Diabetes mellitus is a chronic metabolic disorder characterized by persistent hyperglycemia resulting from defects in insulin secretion, insulin action, or both, leading to disturbances in carbohydrate, fat, and protein metabolism. ^[¹^] the chronic Hyperglycemic state of diabetes is associated with long-term damage, dysfunction, and failure of various organs, particularly the eyes, kidneys, nerves, heart, and blood vessels. ^[¹^] Diabetes mellitus has emerged as one of the most significant non-communicable diseases worldwide, posing a substantial burden on healthcare systems and national economies. ^[2] According to the International Diabetes Federation (IDF), approximately 537 million adults were living with diabetes globally in 2021, and this number is projected to rise to 643 million by 2030 and 783 million by 2045. ^[2] India is among the countries with the highest number of people living with diabetes, with more than 77 million affected adults, and the prevalence continues to increase due to rapid urbanization, sedentary lifestyle, unhealthy dietary patterns, obesity, and genetic susceptibility. ^[2,3] The increasing prevalence of diabetes in India is also associated with a high proportion of undiagnosed cases, contributing to delayed diagnosis and increased risk of chronic complications. ^[3]

Diabetes mellitus is broadly classified into Type 1 Diabetes Mellitus (T1DM), Type 2 Diabetes Mellitus (T2DM), Gestational Diabetes Mellitus (GDM), and other specific types due to genetic defects of β-cell function, pancreatic diseases, endocrinopathies, infections, or drug-induced causes.^[1] Type 1 diabetes mellitus is characterized by autoimmune destruction of pancreatic β-cells leading to absolute insulin deficiency and commonly presents in childhood or adolescence.^[1] Type 2 diabetes mellitus accounts for nearly 90–95% of all diabetes cases and is characterized by insulin resistance combined with relative insulin deficiency.^[1,2] Gestational diabetes mellitus is defined as glucose intolerance first recognized during pregnancy and is associated with significant maternal and fetal morbidity if not adequately managed.^[1]

The diagnosis of diabetes mellitus is based on standardized biochemical criteria, including fasting plasma glucose ≥126 mg/dL (7.0 mmol/L), 2-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test, glycated haemoglobin (HbA1c) ≥6.5%, or a random plasma glucose ≥200 mg/dL in the presence of classic symptoms of hyperglycemia.^[1] Early diagnosis and prompt initiation of treatment are essential to prevent microvascular complications such as diabetic retinopathy, nephropathy, and neuropathy, as well as macrovascular complications including coronary artery disease and stroke. ^[1,4]

The management of diabetes mellitus involves a comprehensive strategy that includes lifestyle modification, dietary regulation, regular physical activity, weight reduction, patient education, and pharmacological therapy.^[1] Pharmacotherapy for diabetes comprises various classes of drugs such as biguanides (metformin), sulfonylureas (glimepiride, glibenclamide), thiazolidinediones (pioglitazone), alpha-glucosidase inhibitors (acarbose, voglibose), dipeptidyl peptidase-4 (DPP-4) inhibitors (sitagliptin, vildagliptin), sodium-glucose cotransporter-2 (SGLT2) inhibitors (dapagliflozin, empagliflozin), glucagon-like peptide-1 (GLP-1) receptor agonists, and insulin preparations.^[5,6] Metformin is recommended as the first-line drug for the management of Type 2 diabetes mellitus due to its proven efficacy, favourable safety profile, cardiovascular benefits, and cost-effectiveness.^[1,5] Insulin therapy remains essential in Type 1 diabetes mellitus and is often required in advanced Type 2 diabetes mellitus when adequate glycemic control cannot be achieved with oral hypoglycaemic agents alone.^[1]

Fixed-Dose Combinations (FDCs) of antidiabetic drugs are increasingly used in clinical practice to improve patient adherence, reduce pill burden, and achieve synergistic glycemic control through complementary mechanisms of action. ^[5] Commonly prescribed FDCs in diabetes management include combinations such as metformin with glimepiride, metformin with sitagliptin, metformin with voglibose, and metformin with dapagliflozin. ^[5] Although FDCs offer therapeutic benefits, significant variation exists in their pricing depending on the manufacturer, brand value, and marketing strategies adopted by pharmaceutical companies. ^[7]

