The costs involved in planning and conducting clinical trials are significant and require adequate allocation of funds and resources. Therefore, it is recommended that researchers carefully plan and budget trial costs in order to secure adequate funding. Some of the major costs involved in clinical trials are: manpower, instruments, and cost pertaining to the investigational product, medical management of participant in case of research related harm, compensation, insurance, equipment, transportation, data processing, ethics committee fees and other consumables.

There are various agencies that fund clinical trials in India which include both domestic and international agencies. The different funding bodies / agencies have varied requirements in terms of information required by them and the format in which this information is sought. Researchers are advised to explore possible funding options for the trial early in the trial development phase. Special attention should be paid to:

• Eligibility criteria for the funding agency
• Format for submission of the documents required by the agency
• Timeline for submission
• Specific requirements specified by the funding agency (for e.g. Public involvement/ICH-GCP/accreditation)

The following section provides information on some of the major funding agencies that fund clinical trials in India. This is not an exhaustive list. It is advisable to check the information provided on the funding agency’s website before any application is prepared or submitted.

Indian funding bodies:

1. Department of Biotechnology (DBT), Ministry of Science and Technology:
   DBT has a mandate to promote and support developments in the field of biotechnology in India. Programs set up by DBT for medical biotechnology aim at early diagnosis, prevention and cure for multiple conditions, through R&D, funding for clinical trials, infrastructure development, etc. These are:
   • Infectious Disease Biology Programme focuses on infectious diseases that are relevant for the country. The overall emphasis is on diseases like Hepatitis, Influenza, Chikungunya, Malaria, Leishmaniasis, HIV/AIDS, Dengue, etc. Specific calls for proposals are invited for funding opportunities under this programme.
     More information can be found here.
   • Human Development and Disease Biology: programme focuses on foetal and maternal health, biology of Sepsis, Pre-Term Birth, ageing, etc.
     More information can be found here.
   • Chronic Disease Biology: programme focuses on developing infrastructure, funding specific disease-biology based projects and setting up prospective cohorts for chronic diseases with Bio-Banking. Focus areas include Cancer, Neurosciences and Mental Health, Metabolic Disorders like Diabetes, Heart diseases, Kidney diseases; Autoimmune Diseases, Skin and Bone Diseases, Reproductive Biology and Health.
     More information can be found here.
   • Vaccines and Diagnostics: focuses on research and development, and clinical trials for vaccines and is being implemented through the following collaborations in India:
     1. Indo-US Vaccine Action Programme (VAP) supports a broad spectrum of activities that are related to new and improved vaccines. The focus areas under this programme are identified by the VAP Joint Working Group and designated as VAP priorities. The funding for VAP is through DBT in India and NIAID (National Institute of Allergy and Infectious Diseases) in the United States. Proposals submitted under this programme are submitted through VAP-specific solicitations at NIH (National Institute of Health, US) and are peer reviewed under their normal competitive process. Major projects initiated under VAP till date are rotaviral diarrhoea, dengue, viral hepatitis, tuberculosis, malaria, typhoid, E. Coli, leishmaniasis, pneumococcal vaccine, HIV/AIDS, etc.
     2. Vaccine Grand Challenge Programme (VGCP) focuses on accelerated development of candidate vaccines (for which earlier leads are available), improvise on current understanding of vaccine science and strengthen the scientific basis for future vaccine design. An additional area of focus of VGCP is the development of cost-effective vaccines and efficient delivery systems for India’s National Immunisation Programme. The VGCP is governed through an Apex Committee that has the power to support funding through various models (Centres of Excellence, R&D projects for 3-7 years and travel grants). More information for vaccines and diagnostics can be found here.
   • • Stem Cell Research and Regenerative Medicine is one of the thrust areas of DBT, with efforts primarily focused on basic, early and late translational research. Programmes are being implemented on all aspects of embryonic, adult and induces pluripotent stem cells; clinical and pre-clinical research. A separate task force considers the proposals submitted under this programme, for funding. More information can be found here.
       In addition, DBT has a number of research grants that are available through its international collaborations.
     • Wellcome Trust – DBT Alliance: is a £160 million initiative, with equal contributions from the Wellcome Trust, UK andDBT. This alliance aims at promoting biomedical research in India through funding and engagement. Some important links:Basic Biomedical Research FellowshipsClinical and Public Health Research FellowshipsFunded areasRemit and Eligibility
     • Indo-Australia Biotechnology Fundssupports and develops collaborative research projects. More information can be found here.

   Some important links for DBT:

   • DBT Call for Proposals
   • eProMIS – online portal for submission of proposals and related documents to DBT.
   • DBT’s Funding Mechanism
2. Biotechnology Industry Research Assistance Council (BIRAC):
   BIRAC is a not-for-profit enterprise that has been set up by DBT, as an interface agency to support, strengthen and undertake research that addresses nationally relevant product needs. BIRAC is an industry-academia interface, that helps bridge existing gaps, and facilitates product development. BIRAC has various programmes and partnerships through which it achieves its mandate:
   • Promoting Academic Research Conversion to Enterprise (PACE)supports and encourages academic institutions to develop technology and products of national/societal importance.
   • Grand Challenges India is a partnership between Department of Biotechnology, India; Bill and Melinda Gates Foundation and BIRAC, to collaborate in scientific and technological research. The priority areas of this partnership include; Reduction of maternal and child mortality and morbidity,Scientific and technical solutions for infectious diseases and Strengthening India’s scientific translational capacity. As a part of this initiative, The Grand Challenges Explorations programme provides small seed funds for exploratory projects. BIRAC also has the responsibility of implementing activities under this collaboration (Program Management Unit – BIRAC). More information can be found here.
   • National Biopharma Mission is an industry-academia collaboration for accelerating discovery research for the early development of biopharmaceuticals. This is a collaboration with the World Bank, to be implemented by BIRAC. More information can be found here.

