Indian Guidelines Research Articles

Good Clinical Practices: An Indian Perspective

Clinical research is a mechanism or a process that provides concrete evidence that new treatments or remedies suggested are safe and effective. The ultimate aim of clinical research is the identification and discovery of contemporary diagnostic methods as well as the establishment of advanced standards of therapy. Good clinical practice (GCP) is an ethical and scientific quality standard for designing, conducting and recording trials that involve the participation of human subjects. Acquiescence with the guideline gives a pledge to the public that the morality, integrity and welfare of humans participating in the trials are protected. India offers distinctive opportunities for performing clinical trials with large patient population, experienced and well-equipped investigators and leading medical institutions with low patient trial cost when compared to the regulated nations. However, to ensure a uniform standard of clinical research in the entire nation and to provide data for registration for new drugs before use in human population in India, there was a need for our own Indian Guidelines. GCP guidelines were developed by an accomplished committee set up by CDSCO along with the clinical experts. This article elucidates the significance of Good Clinical Practice from an Indian Clinical Research perspective, whilst defining and outlining the goals and objectives of GCP. It addresses the historical events that led to the emergence of Good Clinical Practices and examines the current scenario with regards to the application of GCP in Clinical trials in India. Finally, the article analyses the challenges faced with regards to maintaining an evidential and competitive system and also suggest a way forward for further enhancing the credibility and efficiency of Good Clinical Practice in Clinical Research.

Management of Stevens-Johnson Syndrome-Toxic Epidermal Necrolysis: Looking Beyond Guidelines!

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe cutaneous adverse reactions, which are mainly caused by drugs; and these are usually associated with high degree of morbidity and mortality. Recently, two detailed guidelines were published on the management of SJS/TEN, Indian guidelines and UK guidelines. Still, there is no consensus on the management of SJS/TEN. In this article, our aim is to conceptualize the management aspect of SJS/TEN considering Indian setup. Early discontinuation of all medicines, supportive measures (hydration, electrolytes, and care of denuded skin), corticosteroids and cyclosporine has been found to be useful. Oral provocation test is reserved for patients, who undergo complete remission and this is to be done after hospitalization, under strict vigilance. As there is no consensus, the treatment should be individualized on case to case basis.

Survey of Probiotic Preparations and Labeling Practices in Indian Market

A cross-sectional survey was conducted across 320 chemists shop in Pune city for their availability and labeling practices. The questionnaire revealed the data about the most sold probiotic preparations, their mode of sale, and their available forms such as tablet, capsule, and sachet. Top ten probiotic preparations were evaluated for labeling practice as per the existing regulations of the Indian Council of Medical Research-Department of Biotechnology, Indian guidelines. Majority of probiotic preparations were listing the best before date, viability, probiotic organisms, net quantity, and batch number, but none of them mentioned the health claims.

Vaccination Status, Knowledge, and Acceptance of Adult Vaccinations against Respiratory Illness among Patients with Type 2 Diabetes Mellitus.

Patients with diabetes mellitus are more prone to develop infections with influenza virus and pneumococcus. Once they develop respiratory infections, they are twice more likely to die of complication related to the infection. Although there are no Indian guidelines, recent publications have recommended vaccination in patients with diabetes of all ages. Our study was undertaken to find the barriers to the uptake of adult vaccination against respiratory illness among patients with diabetes attending a diabetic clinic in a tertiary care institution. Of the 149 patients interviewed, only 2% and 0.7% had been previously vaccinated against influenza and pneumococcus, respectively. Although 52% of patients agreed that vaccination was safe and effective, only 17.4% got vaccinated during the period of observation after counseling. The primary reasons for refusal were financial (51.7%), while some were not completely convinced of its benefits (9.4%); the other reasons included fear of complications (7.4%) and needles (0.7%).

Creating the Indian airway guidelines and beyond

Creating the Indian airway guidelines and beyond

The new Indian ethical guidelines for biomedical and health research-delving new vistas

The new Indian ethical guidelines for biomedical and health research-delving new vistas

Blood donor notification: Boon for the community, bane for blood donors, and blood centers?

