports of Myanmar In the Field of Health Research was signed on 27th February 2020 during the visit of Hon’ble President of Myanmar to India. The collaboration is in the areas of Elimination of Infectious Diseases, Development of network platform for emerging and viral infections, training/ capacity building in Research methodology management, clinical trials, ethics etc. and harmonization of regulatory mechanism. (pdf)
  24. Various activities have been initiated under these Joint Statements and MoUs. Several workshops on topics of mutual interest have been organized and many of exchange visits by the Indian Investigators under the approved collaborative research projects have been funded by ICMR. Under these MoUs/Jt. Statements, the collaboration has fruitfully led to publication of several research papers as well as transfer of technology and infrastructure strengthening of Indian research institutes. The cooperation is reviewed through annual meetings of Joint Working Group or Joint Steering Committee organized in India and respective countries from time to time.

Forms and other details

  • The Joint Call for Proposals under the above mentioned MoUs/Joint Statements of ICMR with various International agencies are advertised on the respective websites of related Parties from time to time along with details on subject area and required documents to be submitted in specific formats.
     
  • For assistance from WHO: The form as prescribed by SEARO, WHO, New Delhi, may be used. For details, visit Website:  http://www.searo.who.int/index.html
     
  • For assistance from other foreign Funding Agencies/Organizations/ Foundations: The prescribed format of the concerned agency is to be used. If there is no prescribed format, proposals are to be prepared by using ICMR Format Download Form.
     
  • National Funding Agencies: Indian investigators are also advised to look out for periodic call for proposals issued under various bilateral or multilateral collaborative programmes by other Indian agencies (such as DBT; DST; CSIR etc) supporting Health/Biomedical research.

Some Important Tips

  1. Please ascertain from foreign collaborator whether he/she would be willing to submit the proposal under joint collaborative programmes of ICMR or under other foreign grants.
  2. If the foreign collaborator agrees to do so, you may obtain the relevant form from the concerned funding agency’s website. PI may also fill in the ICMR summary sheet for international collaborative projects in the prescribed format.
  3. The Indian & foreign investigators should submit their proposals to ICMR and respective foreign funding agency simultaneously for review.
  4. The following general information is to be given in the documents while submitting proposals for foreign collaboration/ assistance by Indian investigators for HMSC consideration:
    • Role/Status/ Expertise of the Indian Principal Investigator along with the CV and consent of all Co-investigators (if any).
    • Availability of infrastructure and manpower in the parent institution.
    • Justification for foreign collaboration/funding.
    • Relevance to India’s national health priorities.
    • Role, consent and bio-data of foreign collaborator/co-investigator(s).
    • Budget with justification and year-wise break-up in single currency i.e. Indian currency including training as well as foreign exchange visits component, if any.
  5. Apart from the technical details such as rationale for the study objectives, review of literature, materials and methods, techniques to be used etc, the following additional information is required for a collaborative project:
    • Nature of work to be done in Indian lab/institution and in foreign collaborator’s laboratory/institution.
    • Number of ongoing international collaborative projects (duly approved by HMSC) being undertaken by the Indian PI and the outcome of such approved projects (publications, patents, etc.).
    • Whether there would be transfer of technology as an outcome of the project.
    • Whether there would be transfer of human biological material from India to the foreign lab, or vice-versa for QA/QC purpose and if so the requisite details for the same, such as nature, number and quantity (percentage wise) of material to be sent abroad; purpose/need of transfer; type of investigation(s) to be done utilizing the material; institution(s)/scientist(s) to whom material is to be sent along with their addresses; a duly signed Material Transfer Agreement (MTA). Download MTA 

    It may be noted that transfer of all samples to the foreign lab is not permissible. If required, representative samples (about 10%) can be transferred to the foreign collaborators lab for QA/QC purposes.

    NOTE : In case of transfer of human biological material under the collaborative proposals, guidelines issued by the Ministry of Health and Family Welfare, Govt. of India, New Delhi, vide O.M. No.L.19015/53/97-IH(Pt.) dated 19th Nov. 1997 are to be followed Download Guidelines.

  6. With the progress in the area of cellular and molecular biology, the following points have become quite important for consideration by scientists during preparation of the proposals, as these may have a bearing on the approval process:
    • Safety during transfer – risk of transportation of biological material. Adequate precautions need to be taken.
    • National security – the research should not lead to development of biological weapons.

    Guidelines on foreign engagement on Bio-safety/ Bio-security matters (dated December, 2015) prepared and issued by Division of Disarmament & International Security Affairs (D&ISA), MEA (duly approved by Cabinet Secretariat) for compliance in order to protect national security (reference Weapons of Mass Destruction Act, 2005 and overall framework of Biological and Toxin Weapons Convention (BTWC).

