National Pharmaceutical Pricing Authority Research Articles

COST VARIATION ANALYSIS OF ANTIMALARIAL DRUGS : A REVIEW

Background: Malaria has been a major issue in India for ages. There are numerous antimalarial brands available on the market. Costly medications can place an economic burden on patients, resulting in lower compliance or even noncompliance. Noncompliance leads to insufficient therapy, which increases morbidity. Increases in patient pharmaceutical costs were found to be related to worse adherence to prescribed medicine. As a result, this study was conducted to analyze the cost variation of malaria drug-therapy. Methods: Price in Indian rupees (₹) of antimalarial drugs manufactured by different pharmaceutical companies in India, in the same strength and in same dosage form were obtained from Current index of medical specialties (CIMS) January-April 2023. Cost ratio and cost variation percentage were calculated and data was analysed. Results: The highest cost ratio and percentage cost variation were observed for Quinine injection 300mg/ml, with a cost ratio of 7 & a percentage cost variation of 599.65%.The lowest cost ratio was found for Mefloquine tablet 250mg injection, with a cost ratio of 1.01 and a percentage cost variation of 1.35%. Overall, the injectable antimalarial medications showed a considerable cost ratio and cost variation Conclusions: Ceiling cost of drugs are fixed by national pharmaceutical pricing authority (NPPA) government of India in accordance with DPCO 2023.Despite this there exists a wide variation of drug costs within one drug with the availability of various brands

COST ANALYSIS OF PRIMARY CARE ANAESTHETICS IN INDIAN MARKET: GENERIC VERSUS BRANDED

Objective: The aim of the study was to study the degree of compliance of primary care anesthesia dispensing companies in following the pricing norms set by drug price control order 2013 (DPCO). Methods: This is an observational and analytical study where the dosage, strength, and ceiling price of the generic primary care anesthetics were obtained from the National pharmaceutical pricing authority updated price list 2022 and similar data of their various counterpart brands were obtained from www.medguideindia.com. Thereafter, comparisons of their ceiling price along with the brands cost range, cost ratio, and percent cost variation were sought. Results: Our study retrieved 150 brands of total 11 injectable/topical primary care anesthetics available in India of which 39.33% brands had prices more than DPCO recommended ceiling price. Maximum price violation (90%) was noticed with brands of Inj. Midazolam 5 mg/mL. The maximum cost variation and cost ratio was seen with brands of Inj. Lignocaine 1–2% (10 mg/mL) of 148.37% and 149.37, respectively. Conclusion: The adjuvant sedative hypnotic, Midazolam which is often used to supplement the action of primary sedative hypnotics in inducing general anesthesia, violating price ceiling is a matter of great concern as it would adversely impact the primary patient care; the most basic level of health care which almost whole population needs at some time or the other. Similarly adding to the misery of the common man is the maximum cost ratio and percent cost variation of the local anesthetic, Inj. Lignocaine 1–2% as it continues its prominence as the most widely used local anesthetic agent.

Does India need a new pharmaceutical policy? Examining the implications of the drug price control order.

This article aims to analyse the impact of the pharmaceutical policy on the availability, accessibility and affordability of medicines to the Indian populace. The article delves into the shortcomings of the Drug Price Control Order 2013 and highlights its real-world implications. Published literature in the form of scientific articles on the proposed reforms that took place in the pharmaceutical policy was reviewed. The study used the memorandums, laws and government decisions published by the Department of Pharmaceuticals, Ministry of Health and Family Welfare and National Pharmaceutical Pricing Authority|National Pharmaceutical Pricing Authorities. The pharmaceutical policy in India underwent several changes during 2013-2020 to enhance the affordability and accessibility of drugs. The stringent policy hampered innovation due to the lack of profitability to the Multinational Companies. Moreover, it was found that the impact of the price control order on the low-cost local generic manufacturers affected much of the country's price-sensitive population. The pharmaceutical policy of India needs to be amended to extend its benefit to its stakeholders. The government should shift its attention to improving the quality of drugs, increasing competition amongst manufacturers and enhancing the accessibility of medicines through state/centre sponsored initiatives.