   Important links:

   BIRAC ‘call for proposals’.

3. Indian Council of Medical Research (ICMR):
   ICMR’s mandate is to formulate, coordinate and promote biomedical research in India. The Council’s research priorities are aligned with the National Health Priorities. Currently, intramural research is being carried out through 26 ICMR research institutes or centres, on tuberculosis, leprosy, cholera, diarrhoeal diseases, viral diseases including AIDS, malaria, kala-azar, vector control, nutrition, reproduction, immunohaematology, oncology, etc. ICMR provides grants for; Medical Innovation, Short term studentship, Extramural Research Programme, Junior Research Fellowship and the Visiting Fellow Scheme.

   The India TB Research Consortium (ITRC), an initiative led by ICMR, supports the development of new tools (diagnostics, vaccines and drugs) to fast-track translational TB research. ITRC’s research portfolio is divided into four major areas: Vaccines, Diagnostics, Therapeutics and Implementation Research.

   ITRC links can be accessed here: Call for proposals,Proposal submission format.

   In addition to the grants and schemes described here, ICMR regularly calls for applications which are posted on its website (Request for Proposals).

4. Department of Science and Technology (DST):
   DST supports technological advances in the field of science. Some of its schemes are:
   • IRHPA (Intensification of Research in High Priority Areas) supports proposals in high priority areas where multidisciplinary /multi-institutional expertise is required. These high priority areas are identified by board members in consultation with various stakeholders.
   • Science for Equity, Empowerment and Development Division (SEED) provides opportunities to scientists that are motivated to work for uplifting financially marginalised population. There are a number of schemes available under SEED for specific target groups.
     Important links for DST: DST schemes open throughout the year, Fellowship opportunities for researchers,DST’s online portal to access schemes and formats for submission of proposals- Call for proposals
5. Council of Scientific and Industrial Research (CSIR):
   CSIR, established under the Ministry of Science and Technology, has various verticals that support technology and innovation in the field of science. The Human Resource Development Group (HRDG) is a division of CSIR that offers various funding opportunities in the form of research grants and fellowships (Emeritus Scientists).
   Important CSIR links include CSIR Funds Disbursal Mechanism and Application Forms.
6. Department of Health Research (DHR):
   DHR has been set up by the Ministry of Health and Family Welfare, to promote and co-ordinate basic, applied, clinical (including clinical trials) and operational research in India. The DHR has a Grant-In-Aid (GIA) Scheme for Inter-Sectoral convergence and coordination for promotion and guidance on research in health. GIA aims at supporting research conducted on identifying knowledge gaps and translating health leads into deliverables.

   The focus areas include cancer, mental health, cardiovascular health, kidney and liver disorders, etc. The complete list can be accessed here. The proposals to DHR are submitted online.

International funding agencies:

1. Bill and Melinda Gates Foundation (BMGF):
   BMGFworks closely with the Central and State Governments, community groups, non-profit organisations, academic institutions and the private sector (in India). The core work of the Foundation is centred around maternal, new born and child health; immunization, family planning and TB.
   Important links for BMGF include
   • Gates Fellowship
   • Process of Grants
   • Grant opportunities
   • What the Foundation does not fund.
2. National Institutes of Health (NIH), U.S. Department of Health and Human Services:The NIH set up by the US government is responsible for biomedical and public health research in the country. As a premier research agency in the US and with an annual budget of about $32 billion, NIH conducts, promotes and supports research globally. Through its Extramural Research Program NIH provides funding for biomedical research.NIH regularly posts Requests for Proposals and Funding Opportunity Announcements. The funding opportunity announcements are parent announcements, that allow researchers to submit Investigator-initiated applications for specific types of activity codes. In addition to these, the Fogarty International Centre awards, supports and administers a variety of grants to international trainees and researchers.Important links for NIH include Grants Process Overview, Guide to grants and contracts
3. World Bank:
   The World Bank works towards sustainable solutions to end extreme poverty and build shared prosperity in developing countries. It provides technical and financial assistance to developing countries around the world. The World Bank concentrates its resources and efforts towards reproductive, maternal, newborn, child and adolescent health; pandemics; nutrition; infectious diseases; tobacco control and mental health.

   World Bank issues calls for proposals regularly, with a tailored-approach. More information about the grant making process can be accessed on their website.

4. Wellcome Trust:
   The Wellcome Trust is a global charitable foundation, that supports medical innovation. The Trust’s priority areas are drug-resistant infections, health, research ecosystems in Africa and Asia; and vaccines.

   Wellcome Trust has various grants that a researcher can apply for, some of which are:

   • Biomedical Resource and Technology Development Grants provides up to 5 years of support, and a maximum of £1.5 million. This grant is for someone who holds an academic / research post, has a track record of applying for grants and holds a salaried position for the duration of the grant.
   • Heightening Institutional Capacity for Government Use of Health Research Award: This award funds one consortium of research and policy-making institution in low and middle income countries, for a duration of up to 3 years. The level of funding is about $1 million.
   • Innovator Awards: This award is open to researchers from any scientific discipline. Examples include: vaccines, devices, diagnostics, therapeutics (small molecules or biologicals), regenerative medicine, digital technology, etc. The level of funding for this award is £500,000 to £750,000 for a duration of 2 – 3 years.
   • Joint Global Health Trials scheme: This scheme funds late stage trials of interventions that provide evidence to help improve health in low and middle income countries (basic, clinical and public health). This fund is provided through a partnership between the UK Department of International Development, UK Medical Research Council, the National Institute for Health Research and Wellcome Trust.

   Important links for Wellcome Trust:

   Scheme finder

   Wellcome Trust Grant Tracker