Clinical and Demographic Characteristics of Patients with Coexistent Hypertension, Type 2 Diabetes Mellitus, and Dyslipidemia: A Retrospective Study from India.

BACKGROUND: Coexisting hypertension, type 2 diabetes mellitus (T2DM), and dyslipidemia (triple disease) can lead to greater risk of cardiovascular morbidity and mortality. The present study sought to comprehend the prevalence, demographic traits, clinical traits, and treatment patterns in Indian patients with these coexisting conditions. METHODS: An electronic medical record (EMR)-based, retrospective, multicenter, cross-sectional study was conducted, and data were collected for patients who were diagnosed with coexistent hypertension, T2DM, and dyslipidemia. Baseline patient variables evaluated were the percentage of patients with triple comorbidity, demographic characteristics, diagnostic laboratory parameters, and treatment pattern details. RESULTS: Data from 4793 centers (clinics) were included, with a total of 6,722,173 patients. Of these, 427,835 (6.36%) patients were found to have coexistent hypertension, T2DM, and dyslipidemia. Most of the patients belonged to the 40-64 year age group (62.10%) and were males (57.00%), while 27.40% patients had a body mass index (BMI) within normal limits, 43.30% patients were pre-obese, and 20.90% patients were class 1 obese. Further, 3402 patients (0.80%) had a recorded history of smoking. Mean glycated hemoglobin (HbA1c) for the patients included in the study was 8.35 ± 1.96 g%. Mean systolic blood pressure (SBP) was 138.81 ± 19.59 mm Hg, while mean diastolic blood pressure (DBP) was 82.17 ± 10.35 mm Hg; 27.60% cases had SBP < 130 mm Hg, while 28.37% cases had DBP < 80 mm Hg. The mean low-density lipoprotein (LDL), total cholesterol, and high-density lipoprotein (HDL) in mg/dl were 98.38 ± 40.39, 174.75 ± 46.73, and 44.5 ± 10.05, respectively. Of the enrolled cases, 55.64% had serum LDL below 100 mg/dl, 72.03% cases had serum cholesterol below 200 mg/dl, and 44.15% males and 71.77% females had serum HDL below the normal prescribed range. The most common monotherapy used for managing hypertension was angiotensin receptor blockers (ARB) (24.80%), followed by beta-blockers (24.30%). The most common combinations administered for management of hypertension were antihypertensives with diuretics (14.30%), followed by ARB plus calcium channel blockers (CCB) (13.30%). For dyslipidemia, the majority of patients (56.60%) received lipid-lowering medication in combination with drugs for other comorbidities. The most common antidiabetic agents prescribed were biguanides (74.60%). CONCLUSIONS: Coexistence of triple disease is not uncommon in the Indian population, with middle-aged patients diagnosed as pre-obese and obese being affected more commonly and receiving treatment for the same. The present study highlights that, though there are medications against the three chronic conditions, the rate of uncontrolled cases of hypertension, T2DM, and dyslipidemia remains high. Coexistence of triple disease increases the risk of cardiovascular and renal complications, which need to be closely monitored and effectively treated.

Time to reposition sulfonylureas in type 2 diabetes management in Indian context: A pragmatic practical approach.

Sulfonylureas (SU) continue to be a vital therapeutic category of oral hypoglycemic agents (OHAs) for the management of type 2 diabetes mellitus (T2DM). Physicians consider modern SU (gliclazide and glimepiride) as "safe and smart" choices for T2DM management. The presence of multiple international guidelines and scarcity of a national guideline may contribute to the challenges faced by few physicians in choosing the right therapeutic strategy. The role of SU in diabetes management is explicit, and the present consensus aims to emphasize the benefits and reposition SU in India. This pragmatic, practical approach aims to define expert recommendations for the physicians to improve caregivers' knowledge of the management of T2DM, leading to superior patient outcomes.

Evolution of Guideline Recommendations on Insulin Therapy in Type 2 Diabetes Mellitus Over the Last Two Decades: A Narrative Review.

