Indian Guidelines Research Articles

Understanding the Challenges Associated with Approval of Anticancer Products to Facilitate the Regulatory Approvals: A Cross-sectional Study

Purpose: Oncological medications face a myriad of challenges, including technological, pre-clinical, clinical, and manufacturing, that lead to regulatory approval delays or failures. The present study aims to identify some challenges encountered by researchers or regulators during the development of novel cancer therapies. Methods: The present cross-sectional observational study used a mixed-method design methodology. The participants were selected via a non-random sampling method via self-selection and snowballing approach. A survey questionnaire was developed and circulated among the selected participants as a hard copy or email or a Google form. Open-ended and closed-ended questions were incorporated to identify the regulatory challenges faced during oncology drug development. The responses were collected from September 2021 to June 2022. These responses were then coded and themes were identified for the challenges. Results: A total of 87 responses were obtained for the questionnaire among the individuals contacted. Seven themes were identified from the collated responses that depicted the challenges for the regulatory approval of anticancer drug products. The majority of responders (38.2%) suggested reduced approval time whereas endpoint selection and study design were considered as a challenge by 12.0% of responders each. Furthermore, 6.0% of responders admit that timely interaction with the regulators is also a challenge that delays approval. Many challenges also exist during the product development phase; hence, 12.0% of responders reported safety issues, and 22.0% of responders reported technical issues during manufacturing as the cause of regulatory failure. Moreover, 12.0% of responders suggested the need for improvements in regulatory guidelines for oncology drug development. Conclusion: The survey indicates a lack of Indian guidelines for anticancer products, whereas limited guidance is available from other countries such as Europe or the United States. Thus, the survey points to the necessity for improvement in the regulatory guidelines and drug approval process to address the challenges unique to cancer drug development.

Management implications of latent TB among under-five children at risk: Insights from a community study in Mumbai, India.

Latent tuberculosis infection (LTBI) management is crucial to WHO's End TB Strategy. Indian guidelines recommend treating under-five children with household TB contacts after ruling out active TB, regardless of TBI testing. However, the precise LTBI burden among children in high TB burden settings like India is unknown. A community-based study in Mumbai's urban slums screened and managed under-five children at LTBI risk to understand its epidemiology and inform TB control interventions. Total 369 eligible under-five children were enrolled for the study. LTBI screening was done using Tuberculin skin test and Interferon gamma release assay. Active TB was ruled out before initiation of TB preventive therapy among LTBI positives. Statistical tests like chi-square, logistic regression analysis and Hosmer-Lemeshow test were used. Overall, LTBI prevalence among under-five children was 12.4% by IGRA and 21.4% by TST. Undernourished children had significantly lower LTBI positivity by IGRA (p = 0.027), while those with household contacts, longer contact duration and drug-resistant tuberculosis (DR-TB) exhibited proportionally greater IGRA positivity (p = <0.001). The study found a lower LTBI prevalence among under-five children compared to adults, with key risk factors being HHC, DR-TB contact, and prolonged exposure. These findings suggest the need to revise or revisit the TPT framework for this age group in India, particularly by implementing a test-and-treat approach.

Inconsistencies in the Indian Guidelines for the Prescription of Antibiotics for Critically Ill Patients.

Raj N, Nath SS, Singh V, Agarwal J. Inconsistencies in the Indian Guidelines for the Prescription of Antibiotics for Critically Ill Patients. Indian J Crit Care Med 2024;28(10):908-911.

Management of Hypertension in Patients with Type 2 Diabetes Mellitus: Indian Guideline 2024 by Association of Physicians of India and Indian College of Physicians.