Altruism, warm glove, kinship and a sense of duty are the primary driving forces behind blood donation. The concept of donor cycle starts with donor recruitment and ends with donor retention and recall or with notification of sero-reactive donors. Donor Selection criteria vary from country to country and from region to region. Blood donor counseling is a confidential dialogue between the donor and a trained counselor aimed at ensuring the safety of donors and health of recipients. Predonation counseling covers modes of transmission of HIV, tests carried out on donated blood, confidentiality of test results, information on alternate testing sites and confidential self exclusion. Counseling during donation helps allay fears and is likely to reduce the incidence of adverse reactions in the donor. Post donation counselling aims at educating the donors on the interval between donations, care of the phlebotomy site, special instructions in case of adverse events and specific instructions depending on their job, besides nutritional /medical advice to deferred donors. Posttest counseling and notification of reactive donors is essential for the health of the donor and his family, prevention of diseases, improving blood bank economy by avoiding wastage of blood, and reducing exposure to healthcare workers. Problems in notification are diverse. It creates donor anxiety and suicidal tendencies in some. The kits used in a blood centre may give false positive results. NAT reactivity, with sero-negativity further compounds the problem. Response rate to notification is often poor. All these have made donor notification a boon for the community, but a bane for blood donors and blood centers. Every country must evolve specific guidelines for donor notification. This paper discusses Indian Guidelines for Blood donor counseling and sero-reactive Donor Notification.

A randomized controlled trial to evaluate the effects of high Protein Complete (lActo) VEgetaRian (PACER) diet in non-diabetic obese Asian Indians in North India

In view of the increasing prevalence of obesity in largely vegetarian Asian Indians, it is important to research a high protein, low carbohydrate vegetarian diet. The present study was designed to evaluate the effects of a “High Protein Complete (lacto) VEgetaRian Diet (Acronym; ‘PACER diet’), on weight, body composition and metabolic profiles in non-diabetic obese Asian Indians living in north India.In this 8-week randomized control trial, 102 vegetarian subjects with body mass index (BMI) >25 kg/m2 were randomized to either a test diet (PACER diet; high protein, high fat and moderately low carbohydrate, lacto-vegetarian diet) or control diet (standard vegetarian diet formulated as the dietary guidelines for Asian Indians) after 4 weeks of diet and exercise run-in period. A standard exercise protocol was followed for both groups. Body weight, BMI, waist circumference (WC), blood pressure, fasting plasma glucose (FPG), fasting serum insulin and lipid profile were assessed before and after the intervention.There was significant weight loss along with improvements in cardio-metabolic risk factors among both the groups post intervention. Percent reductions in the intervention group for weight (6.1± 2.9; p < 0.001), WC (3.9 ± 1.7; p < 0.001), FPG (5.9 ± 3.2; p < 0.001), total cholesterol (10.2 ± 6.3: p < 0.001), serum triacylglycerol (13.6 ± 10.6; p < 0.001) and low-density lipoprotein cholesterol (11.9 ± 7.1; p < 0.001]) were significantly greater than the control diet group. In summary, intervention with a PACER diet (high protein, high fat and moderately low carbohydrate, lacto-vegetarian diet) showed significant improvement in weight loss, body composition and cardio-metabolic profile as compared to a standard vegetarian diet among obese Asian Indians in north India.

Seismic Behavior of Under Confined Square Reinforced Concrete Columns

The role of confining reinforcement in dissipating a large amount of energy in reinforced concrete (RC) elements at the time of seismic events has been well demonstrated in previous studies. In India, this practice of providing special confinement in RC elements began to be followed after the ductile detailing code came into being in the year 1993. Hence, the structures built before 1990s in seismicaly active areas had no ductile detailing, as the design recommendation of pre 90s era do not consider adequate confinement requirements. The Present experimental study is a part of an ongoing project of upgrading these old reinforced concrete structures, which had no special confinement and are located in seismically active regions. Three full-scale columns with different amount of transverse reinforcement (volumetric ratio of 1.31, 0.33, and 0.22) were tested in a specially made testing setup. One specimen was designed as per the current Indian guidelines for ductile detailing (IS 13920:2016), while the other two specimens were designed as per the guidelines which existed before the Code on ductile detailing was implemented. The response of the columns under quasi-static reverse lateral cyclic loading (at constant axial load) was recorded in terms of lateral load v/s deflection, moment v/s curvature, energy dissipation, stiffness reduction and different ductility parameters. As expected, the results of the study show inferior seismic performance of under-confined columns as indicated by the key strength and ductility parameters. The results have though quantified the strength and ductility deficit of these under confined RC columns, which shall be of great help in designing suitable retrofit for the existing structures constructed with no ductile detailing features.