In India, a substantial proportion of healthcare expenditure is borne out-of-pocket by patients, making the cost of long-term pharmacotherapy a critical determinant of treatment adherence. ^[8] Chronic diseases such as diabetes require lifelong therapy, and even modest differences in drug prices may translate into a considerable financial burden over time. ^[8] Studies have demonstrated wide price variation among different branded formulations of the same antidiabetic drug available in the Indian pharmaceutical market. ^[7]

To improve accessibility and affordability of essential medicines, the Government of India launched the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), which aims to provide quality generic medicines at affordable prices through dedicated Jan Aushadhi Kendras across the country. ^[9] Jan Aushadhi generic medicines contain the same active pharmaceutical ingredients, dosage form, strength, and therapeutic efficacy as branded medicines but are marketed at significantly lower prices due to reduced promotional and distribution costs. ^[9] Under the PMBJP scheme, various antidiabetic drugs including metformin, glimepiride, pioglitazone, voglibose, acarbose, insulin preparations, and several fixed-dose combinations are made available to the public at affordable rates. ^[9] Several Jan Aushadhi Kendras are operational in Jammu, providing economical antidiabetic medications and thereby potentially reducing the economic burden on patients requiring long-term therapy. ^[9]

Despite the availability of Jan Aushadhi generics, many patients continue to purchase branded medicines due to brand loyalty, physician prescribing habits, perceived differences in quality, and lack of awareness about generic alternatives. ^[7] Comparative evaluation of drug costs between Jan Aushadhi generic medicines and branded antidiabetic drugs available in the market is therefore essential to generate evidence regarding potential cost savings. ^[7] Pharmacoeconomic analysis of antidiabetic drug pricing can assist clinicians, policymakers, and patients in making informed decisions and can promote rational and cost-effective prescribing practices. ^[7,8] Therefore, the present study was undertaken to compare the cost of antidiabetic drugs available under the Jan Aushadhi scheme with their branded counterparts in the Jammu market.

Study Place

The present study was conducted in the Pharmacy and Outpatient Departments of a tertiary care teaching hospital located in Jammu, India. In addition, data were collected from designated Jan Aushadhi Kendras operating under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana in Jammu, as well as selected private retail pharmacies in the local market. Jammu represents a semi-urban and urban mixed population setting where both branded medicines and government-supplied generic medicines are widely available, thereby providing an appropriate setting for cost comparison.

Study Type

This study was designed as a cross-sectional observational cost comparison study. The primary objective was to assess and compare the prices of antidiabetic drugs available as Jan Aushadhi generic formulations with their corresponding branded counterparts available in retail pharmacies. The study focused solely on price evaluation and did not involve any clinical intervention or patient follow-up.

Sample Size Calculation

The sample size was determined based on the number of distinct antidiabetic drug formulations available under the Jan Aushadhi scheme and their corresponding branded equivalents in the market. Assuming an expected minimum price difference of 50% between Jan Aushadhi generic drugs and branded drugs, with a confidence level of 95% and statistical power of 80%, it was estimated that at least 30 comparable drug pairs (generic versus branded formulations of identical strength and dosage form) would be required to obtain statistically meaningful results. Each drug pair consisted of one Jan Aushadhi formulation and one or more branded formulations of the same active pharmaceutical ingredient.

Inclusion Criteria

1. Oral and injectable antidiabetic drugs listed in the official product catalogue of the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP).
2. Corresponding branded formulations containing the same active pharmaceutical ingredient.
3. Drugs having identical strength, dosage form, and pack size in both Jan Aushadhi and branded versions.
4. Formulations available in stock at Jan Aushadhi Kendras during the study period.
5. Branded equivalents available in retail pharmacies in the Jammu market during the study period.
6. Fixed-dose combinations (FDCs) of antidiabetic drugs listed under PMBJP with comparable branded alternatives.