In India and the Southeast Asian population, hypertension and type 2 diabetes mellitus (T2DM) are the leading lifestyle-related diseases, responsible for a majority burden of morbidity and mortality. Multiple population-spanning studies have revealed the staggering prevalence of both diseases in India, and the prevalence of both will only increase further due to factors such as an aging population, rapid urbanization, increased obesity, and sedentary lifestyles. More than 50 percent of hypertensive patients in India are also diagnosed with T2DM, and a detailed management protocol for the same is required, especially when a major portion of the disease is managed at the primary care level. The Association of Physicians of India (API) guidelines for the management of hypertension in patients with T2DM have been formulated based on consultation with leading physicians, cardiologists, diabetologists, and endocrinologists of India and Southeast Asia, keeping in mind the challenges faced by the patients in these countries and the appropriate management protocols that will be beneficial. While standard office-based blood pressure (BP) measurement forms the cornerstone of hypertension diagnosis and demands a uniform methodology to be followed, home blood pressure monitoring (HBPM) is recommended for long-term follow-up with validated devices. Ambulatory blood pressure monitoring (ABPM) offers comprehensive insights crucial for cardiovascular (CV) risk stratification. The complications of diabetic hypertension can span from increased CV risk, heart failure (HF), and renal dysfunction, and nonpharmacological and pharmacological management should be aimed toward not only control of the BP values but also protecting the end organs. While nonpharmacological measures include a focus on nutrition and diet, they also focus on approaches to weight loss, including a novel section covering the benefits of yoga. The guideline also focuses on a novel section of factors influencing CV risk, especially in the Indian population. For the pharmacological management, the guidelines address each of the categories of antihypertensive drugs, emphasizing the significance of combination therapies in the management of diabetic hypertension. In line with leading global guidelines for the management of hypertension in T2DM, for diabetic patients who often struggle with BP management and carry a high CV risk, the recommended dual combination antihypertensive therapy is particularly crucial and should be considered as first-line management therapy. While angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs) play a highly beneficial role in the management of diabetic hypertension, a combination of ACEi or ARB with dihydropyridine calcium channel blockers (DHP-CCBs) is recommended to reduce the risk of complications and enhance patient adherence. To achieve the target of effective BP control and end-organ protection, it is beneficial and recommended to include newer CCBs (e.g., cilnidipine) in the management protocol in combination with ACEi/ARBs. Combination therapy including ARBs and DHP-CCBs should be preferred over β-blockers and thiazides. Among the CCBs, cilnidipine, a novel molecule, is a more effective and safer option for diabetic hypertensive patients in India. β-blockers should be used if there is a history of myocardial infarction (MI), HF, coronary artery disease (CAD), or stable angina along with the initial hypertensive regimen. The guideline also focuses on the novel reno- and cardioprotective molecules such as finerenone and sodium-glucose cotransporter 2 inhibitors (SGLT2i) and their benefits in the management of diabetic hypertension.

Expert opinion on current issues and challenges in irritable bowel syndrome

Irritable bowel syndrome (IBS) is a widely prevalent functional gastrointestinal disorder characterized by symptoms such as abdominal pain, irregular bowel movements, and bloating, which significantly impact affected individuals' well-being. The increasing prevalence of IBS in India places a substantial burden on clinical practice. Although diagnostic criteria, such as the commonly used Rome IV criteria, have shown reasonable sensitivity, the diagnosis of IBS remains a nuanced and culturally influenced process. This comprehensive review systematically examines current challenges surrounding IBS prevalence, diagnostic intricacies, and the complex pathophysiology involving visceral hypersensitivity. The review highlights the imperative for noninvasive biomarkers to augment diagnostic precision and emphasizes on following a holistic approach to IBS management as advocated by Indian guidelines. This approach integrates dietary modifications, antispasmodic medications, psychological therapy, and yoga, with specific emphasis on tailoring treatments to individual IBS subtypes. Among antispasmodic drugs, pinaverium bromide because of its unique mechanism of action as a calcium channel antagonist within the gastrointestinal tract has shown promise in alleviating IBS symptoms.

Performance Evaluation of Self-Compacting Concrete Prepared Using Waste Foundry Sand on Engineering Properties and Life Cycle Assessment