Impact of the Drug Prices Control Order (2013) on the Utilization of Anticancer Medicines in India: An Interrupted Time-Series Analysis.

ObjectivesThe National Pharmaceutical Pricing Authority introduced a series of Drug Prices Control Orders since 1970 to regulate the prices of essential medicines in India. This study evaluated the impact of the Drug Prices Control Order of 2013 on the utilization of anticancer medicines in the Indian private sector.MethodsWe used monthly sales audit data for a period of 2012-15, provided by Intercontinental Medical Statistics (IMS) Health. Through interrupted time series design and segmented regression models, we estimated the change in utilization of anticancer medicines following the drug pricing policy implementation.ResultsOf 1556 anticancer drug packs, 22.3% (n= 347) were price-controlled. The policy led to an immediate monthly reduction of 27.3% (95% CI -38.6%, -13.9%; p=0.001) and a long-term monthly reduction of 0.7% (95% CI -1.6%, 0.3%; p=0.16) in price-controlled formulation’s utilization. In the final study month, the price-controlled formulation’s utilization was 5.03 thousand standard units lower than what would have been expected without the policy. Melphalan showed the highest immediate reduction, and alpha-interferon showed the highest long-term reduction in utilization.ConclusionDrug prices control order 2013 caused an immediate and long-term decline in the utilization of anticancer medicines in the Indian private sector. However, study data was limited to a specific part of the Indian anticancer drug market, which must be considered when interpreting findings.

Comparative overview of enhancing Drug pricing transparency in India and USA

The United States and other different countries, drug prices are out of control. In that the prescription drug prices increasingly the medical costs and other different healthcare costs. The branded drugs are launched with high prices that increase by double percentage over year. So, many states and countries are focusing on new ways or new approaches to drug pricing problems using different ways and clarity about drug price transparency are mainly that the study about drug transparency and identify the cost key drivers. India is one of the world's developing countries. The ability to obtain health-related services at a reasonable cost is a major worry for them. As a result, medical costs are a determining element for health-care facilities, particularly when it comes to price management of health-care institutions with a greater budget. NPPA (National Pharmaceutical Pricing Authority) and DPCO (Department of Pharmaceutical Pricing and Control) are two Indian regulatory bodies that oversee pharmaceutical pricing (Drug Pricing control order). Despite the establishment of the DPCO, significant price fluctuation is observed between goods containing the same API (Active Pharmaceutical Ingredient), and various reasons are responsible for this. TRIPS (Trade Related Intellectual Property Rights) offers Compulsory Licenses for which drugs have a distinctive function to play in the affordability of medicines to minimize the stated problem and govern the trade practice by patent holder/brand maker. Essential medicine is a basic requirement of the health-care system in order to serve its consumers, and as a result, an effective and overt price restriction on drugs is currently required.

Cost variation analysis of commonly prescribed anti-diabetic drugs available in Indian market: a pharmaco-economic study

Cost variation analysis of commonly prescribed anti-diabetic drugs available in Indian market: a pharmaco-economic study

1504O Anti-cancer drug price regulation in India: Financial implications and annual savings to patients

The projected incidence of patients with cancer in India among males was 679,421 (94.1 per 100,000) and among females 712,758 (103.6 per 100,000) for the year 2020. Most Indian patients bear their expenses out of pocket. The escalating costs forces them to compromise treatment and sometimes avoid necessary medical care. This has a negative impact on quality of life and overall survival. Reducing prices of chemotherapeutics by the National Pharmaceutical Pricing Authority (NPPA) is a welcome step.

