Prevention of Neural Tube Defects in India

EXECUTIVE SUMMARY In India, 300 babies are born every day with neural tube defects (NTDs), which are life-threatening developmental defects of the embryonic nervous system that can form shortly after conception. Most NTDs can be prevented by ensuring optimum blood levels of folate and vitamin B12 in women before pregnancy. However, up to three-quarters (or more) of Indian women, from early childhood, subsist on an insufficient dietary intake of folate and vitamin B12. These two vitamins work in tandem in metabolic pathways critical for deoxyribonucleic acid (DNA) synthesis and proliferation of cells. Consequently, deficiency of either vitamin can result in megaloblastic anemia, but vitamin B12 deficiency can independently lead to severe dysfunction of the central and peripheral nervous systems at any stage of life. Therefore, this public health issue warrants urgent action to reduce these NTDs, with a focus on optimization of both these vitamins among all Indian adolescent girls and women of childbearing age. The Indian National Academy of Medical Sciences (NAMS), the key advisory body to the Government of India on National Health Policy, recommended formation of this Task Force to document the problem of NTDs in India, identify a pragmatic solution, and provide a blueprint for implementation across India. Fortification of wheat flour with folic acid has substantially reduced the risk of NTDs in several countries, is highly cost-effective, and safe. However, logistical issues [unique to India] preclude the implementation of a similar approach. Nevertheless, the efficacy of common alternative foods capable of large-scale fortification with folate and vitamin B12 has now come to light, with a promise to ensure rapid vitamin replenishment of Indian women. The present report details the state-of-the-art knowledge on many closely related issues associated with NTDs in India. These include current knowledge on key scientific [basic science and clinical] results on the role of folate and vitamin B12 in human health; how nutritional insufficiency of these two vitamins leads to serious adverse consequences for in utero development of the conceptus, as well as the health of Indians at all life-stages; the challenge of finding a contextually appropriate food for fortification with both vitamins that meets the need of all Indians (from among a variety of candidate food vehicles); an overview of pros and cons of vitamin-fortified food vehicles [such as wheat, rice, salt, and tea], which have the potential to reverse the nutritional insufficiency of both vitamins across India within a single generation. Finally, Annexure 1 provides more details on relevant basic science, preclinical, and clinical information related to folate and vitamin B12 physiology, pathobiology, and various therapeutic options available; Annexure 2 addresses a variety of common concerns and frequently asked questions. The central pillar of this tripartite initiative necessarily relies on the ready availability of large-scale Folate and Vitamin B12 Fortified Food(s) [and tablets] to enable rapid therapeutic replenishment of both vitamins within ∼4-months, followed by a comprehensive nationwide distribution scheme to reach all adolescent girls and women of childbearing age across the length and breadth of India. Two additional supporting pillars are integral to the success of this program: The first pillar focuses on a National Educational Campaign to create awareness of the serious problem of low folate and vitamin B12 status (especially among women and their progeny) and emphasis on their role in partaking of the solution (related to the use of vitamin-fortified food). The third pillar, which is best achieved by an interconnected network of a National Birth Defect Surveillance Registry in all Indian States, focuses on assessment and documentation of the efficacy of implementation of large-scale distribution of vitamin-fortified food (or tablets) in reaching all Indian adolescent girls and women of childbearing age; assessing the efficacy of vitamin-fortified food in optimizing the folate and vitamin B12 status in women at childbirth; and documenting the effectiveness in reduction of NTDs and other midline birth defects, as well as other developmental origins of disease in utero. This NAMS Task Force-commissioned White Paper provides a blueprint for the Government of India’s Ministry of Health and Family Welfare to initiate the process of effectively eliminating two common vitamin deficiencies among adolescents and women in India by a comprehensive, feasible strategy. And, based on the axiom that ‘improvement in the health of a single woman invariably improves the health of others within her sphere of influence,’ this initiative will have a long-lasting, significant, and beneficial outcome on the health of all Indians. “If the core responsibility of government is to care for its people, it is in our best interest as a nation to ensure that women and girls everywhere have the access, care, and support they need to fulfill their potential throughout their lives.” – Natalie Gonnella-Platts “The ultimate moral test of any government is the way it treats three groups of its citizens. First, those in the dawn of life —our children. Second, those in the shadows of life — our needy, our sick, our handicapped. Third, those in the twilight of life — our elderly.” – Hubert Humphrey