Exclusion Criteria

1. Herbal, ayurvedic, nutraceutical, or proprietary antidiabetic products not listed under the PMBJP catalogue.
2. Drugs without a directly comparable branded counterpart of identical strength and dosage form.
3. Formulations that were out of stock, discontinued, or unavailable during data collection.
4. Modified-release or special formulations (e.g., sustained-release, extended-release) if exact equivalents were not available in both categories.
5. Combination drugs with differing compositions between Jan Aushadhi and branded products.
6. Drugs with incomplete price information or unclear labelling.

Study Plan

The study was conducted over a period of three months, Initially, a comprehensive list of antidiabetic medications available under the Jan Aushadhi scheme was obtained from the official PMBJP product catalogue and price list. For each generic formulation identified, equivalent branded products available in the Jammu retail market were identified through direct pharmacy visits and verification of printed or digital price lists. The collected data were systematically recorded in a structured data collection format for further analysis.

Data Collection

For each selected antidiabetic drug formulation, detailed information was recorded including the generic name of the drug, strength, dosage form, and pack size. The maximum retail price (MRP) of the Jan Aushadhi generic formulation was documented as per the official price list. The market price of branded drugs with identical composition, strength, and dosage form was recorded from retail pharmacies. In cases where multiple branded products of the same formulation were available, the prices of at least three commonly prescribed brands were noted and the average market price was calculated to ensure representative comparison.

Methodology

In the first step, the list of antidiabetic drugs was extracted from the official Jan Aushadhi product catalogue. The formulations included commonly prescribed oral hypoglycemic agents such as metformin, glimepiride, voglibose, acarbose, pioglitazone, various fixed-dose combinations, and insulin preparations.

Subsequently, a market survey was conducted in selected retail pharmacies within Jammu to obtain the prices of branded equivalents. Care was taken to ensure uniformity in dosage form, strength, and pack size to maintain comparability.

Cost comparison was performed by calculating the absolute price difference and percentage price variation between the Jan Aushadhi generic drug and the corresponding average branded drug price using standard pharmacoeconomic formulas. Percentage price variation was calculated using the formula: ^[10]

Percentage price difference = [(Price of branded drug – Price of Jan Aushadhi drug) / Price of Jan Aushadhi drug] × 100

Cost Calculation Parameters

Percentage Cost Difference was calculated using the formula:

Cost Ratio was calculated using the formula:

Ethical Considerations

The study was conducted after taking permission from the institutional ethics committee. the proposal vide No IEC/GMCK/40 dated 29-05-2024.

Statical analysis:

The statical analysis was done by using SPSS software all the data was entered into MS Excel sheet, statical analysis was done mean average and percentage was done for this study.

Table No 1 Pharmacological Category-wise Distribution of Antihypertensive Agents Included in the Present Study

Table 2: Cost Comparison of Jan Aushadhi Generic and Branded Antidiabetic Drugs – Single Drug Therapy

Table 3: Cost Comparison of Jan Aushadhi Generic and Branded Antidiabetic Drugs – Dual Drug Therapy

Table 4: Cost Comparison of Jan Aushadhi Generic and Branded Antidiabetic Drugs – Injectable Therapy

In the present study, a total of 35 antidiabetic drugs were analyzed across 11 pharmacological categories. Sulfonylureas constituted the highest proportion (5 drugs), followed by biguanides, DPP-4 inhibitors, SGLT2 inhibitors, and insulin preparations (4 drugs each). Alpha-glucosidase inhibitors accounted for 3 drugs, while thiazolidinediones and GLP-1 receptor agonists comprised 2 drugs each. Additionally, fixed-dose combinations such as biguanide + sulfonylurea (3 drugs), biguanide + DPP-4 inhibitor (2 drugs), and biguanide + SGLT2 inhibitor (2 drugs) were included. This distribution reflects contemporary treatment strategies for type 2 diabetes mellitus, where metformin remains the first-line therapy and sulfonylureas continue to be widely prescribed due to cost-effectiveness and clinical familiarity. Similar distribution patterns were reported by Jadhav et al. (2013) ^[10], who found that metformin and sulfonylureas represented the largest proportion of marketed antidiabetic drugs in India. Likewise, Karve and Chattar (2013) ^[11] observed an increasing availability of newer agents such as DPP-4 inhibitors and combination therapies, consistent with the present study. The inclusion of SGLT2 inhibitors and GLP-1 receptor agonists in our analysis further indicates the evolving therapeutic landscape.