The prevalence of type 2 diabetes mellitus has been increasing worldwide. As the therapeutic options for type 2 diabetes mellitus have evolved over the last 2 decades, national and global guidelines related to type 2 diabetes mellitus pharmacotherapy issued by various organizations have tended to vary in their recommendations. This narrative review aimed to analyze the key recommendations by major global and national guidelines on the initiation of insulin therapy in patients with type 2 diabetes mellitus over the last 20 years. Strategies for insulin therapy for titration and intensification were also assessed. All guidelines recommend initiation of insulin (basal/ premixed/other formulations) when glycemic targets are not achieved despite lifestyle measures and oral antidiabetic drugs. In the recent decade, early initiation of insulin has been recommended when the glycated hemoglobin levels are >10% or blood glucose levels are ≥300 mg/dL (16.7 mmol/L). Initiation is recommended at a dose of 10 units or 0.1-0.2 U/kg. Titration is advised to achieve the optimal dosage, while intensification is recommended when glycemic targets are not achieved despite titrating to an acceptable level. Glucose monitoring at periodic intervals is recommended for adequate glycemic control. The guidelines further suggest that the choice of insulin should be individualized, considering the clinical status of patients with type 2 diabetes mellitus. The physicians as well as patients should be a part of the decisions made regarding the therapeutic choice of regimen, preparation, and delivery device.

Clinical Utility of a Digital Therapeutic Intervention in Indian Patients With Type 2 Diabetes Mellitus: 12-Week Prospective Single-Arm Intervention Study.

BACKGROUND: Patients with type 2 diabetes mellitus (T2DM) having elevated levels of blood glucose and glycated hemoglobin (HbA1c) are at higher risk of macro- and microvascular complications. Nonetheless, the goal of achieving glycemic control cannot be met with the use of pharmacotherapy alone. The recent emergence of digital therapeutic tools has shown the possibility of improving the modifiable risk factors and self-management of diabetes. OBJECTIVE: The aim of this study was to examine the clinical utility of a digital therapeutic intervention as an add-on therapy to achieve glycemic control in patients with T2DM. METHODS: This was a 12-week prospective, single-arm digital intervention study in patients with T2DM receiving regular antidiabetic treatment. The eligibility criteria included male and female patients with HbA1c≥6.5%, functional English literacy, and a mobile phone capable of running the intervention app. Outcome measures of the study were mean changes in HbA1c, fasting blood glucose (FBG), postprandial blood glucose (PPBG), BMI, and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index at the end of 12 weeks. RESULTS: A total of 128 participants completed the study period of 12 weeks. There were 54.7% (70/128) men and 45.3% (58/128) women with a mean age of 48.48 years (SD 10.27). At the end of 12 weeks, the mean change in HbA1c, FBG, PPBG, and BMI for the overall study population was -0.84% (P<.001), -8.39 mg/dl (P=.02), -14.97 mg/dl (P<.001), and -0.24 kg/m2 (P=.06), respectively. Among the participants showing improvement in the HbA1c value at the end of 12 weeks (responders), the mean change in HbA1c, FBG, PPBG, and BMI was -1.24% (P<.001), -12.42 mg/dl (P=.003), -21.45 mg/dl (P<.001), and -0.34 kg/m2 (P=.007), respectively. There was an increase in HOMA-IR values for the overall study population (0.54, P=.29). HbA1c response showed a significant association with a baseline HbA1c level ≥7.5%, no prior history of smoking, and no prior COVID-19 infection, as well as with higher levels of program engagement. CONCLUSIONS: A digital therapeutic intervention when used alongside standard medications significantly reduces HbA1c, FBG, and PPBG levels in patients with T2DM.

The impact of peer coach-led type 2 diabetes mellitus interventions on glycaemic control and self-management outcomes: A systematic review and meta-analysis.

Type 2 diabetes mellitus (T2DM) is a major health risk and dominant cause of global mortality and morbidity. Disease-specific support from peers with similar chronic condition has shown to improve chronic disease self-management outcomes. The purpose of this systematic review is to summarise the existing evidence on the impact of peer coach-led type 2 diabetes mellitus self-management interventions on glycaemic control and self-management outcomes. Databases including MEDLINE, PubMed, CINAHL Plus, Scopus, ProQuest Central, ScienceDirect, web of science, Wiley Online Library and UOW Library were searched for eligible papers. Thirteen randomised controlled trials (RCTs) published between 2008 and 2021 were included in this review. Random-effects meta-analyses found that there were statistically significant changes in Haemoglobin A1c HbA1c) after the interventions. However, the meta-analyses showed no significant changes in LDL (low-density lipoprotein), BMI (Body mass index), systolic BP (Blood Pressure), and HRQoL (Health-related quality of life) among intervention and control groups after the intervention. The identified studies mainly recruited patients with suboptimal glucose levels; majority of them belonging to low-income population. Our findings showed that peer coaching was helpful in improving HbA1c levels, quality of life, self-efficacy, diabetes distress and patient activation. Moreover, peer coaching associations with medication adherence, hypoglycaemic symptoms, diabetes specific social support and depression were inconclusive. This review concludes that peer-led community-based interventions with longer follow up, using a mixed method of delivery among patients with suboptimal levels of HbA1c were more efficient compared to usual care for improving T2DM self-management.