Anthropometry and Twin Epidemic of Malnutrition among Urban Population of Varanasi

As life expectancies increase the major causes of death shift to the chronic and non communicable diseases, Indian population is increasingly facing modern risks due to overweight and obesity and other diet-related factors. As a result, people are facing a growing burden from the modern risks to health, while still fighting an unfinished battle with the traditional risks that results in dual burden of risks and diseases. This study aims at estimating the prevalence of under nutrition and over nutrition based on anthropometric indices. A community based cross-sectional study with multi-stage sampling design was conducted among urban population of Varanasi aged 25-64 years living in the selected area. A pre designed and pre tested proforma was used to collect the basic characteristics of 640 study subjects. Anthropometric measurements (height, weight, waist circumference and hip circumference) were recorded by following standard procedures. WHO International and Asia pacific guidelines for BMI were used to define Chronic Energy Deficiency (CED), overweight and obesity. Waist circumference and WHR for identifying abdominal obesity were defined by Indian guidelines. Mean height and weight of male subjects (n=301) were 167.5 ± 7.5 cm and 66.8 ± 12.5 kg, respectively and height and weight of female subjects (n=339) were 153.5 ± 6.01 cm and 57.6 ± 10.2 kg, respectively. Mean BMI was higher among female (24.4 ± 3.92 kg/m2) than male subjects (23.8 ± 3.95 kg/m2). The prevalence of CED, overweight and obesity were 8.6, 22.8 and 38.3% respectively by Asian classification and 8.6, 29.1 and 9.3% respectively by Global classification. The prevalence of thinness was higher among males, whereas prevalence of overweight and obesity was higher among females. Prevalence of abdominal obesity was higher among females as compared to their male counterparts.

Generation of spectrum-compatible acceleration time history for Nepal

The 25 April 2015 Gorkha earthquake in Nepal caused severe structural damage in central Nepal, including the capital city Kathmandu. Both seismic vulnerability analysis of affected buildings and nonlinear time history analysis need increasing time history. However, no adequate records are available in Nepal, thus structural engineering practices follow Indian guidelines. The Nepal building code allows time history analysis along with the seismic coefficient and response spectrum methods, so nonlinear time history analysis can be used to assure adequate seismic safety. To fulfill the gap of recorded accelerograms, we developed artificial acceleration time histories considering the seismic hazard model of Chaulagain et al. (2015). We compared the synthetic accelerograms developed in this study with the records of Gorkha earthquake; the recorded maximum peak ground acceleration during the Gorkha earthquake showed comparable acquaintance only to the peak amplitudes of synthetic accelerograms generated for 300- and 475-year return periods.

RATIONALITY ASSESSMENT OF ZINC FORMULATIONS AVAILABLE IN INDIA

Objective: To critically analyze the essentiality and irrational zinc preparations available in Indian market. Methods: This was conducted as cross-sectional analysis by department of pharmacology of our tertiary care hospital between June and December 2016. Data regarding various formulations of zinc were retrieved from current index of medical sciences and drug India database. Rationality assessment was done using prescribed guidelines and approved formulations of zinc by Central drug standard control organisation. Essentiality was checked using National list of essential medicine India, 2013 and latest version of WHO list essential medicine bulletin. Dosage regulation was assessed using Indian pharmacopeia guidelines, National institute of nutrition, India recommendation and upper daily intake toxicity intake, United States of America (USA)Results: Our study results showed wide variation in the number of zinc preparation. Total number of formulation available in the market is 335. Among zinc preparation, the preparation that contains 20 mg of zinc as recommended by various guidelines is 10 in number. About 325 preparations of zinc are added with one or more nutraceuticals. None of these fixed dose combination of zinc containing preparation is recommended as essential fixed regimen.Conclusion: Zinc has lot of relevance in treating recurrent diarrhoeal illness, especially in paediatric cases; however legal, regulatory and educational measures should be followed to curtail all the irrational zinc prescription development, promotion, marketing and prescription.