The present study demonstrated significant inter-brand price variation among single-drug oral antidiabetic therapies. Metformin (500 mg) showed a percentage cost difference of 216.67% (cost ratio 3.17), and the 1000 mg strength showed a 195.24% difference (cost ratio 2.95). Glimepiride exhibited even greater variation, with 264.71% (1 mg) and 246.15% (2 mg) differences, corresponding to cost ratios of 3.65 and 3.46 respectively. Pioglitazone showed a 263.64% variation. Among newer drugs, sitagliptin (158.82%) and dapagliflozin (200%) also demonstrated substantial price disparities.

These findings indicate that branded drugs were approximately 2–4 times costlier than Jan Aushadhi generics. Comparable results were reported by Rataboli and Dang (2007) ^[12], who documented cost variations exceeding 200% among antihypertensive and antidiabetic drugs in the Indian market. Similarly, Jadhav et al. (2013) ^[10] found that oral antidiabetic drugs showed wide inter-brand variation, often exceeding 250%, thereby increasing the financial burden on patients. The present findings strongly align with these previous reports and highlight the persistent issue of drug price variation in India.

Fixed-dose combination therapies showed similarly high cost variation. The metformin + glimepiride combination exhibited the highest percentage cost difference of 260% (cost ratio 3.60). Metformin + sitagliptin showed a 178.95% difference (cost ratio 2.79), while metformin + dapagliflozin showed a 172.73% difference (cost ratio 2.73). These findings suggest that combination therapies, although clinically beneficial for improved glycemic control and adherence, significantly increase economic burden when branded versions are prescribed.

Comparable observations were made by Karve and Chattar (2013) ^[11], who reported marked cost variation in fixed-dose antidiabetic combinations in India. Additionally, Bisht et al. (2018) ^[13] found substantial inter-brand variation in metformin-based combinations, emphasizing that cost differences in combination therapy may exceed those of single agents. These studies coincide with the present findings, reinforcing the importance of promoting generic alternatives for combination therapy.

Injectable insulin preparations showed relatively lower percentage variation compared to oral agents. Human insulin (Regular) demonstrated a 50% cost difference with a cost ratio of 1.50. Human insulin (NPH) also showed moderate variation between generic and branded formulations. Although the percentage variation was lower than oral drugs, the absolute cost of insulin remains high due to its chronic and lifelong use.

Similar findings were reported by Sharma et al. (2016) ^[14], who observed comparatively lower inter-brand variation for insulin preparations but emphasized the economic burden associated with long-term insulin therapy. Furthermore, Selvaraj et al. (2010) ^[15] highlighted concerns regarding insulin affordability in India, noting that even moderate price differences can significantly impact patients due to the continuous nature of insulin therapy. The present study corroborates these findings, suggesting that Jan Aushadhi insulin preparations may improve affordability.

This study analysed 35 antidiabetic drugs from 11 categories, including single drugs, combination therapies, and insulin preparations. Sulfonylureas were the most common group, followed by biguanides, DPP-4 inhibitors, SGLT2 inhibitors, and insulin. A significant cost difference was observed between Jan Aushadhi generic drugs and branded drugs. In single-drug therapy, branded medicines were about 2–4 times more expensive than generics, with cost differences ranging from 158% to 265%. Dual-drug combinations also showed high price variation, with differences above 170%. Injectable insulin showed a smaller price difference (around 50%), but since insulin is used long-term, even this difference can increase the financial burden on patients. Overall, generic medicines were much more affordable than branded drugs.

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