Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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On Sep 2018




Prof. Somashekhar Nimbalkar

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Prof. Somashekhar Nimbalkar
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Chairman, Research Group, Charutar Arogya Mandal, Karamsad
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Ex-Member, Governing Body, National Neonatology Forum, New Delhi
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Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



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Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
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Dr. Saumya Navit

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Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




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Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




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Best regards,
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Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2021 | Month : July | Volume : 15 | Issue : 7 | Page : FC01 - FC05 Full Version

Cost Excursion Study of Various Insulin Preparations Available in India


Published: July 1, 2021 | DOI: https://doi.org/10.7860/JCDR/2021/48116.15107
Mayur B Phulpagare, Smita A Tiwari, Rajesh S Hiray

1. Junior Resident Doctor-3, Department of Pharmacology, B. J. Government Medical College and Sassoon Government Hospital, Pune, Maharashtra, India. 2. Associate Professor, Department of Pharmacology, B. J. Government Medical College and Sassoon Government Hospital, Pune, Maharashtra, India. 3. Professor and Head, Department of Pharmacology, B. J. Government Medical College and Sassoon Government Hospital, Pune, Maharashtra, India.

Correspondence Address :
Smita A Tiwari,
Associate Professor, Department of Pharmacology, B. J. Government Medical College and Sassoon Government Hospital, Pune-411001, Maharashtra, India.
E-mail: drsmitamd@gmail.com

Abstract

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.

Keywords

Cost variation, Diabetes mellitus, Drug price, Insulin analogues, National pharmaceutical pricing authority, Pharmacoeconomics

Pharmacoeconomics is defined as “the description and analysis of the cost of drug therapy to health care system and society”. It identifies measures and compares the cost and consequences of pharmaceutical products and services (1). Cost analysis is a type of pharmacoeconomic evaluation in which comparison of costs of two or more alternative medication is made without regard to outcome (2),(3). Individual drugs have great cost variation in the market which may directly influence the patient compliance (4),(5),(6).

Compliance is defined as the extent to which a patient follows a regimen prescribed by a healthcare professional. Compliance in a patient is a composite outcome of various patient and drug related factors like age, financial status, market availability of medication, dosing frequency, adverse effects, etc., (7). Poor or non compliance not only affects the clinical outcome but also increases healthcare costs (8). Interventions and regulations of drug prices can improve the accessibility and affordability for everyone (9). This implies the need for cost analysis of available drug formulations, which may promote the practice of selecting affordable alternatives while prescribing (10). The consideration of the cost of treatment for ailments is an important aspect of health economics (11). In the Indian scenario, a majority of the healthcare costs are borne by the patients and India is one of those countries that have the highest Out-Of-Pocket (OOP) expenses on healthcare. A significant portion of this health expenditure is on medicines (12).

Diabetes mellitus is associated with significant human and economic burdens. Diabetes is the leading cause of adult onset blindness, end stage renal disease, and non traumatic amputation and is a major contributor to cardiovascular disease (13). The treatment of diabetes involves a combination of various interventions, with the primary aim to achieve the best glycaemic control with minimal side effects (14). Insulin is an essential medication in the management of type I diabetes and in certain cases in type II diabetes too (15),(16).

A Diabetes Outcome Progression Trial (ADOPT) showed that the incidence of monotherapy failure at five years in patients with type II DM was 34% for glyburide and 21% for metformin (17). Patients with diabetes have per capita medical expenses 2.3 times higher than their non diabetic counterparts (18).

Insulin is available from various sources (animal, recombinant human, analogues), have variable strengths (40, 100 IU/mL) and different delivery vehicles (phials, cartridges, pens). Insulin preparations (e.g., insulin lispro, insulin aspart, insulin glargine and insulin degludec) are the most recent advancement in insulin therapy, attenuating many of the common barriers to traditional insulin use. The use of new insulin products, that lessen the clinical barriers to insulin use, have also demonstrated potential to reduce the overall healthcare economic burden associated with diabetes management (19).

