Two-fifths (42%) of all fatalities worldwide resulting from non-communicable diseases (NCD) are attributable to cardiovascular illnesses (CVD).1 CVDs are the cause of over half (52%) of all premature deaths globally. Globally, CVDs account for over 17.5 million deaths annually 2. South Asian nations saw the largest rise in CVD-associated mortality (97.3%) between 1990 and 2013 3. About one in four fatalities in India are attributable to CVDs, mostly stroke and ischemic heart disease 4. According to the Global Burden of Disease report, India has an age-standardized CVD mortality rate of 272 per 100,000 people, which is much higher than the 235 global averages.5 Compared to 15·2% and 6·9%, respectively, in 1990, chronic diseases (CVDs) accounted for 28·1% of all deaths and 14·1% of all disability-adjusted life years (DALYs) in India in 2016.6 Dyslipidemia is one of the major risk factors of cardiovascular diseases. Hypercholesterolemia is the most common form of dyslipidemia. The primary feature of dyslipidemia is elevated low-density lipoprotein (LDL) cholesterol, which is linked to a higher risk of cardiovascular disease, especially in those with atherosclerotic cardiovascular disease (ASCVD).7 As a result, one of the most widely used methods for treating and preventing ASCVD in clinical practice is reducing LDL cholesterol levels.8 For decreasing LDL cholesterol, statins are currently the first line of treatment in the majority of clinical situations. 9

The availability of several brands and generic medications causes a wide range in the pricing at which they are sold. Rosuvastatin (Tablet, 10 mg), a cholesterol–lowering agent, is marketed through 127 brands by 105 companies. Three brands of the same formulation of rosuvastatin are marketed by four companies. Price comparisons between branded generics in the private retail market and pure/unbranded generics in the public procurement market for Atorvastatin (10 mg tablet) found that atorvastatin (10mg) is procured by the procurement agency at Rs. 0.21 (21 paise) while the same is sold at Rs. 5.1 in the private retail segment, resulting in a 184% price difference. The highest-priced brand of atorvastatin (10 mg) is sold at Rs. 7.4 per tablet whereas the same is also sold at Rs. 2 per tablet.10 This leaves consumers, healthcare professionals, and prescribers perplexed about what constitutes a reasonable and appropriate product. Drug prices that vary significantly and are routinely used by a big portion of the population will have significant economic effects. Patients whose treatments account for the majority of their income are likewise impacted in terms of compliance. 11

To regulate the cost of medications, the Indian government enacted the Drug Price Control Order (DPCO). Once a medication is covered by DPCO, its price cannot be raised above what the government specifies. The number of medicines covered by DPCO has declined over the past many years, which has increased the cost of medications and placed a financial strain on the population of low-income people. 12

The purpose of our study was to determine the variation in the cost of oral hypolipidemic drugs such as statins, sterol inhibitors, lipoprotein and triglyceride inhibitors, and peroxisomal proliferator–activating receptor agonists (fibrates) that are available in India, either alone or in combination with other hypolipidemic drugs. We also aimed to assess the differences in cost between different brands of the same oral hypolipidemic drug by computing the percentage variation in cost in Indian rupees (INR).

This study was conducted in the Department of Pharmacology at Assam Medical College and Hospital over a period of 3 months. ‘‘Current Index of Medical Specialities (CIMS)’’ April-July 2023 and “Indian Drug Review (IDR) 2023’’ drug manuals was used to analyze the prices of hypolipidemic drugs. The NPPA website was used to gather information about the generic drug pricing set by the NPPA (National Pharmaceutical Pricing Authority) under the DPCO (Drug price control order).

The cost was cross-checked at pharmacy shops (retail drug stores). The fixed dose combinations (FDC) of hypolipidemic drugs were analyzed for the cost differences. The FDC is the formulation including two or more active pharmaceutical ingredients combined in a single dosage form. FDCs included in the study were formulations containing two or three active ingredients combined in single dosage form.

