|The Health Ministry's Screening Committee (HMSC) operated by Department of Health Research/ICMR has been recently reconstituted by Ministry of Health & FW, GoI as per the directive of Cab Sec. HMSC is chaired by the Secretary, Department of Health Research (DHR), MOH&FW, GoI and Vice- Chairperson of the Committee is Secretary Department of Biotechnology(DBT). It has representatives from Department of Science and Technology; Ministry of Health & F.W.:, Directorate General of Health Services; Ministry of AYUSH; Ministry of Home Affairs; Ministry of External Affairs; Department of Economic Affairs, Ministry of Finance; Ministry of Defence; Central Drugs Standard Control Organization; Department of Agricultural Research and Education, Ministry of Agriculture; Ministry of Environment, Forest and Climate Change; Ministry of Fisheries, Animal Husbandry and Dairying; The Chair of the Review Committee for Genetic Manipulation; Directorate General of Foreign Trade and four independent subject experts as a standing expert group from governmental/non-governmental organizations/autonomous institutions representing different disciplines for expert opinion.|
|Department of Health Research (DHR/ICMR) is the Secretariat of HMSC and facilitates technical review of the international collaborative proposals for placement before this Committee as a mandatory requirement. The domain for HMSC is: https://hmsc.dhr.gov.in/|
|As per the revised Terms of Reference (ToRs), the reconstituted HMSC will carry out the screening and clearance of proposals involving international collaboration/funding in health research including studies in humans, animals, plants and environment for entities pertaining to non Governmental Organizations. Committee will meet at least every two months to clear projects received for HMSC’s consideration. MoHFW order|
|An integrated portal named Biological Research Regulatory Approval Portal (BioRRAP), coordinated by DBT,GoI, is to provide regulatory information to researchers and facilitate approvals. It is one-of-a-kind gateway intended to make science and scientific research more accessible as well as making it easier to create businesses. For any proposal to be submitted henceforth for HMSC consideration, it has been made mandatory by GoI to register through BioRRAP for a unique BioRRAP ID and then submit the proposal on the HMSC portal with a valid BioRRAP ID. Further details in this regard are available at https://biorrap.gov.in|
|Additionally, it is mandatory for the ICMR scientists to apply for HMSC clearance for the international research projects in the area of health research requiring foreign funding and/or collaboration (even ones under bilateral programmes of other Indian Funding Agencies). The proposals submitted by ICMR Institutes / Centers should submit the recommendations of the Scientific Advisory Committee (SAC) of their institute/centre.|
|The research proposals submitted by Indian Principal Investigators through Call for Proposals mechanism under the bilateral MoUs signed by ICMR with international organizations/agencies (advertised by the concerned Technical Divisions of ICMR as and when decided by ICMR and the partner agency) will also be considered by the reconstituted HMSC.|
Some Important points for consideration by PIs:
|1.||Please ascertain from foreign collaborator whether he/she would be willing to submit the proposal for obtaining any foreign grant.|
|2.||If the foreign collaborator agrees to do so, Indian PI may obtain the relevant form from the concerned funding agency’s website. PI also has to fill in the HMSC summary sheet for international collaborative projects in the prescribed format. (Download Format for Summary Sheet)|
|3.||The Indian & foreign Investigators should submit their proposals to DHR/ICMR and respective foreign funding agency simultaneously for review to avoid undue delay.|
|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:
i. Role/Status/ Expertise of the Indian Principal Investigator along with the CV and consent of all Co-investigators (if any).
ii. Availability of infrastructure and manpower in the parent institution.
iii. Justification for foreign collaboration/funding.
iv. Relevance to India’s national health priorities.
v. Role, consent and bio-data of foreign collaborator/co-investigator(s).
vi. 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:
i. Nature of work to be done in Indian lab/institution and in foreign collaborator’s laboratory/institution.
ii. Number of ongoing international collaborative projects (duly approved by GoI) being undertaken by the Indian PI and the outcome of such approved projects (publications, patents, etc.). A max. of 5 ongoing international collaborative projects being undertaken by a PI is advisable.
iii. 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:
i. Safety during transfer – risk of transportation of biological material. Adequate precautions need to be taken.
ii. National security – the research should not lead to development of biological weapons.
Reference 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).
iii. Risk (relative) from the defence and internal security point of view of the country.
iv.Intellectual Property Rights issues, if any.
v. Potential for commercial exploitation, such as by development of vaccines, diagnostics, therapeutics, drugs, etc.
|7.||Institutional Ethics Committee (IEC) clearance to be submitted for each of the participating centers/sites at the time of submission of the proposal. The project is likely to be deferred by HMSC in the absence of IEC clearance certificate & IRB/IEC should be registered with the National Ethics Committee Registry for Biomedical and Health Research in DHR/MoHFW.|
|8.||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.|
|9.||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.|
|10.||For research projects involving clinical drug trials, clearance from office of Drugs Controller General of India (DCGI) is to be submitted by Indian PI.
The regulatory requirements of DCGI 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.
|11.||In case of clinical trial, 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: http://www.ctri.nic.in/|
|12.||Institutes receiving foreign assistance should ensure to have the requisite Foreign Contribution (Regulation) Act (FCRA) clearance as per the requirement of DEA, Ministry of Finance, GOI. https://fcraonline.nic.in/home/PDF_Doc/doc00600120151214130739.pdf|
|13.||Mutual agreement on IPR claims addressing the IPR issues is to be submitted, if applicable.|
|14.||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. An MoU on Data sharing/ Clinical Trial Agreement is to be submitted, wherever applicable.|
|15.||If the project involves field work/ utilization of State health facilities, then necessary approval of concerned State health authorities is to be provided.|
|16.||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.|
|17.||Any other regulatory requirement as considered necessary and relevant as per the study topic by other Ministries/ Departments will be notified subsequently, which are to be obtained and submitted by Indian PI.|
|18.||No modification/alteration in the format of HMSC Summary Sheet is allowed by Indian PI. The PI should strictly follow the format provided for consideration of HMSC.|
|19.||No modification/alteration in the format of HMSC Summary Sheet is allowed by Indian PI. The PI should strictly follow the format provided for consideration of HMSC.|
|20.||The documents to be submitted by NGOs.
i. The annual reports, statement of accounts, achievements and their role in the project.
ii. Justification for the budget with exact amount to be used under different heads with full explanation.
iii. The composition of the Institutional Ethics Committee as per the ICMR ethics guidelines for biomedical research on human subjects.
iv.Registration/Unique ID No. assigned by NITI Aayog, GoI-NGO DARPAN Portal. https://ngodarpan.gov.in/
|Applications for International Collaborative Projects should be submitted online along with the listed documents for consideration of HMSC. : https://hmsc.dhr.gov.in|
|Click here to Apply: https://biorrap.gov.in/|
1. Indian investigators are required to obtain HMSC clearance for international collaborative projects. DHR/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. Incomplete proposals will not be placed for consideration of Health Ministry’s Screening Committee (HMSC).