Continuing its effort to improve the scientific research temperament of the country, the Indian Council of Medical Research (ICMR), the apex body in India for the formulation, co-ordination and promotion of biomedical research, has emarked upon a series of new venture which will help reduce the total burden of diseases in the country and also will promote health and well-being of the population.
ICMR is planning to establish a National Animal Resource Facility (NARF) for bio-medical research at Genome Valley in Hyderabad. The estimated cost of the project is Rs.338.58 crore and the resource centre is expected to be functional by 2018-19.
The Union Cabinet, chaired by Prime Minister Narendra Modi, has given its final nod for a proposal in this regard by the department of health research (DHR) in the ministry of health and family welfare.
The institution will be the first of its kind for quality laboratory animals for basic and applied biomedical research in the country.
It will be developed as a world-class facility for breeding and housing of animals such as primates, cabines and other specialized models such as transgenic and knockout rodents required for testing of various R&D products. The facility will create, develop and provide access to a range of laboratory animals and related technological resources for advancement of biomedical research in the country, mainly to facilitate research in medical colleges, research and academic institutions, universities and biotech/bio-pharma companies.
The facility will also provide training facilities for personnel in the specialized areas in the field of biomedical research.
The state government has allotted 102.69 acres of land at Genome Valley, Hyderabad, free of cost, to the ICMR for establishment of NARF for biomedical research.
Monitoring NCDs targets
Even as noncommunicable diseases (NCDs) are contributing to rising proportion of sickness and deaths worldwide including India, the Union health ministry has identified ICMR as the nodal agency for conducting a survey for monitoring national NCDs targets in the country.
According to senior officials, the ICMR has received sanction of budget to undertake the national level survey for monitoring the national NCDs targets during 2015-2016. This will generate country/national level estimates of key NCD related indicators (risk factors and health system response) identified in the national NCD monitoring framework for the year 2015, create a central and regional pool of resources (protocols, standard tools, training manuals etc.) to support conduct of similar surveys at state level, and strengthen capacities for monitoring of NCDs at national and sub-national level.
The 10 NCD targets include 25 per cent relative reduction in overall mortality from cardiovascular diseases, cancers, diabetes or chronic respiratory diseases; 10 per cent relative reduction in the harmful use of alcohol; 30 per cent relative reduction in prevalence of current tobacco use in persons aged over15 years; 10 per cent relative reduction in prevalence of insufficient physical activity; 30 per cent relative reduction in mean population intake of salt/sodium; 25 per cent relative reduction in prevalence of raised blood pressure; halt the rise in obesity and diabetes; 50 per cent relative reduction in the proportion of households using solid fuels (wood, crop residue, dried dung, coal and charcoal) as the primary source of cooking; 20 per cent of eligible people receive drug therapy and counselling (including glycaemic control) to prevent heart attacks and strokes; and 80 per cent availability of affordable basic technologies and essential medicines, including generics, required to treat major NCDs in both public and private facilities.
The survey will enable assessment of progress on some of the targets being made at the country level towards achieving them by 2025 through repeat surveys. The survey will be done on a nationally representative population sample drawn from various regions of the country, and will include face to face interviews with selected male and female population, aged 15-69 years, residing in urban and rural areas, on key behavioral risk factors, physical measurements, laboratory assessments and health facility assessments for national systems response.
The survey will be implemented in partnerships with key institutions/agencies with relevant experience. The oversight will be provided by the national apex committee and national technical working group on NCD surveillance.
Management of celiac diseas
ICMR has issued draft guidelines on diagnosis and management of celiac disease, which is a chronic immune-mediated enteropathy that is caused in genetically susceptible individuals by ingestion of gluten proteins present in wheat, barley and oats.
Celiac disease (CeD) was originally described as a disease causing chronic diarrhoea and malabsorption. Flattening of the villi, inflammatory cell infiltration in the mucosa and loss of surface area were the major reasons for the clinical manifestations. The understanding that this is an immune process in which the intestinal epithelium is damaged is now well accepted. Following from the original descriptions by Dicke relating wheat consumption to CeD, a large number of studies have now established the central role played by proteins from wheat, and to a lesser extent barley or oats. The disease occurs only in individuals with a certain genetic predisposition, but at the same time it does not necessarily occur in all such individuals.
Earlier, the ICMR had created a Task Force on CeD in 2008, recognizing the need to focus on a disease that was beginning to be reported in sizeable sections of the population in several states of northern India. As recommended by the Task Force, data were collected on the prevalence of celiac disease in three regions of India through a population-based study carried out in three regions of the country. The Task Force also recommended that ICMR develop guidelines for the diagnosis and management of celiac disease in India.