The cost of a particular drug (single drug or drug combinations) in the same strength and number of brands being manufactured by different companies were compared in Indian rupees per 10 tablets/capsules. The drugs manufactured by only one company or by different companies, however, in different strengths were excluded. Parenteral formulations were also excluded. The following formulas were used to calculate the Cost ratio and Cost variance. 13

The maximum cost of hypolipidemic drugs (as per NLEM) were compared with their ceiling price (as per DPCO). Ceiling prices of 10 tablets/capsules were calculated. The cost difference between maximum cost and ceiling price will be analyzed.

To compare the prices of brand drug with generic drug, http://janaushadhi.gov.in/ProductList.aspx were used as source for generic drug price. 14

The prices of a total of 14 drugs (3 single and 11 combination preparation), available in 22 different formulations were analyzed. All formulation were manufactured by different pharmaceutical companies.

The results were formulated using Table 1, Table 2, Table 3, Table 4.

Among the single drug formulations in our study, the cost variation observed in the present study was as high as 3043.9393% in case of Atorvastatin 10mg, Atorvastatin 20mg (1757.1428%) Rosuvastatin 40mg (705%). (Figure 2)

Among the fixed drug combinations, the maximum cost variations were seen in case of Rosuvastatin 10mg + Aspirin75mg (561.341%), Atorvastatin 10mg + Ezetimibe 10mg (484.615%), Atorvastatin 10mg +Clopidogrel 75mg + Aspirin 75mg (372.868%), Rosuvastatin 10mg + Clopidogrel 75mg (323.076%). (Figure 3)

The cost ratio was seen to be highest for Atorvastatin 10mg (31.439) followed by Rosuvastatin 40mg (8.05), Simvastatin 5mg (1.972) and the combination of Rosuvastatin 10mg + Aspirin 75mg (6.613). (Figure 4)

Maximum cost difference between maximum price of branded formulations & generic Medicines (Jan Aushadhi) was found in case of Atorvastatin 20mg (507.9 rupees), Atorvastatin 80mg (449.5 rupees), Rosuvastatin 40mg (439 rupees). (Figure 5)

In our study findings showed a very high fluctuation in the minimum and maximum price of hypolipidemic drugs. The cost ratio was also observed to be high. The percentage variation in the cost was above 100% with most of the commonly used hypolipidemic drugs and also with combination form of hypolipidemic drugs. Similar results were found as per study done by Ujjawal Rawat et.al (2023) where atorvastatin 10mg (3668.50%) had the highest cost variation percentage of single hypolipidemic drugs followed by atorvastatin 20mg (3293.90%) 15. The study done by Shinde and Khushwah (2021) found Atorvastatin 80mg to have the highest cost variation percentage (3284%). Minimum cost variation percentage of single hypolipidemic drugs is Atorvastatin 40mg (45.707%) in our study. Among 11 FDCs studied, cost variation was highest for Rosuvastatin 10mg + Aspirin 75mg (561.341%) and minimum was seen in Atorvastatin 20mg + Clopidogrel 75mg + Aspirin 75 mg (66.293%). Maximum cost variation of FDCs in studies done by Sondarva DB et al. (2020) was atorvastatin 10 mg + fenofibrate 160 mg (500.32%) 13 and Shinde et al. (2021) 16 was atorvastatin 10mg + ezetimibe 10 mg (484%). In our study we found that minimum price of branded formulation of Atorvastatin 10 mg (2.64 INR) is less than the generic price (8.8 INR). When we compared the generic prices of various hypolipidemics with their maximum branded price, it was found that the maximum cost difference was seen in Atorvastatin 20 mg (394.5%).

Two essential components that allow expensive medications to sustain even in the presence of lower priced alternatives particularly generic medicines that lack functional differentiation are:

Our analysis revealed significant price variations for hypolipidemic medications on the Indian market. This study led us to the conclusion that the majority of hypolipidemic medications should be governed by DPCO in order to lessen the economic load of healthcare services on the Indian population and to enhance community health through treatment adherence. Physicians should prescribe more generic medications and take the patient's financial situation into account before writing a prescription for any medication. Therefore, doctors may provide their patients better healthcare services at a price that they can afford if they have easy access to information about prescription pricing. Research by Frazior et al. has demonstrated that providing doctors with a handbook of comparable drug prices together with prescribing guidance lowers their patients' drug costs. 17