Prescribing Patterns and Response to Antihyperglycemic Agents Among Novel Clusters of Type 2 Diabetes in Asian Indians.

Aim: To assess the prescribing patterns and response to different classes of antihyperglycemic agents in novel clusters of type 2 diabetes (T2D) described in India. Materials and Methods: We attempted to replicate the earlier described clusters of T2D, in 32,867 individuals with new-onset T2D (within 2 years of diagnosis) registered between October 2013 and December 2020 at 15 diabetes clinics located across India, by means of k-means clustering utilizing 6 clinically relevant variables. Individuals who had follow-up glycated hemoglobin (HbA1c) up to 2 years were included for the drug response analysis (n = 13,247). Results: Among the 32,867 participants included in the study, 20,779 (63.2%) were males. The average age at diagnosis was 45 years and mean HbA1c at baseline was 8.9%. The same four clusters described in India earlier were replicated. Forty percent of the study participants belonged to the mild age-related diabetes cluster, followed by insulin-resistant obese diabetes (27%), severe insulin-deficient diabetes (21%), and combined insulin-resistant and insulin-deficient diabetes (12%) clusters. The most frequently used antihyperglycemic agents were sulfonylureas, metformin, and dipeptidyl peptidase-4 inhibitors apart from insulin. While there were significant differences in HbA1c reduction between drugs across clusters, these were largely driven by differences in the baseline (pretreatment) HbA1c. Conclusions: In this new cohort, we were able to reliably replicate the four subtypes of T2D earlier described in Asian Indians. Prescribing patterns show limited usage of newer antihyperglycemic agents across all clusters. Randomized clinical trials are required to establish differential drug responses between clusters.

QTc prolongation Safety and Effectiveness of Teneligliptin in Indian patients with type 2 Diabetes Mellitus: A real world study (QSET 2).

AIMS: To evaluate the safety with respect to QTc prolongation and effectiveness of Teneligliptin in Indian Type 2 Diabetes Mellitus (T2DM) patients. METHODS: Retrospective data of T2DM patients on teneligliptin 20 mg or 40 mg once daily as a monotherapy or add-on therapy and having ECG records (before and after teneligliptin initiation) was collected. Safety was evaluated by change in QTc interval and effectiveness was evaluated by changes in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and haemoglobin A1C (HbA1c) from baseline to 12-weeks. RESULTS: There was no significant change in mean QTc interval from baseline [418.68 milli seconds (ms) to 419 ms; mean change +0.33 ms; P = 0.1023] to follow up visit (mean duration 91 days). There was a significant reduction from baseline to 12 weeks in FPG [173.1 mg/dl (9.61 mmol/L) to 128.4 mg/dl (7.12 mmol/L), mean change - 44.64 mg/dl (2.47 mmol/L), P ≤ 0.001], PPG [242.5 mg/dl (13.46 mmol/L) to 176.5 mg/dl (9.79 mmol/L), mean change - 65.93 mg/dl (3.66 mmol/L), P ≤ 0.001], and HbA1c [8.2% (66 mmol/mol) to 7.2% (55 mmol/mol), mean change - 1.00% (10.9 mmol/mol), P ≤ 0.001]. CONCLUSION: Teneligliptin did not cause QTc interval prolongation and was significantly effective in improving glycemic control.

Expert Group Recommendations on the Effective Use of Bolus Insulin in the Management of Type 2 Diabetes Mellitus.