The primary objective of this research is to utilize an industrial waste byproduct such as waste foundry sand (WFS) as an alternative for fine aggregate in self-compacting concrete (SCC). This research focuses on the use of WFS in SCC to enhance durability and mechanical properties, to find an alternative for fine aggregate in SCC, to reduce the disposal challenges of WFS, and to make SCC lightweight and environmentally friendly. Initially, WFS was treated with chemical (H2SO4), segregating, and sieving to remove the foreign matter and clay content. For this study, WFS is considered in varying percentages such as 0, 10, 20, 30, 40, and 50. For this investigation, M60 grade SCC is considered as per Indian standards and EFNARC guidelines. After that, this research focuses on tests on various fresh properties of SCC in each batch to find the flowability and passing ability of various mixes prepared using WFS. Similarly, the mechanical properties of SCC such as compressive, flexural, and split tensile strength tests were performed at 7, 28, and 90 days curing periods, respectively. Likewise, durability properties of SCC were found in all the mixes prepared using WFS such as water absorption, sorptivity, resistance to chemical attack, and chloride ion penetration; tests of these properties were performed at 28 and 90 days curing periods, respectively. Based on the experimental investigation of SCC, it was found that WFS can be used in M60 grade SCC as an alternative for fine aggregate up to 30% without compromising much on its properties. Finally, this establishes that using treated WFS in SCC helps in reducing the generation of waste and prevails as a meaningful utilization method. This research will also establish that the use of treated WFS will reduce the density and make SCC a lightweight, green, and sustainable material.

Treatment of Acute Pancreatitis – A Review of the Indian Literature

Acute pancreatitis is an inflammatory condition with a diverse range of presentations, spanning from self-limiting cases to rapidly progressive inflammatory responses involving local complications, multiorgan failure, and mortality. Despite the presence of international guidelines for managing acute pancreatitis, there is a lack of standardized Indian guidelines. This article reviews Indian publications focused on the treatment of acute pancreatitis.

Systematic identification and quality appraisal of guidelines developed for the pediatric population in India

BackgroundWell-developed clinical practice guidelines are the cornerstone of evidence-based healthcare practice and policy. ObjectiveThis study was undertaken to systematically identify clinical practice guidelines developed in India for the pediatric age group, and appraise their methodological quality. MethodsWe conducted a systematic review to identify all Indian guidelines designed for implementation in the pediatric age group. We searched databases of published literature, and websites of national agencies, and used a step-wise approach to screen titles, abstracts and full-texts of eligible publications. We appraised the methodological quality of the included guidelines using the standard AGREE II (Appraisal of Guidelines Research and Evaluation) checklist, scoring each guideline across six domains. ResultsThe literature search identified 10,959 citations. Step-wise screening resulted in the inclusion of 138 Indian guideline documents, pertaining to pediatric care. The overall AGREE II score of the included guidelines ranged from 12 to 72.5%, the median (IQR) being 30% (24.6, 37). Only 2 (1.4%) guidelines scored above 60%. There was wide variation in the scores across quality appraisal domains. The domain-wise median (IQR) scores were as follows. Scope and purpose: 50% (43, 66.7), Stakeholder involvement: 44.5% (39, 50), Rigor of development: 12.5% (8, 23.4), Clarity of presentation: 50% (39, 61), Applicability: 0% (0, 12.5), and Editorial independence: 66.7% (0, 67). Although guidelines published during 2011–2020 had higher quality scores (compared to previous decades), there was no significant further improvement from 2021 onwards. ConclusionThis study identified overall low methodological quality of Indian pediatric guidelines, and suggests urgent need for improvement.

Pharmacognostic, Physicochemical, Phytochemical and Chromatographic Characterization of Vaividanga Choornam, A Siddha Polyherbal Formulation

Standardization of herbal formulations as determined by the concentration of their activecomponents is essential to appraise the quality of drugs. The current study intends to investigate the phytochemical and physicochemical analyses of Vaividanga Choornam, a traditional Siddha polyherbal composition. This Vaividanga choornam contains the ingredients like Vaividangam (Embelica ribesBurm.), Milagu (Piper nigrumL.), Chukku (Zingiber officinale Rosc.), Omam (Trachyspermum ammi (L) Sprague), and Nilavaagai leaves (Cassia angustifolia Vahl. - syn. Cassia senna). It treatspitha diseases, constipation, indigestion, flatulence, burning sensation, bronchial asthma, and Kapha diseases. It is also an effective medicine for treating intestinal helminths caused by heavy worm burdens in young children. This study aims to estimate the quality of Vaividanga Choornam by performing pharmacognostic studies, preliminary phytochemical analysis, physiochemical parameters like ash value, extractive value, and loss on drying as per pharmacopoeial laboratory for Indian medicine guidelines, and also with the help of tests done with High-Performance Thin Layer Chromatography (HPTLC), FTIR Spectroscopy, and UV -Vis spectrometric analyses. The results obtained fromthose analyses showed the presence of various phytochemicals. The results indicate that the drug is of adequate quality and may be used to establish pharmacopeial standards of the medicine.