Cost Excursion Study of Various Insulin Preparations Available in India

Introduction: Poor drug compliance affects clinical outcome and increases healthcare costs in various disease setting. Several type II diabetes mellitus patients, not controlled on oral hypoglycaemics eventually require insulin therapy. Antidiabetic treatment is to be taken lifelong and in such a setting insulin price variation imposes a huge economic burden on poor diabetic patients. Moderating drug cost is associated with improved adherence to the medication regimen. Aim: To study the variation in cost amongst various brands of insulin analogues. Materials and Methods: This was an observational, cross-sectional study. Data regarding the 116 formulations and cost of 18 types of insulin preparations was collected from sources like Current Index of Medical Specialties (CIMS), National Pharmaceutical Pricing Authority (NPPA), Government of India official website (https://nppaimis.nic.in/nppaprice/pharmasahidaamweb.aspx) and compared with its lowest counterpart. The cost ratio and percentage cost variation was analysed and expressed as percentages. Results: This study showed a noticeable variation in the prices of insulin analogues. The highest percentage of cost variation was found for Insulin (Highly Purified) Zinc-40 IU (135.17%), followed by Insulin (Analogue) Glargine-100 IU (109.31%). The lowest percentage were for: Insulin (Human-Isophane Recombinant)-40 IU (1.40%), and Insulin (Analogue) Aspart- 100 IU (6.26%). Conclusion: A noticeable variation in cost prices was observed especially in commonly used intermediate acting insulin that help basal glycaemic control. Similarly, the lowest variation was observed with recombinant counterparts as an effect of pre-existing high prices of each. Need for vital medication like insulin at affordable costs has incited national and global efforts to make it cheaper and accessible to maximum beneficiaries.

Cost variation analysis of various brands of selective serotonin reuptake inhibitors currently available in the Indian market: An observational study

Background: India being the world’s largest supplier of generic drugs provides 50% of the drugs globally. Selective Serotonin Reuptake Inhibitors (SSRI) (hereafter referred to as SSRI) is the most commonly prescribed drugs for depression (prevalence of 5.25%) and Anxiety (prevalence of 5.8%). The cost of these drugs influences the patient compliance with treatment and thereby the clinical outcome significantly. Aim and Objectives: The aim of the study was to analyze the cost-variation of SSRIs available in the Indian market. Materials and Methods: Maximum and minimum costs of various SSRIs used in the treatment of depression and anxiety were obtained from the monthly index of medical specialties (November 2020) online, Jan Aushadhi Sugam App (Generic drugs), and National Pharmaceutical Pricing Authority online. The cost of various SSRI being manufactured by different companies in the same strength and dosage form were compared. Cost ratio (Maximum cost/Minimum cost) and percentage cost variation ([{Max cost–Min cost}/Min cost] × 100) in INR (₹) were calculated. Data were analyzed and represented using descriptive statistics. Results: Percentage cost variation was maximum with Fluoxetine 20 mg (3477.85%), followed by Sertraline 50 mg (1631.61%) and Escitalopram 10 mg (1288.89%). Percentage cost variation was minimum with Vilazodone 40 mg (16.31%). Conclusion: This study provides awareness about cost variation among different brands of SSRI used in the treatment of depression and anxiety. Wide variation can cause dissatisfaction, poor compliance, and economic burden among patients. It strengthens the usage of generic drugs among general population and healthcare providers.

Pharmaceutical Market Structure in India & Competition Concerns

Health Status of any country depends upon its preventive, curative, and promotive measures. But to implement these measures with available skilled human resources, and infrastructure, the growth of the pharmaceutical market is an essential one. Health Status is a function of health professionals, health infrastructure, invention, and innovations in the health sector, and the nature of government programs and policies. The Government of India exposed ‘Pharma Vision 2020’ aimed at making India a global leader in end-to-end drug production. Permission time for new facilities has been reduced to boost investments. Further, the government introduced devices such as the Drug Price Control Order and the National Pharmaceutical Pricing Authority to deal with the issue of affordability and availability of medicines (www.idma.com). India’s cost of making is significantly lower than that of the US and almost half of that of Europe. It gives a competing edge to India over others. (Sectoral Report / Sep 2016). The competition in these markets is very crucial for making quality drugs at affordable prices to consumers. Competition law plays an essential role in dealing with anti-competitive issues in the sector and maintains competitive markets. Hence the researcher attempted to view the status of existing Indian pharmaceutical market structure, government regulations, an,d common anti-competitive concerns in the sector. Too much regulation reduces competition in the market. An equal act of management and maintaining competition is required to benefit human society in reducing theirs out of pocket expenditure for pharmaceutical products.