Cost effective management of diabetes with insulin therapy has been shown to improve glycaemic control in poorly controlled type 2 DM patients, without adversely affecting the quality of life (20). Despite having a century old experience with the discovery of insulin, it unfortunately is still not available and/or affordable for millions of diabetic patients world-over.

Generally, in India most of the diabetic patients seek private medical consultation and treatment for their medical condition that adds to their financial burden in the form of out of pocket payments for health care. Taking in view this aspect, it is therefore essential to estimate the availability and cost variation of insulin and its analogues (21).

The NPPA was established in 1997 for ensuring availability and affordability of the drugs (22). Drug Price Control Order (DPCO) issued by NPPA fixes the ceiling price of a scheduled formulation of any brand or generic drug of a pharmaceutical company having more than or equal to one percent share in the market. Currently, only three insulin preparations are covered under DPCO (22).

As antidiabetic treatment is required lifelong, it contributes to the economic burden on patients (23). A decreased drug cost is associated with improved adherence to the medication regimen (24). This study was aimed at investigating and comparing the costs of various brands of the insulin preparations to observe the cost variations among them.

Material and Methods

This observational cross-sectional study was carried out after approval from Institutional Ethics Committee (BJGMC/IEC/Pharmac/ND-DEPT
1219258-258). Data was collected from 15 January 2020 to 15 February from various sources namely CIMS, NPPA official website of Government of India and website for “medguideindia” (25),(26),(27).The further data refining and analysis were done over additional two months, till April 2020.

In the current study, insulin preparations manufactured by more than one company were considered. The study included price of insulin preparation dispensed in vials only. The newer insulin preparation manufactured by a single company and insulin preparations with no cost information available were excluded. Insulin preparations available in newer drug delivery systems were not considered for this study.

Prices of insulin preparations of different strength available in India were noted from:

(a) CIMS (25)
(b) NPPA, GoI official website (26)
(c) Website for “medguideindia” (27)

Unit prices (per 10 mL) were expressed in Indian Rupee (INR) of drug formulations and compared with DPCO price list 2013 (Price Revision w.e.f. 1.4.2019) (22). The cost ratio and percentage cost variation were noted for each brand. The prices of 18 insulin preparations, available in 116 different products were analysed as:
1. Cost of a particular insulin preparation (cost per 10 mL), in the same strength and dosage forms being manufactured by different companies was obtained to identify the price (in INRs) of various brands of insulin preparation- i.e., Minimum price (INR), and maximum price (INR) (of a particular insulin preparation manufactured by various pharmaceutical companies in the same strength).
2. The cost ratio, the ratio of the highest cost brand to lowest cost brand of the same insulin preparation was calculated. This calculation gives an assessment for the ratio of cost variation of the most expensive brand from the cheapest insulin preparation. This tells, how many times costliest brand costs more than the cheapest one in each insulin preparation group (28).

Statistical Analysis

The data collected was entered in Microsoft Excel 2018. Cost ratio and percentage cost variation were calculated. The data was presented in the form of tables as percentages.

Results

The cost of a total of 116 insulin preparation formulations was analysed. The insulin formulations for which more than five preparations are available in the Indian market are as that shown in (Table/Fig 1).

A noticeable variation in the prices of insulin preparations was observed in the current study. As per study protocol when the maximum and minimum rates were compared for the respective insulin preparations, the highest percentage of cost variation was noticed for Insulin (Highly Purified) Zinc-40 IU (135.17%). The second preparation with high cost variation was Insulin (analogue) Glargine-100 IU (109.31%), which was closely followed by Insulin (Highly Purified)-40 IU (105.98%).

There were four insulin preparations that had low cost variation i.e. less than 10%. The lowest cost variation was seen with Insulin (Human - Isophane Recombinant)- 40 IU i.e., 1.40%. Insulin (Analogue) Aspart-100 IU had a cost variation of 6.26%. Other preparations like {Insulin (Human Recombinant)- 40 IU had a cost variation of 7.51% and that of Insulin (Human)-40 IU was 9.92%, which was less than 10% or rather low cost variation. Cost variation of preparations like Insulin (Human)-30%/Insulin (Human-Isophane)-70%-40 IU was 13.23% and Insulin (Human)- 100 IU was 25.64% which were low but more than 10% and limited to 25% only (Table/Fig 2).