    • Risk (relative) from the defence and internal security point of view of the country.
    • Intellectual Property Rights issues, if any.
    • Potential for commercial exploitation, such as by development of vaccines, diagnostics, therapeutics, drugs, etc.
  7. For exchange visits under projects approved under ICMR bilateral program, the approval of regulatory authorities of Government of India is to be taken. Papers need to be submitted at least 6-8 weeks in advance along with CV, passport details, consent of visits to be undertaken by Indian /foreign PI etc.
  8. Institutional Ethics Committee (IEC) clearance to be submitted for each of the participating centers/sites at the time of submission of the proposal to ICMR. The project is likely to be deferred by HMSC in the absence of IEC clearance certificate & IRB/IEC should be registered with the Licensing Authority/DCGI.
  9. For international collaborative studies involving multiple sites/centers in India, a single proposal may be submitted by one of the Indian Investigators (acting as a Coordinator). However, Institutional Ethics Committee clearances of all centers and their individual budgets/ roles in the study need to be submitted along with the common protocol.
  10. Appropriate clearances for research involving human subjects, animal experimentation /radio-tagged material (for clinical and/or experimental purposes), recombinant DNA/genetic engineering work are to be submitted.
  11. For research projects involving clinical drug trials, clearance from office of Drugs Controller General of India (DCGI) is to be submitted by Indian PI to ICMR.
  12. The regulatory requirements of DGCI should be fulfilled and all necessary approvals as per the latest amendments by GoI of Jan/Feb 2013 in the Drugs and Cosmetics Rules 1945 should be followed /fulfilled by the Indian PIs. The decision of DCGI and Hon’ble Supreme Court of India on Clinical Trials of new drug entities would be applicable on such studies.
  13. The project also needs to be registered with the Clinical Trial Registry in ICMR (CTRI) Before Initiation of this study (wherever applicable). For details visit Website: www.ctri.nic.in
  14. Institutes receiving foreign assistance should ensure to have the requisite FCRA clearance as per the requirement of DEA, Ministry of Finance, GOI. (pdf)
  15. The proposals submitted by ICMR institutes / centers should submit the recommendations of the Scientific Advisory Committee (SAC) of their institutes/centres.
  16. Mutual agreement on IPR claims addressing the IPR issues is to be submitted, if applicable.
  17. MoU on Data sharing/ Clinical Trial Agreement is to be submitted, wherever applicable.
  18. If the project involves field work/ utilization of State health facilities, then necessary approval of concerned State health authorities is to be provided.
  19. Any self funded Scholarship/Fellowship awarded to the candidate/scholars to work in India for pursuing higher education/research can be initiated by taking necessary permission and fulfilling regulatory requirements of the host institute and/or concerned department by circulation. These are considered as an educational activity as part of their career development. Only if felt necessary by IEC, the case may be referred for HMSC consideration.
  20. Sharing of raw data by Indian PI with the foreign agency in any form is not permitted. Only de-identified/anonymized /analyzed data can be shared.
  21. The Nagoya Protocol on Access and Benefit Sharing (ABS), (a new international treaty adopted under the auspices of the Convention on Biological Diversity (CBD) in Nagoya, Japan in 2010) which aims at fair and equitable sharing of benefits arising from the utilization of genetic resources is required to be followed.
  22. No modification/alteration in the format of ICMR Summary Sheet is allowed by Indian PI. The PI should strictly follow the format provided for consideration of HMSC.
  23. Additional documents to be submitted by NGO:
    • The annual reports, statement of accounts, achievements and their role in the project.
    • Justification for the budget with exact amount to be used under different heads with full explanation.
    • The composition of the Institutional Ethics Committee as per the ICMR ethics guidelines for biomedical research on human subjects.
    • Registration/Unique ID No. assigned by NITI Ayog, GoI-NGO DARPAN Portal. https://ngodarpan.gov.in

    Applications for International Collaborative Projects may be submitted online along with the listed documents for consideration of HMSC.

    Click here to Apply and for any queries kindly send an email on hmscihdicmr@gmail.com

Note
  1. Indian investigators are required to obtain HMSC clearance for international collaborative projects. ICMR receives applications from Indian PIs only.
  2. The requisite clearances /documents as required should be submitted by the PIs to avoid undue delay.
  3. The proposals can be submitted throughout the year unless there is a prescribed deadline in a specific call for proposal under a bilateral programme.
  4. In view of the increased frequency of HMSC meetings, the fast track mechanism has been stopped except for extremely exceptional cases (case to case basis).
  5. Incomplete proposals are not placed for consideration of Health Ministry’s Screening Committee (HMSC).
CONTACT PERSON AT ICMR

Dr. Mukesh Kumar
Scientist G & Head
International Health Division
mukeshk.hq@icmr.gov.in

Tel. 91-11-26588755
Tele. 26589794,26588980
Extn.242

Dr. Harpreet Sandhu
Scientist F
International Health Division
sandhuh.hq@icmr.gov.in

Tele Fax. 91-11-26589492
Tele. 26589794,26588980
Extn.237

Dr. Reema Roshan
Scientist C
International Health Division
reemaicmr@gmail.com

Tele Fax. 91-11-26589492
Tele. 26589794,26588980
Extn.347

International Health Division (IHD)
Indian Council of Medical Research
V. Ramalingaswami Bhawan,
Ansari Nagar,
New Delhi - 110029, India 
Website:http://icmr.nic.in

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