Impact of coronary stent pricing regulation in a private sector health care system in India: a retrospective cohort analysis

Background: National pharmaceutical pricing authority of India slashed prices of coronary stents by up to 80% (February 2017) to increase affordability of percutaneous coronary interventions (PCI). This study aimed to assess its impact.Methods: A retrospective cohort study in a private sector tertiary care hospital in Mumbai, India evaluating data of patients admitted for PCI from 13 February 2015 to 12 January 2019. Cost of undergoing PCI before and after price capping of coronary stents was analysed and studied under different subgroups along with other associated parameters.Results: Of 1015 patients included, 514 of them underwent PCI before and 497 after the price capping. 967 stents at an average 1.88 stents/case and 1011 stents at average 2.03 stents/case were implanted before and after the price capping respectively. Cost of PCI decreased by 11.64% and 28.14% in non GIPSA (private insurance providers and self-paying) and GIPSA (public sector insurance providers) category respectively under single room class and by 2.79% and 19.87% in non GIPSA and GIPSA category respectively under twin sharing room class. In multi sharing room class cost of PCI increased by 3.99% in non GIPSA category and decreased by 26.87% in GIPSA category. Usage of adjunct devices and number of complex PCIs increased significantly.Conclusions: Cost of undergoing PCI has dropped significantly after price regulation of coronary stents in most subgroups despite increased usage of adjunct devices like IVUS, FFR/iFR for better patient outcomes. There was no effect on number of PCIs performed.

Cost comparison of commonly used antidepressant drugs with drug price control order in India

Background: Price of a drug is an important factor for compliance to the treatment. So, to overcome the high prices of drugs, National Pharmaceutical Pricing Authority (NPPA) under government of India has issued Drug Price Control Order (DPCO) list containing commonly used drugs. Pharmaceutical companies can be punished if they keep their prices higher than the ceiling price mentioned in the DPCO. To find out the price variations of commonly used antidepressant drugs included in DPCO list of 29th April 2019.Methods: A list of all oral antidepressant drugs included in DPCO of 29th April 2019 and available in Indian market was procured from medguide India. Analysis of number of total brands following as well as not following DPCO ceiling price was done.Results: Author found 17 formulations of four antidepressant drugs included in DPCO. Total 556 brands found out of which 84.6% were following the DPCO and 15.4% of brands prices were higher than the ceiling price of DPCO.Conclusions: Though large number of companies are following the DPCO but still strict regulation is needed to further increase the compliance of guidelines.

Segmentation Strategies:Empirical Evidences from Pharmaceutical Companies

The Indian Pharmaceutical sector is highly fragmented with more than 20, 000 registered units. The organized sector of India's pharmaceutical industry consists of 250 to 300 companies, which account for 70 percent of products on the market, with the top 10 firms representing 30 percent. Multinationals represent only 35% of the market, down from 70% thirty years ago. Because of differences in the industry structure and combination of market opportunities for domestic companies and multinationals, they are likely to differ on strategic issues. Hence domestic companies and multinational firms need to pursue different strategies to achieve desired goals. The study covers pharmaceutical companies operating in Madhya Pradesh state of India. The data or information required is related to segmentation strategies adopted by these pharmaceutical companies. The participants are selected from the directory of pharmaceutical manufacturing units in India, published by national pharmaceutical pricing authority. ANOVA is used for testing of hypothesis. The results show that there are visible differences in the segmentation strategies followed by different pharmaceutical companies of Madhya Pradesh. Small & medium domestic pharmaceutical companies have very little inclination towards segmentation strategies. MNCs and large domestic pharmaceutical organizations in Madhya Pradesh are following the segmentation strategies but this is also limited to demographic and geographic segmentation mostly. They also follow integrated segmentation strategies to some extent.