It was observed that Insulin (highly purified) Zinc-40 IU had a cost ratio of 2.35 i.e., the costliest brand (Rs. 218) of this preparation was 2.35 times costlier than the cheapest brand (Rs. 92.7) of the same formulation available in the Indian market. The other two insulin preparations that had such cost ratio of two and more were Insulin (analogue) Glargine-100 IU (2.09) and Insulin (highly purified)-40 IU (2.06).

There are three other insulin preparations that had cost ratio of more than 1.5. Premix Insulin (human)-30%/Insulin (human-Isophane)-70%-100 IU had a cost ratio of 1.85, Insulin (highly purified) Isophane (NPH)-40 IU and Insulin (highly purified)-30%/Insulin (highly purified) Isophane (NPH)- 70%-40 IU also had a cost ratio of more than 1.5.

In the short acting insulin preparation group, Insulin (highly purified)- 40 IU had a highest cost variation of 105.98%, where the cheapest brand of this preparation costed Rs. 90 and the costliest one was available for Rs.185.38. Similarly, the lowest cost variation was observed with Insulin (human recombinant) -40 IU which was around 7.51% (Table/Fig 3).

It was observed that in intermediate acting insulin preparation group, Insulin (Highly Purified) Zinc-40 IU had highest cost variation of 135.17%, where the cheapest brand of this preparation costed Rs. 92.7 and the costliest one was available for Rs. 218. Similarly lowest cost variation was noted with Insulin (Human-Isophane Recombinant)- 40 IU which was 1.40% (Table/Fig 4).

According to DPCO 2013 (w.e.f. 01.04.2019), Premix Insulin 30:70 Injection (Regular:NPH) (40 IU), Insulin (Soluble) (40 IU), Intermediate Acting (NPH) Insulin (40 IU) prices were under price control by NPPA, Government of India. Yet, intermediate acting (NPH) Insulin (40 IU) had cost variation of 30.41% with DPCO ceiling price (Table/Fig 5).

Discussion

This study was carried out with the objectives of computing the costs and percentage price variation among insulin preparations across the different brands available in the Indian market. The study findings reveal that among the different insulin preparation, three formulation have price variation of more than 100%, only five <15%.

Highest price variation was seen with Insulin (Highly Purified) Zinc-40 IU, Insulin (analogue) Glargine-100 IU. Newer drug delivery system are available as disposable pens, flexpens, prefilled pens, kwikpens, catridges and flextouch. Such novel drug delivery systems are lucrative and user friendly, but offer an additional financial burden. Such modalities of therapy may not be pocket-friendly for patients with lower socioeconomic status.

Cost variation issues are not only limited to insulin preparations but also are seen regarding available preparations of antiasthamatics (29), antidepressants (12), antihypertensives (30), dyslipidaemic drugs (31). Similar cost variation study done by Mehani R and Sharma P, for various antidiabetic drugs available in Indian market showed maxiumum variation with sulfonylureas which is the most commonly used oral hypoglycaemic and minimum was observed with meglitinide analogues (32).

According to DPCO 2013 (w.e.f. 1.4.2019) Only Premix Insulin 30:70 Injection (Regular:NPH) (40 IU), Insulin (Soluble) (40 IU), Intermediate Acting (NPH) Insulin (40 IU) prices are under price control by NPPA, Government of India. These are also included in national list of essential medicine, 2015 as well as in World Health Organisation (WHO) essential medicine list for adults, 2019 (40 IU,100 IU in 10 ml vial), (except Premix Insulin 30:70 Injection (Regular:NPH)) (33). Therefore, prices of all insulin analogues available in the market are not controlled by DPCO of India (22).

Medicine pricing plays a significant role in a developing country like India. This situation is further complicated by the number of branded formulations for different drugs. The price of medicine in India is regulated by DPCO issued by Government of India through the official gazette. This in turn is implemented by NPPA. This helps in regulation of prices of various essential drugs mentioned in the National Essential Drug List.