Localized Rectal Cancer: Indian Consensus and Guidelines

AbstractThe rising incidence of colorectal cancer (CRC) in India, particularly the prevalence of rectal cancer over colon cancer (0.7:1), has been a growing concern in recent decades; especially notable is the trend of increasing cases among young CRC patients. Given the diverse treatment approaches for rectal cancer globally and the varying economic capacities of patients in low to middle-income countries (LMICs) like India, it is essential to establish consensus guidelines that are specifically tailored to meet the needs of these patients. To achieve this, a panel comprising 30 eminent rectal cancer experts convened to conduct a comprehensive and impartial evaluation of existing practices and recent advancements in the field. Through meticulous scrutiny of published literature and a consensus-building process that involved voting on pertinent questions, the panel formulated management strategies. These recommendations are the result of a rigorous, evidence-based process and encapsulate the collective wisdom and judgment of leading authorities in the field.

Indian clinical practice consensus guidelines for the management of laryngeal cancer: Update 2022

In laryngeal cancer, the goal of treatment is to achieve maximum cure and preserve function of the larynx with good voice quality. In early disease, transoral laser microsurgery is the preferred choice of treatment. An option for treatment of carcinoma in situ is radiotherapy (RT). In locally advanced laryngeal carcinoma, concurrent chemoradiotherapy (CTRT) is an option. Induction therapy with docetaxel, cisplatin, and 5-flourouracil (TPF), followed by definitive RT or definitive CTRT can be one of the organ preservation approaches for patients undergoing total laryngectomy. For resectable locally advanced disease (T3, N0-3), surgery (laryngectomy with thyroidectomy, ipsilateral or bilateral neck dissection, and pretracheal and ipsilateral paratracheal lymph node dissection) with RT or CTRT should be considered.

Indian clinical practice pre-treatment imaging guidelines for head-and-neck cancers

Site-specific imaging for head-and-neck cancers is essential to convey the relevant information on the radiological tumor stage accurately to the surgeons/treating physicians, thus helping them to decide upon the management. Additionally, the role of imaging cannot be overemphasized for neck screening for nodes and metastasis. Certain crucial structures at each head-and-neck site elude direct visualization on clinical examination; hence, it is pertinent to be aware of these structures, the involvement of which, on imaging, can change the management plan from curative to palliative intent. Though international guidelines exist, there have been no dedicated imaging guidelines for head-and-neck cancers in India. We propose site-specific pre-treatment imaging guidelines for various head-and-neck cancers and neck nodes, including the choice of imaging modalities for each site, protocols, and management implications of crucial structure involvement at each site. By proposing these recommendations, we intend to standardize head-and-neck imaging throughout the country.

Introduction to Indian clinical practice consensus guidelines for the management of squamous cell carcinoma the head-and-neck: Update 2022

Head-and-neck cancer (HNC), a malignant tumor of the upper aerodigestive tract, is the sixth most common cancer worldwide. In India, around 30-40% of all cancers are HNCs. Even though there are global guidelines and recommendations for the management of HNCs, these may not be appropriate for the Indian scenario. In order to discuss current practices, and latest developments, and to come to a consensus on management strategies for different anatomical subsites of HNCs for Indian patients, a group of experts (medical, surgical, and radiation oncologists, and dentists) came together. A review of literature from medical databases (PubMed, Google Scholar) was conducted to provide the best possible evidence, which was reviewed by experts in 2019 when the first consensus guidelines were developed. These guidelines were published in the Indian Journal of Cancer in February 2020. To update these guidelines regularly, the experts reconvened on July 27, 2022, and updated the recommendations for all subsites based on the recent evidence.

