Toddler Food Partners (TFP) has continued our activity in India. Here are some of the highlights.
Plans for 2015-2016
- Initiate clinical trials with new formulas developed by Sion and IIT Bombay. TFP will provide funds for the cost of the new products as they are not covered by UNICEF grant.
- Complete large scale field trial in Nandurbar district led by Tata Trust. TFP will continue to work with Hexagon and Tata trust to insure that locally produced MNT is available for the project.
- Develop a holistic approach to the prevention of malnutrition in India by leveraging locally acceptable products with appropriate fortification. Project under consideration includes treatment of pregnant and lactating women as well as SAM/MAM children. Supplemental nutritional products appealing to the local population are being developed at IIT Bombay. The products will be field tested in several villages in the Ahmednagar district if Maharashtra. TFP will provide technical guidance with project partners—volunteers from General Mills India office, and Tata Center for Technology and Design at IIT Bombay.
- TFP will continue to work with Hexagon Nutrition to enable them to meet all the International certification requirements for product quality and safety. TFP will assist them as they develop additional trials with MNT to treat SAM children with the State Governments of Maharashtra, Madhya Pradesh and Rajasthan.
- TFP will continue to explore partnerships with like-minded entities in India to promote the use of MNT for the treatment of SAM children.
TFP Update: India MNT Project in Mumbai, March 2015
The project to introduce RUTF to treat children with severe acute malnutrition (SAM) in Mumbai is going well. Our goal is to create evidence to influence decision makers in India to approve this life-saving product for widespread use.
Ready to Use Therapeutic Foods (RUTF) have been recommended for the treatment of Severe Acute Malnutrition (SAM) by UNICEF since 2007. Typical treatment requires approximately 150 sachets of calorie dense, protein rich fortified food paste given over an 8 week period. For children without other medical complications the recovery rate is greater than 85%. The current International cost of the product itself is approximately $50 per child.
RUTF was banned in India in 2009 pending evaluations by Indian scientific community, clinical trials in India demonstrating its effectiveness versus current practices, evidence of its suitability in local population and indigenous manufacturing know-how. Several large projects were funded by the Department of Biotechnology (DBT) and a scientific panel was set up in 2010 to study the literature and make recommendations regarding the use of RUTF for the treatment of SAM in India. The Indian Academy of Pediatrics published a consensus statement in their journal; Indian Pediatrics April 2013, Volume 50, issue 4, pp 399-404. The statement includes the following;
“Management of SAM should not be a stand-alone program. It should integrate with community management therapeutic programs and linkages with child treatment center, district hospitals and tertiary level centers offering inpatient management of SAM and include judicious use of ready-to-use-therapeutic-food (RUTF). All sections of healthcare providers need to be trained in the integrated management of SAM”
This statement has opened the doors for the use of RUTF in well-designed programs with proper training and protocol in India.
Toddler Food Partners (TFP), an NGO based in Minneapolis, Minnesota, USA joined hands with IIT Bombay and Sion Hospital to address each of these concerns. A small scale production unit was established on the premises of Sion Hospital in Dharavi and a clinical trial was initiated in 2011 where MNT (Medical Nutrition Therapy; local version of RUTF based on publicly available formulations) was tested versus SNT (Standard Nutrition Therapy) used at the Sion Hospital to treat SAM children. In 2012 a Mumbai based NGO SNEHA joined hands to recruit more SAM children for the study and to test the product in the community (Dharavi and other slums in Mumbai) through an outreach program.
The data from the hospital-based study presented at a Regional Scientific Conference in September 2013 showed that MNT was significantly better than SNT. Further research on improving the cost benefits of the protocol are continuing. The data from SNEHA study is equally compelling and it was shared at a conference in Brazil in 2014. The ongoing work at the Sion Hospital provided key input to the deliberations by the Scientific Committee in preparing the consensus statement.