There is a great price variation between different brands of the same drug and some drugs still cost more than the prescribed limits by DPCO (34),(35). The price variation can be due to different factors like cost of the ingredients, methods used in preparation of drug, procurement mechanism in public and private pharmacies. In the government sector, procurement is made directly from pharmaceutical manufacturers recognised by the government or from government established manufacturing facilities, whereas in the private sector there is multi-layered procurement mechanism leading to increase in price of medicine brought by consumer (patient) (36). According to Singal GL et al., a substantial margin of 25-30% can be gained in the sales of branded medicine in private retail pharmacy. This profit margin rises to a whooping range around 200% to more than 1000% in case of branded generics (37). Interestingly, a cost ratio of two or more and percentage of price variation more than 100 are worrisome and assume significance. Such prevalent factors contribute to unaffordable healthcare (38).

The penalty for selling drugs at prices over and above the ceiling price or that notified by the government, is relatively mild. The manufacturers only need to deposit the overcharged amount in addition to the interest from the date of such an event. Thus, Government policy towards the pharmaceutical companies is not too stringent, as it may adversely affect the production of drugs under DPCO regulation, as it is a well known fact that less profits hamper the pharmaceutical industry growth (39). Therefore, rational and pharmacoeconomical prescribing practices by physicians is an alternative for providing cost-effective therapy (40).

It has been observed that there is lack of appreciation among the physicians for the cost difference between the inexpensive and expensive drugs (41). This can result in increased overall health care costs. Such factors can be improvised by imbibing the concepts of pharmacoeconomic at the undergraduate and postgratudate curriculum in practical sessions (42).

According to WHO Bulletin 2015, an estimated 8% of the Indian population had been pushed below the poverty line by high OOP payments for healthcare (43). Most of the insulin analogues are prescribed on an outpatient basis. Studies have shown that increase in “out of pocket spending” from patients and this may affect drug compliance and add to the cost of the drug making it difficult to reach a broad fraction of the population (44).

As appropriately commented by Rataboli PV and Dang A in their study, Government should include lifesaving and essential drugs (barring innovator products) under the DPCO (45). The Government of India on 25th November 2008 had started the Jan Aushadhi Campaign. Numerous ‘Jan Aushadhi Medical Stores” were opened in India as an initiative for providing affordable drugs without compromising on quality. This scheme was later renamed as “Pradhan Mantri Bhartiya Janaushadhi Pariyojana” (PMBJP) (46). Increasing market competition, particularly from Indian companies through by opening up the option of lower priced quality assured biosimilars can provide a ray of hope to improve insulin access and affordability (47).

At the global level the WHO announced the start of a pilot programme to prequalify human insulin on 13 November 2019. Prequalification of Medicines Programme devised by WHO accelerates and increases access to critical medical products that are quality assured, affordable and adapted for markets in low and middle income countries (48).

Limitation(s)

The study did not compare cost of all the insulin preparation available in newer drug delivery system as such preparations that are not covered under DPCO. The costs computed also purely reflect drug cost and is not a complete estimate of health care expenditure in diabetic patients.

Conclusion

The DPCO implemented by NPPA helps in regulation of prices of drugs mentioned in the national essential drug list. Despite of the regulation, there is a huge price variation is present between different brands of the same drug although capped by DPCO. A noticeable variation in the prices of insulin preparations was observed in the current study. The highest percentage of cost variation and cost ratio was noticed for Insulin (Highly Purified) Zinc-40 IU followed by Insulin (Analogue) Glargine-100 IU. The lowest cost variation was seen with Insulin (Human- Isophane Recombinant) 40 IU as the cheapest brand had a higher cost than the conventional insulin counterpart and for similar reasons lowest cost variation was observed with Insulin (Human Recombinant)-40. Initiatives are taken at national and global levels to make such a vital medication affordable and accessible to patients of all economic background all over the world.

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DOI and Others

10.7860/JCDR/2021/48116.15107

Date of Submission: Dec 13, 2020
Date of Peer Review: Jan 14, 2021
Date of Acceptance: Apr 07, 2021
Date of Publishing: Jul 01, 2021

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? No
• For any images presented appropriate consent has been obtained from the subjects. No

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