PMD33 - Price Ceiling on Coronary Stents: Impact on Utilization and Cost of Percutaneous Coronary Interventions (PCI) in Tertiary Care Hospitals in Mumbai, India

1) To comprehend cardiologists’ rationale behind using Drug Eluting Stents (DES) over Bare Metal Stents (BMS). 2) To gauge the impact of price ceiling (recently commissioned by the National Pharmaceutical Pricing Authority, NPPA) on utilization of coronary stents. A questionnaire-based survey directed towards cardiologists was conducted in 3 multispecialty hospitals. The questions were aimed to study benefits of DES over BMS; and change induced by the price ceiling in number and cost of Percutaneous Coronary Interventions (PCI). 1) DES account for majority of stents placed due to factors like risk minimization, improved patient outcomes and prevention of re-occlusion. However, Dual Antiplatelet Therapy (DAPT) was prescribed for up to 2 years, irrespective of the type of stent(s) used. 2) Of the total cases of Ischemic Heart Disease, 50% were recommended PCI. The cost of the intervention (with 1 stent) ranges from 2,00,000 to 3,00,000 INR. The number and cost of PCIs performed per month saw no significant change. The cost of BMS has been reduced by about 81% (from an average of 45,095 to 7,260 INR) and that of DES by about 76% (from an average of 1,21,000 to 29,600 INR) irrespective of subcategory. Despite this substantial drop, the cost borne by patients remains unchanged. This is likely due to raised auxiliary costs. Although the price ceiling may favor local stent manufacturing companies, it curbs potential for entry of high-end products by making the Indian market less rewarding to innovators. As a result, patient choice is limited. This initiative could be boosted by adopting strategies such as rationalization of trade margins and implementation of systematic differential pricing. Hence, the government, in conjunction with manufacturers, can take a prudent call to revise this policy such that interests of all stakeholders are protected.

NEED FOR DRUG PRICE CONTROL IN INDIA

India is one of the developing countries. A substantial proportion of population of this country is largely exposed to the drug market whose purchasing power is extremely low. Around 42% population of this country lives under the National poverty line ($1.25 per day). Vital issue concerning them is to access the health care facility at an affordable cost. Medicine is a part of health care cost and it costs to around 70% to 80% of total cost. Thus, cost of medicine is a governing factor of health care system especially when it comes to price control of health care facilities. To bring down the cost of health care facilities, government spends money for health care facilities. A comparative expenditure made by state government is depicted in this article. NPPA (National Pharmaceutical Pricing Authority) is the Indian pharmaceutical pricing regulating authority and it achieves its objectives by implementing the DPCO (Drug Pricing control order). In spite of existence of the DPCO, drastic price variation is observed between the products of same API (Active Pharmaceutical Ingredient) and several factors are responsible for the same. To overcome the stated problem and monopolistic trade practice by patent holder/brand manufacturer, TRIPS (Trade Related Intellectual Properties Rights) provides Compulsory Licenses which has its unique role to play in affordability of medicines. Essential medicine is a basic requirement of health care system to serve their customers and hence an effective and overt price control on drugs is the need of present. This study will thus try to justify the need to bring NLEM (National List of Essential Medicine) under DPCO.