While several international groups have generated guidelines for the diagnosis and management of celiac disease, these were largely rooted in the experience of western countries. There has been considerable skepticism over the applicability of these guidelines in a country like India where tropical enteropathy or environmental enteropathy is so widely prevalent, and where the incidence of parasitic and other infections of the small intestine is significant.
Celiac disease classically presents with symptoms of diarrhea and nutritional deficiencies secondary to nutrient malabsorption. This indicates that the small intestine is the target organ most commonly affected in patients with CeD. Small intestinal changes, primarily an increase in intraepithelial lymphocytes associated with varying degrees of crypt elongation and villous blunting, form the primary histological hallmark of CeD. Studies have shown that the intestinal epithelium was the target of autoantibody deposition in CeD. In the bowel, the proximal small intestine appears to be the site of greatest mucosal damage as indicated by the fact that deficiency of iron and folate, which are absorbed preferentially from the proximal small bowel, are the most common nutrient deficiencies clinically manifest in CeD. The infrequency of vitamin B12 malabsorption in CeD shows that involvement of the distal small intestine is relatively infrequent in CeD.
Ethics guidelines for biomedical research
ICMR has also issued the national ethics guidelines for biomedical research involving children.
The guidelines cover the ethical and legal issues that researchers need to consider when carrying out biomedical research in neonates and children. It is aimed to set out general principles that can be applied in most situations rather than to cover each and every situation. These guidelines need to be used in conjunction with the other existing ICMR guidelines. These guidelines are meant for use by researchers, ethical committees and other involved stakeholders.
Biomedical research involving children is needed for the benefit of the future generations of humanity. It leads to advances in medical care which can potentially improve the health and quality of life of children. There are numerous opportunities to develop interventions to promote health, and prevent and treat diseases that affect children. This can only be achieved through experimentation. Research and innovation is therefore the core of the endeavour to generate and translate knowledge into clinical care.
In India, there is an additional challenge of applying universal ethical principles to biomedical research in the multicultural Indian society with a wide diversity of health-care systems of considerably varying standards. Medical research involving children is essential for advancing child health. In most situations, research with adults cannot simply be generalised or extrapolated to infants, children, and adolescents and, research involving children is essential if children are to share fully in the benefits derived from advances in biomedical sciences.
The biomedical research is necessary in children because the disease may affect only children and newborns, e.g. hyaline membrane disease, birth asphyxia, neonatal hyperbilirubinemia, extrahepatic biliary atresia, infantile spasms, infantile tremor syndrome, Kawasaki disease, etc. Such diseases have no close parallels in adults, therefore it is necessary to carry out research with children to advance the knowledge in these diseases. Additionally, even if the same disease affects both children and adults, the pathophysiological processes and responses to treatment in children may differ from those in adults.
Disease burden initiative
ICMR in association with Public Health Foundation of India (PHFI) and the Institute for Health Metrics and Evaluation (IHME), University of Washington, Seattle, USA, has launched the state level disease burden initiative in India.
This is the first of its kind collaborative initiative in India to generate state-level disease burden and risk factors estimation in India utilising the robust global burden of disease (GBD) methodologies in understanding regional and national disease and risk factor trends.
The ICMR's initiative in this regard is significant with over 1.25 billion population, every sixth person in the world lives in India, and many states of India have populations larger than that of most countries. For example, while the most populous 20 countries in the world have a population of over 65 million, 7 of the 29 states in India have this population including three exceeding 100 million. Reliable sub-national estimation of disease burden in India is therefore crucial for an informed health system response to improve population health, as national level estimates do not provide enough nuance for specific action needed in large heterogeneous India.
In order to address the need for reliable state-level estimates for disease burden and risk factors for effective action to improve health at the local levels in India, the ICMR has embarked on this collaborative initiative on state-level disease burden estimation in India. ICMR and PHFI have both worked extensively on various aspects of disease burden estimation in India and use of this in policy making, and IHME leads the global burden of disease (GBD) study. GBD is a systematic scientific effort to quantify the comparative magnitude of health loss due to diseases, injuries and risk factors by age, sex and geographies for specific points in time along with measures of uncertainty.
GBD has about 1200 collaborators in over 100 countries. Findings from the GBD study in 2010 and 2013 have been published and are used extensively. These findings are quoted widely and are considered the most robust estimates of disease burden globally. Besides the country-level estimates, state or province level estimates have recently been produced for China, Mexico and UK as part of the GBD study, which are proving very useful in enhancing health planning in these countries at the local levels.