Lipid management in India: a nationwide, cross-sectional physician survey

BackgroundCurrent international guidelines on dyslipidemia are not concordant on various aspects of management. Also, there are no uniformly accepted Indian guidelines. We, therefore, performed a physician survey to understand lipid management practices in India.MethodsAn anonymous survey questionnaire was administered to gauge physicians’ self-reported behavior regarding lipid management aspects. Results were expressed in terms of percentages based on the number of responses obtained.ResultsA total of 404 physicians participated in the survey. Eighty-eight percent respondents ordered a lipid profile before starting statin therapy, and 80% preferred to set lipid targets, though the tools used for calculating cardiovascular risk varied. Atorvastatin was preferred over rosuvastatin in primary prevention (72.9 vs. 32.4%), secondary prevention (54.6 vs. 46.7%), diabetic patients (56.3 vs. 40.3%) and post-ACS (78.3 vs. 34%). High-intensity statins were preferred by 73.7% of respondents in post-ACS cases. Fifty percent doctors chose not to use a statin in diabetic patients, irrespective of their LDL-C levels. The most preferred drug option for managing atherogenic dyslipidemia and moderate hypertriglyceridemia was statin-fibrate combination (55.1%) and fibrates (35.4%), respectively. Sixty-three percent doctors preferred to prescribe statins in patients with moderately high LDL-C and normal triglycerides, without CHD or CHD risk equivalents. Around 28% of doctors preferred not to use pharmacotherapy for managing isolated low HDL. Of the participants, 73% used fibrates in ≤20% of their dyslipidemic patients, with fenofibrate being the most preferred (90.5%). Ezetimibe was mainly used in patients with uncontrolled LDL-C despite statin therapy (52.4% respondents). Most preferred approaches to manage statin intolerance included reducing statin dose (39%) and stopping and restarting statins at a lower dose (34.5%). Fifty-two percent of doctors chose not to alter pre-existing therapy in patients who had LDL-C levels at goal but elevated non-HDL-C levels.ConclusionThis is the first survey in India that provides useful insights into Indian physicians’ self-reported perspectives on managing dyslipidemia in routine clinical practice. Despite concordance with the currently available guidelines in certain aspects, there is incongruence in managing specific dyslipidemia problems. Further continuing medical education and the development of evidence-based, India-specific lipid guidelines can help reduce some of these differences.

Effects of upstream terrain characteristics on aerodynamic coefficients of structures

Most research investigations and standards have not emphasized the effects of upstream terrain characteristics on aerodynamic coefficients of structures. Hence in this investigation, pressure measurements study on a 1:2:3 rectangular building model has been simulated through wind tunnel test under uniform, open and suburban terrain condition for 0° and 90° angles of wind incidence. From the variation of pressure and force coefficient values of present study, it is seen that the mean pressure and force coefficient values of all levels of uniform flow condition are on higher side by about 15–40% than the open and suburban terrain values for 0° angles of wind incidence as expected. However the mean pressure and force coefficient values of uniform flow condition are also showed that the values of all levels for 90° angle of wind incidence are on lower side with 20–40% difference than the boundary layer flow values when compared to the values of 0° angle of wind incidence. In addition, the mean pressure and force coefficients of present study has been compared with the Indian and international guidelines to highlight the limitations of codal standards.