Evidence suggests a major contribution of postprandial glucose (PPG) excursions to the increased risk of micro- and macro-vascular complications in individuals with type 2 diabetes mellitus (T2DM). Administration of bolus insulin remains a very effective therapeutic option for PPG control. The aim of this expert group recommendation document was to provide practical and easy-to-execute guidelines for physicians on the appropriate use of bolus insulin in the management of T2DM. A panel of key opinion leaders from India reviewed and discussed the available clinical evidence and guideline recommendations on the following topics: (1) optimum control of PPG; (2) choice of bolus insulin; and (3) special situations and practical considerations. The expert panel critically analyzed the current literature and clinical practice guidelines and factored their rich clinical experience to develop a set of nine expert group recommendations for the effective use of bolus insulin. These recommendations will not only result in a more evidence-based application of bolus insulin in the clinical setting but also trigger further research and provide a valuable base for the development of future guidelines on the use of bolus insulin in the management of individuals with T2DM.

Evaluating Glycemic Control in Patients of South Asian Origin With Type 2 Diabetes Using a Digital Therapeutic Platform: Analysis of Real-World Data.

BACKGROUND: Digital therapeutics are evidence-based therapeutic interventions driven by high-quality software programs for the treatment, prevention, or management of a medical disorder or disease. Many studies in the western population have shown the effectiveness of mobile app-based digital therapeutics for improving glycemic control in patients with type 2 diabetes (T2D). However, few studies have assessed similar outcomes in the South Asian population. OBJECTIVE: This study aims to investigate the real-world effectiveness of the Wellthy CARE digital therapeutic for improving glycemic control among the South Asian population of Indian origin. METHODS: We analyzed deidentified data from 102 patients with T2D from India enrolled in a 16-week structured self-management program delivered using the Wellthy CARE mobile app. Patients recorded their meals, weight, physical activity, and blood sugar in the app, and they received lessons on self-care behaviors (healthy eating, being active, monitoring, medication adherence, problem solving, healthy coping, and reducing risks); feedback provided by an artificial intelligence-powered chatbot; and periodic interactions with certified diabetes educators via voice calls and chats. The primary outcome of the program was a change in glycated hemoglobin A1c (HbA1c). Secondary outcomes included the difference between preintervention and postintervention fasting blood glucose (FBG) and postprandial blood glucose (PPBG) levels; changes in BMI and weight at the completion of 16 weeks; and the association between program engagement and the changes in HbA1c, FBG, and PPBG levels. RESULTS: At the end of 16 weeks, the average change in HbA1c was -0.49% (n=102; 95% CI -0.73 to 0.25; P<.001). Of all the patients, 63.7% (65/102) had improved HbA1c levels, with a mean change of -1.16% (n=65; 95% CI -1.40 to -0.92; P<.001). The mean preintervention and postintervention FBG levels were 145 mg/dL (n=51; 95% CI 135-155) and 134 mg/dL (n=51; 95% CI 122-146; P=.02) and PPBG levels were 188 mg/dL (n=51; 95% CI 172-203) and 166 mg/dL (n=51; 95% CI 153-180; P=.03), respectively. The mean changes in BMI and weight were -0.47 kg/m2 (n=59; 95% CI -0.22 to -0.71; P<.001) and -1.32 kg (n=59; 95% CI -0.63 to -2.01; P<.001), respectively. There was a stepwise decrease in HbA1c, FBG, and PPBG levels as the program engagement increased. Patients in the highest tertile of program engagement had a significantly higher reduction in HbA1c (-0.84% vs -0.06%; P=.02), FBG (-21.4 mg/dL vs -0.18 mg/dL; P=.02), and PPBG levels (-22.03 mg/dL vs 2.35 mg/dL; P=.002) than those in the lowest tertile. CONCLUSIONS: The use of the Wellthy CARE digital therapeutic for patients with T2D showed a significant reduction in the levels of HbA1c, FBG, and PPBG after 16 weeks. A higher level of participation showed improved glycemic control, suggesting the potential of the Wellthy CARE platform for better management of the disease.

Relationship between diabetic retinopathy microalbuminuria and other modifiable risk factors.