Tata Trust requested TFP to conduct a scale-up feasibility study to reduce the cost of the product. TFP led a feasibility study along with IIT Bombay. The team included Hexagon Nutrition Private Limited (HNPL), General Mills India office, the State Nutrition Mission and Tata Chemicals. The feasibility study was completed in February 2014. HNPL on their own began researching and acquiring manufacturing know-how from their Sion association and their primary skills as a manufacturer and blender of vitamins and minerals to Government, Industry and International manufacturers of fortified products. TFP agreed to partner with them by providing technical guidance. TFP is consulting with HNPL without any financial considerations. In August 2014 Hexagon reached an agreement with Tata Trust to provide 400,000 sachets of product for the Nandurbar project. HNPL supplied the products in August-September 2014.
TFP visited HNPL’s plant in Nashik in February 2015. Several improvements have been made since the initial start-up in August, 2014. The sachet packaging material has been upgraded and the product shelf life has been increased to one year (from six months). Shelf life studies are continuing to assess potential increase to two years so that they could bid for International tenders.
TFP Accomplishments July 2014 to February 2015
- Phase 1 hospital-based clinical trial in Mumbai has been completed. Results were presented at a conference in Nepal in September 2013. Sion hospital has switched to MNT for all their patients since July 2014. A paper has been submitted to American Journal of Clinical Nutrition for publication. It is under peer review.
- Phase 2 community-based clinical trial with the help of local NGO SNEHA in the slums of Mumbai has been completed. Preliminary data was presented by the Dean of Sion hospital at a conference in Brazil.
- The Nutrition Research and Rehabilitation Center (NRRC) at the Sion hospital has been upgraded. Funding for the upgrade and ongoing activities at Sion hospital are being provided by UNICEF, Mumbai.
- A large scale field study with up to 11,000 children in the NanduTFP provided technical guidance to Hexagon Nutrition to scale up MNT production to a capacity of 1,000 Metric Tons/year. This is sufficient to treat 60,000 SAM children.rbar district of Maharashtra has been initiated by Tata Trust in partnership with UNICEF, Mumbai and the State Government. Hexagon Nutrition supplied 400,000 sachets of MNT to the project in 2014. They are likely to supply additional product in 2015.
- With guidance from TFP, alternate formulas of MNT have been developed by Sion hospital and IIT Bombay. They include soy protein and jiggery as alternate ingredients. The new formulas will have a different flavor profile and they will be less expensive.
Clinical Trials
Toddler Food Partners has made significant progress in the TFP funded clinical trial at Sion Hospital in Mumbai. The trial compared our RUTF product (locally called Medical Nutrition Therapy – MNT) with Standard Nutrition Therapy (SNT). Trial results were presented at a regional conference in Nepal and the presentation was well received.
Additional community based studies with MNT are in progress with Sion Hospital’s partner SNEHA an NGO working in Dharavi. They are testing three modes of delivery to SAM children in the slums of Mumbai:
- Setting up special day care centers
- Using mobile vans to distribute MNT
- Having field workers deliver MNT for home based treatment
All of these methods will have frequent follow-up. More data will be available in the coming year.
More Partners
A very large philanthropic foundation in Mumbai, Tata Trust, approached TFP to join a feasibility team to scale up MNT production to more than 500 tons annually to reduce production costs. The current plant at Sion produces 15 tons annually with an approximate cost of $0.50 per package ($75 for treating a child). The team completed its feasibility study in March 2014. With a capital investment in the $500K range, it is possible to produce more than 500 tons annually with a lower cost per package.
Hexagon Nutrition, a Mumbai based pharmaceutical company, has stepped up to make the investment and will have the capacity to manufacture 500 to 1000 tons annually. They will supply the product atlower cost per package in 2014. TFP will provide guidance to them so they could be the lowest cost producer of MNT in India by 2016.
More Backing for MNT Use
The Indian Academy of Pediatrics published a new protocol for the treatment of SAM in India. For the first time, it endorses the use of MNT in the treatment protocol. We expect government approval in the coming year.
Goals for 2015-2016
- Provide technical assistance to the pharmaceutical company to increase production capacity in India and to reduce the cost of the product.
- Guide our partners to continue clinical trials at Sion Hospital with alternative MNT formulas for children, pregnant women and lactating mothers.
- Identify new partners to reach out to more SAM children.
- Participate in a project through Tata Center for Technology and Design at IIT Bombay to develop strategies, policy recommendations and products to address malnutrition and eliminata the prevalence of SAM in India.
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