Environmental effects of shifting to healthy diets in India: a nationally representative study

BackgroundFood production is a major driver of environmental change, while dietary risks are the leading cause of global disease burden. Dietary shifts in high-income countries can provide benefits for both health and the environment. However, little is known about such options in low-income and middle-income countries, which often face high burdens of both undernutrition and diet-related chronic disease. As an example, we assessed the changes in greenhouse gas emissions, water footprints, and land use, from shifting current nationally representative patterns of Indian food consumption to healthy diets. MethodsDietary data were derived from a national 2011–12 household expenditure survey. We modelled the changes in consumption of 36 food groups necessary to meet Indian dietary guidelines. These changes were combined with food-specific data for greenhouse gases emissions, calculated using the Cool Farm Tool, water footprints, from the Water Footprint Network, and land use adapted from the UN Food and Agriculture Organisation. FindingsShifts to healthy diets nationally required a minor increase in calories (3%), with larger increases in fruit (12%) and vegetables (20%). Percentage of calories from fat and protein were adequate. Meeting healthy guidelines marginally increased environmental footprints, between 1–4% for greenhouses gas emissions, water footprint, and land use. However, these national averages masked substantial variation within subpopulations. For example, shifting to healthy diets among those at risk of undernutrition would require increases of 11% in greenhouse gas emissions, 28% in water footprint, and 39% in land use, whereas decreasing environmental effects from those who currently consume above recommended calories. Environmental effects also varied substantially between six major Indian subregions. InterpretationProviding healthy diets in India, a country of 1·3 billion, might only necessitate slight increases in environmental footprints. However, major efforts could be required to prevent widespread business-as-usual shifts to caloric-intensive and environmentally intensive affluent diets. FundingLeverhulme Centre for Integrative Research on Agriculture and Health; Wellcome Trust (Our Planet, Our Health programme).

Ambiguities in the Guidelines for the Management of Arterial Hypertension: Indian Perspective with a Call for Global Harmonization.

Many medical professional societies have formulated guidelines to treat hypertension, but there existed differences with respect to diagnosis, blood pressure (BP) targets, pharmacotherapy of hypertension, and grades of evidence. A MEDLINE search for hypertension guidelines was performed to compare Indian guidelines for hypertension (IGH) with these guidelines. A majority of the guidelines had consensus on the cutoff value (140/90mmHg, recorded twice) to diagnose hypertension. The Joint National Committee 8 (JNC 8), IGH, Japanese Society of hypertension (JSH), Canadian Hypertension Education Program (CHEP), and American Society of Hypertension/International Society of Hypertension (ASH/ISH) guidelines provide a higher BP target for the elderly hypertensive populations, while the National Institute for Health and Care Excellence (NICE) and European Society of Hypertension (ESH) guidelines provided a lower BP target for the elderly patients. However, a meta-analysis showed benefits of having a systolic BP target of <130mmHg for all patients. Treatment of hypertension according to JNC 8, NICE, and ASH/ISH guidelines varies among the black and the non-black population which recommended thiazide or calcium channel blockers for the black population. There is no special mention of pharmacotherapy or BP targets for the South Asian population in various guidelines including IGH despite evidence of higher risk of hypertension-associated complications in this population. It is suggested that all the available guidelines should be harmonized with highest level of evidence available to minimize ambiguities associated with management of hypertension.

Cumulative quality assessment for whole blood-derived platelets: A compliance review

Background and Objectives: Quality control (QC) results of platelet‑rich plasma and buffy coat‑reduced platelet concentrates (PCs) are presented with the goal to assess their compliance with published guidelines and corrective action taken for any process deviation during their manufacture. Subjects and Methods: Retrospective QC of in‑house prepared whole blood‑derived platelets (2009–2013) was conducted. Their cumulative results were compared to the published quality standards given by the American Association of Blood Banks, Council of Europe, and Indian guidelines. Data was analyzed using SPSS Statistics version 20. Results: A total of 36,053 PCs were prepared during the study period, and 1.43% (n = 516) was subjected to QC. The aggregate five years mean ± standard deviation (range) of product per bag were volume 58.4 ± 9.5 (37–90) mL, platelet yield 5.89 ± 1.28 (3.1–8.7) × 1010, residual leukocyte count 1.5 ± 1.2 (0.02–5.5) × 107, pH 6.67 ± 0.48 (6.0–7.3), and erythrocyte contamination 0.29 ± 0.2 (0.03-2.0) mL. Swirling was present in all the units. None of the bags showed any microbial growth. Against volume, yield, and erythrocyte contamination 90.0%, 94.3%, and 87.0% units showed compliance to the Indian standards, respectively. All the PCs had pH and leukocyte counts well within the recommended norms. Conclusions: Quality of our platelet product although suboptimal to International standards was well within the national requirements.