BACKGROUND: Diabetic Retinopathy (DR) is an important microvascular complication of diabetes that can lead to irreversible blindness. Microalbuminuria is strongly associated with diabetic retinopathy and can be used as a reliable marker of diabetic retinopathy. AIM: To assess the association between DR, microalbuminuria, and other modifiable risk factors in patients with type 2 diabetes. METHODOLOGY: 3090 patients with T2DM visiting North Delhi Diabetes Centre, New Delhi between July 2016 to October 2019 were evaluated for the clinical and biochemical parameters that included urinary albumin, HbA1C, lipid profiles, serum creatinine estimation and underwent biothesiometry. RESULTS: 3090 patients (1350 females and 1740 males), with mean age of 52.7 ± 9.2 years and diabetes duration ranging from 1 to 19 years (mean 9.4 ± 6), duration of less than 5 years, 6-10 years and more than 10 years in 52%, 26% and in 22%, respectively. Duration of diabetes was strong predictor of retinopathy (p = 0.001). The HbA1c and BMI in patients with DR was significantly higher than in those without DR. 18.2% patients were diagnosed to have retinopathy. Peripheral neuropathy was observed in 24.2% and was positively associated with DR (p = 0.002). 33.9% and 4.5% patients had microalbuminuria macroalbuminuria, respectively and 9.7% patients had creatinine >1.3 mg/dL. There was significant positive relationship between different grades of retinopathy and albuminuria. CONCLUSIONS: Our study is a large real-world study that demonstrates that HbA1c, BMI, duration of diabetes, microalbuminuria and peripheral neuropathy are relatively, yet cohesively contributing factors towards varying grade of retinopathy.

Optimizing the treatment of newly diagnosed type 2 diabetes mellitus with combination of dipeptidyl peptidase-4 inhibitors and metformin: An expert opinion.

The expanding burden of Type 2 Diabetes Mellitus (T2DM) in today's world, with respect to incidence, prevalence, and cost incurred, is an existential risk to society. Various guidelines recommend individualization of treatment. This expert opinion aims to review the recent evidences and reach a consensus on the preferable combination therapy for use in newly diagnosed Indian T2DM patients with HbA1C >7.5%. The core committee included seventeen diabetes specialists. Three statements were developed, discussed, and rated by specialists and recommendations were noted. Specialists were requested to rate the statements using a 9-point Likert's scale with score of 1 being "Strongly Disagree" and 9 being "Strongly Agree". Statement-specific scores of all the specialists were added and mean score of ≥7.00 was considered to have achieved a consensus. Statements used to meet the consensus were: Statement 1. Majority of newly-diagnosed Indian diabetics have HbA1C >7.5%; Statement 2. Patients with HbA1C >7.5% may be initiated with dual therapy of dipeptidyl peptidase-4 inhibitors (DPP4Is) + Metformin; and Statement 3. In Indian patients with HbA1C >7.5% at diagnosis, DPP4Is + Metformin may be considered as a first-line therapy. Literature review revealed that HbA1C level at the time of diagnosis in majority of Indian T2DM patients is >7.5%. Consensus was reached that dual anti-diabetic therapy should be initiated in patients with HbA1C >7.5%. DPP4Is + Metformin is the preferred cost-effective option and may be considered as a first-line therapy in Indian T2DM patients with HbA1C >7.5% at diagnosis.

In the Spotlight: Role of Gla-100 in the Glycemic Management of Hospitalized people with diabetes.

Both hyperglycemia and hypoglycemia in hospitalized patients represent a major concern as they are associated with adverse outcomes-including increased rates of infection, longer hospital stay, and even death. Insulin therapy is the mainstay in the management of inpatient hyperglycemia. The traditional approach of sliding scale insulin (SSI) therapy for the temporary management of blood glucose levels in hospitalized patients, has now given way to basal-bolus insulin (BBI) therapy. This is owing to the BBI affording a better glycemic control in non-critical hospital settings as observed in multiple clinical studies using insulin glargine 100 U/mL (Gla-100) as the basal component. Furthermore, a string of clinical studies has also attested to Gla-100 being used effectively even in patients on corticosteroids, enteral or parenteral nutrition, and in perioperative settings. Hence, overall, the existing evidence would point to the growing role of BBI regimens centering around basal insulin like Gla-100 as an effective option with low safety concerns for insulin therapy in both hospitalized and out-patient settings in the treatment of patients with type 2 diabetes mellitus (T2DM).

Diagnosis and principles of management of gestational diabetes mellitus in the prevailing COVID-19 pandemic.