Indian Thyroid Cancer Guidelines: Addressing Challenges and Optimizing Care

Indian Thyroid Cancer Guidelines: Addressing Challenges and Optimizing Care

Indian clinical practice consensus guidelines for the management of oral cavity cancer: Update 2022

The treatment of oral cavity cancer primarily depends on the location, tumor size, and feasibility of organ preservation in patients with negative margins. A liquid biopsy is a minimally invasive approach for detecting blood-based signatures such as circulating tumor cells (CTCs) and circulatory tumor DNA (ctDNA). To assess the presence of occult metastatic disease, sentinel lymph node biopsy (SLNB) is recommended in early-stage oral cavity cancer (OCC). In India, surgery is the preferred choice of treatment for oral cancers. Selected patients, who are medically inoperable or refuse surgery, should be given definitive radiotherapy (RT) as an alternative to surgery. Concurrent chemoradiation (CCRT) may be considered an alternative option to definitive RT in patients with unresectable oral cancer.

Indian clinical practice consensus guidelines for the management of very advanced head-and-neck squamous cell carcinoma: Update 2022

The management of recurrent or metastatic head-and-neck cancers is evolving. Promising novel immunotherapies and targeted therapies have led to a paradigm shift in the management of very advanced disease. Single-agent systemic therapy including cisplatin/carboplatin/paclitaxel/docetaxel/5-florouracil/methotrexate/cetuximab/gemcitabine/capecitabine or combination chemotherapy may be considered. Immunotherapy alone or in combination with chemotherapy has improved survival and should be considered. Oral metronomic chemotherapy with or without immunotherapy also improves oncologic outcomes. The challenges associated with the disease may be resolved by using an integrated approach of combining locoregional and systemic therapies. Salvage treatments like re-radiation or surgery are useful for the management of locoregional recurrences.

Indian clinical practice consensus guidelines for the management of oropharyngeal cancer: Update 2022

The aim of oropharyngeal cancer treatment should be to treat the disease while preserving speech and swallowing abilities. Early-stage disease is generally treated with surgery/radiotherapy (RT). A combination of chemotherapy and RT should be considered instead of RT alone for patients with locally advanced disease. Patients with locally advanced resectable disease can be treated with transoral or open resection of the primary + ipsilateral/bilateral neck dissection ± adjuvant chemoradiotherapy (CTRT)/adjuvant RT. In unresectable locally advanced disease, sequential induction chemotherapy (TPF [docetaxel, cisplatin, fluorouracil]) followed by locoregional treatment with RT or CTRT can be considered. Adding targeted therapies like nimotuzumab to cisplatin-based CTRT in locally advanced head-and-neck squamous cell carcinoma improves the progression-free survival, locoregional control, and disease-free survival without negatively impacting the quality of life.

Indian clinical practice consensus guidelines for the management of hypopharyngeal cancer: Update 2022

In early hypopharyngeal cancer, definitive radiotherapy (RT) is the preferred modality of treatment. The surgical treatment options are transoral laser microsurgery with selective neck dissection or a partial laryngopharyngectomy plus neck dissection. In locally advanced disease, concurrent chemoradiotherapy (CTRT) is the treatment of choice. Neoadjuvant chemotherapy (NACT) is also a recommended treatment option followed by radical RT/CTRT or surgery followed by adjuvant RT/CTRT, depending on the response. Some patients with locally advanced disease may require total or near total laryngectomy/total or partial pharyngectomy with appropriate neck dissection. Adding targeted therapies like nimotuzumab to cisplatin-based CTRT in locally advanced head-and-neck squamous cell carcinoma improves progression-free survival, locoregional control, and disease-free survival without negatively impacting the quality of life.

Chapter 1: Introduction to Indian Thyroid Cancer Guidelines

Chapter 1: Introduction to Indian Thyroid Cancer Guidelines

Indian clinical practice consensus guidelines for the management of nasopharyngeal cancer: Update 2022

Patients with early-stage nasopharyngeal cancer are treated with definitive radiotherapy alone, including both sides of the neck and retropharyngeal nodes. For patients with locoregionally advanced nasopharyngeal cancer, the recommendation is concurrent chemoradiotherapy with additional chemotherapy (either before or after chemoradiotherapy). Adding targeted therapies like nimotuzumab to concurrent chemoradiation in the management of nasopharyngeal cancer has been shown to improve overall survival with excellent safety and tolerability.