Current Indicators of Nutritional Care in Children with Type 1 Diabetes in India: Do we Need a National Nutritional Guideline?

Background:Nutrition is an important pillar of management in children with type 1 diabetes. Indian food is heavily influenced by region, religion, traditions, seasons, and cultural choices. This survey was done to assess current practices and the need for India specific nutritional guidelines for children with type 1 diabetes.Materials and Methods:Two 12-item questionnaires were administered to forty health-care professionals across India. The first questionnaire evaluated current clinical practice indicators for nutrition in these children and second assessed practices for counseling a child on dietary habits.Results:There is great heterogeneity across the country with regard to dietary advice offered to children with type 1 diabetes. 97.5% of the respondents feel there is a need for an Indian dietary guideline for children with type 1 diabetes.Conclusion:There is need of India specific nutritional guidelines that should be made considering key variants such as age, region, cultural preference, economic burden and psychosocial beliefs, to offer guidance to diabetes care professionals.

Evidence and Suggested Therapeutic Approach in Psoriasis of Difficult-to-treat Areas: Palmoplantar Psoriasis, Nail Psoriasis, Scalp Psoriasis, and Intertriginous Psoriasis.

Psoriasis is resistant to treatment and it shows frequent relapse; systemic treatment is often associated with toxicities, and long-term safety data are lacking for most of the newer drugs like biologics. Moreover, some body areas such as hands, feet, intertriginous areas, scalp, and nails are even more resistant. Frequently, systemic treatments are necessary considering the higher psychological impact on the patient. There is a lack of agreement on the best therapeutic modalities in the management of psoriasis involving difficult-to-treat locations. At present, there are no Indian guidelines for these conditions. Available literature has been reviewed extensively on the treatment of psoriasis involving difficult-to-treat locations; level of evidence has been evaluated as per the Oxford Centre for Evidence-Based Medicine 2011 guideline, and therapeutic suggestions have been developed. Best care has been employed to consider socioeconomic, cultural, genetic, and ethnic factors to prepare a therapeutic suggestion that is appropriate and logical to be used among Indian population and people of similar ethnic and socioeconomic background.

Real-world scenario of retinopathy of prematurity in Kerala

Objective: The objective was to study the incidence and risk factors predisposing to retinopathy of prematurity (ROP) and to assess the outcome after laser photocoagulation. Design: This was a retrospective cohort observational study. Materials and Methods: Infants admitted to a Neonatal Intensive Care Unit of 12 referral hospitals in Kerala between May 2015 and June 2016 were followed up till retinal vascularization completes. Preterm infants with birth weight 34 weeks were screened for ROP at 4 weeks after birth or 31–33 postconceptional age, whichever was later. Infants with birth weight >1700 g and gestation >35 weeks were screened only on neonatologist's discretion. All infants were screened according to the Indian guidelines of type 1 and 2 ROP. We treated both eyes of all infants showing threshold ROP. Statistical analysis was done using SPSS version 16 (SPSS Inc., Chicago, IL, USA). Results: The incidence of ROP in 622 infants screened was 158 (25.4%), of which threshold ROP was seen in 61 (9.80%). No ROP was found in infants weighing >2000 g or with a gestational age >36 weeks. Risk factors predisposing to ROP were hours on ventilator, hemoglobin%, oxygen therapy, and number of blood transfusions, which were more significant in infants with type 1 or threshold ROP than type 2 ROP. Out of 97 infants with type 2 ROP, we saw stage 1 in 31 (30.92%), stage 2 in 59 (60.82%), and stage 3 in 7 (7.21%) infants. 61 (9.80%) infants with threshold ROP were treated with laser photocoagulation. Aggressive posterior ROP or rush disease was seen in 29 (47.54%) of 61 infants with type 1 ROP. Only 2 (3.27%) infants showed falciform fold over macula and 1 (1.63%) infant was blind due to retinal detachment. Conclusion: One-fourth of the infants showed ROP, of which one-tenth needed laser photocoagulation, the outcome of which was good. Risk factors predisposing to ROP were low hemoglobin, high oxygen therapy, increased number of blood transfusions, and hours of ventilator.