BACKGROUND: Limited medical facilities are available due to Covid-19 pandemic. Nevertheless, all efforts should be made in planning judicial and possible methods of delivering health care, particularly to pregnant woman with GDM. GDM may play a crucial role in the increasing prevalence of diabetes and obesity and also may be the origin of cardiometabolic diseases. METHODS: It is mandatary to diagnose and care pregnant woman with GDM. The test suggested to diagnose GDM has to be evidence based and in this regard "a single test procedure" evaluated meets this requirement. This doable test has been accepted by the Diabetes in Pregnancy Study Group India (DIPSI) and approved by MHFW-GOI, WHO, International Diabetes Federation, and International Federation of Obstetricians and Gynecologists. MHFW-GOI also recommends testing at first antenatal visit and then at 24-28 weeks of gestation. This opportunity can also be utilized for performing ultrasonography for assessing fetal development. RESULT: The first-line management is MNT and life style modifications. Non-responders may require insulin or OHA. The target glycemic control is FPG ~ 5.0 mmol/dl (90 mg/dl) and 2 h PPPG ~ 6.7 mmol/dl (120 mg/dl). The goal is to obtain newborns birth weight appropriate for gestational age between 2.5 and 3.5 kg, a step to prevent offspring developing diabetes. CONCLUSION: The essential precaution required during COVID pandemic is to wear face mask, avoid crowded places, and maintain social distancing. Finally, the economical and evidence based "single test procedure" of DIPSI is most appropriate for screening during the COVID pandemic.

Management of periodontal disease in patients with diabetes- good clinical practice guidelines: A joint statement by Indian Society of Periodontology and Research Society for the Study of Diabetes in India.

There is a huge body of literature suggesting an association and a bidirectional relationship between periodontal disease and diabetes. Diabetes and periodontal diseases are both chronic diseases with a high prevalence. Dentists/periodontists, in their daily clinical practice, very often attend to diabetes patients with diverse oral health conditions and cater to their dental treatment needs. Safe and effective periodontal therapy in this population requires a broad understanding of diabetes, medical management of diabetes, and essential modifications to dental/periodontal therapy that may be required. This paper describes a joint statement put forth by the Indian Society of Periodontology and the Research Society for the Study of Diabetes in India aiming to provide expert consensus and evidence-based guidelines for optimal clinical management of periodontal conditions in diabetes patients or patients at risk for diabetes. Although this paper is not envisioned to be a comprehensive review of this topic, it intends to provide the guidelines for dental professionals and periodontists.

Medical Management of Diabesity.

The intricate relationship between obesity and T2DM is well recognised, as evidenced by the coining of the term 'diabesity' by Dr Ethan Sims that encompasses the two.Most patients with type 2 diabetes are obese and the global rise in obesity largely explains the epidemic rise in incidence and prevalence of type 2 diabetes(T2DM) over the last few decades. Obesity has been linked to insulin resistance and predisposes to metabolic abnormalities including prediabetes, type diabetes and the metabolic syndrome.Weight reduction is an essential component to prevent progression from prediabetes to T2DM in obese individuals and also forms an essential component of all T2DM management strategies in association with other lifestyle modifications, diet and pharmacotherapy. Obesity management today is a high priority preventive as well as treatment intervention for diabetes and various chronic diseases. Achieving effective weight loss and sustaining it is a huge practical challenge for all obese individuals, more so for the obese type 2 diabetic individuals who many times are prescribed various antihyperglycemic therapies that may be associated with weight gain. This chapter focusses on current treatment strategies for patients with coexisting obesity and T2DM and the role of different anti-obesity agents in the medical management of diabesity.

Clinical Benefits of Fixed Dose Combinations Translated to Improved Patient Compliance.

Pharmacotherapy with fixed dose combination (FDC) drugs is becoming popular as evidence-based clinical guidelines recommend using multiple therapeutic agents in complex regimens for many chronic diseases including type 2 diabetes mellitus (T2DM). FDC formulations have unique advantages such as complementary mechanism of action, synergistic effects, better tolerability, elongated product life-cycle management, and cost savings. Polypharmacy is a frequent problem in T2DM patients having hypertension, dyslipidemia, and other comorbidities. Use of FDCs is a rational approach for achieving optimal therapeutic benefits while minimizing pill-burden. Greater convenience with decreased pill-burden leads to improved adherence, resulting in superior clinical outcomes and greater cost-effectiveness. However, the general guidance for the clinical development and approval of FDC drugs in India is not much standardized. For rationale approval, the central and state regulators must harmonize their procedures for licensing FDCs. Because regulatory approval of FDCs is based on bioavailability data, similar to the way generic medications are approved, the lack of prospective, randomized controlled trials directly comparing FDCs with their component drugs administered as separate pills should not be considered a limitation to their use. Nevertheless, all new and existing FDC products should be subjected to submission of longterm safety surveillance through closely monitored national level postmarketing studies.