A Comparative Study of Marketing Authorization of Drug Eluting Coronary Stents (DES) in India and Developed Countries (USA & EU)

Background: India presents a peculiar case for Drug Eluting Stents (DES). 85% of India's stent need is met through imports which enjoy perception premium in terms of quality. Recently, drug eluting stents' prices were capped to INR 30,000 in India by National Pharmaceutical Pricing Authority (NPPA) of DES to curb soaring high prices. Indian Market offers tremendous opportunities for stent makers. The total market for stents in India is estimated to be of US$ 531 mn by 2016 end and is expected to expand at a CAGR of 14.0% from 2016-2026) [1]. </P><P> Objective: This paper attempts to study and compare marketing authorization provisions and regulatory standards that need to be met to obtain marketing approval for Drug Eluting Stents in the three regions and provide recommendations for Indian regulatory system. </P><P> Discussion: Regulatory authorities of developed countries outline their data expectation in the form of non-binding guidance document for industry; however, there are no such equivalent documents in India. Technical data ranging from specification of ‘stent platform', ‘eluting drug' and the ‘finished product' is furnished to the Regulatory authority prior to grant of marketing authorization. Data in application include both Clinical and Non-Clinical (Bench Tests) information obtained during the course of device development. In USA, a Premarket Application (PMA) should be submitted to FDA. In EU, an application dossier is to be submitted to the Competent Authority and in India marketing authorization application is to be made to the CDSCO. Regulatory authorities of developed countries outline their data expectation in the form of non-binding guidance document for industry however, there are no such equivalent documents in India. </P><P> Conclusion: This article enlists and provides a comparative grid of Regulatory requirements of Drug Eluting Stents in the said regions. Any organization involved in regulatory affairs of DES could use this article as point of reference on the subject.

Study of price variation among the different brands of anti-tubercular drugs available in India

Background: India is one of the largest Tuberculosis (TB) burden countries in the world. Although Revised National Tuberculosis Control Programme provides free cost of therapy, sometimes patient get treated by private practioners. This can sometimes lead to irregular course of treatment due to decreased patient compliance. This in turn may lead to multi drug resistance among TB bacilli. One of the reasons for decreased patient compliance is cost of therapy. The present study was undertaken to evaluate the cost of therapy of various anti-TB drugs and their combinations available in India.Methods: The maximum and minimum cost in rupees (INR) of all anti-TB drugs manufactured by various pharmaceutical companies was noted. The cost of 10 tablets/capsules or their fixed dose combinations (FDCs) was calculated. The cost ratio and percentage price variation were calculated for each brand and compared.Results: Percentage variation in cost of oral anti-TB drugs marketed in India was highest in ethambutol 400mg (474.51), cycloserine 250mg (384.61), ethambutol 800mg (321.84) and rifampin 450mg (258.45). The lowest percentage cost variation was seen with pyrazinamide 225mg (10.04), ethambutol 1000mg (18.82) and rifampin 100mg (22.78). Among the FDCs lowest percentage cost variation seen with rifampin 150mg +isoniazid 75mg+pyrazinamide 400mg (0.16) and highest percentage cost variation is seen with rifampin 450mg+isoniazid 300mg+pyrazinamide 750mg+ethambutol 800mg (232.73).Conclusions: There is a significant variation in the cost of different brands of oral anti-TB drugs and their FDCs available in India. The National Pharmaceutical Pricing Authority (NPPA) should take more proactive steps for bringing down the prices of first line anti-TB drugs and the clinicians prescribing them should be aware of the price variation among the various brands of anti-TB drugs available in India.

PHARMACEUTICAL PRICING POLICY AND CONTROL– INDIAN PERSPECTIVE

ABSTRACTPharmaceutical sector is playing a vital role towards the wellness of the people and economic development of India. The innovation, development, production and marketing of medicines are accountable to pharmaceutical industry. Drugs and pharmaceuticals, healthcare delivery, medical devices among others come under the purview of healthcare sector. It is the duty of the Government to ensure the availability of the lifesaving drugs at reasonable prices by means of considering the interest of both the producers and the buyers. In order to safeguard the public health, National Pharmaceutical Pricing Authority (NPPA) is the watchdog in India, which controls the prices of drugs.Keywords: Pharmaceutical sector, Price, Drugs, Regulator,NPPA,DPCO

Light at the end of the tunnel?: The Great Indian Pharmacoeconomics story

OPINION article Front. Pharmacol., 13 December 2013Sec. Drugs Outcomes Research and Policies https://doi.org/10.3389/fphar.2013.00153