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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
Original article / research
Full Version
The Indian Battle of Selecting a Brand versus Generic Medicine Continues: A Cost Variation Study of Oral Fluoroquinolones
Correspondence Address :
Shrikant Manwatkar,
P165/4, Golden Jubilee Officers Enclave, Command Hospital Air Force, Bengaluru-560007, Karnataka, India.
E-mail: shrikantxy@gmail.com
Introduction: According to the World Health Organisation (WHO), the rational use of medicine occurs when the medication received by the patient is appropriate to the clinical need, at the proper dose, for the appropriate duration and at the lowest cost that the patient can afford. Fluoroquinolones are widely prescribed medications in India. After being included in the Drug Price Control Order (DPCO) list and having ceiling prices set for a few fluoroquinolones, there is a need to assess the pricing of fluoroquinolones in the market.
Aim: To evaluate the cost variation of different brands and generic medicines of oral fluoroquinolones and their combinations in India.
Materials and Methods: A cross-sectional descriptive analytical study was carried out in December 2022 and August 2024 as a follow-up to observe improvements in the situation. Authors from different locations in India (Command Hospital, Air Force, Bangalore; AIIMS Gorakhpur; and INHS Ashvini) collaborated to utilise commercial drug directories for the study. The costs of specific oral fluoroquinolones were obtained from the “Current Index of Medical Specialties (CIMS) April – July 2022 and Drug Today April – July 2022,” as well as the latest CIMS April – July 2024 and Indian Drug Review May – June 2024, which are all authentic commercial drug directories. To compare the prices of branded drugs with the corresponding generics, the prices of the generic formulations available in Jan Aushadhi Kendra (JAK) were used.
Results: In 2022, Norfloxacin (400 mg) and Tinidazole (600 mg) had the highest percentage variation (3,233.33%), followed by Ofloxacin (200 mg) and Ornidazole (500 mg) with 2,364.28%. In 2024, the percentage cost variation was highest for Ofloxacin (200 mg) and Ornidazole (500 mg), with 1,029.73%, followed by Norfloxacin (400 mg) and Tinidazole (600 mg). In 2022, 16 out of 25 formulations showed more than 100% variation.
Conclusion: A wide cost variation in the formulations of oral fluoroquinolones was noted. There is a need to sensitise all stakeholders to this cost variation in order to achieve the goal of safe, affordable and effective medications for all.
Affordable, Drug, Medication, Pharmacoeconomics, Rational
The WHO defines the rational use of medicine as the provision of medication that aligns with the patient’s clinical needs, administered at the correct dosage, for the appropriate period and at the lowest cost affordable to the patient (1),(2). Hence, cost consideration by the prescriber is an important criterion, along with other criteria of rational prescription, while achieving an affordable therapeutic cure. India is known as the “pharmacy of the world” (3). The Indian pharmaceutical industry encompasses around 3,000 drug companies and more than 10,500 manufacturing units (4). There are over 60,000 generic brands across 60 therapeutic categories available (5). Indians consume Rs. 56,000 crore in medicines through private pharmacists (6). The second leading cause of rural debt in India is healthcare, after dowry (7),(8). Although not universal, the Medical Council of India (MCI) recommends that doctors write generic prescriptions (9). The prescribing doctor expects a certain treatment outcome. The doctor must protect the patient by prescribing an affordable, good-quality generic or brand that matches their needs (10). Otherwise, therapy may fail. Failure to comply due to the cost of an unaffordable brand could result in antibiotic resistance or failure to treat infectious diseases (11).
Fluoroquinolones are among the most valuable and widely used antibiotics. About 30% of the global pharmaceutical market consists of fluoroquinolones. Levofloxacin and ciprofloxacin account for 65% ($3.3 billion) of fluoroquinolone sales (12). The National Pharmaceutical Pricing Authority (NPPA) of India has imposed a ceiling on drug costs via the DPCO to regulate soaring drug prices. Pharmaceutical companies can only price drugs below the ceiling set. The 2024 DPCO list includes levofloxacin, ciprofloxacin, moxifloxacin and ofloxacin. JAK is an Indian government program that provides affordable generic medications, helping to make healthcare more affordable in India (13).
In India, cost variation studies are scarce (14),(15),(16). Few research studies have investigated fluoroquinolone cost variation in the past (17),(18),(19),(20), highlighting the issue of high variation. After the inclusion of certain fluoroquinolones in the DPCO list (13) and the setting of ceiling prices, an assessment of the situation is necessary as it will provide insight into current conditions. In this first-of-its-kind study, a situation analysis is being conducted in 2022 and will be compared to data from 2024. Additionally, none of the studies have compared cost variation with the prices set by the NPPA list in India. Hence, a study was planned to evaluate the cost variation in oral fluoroquinolone brands and generics available in India, either as a single drug or in combination. This study aimed to evaluate the difference in the cost of various brands of specific fluoroquinolones with respect to cost ratio and percentage variation in costs between the years 2022 and 2024. The secondary objectives were to determine if generic drugs were cheaper than brand-name drugs and to compare price differences with the maximum prices set by the DPCO for the medicines on the list for 2022 and 2024.
A cross-sectional descriptive analytical study was carried out between December 2022 and August 2024 to provide a perspective on the latest information across the two-year study period. Authors from different locations in India collaborated to use commercial drug directories for the study. The research was conducted at Command Hospital (Air Force) in Bengaluru, Karnataka, India. Ethical committee clearance was obtained (IEC Certificate No: CHAFB/IEC/77/2024) for the study.
Data collection: The costs of oral fluoroquinolones, both as single medications and in combinations, of the same strength and dosage form manufactured by different companies were obtained from the CIMS for April to July 2022 (21) and “Drug Today” for April to July 2022, along with the latest CIMS for April to July 2024 and “Indian Drug Review" for May and June 2024. All of these are authentic commercial drug directories (22),(23),(24). The Bureau of Pharma PSUs of India (BPPI) websites were reviewed for generic drug pricing to compare branded and generic prices (25). This study utilises JAK for generic medication costs. The ceiling costs of fluoroquinolone tablets were taken from the NPPA list for April 2022 and May 2024 and compared to the maximum prices after extrapolating for 10 tablets (26),(27). The difference between the maximum and minimum prices of drug formulations manufactured by different pharmaceutical companies was calculated, along with the cost ratio and percentage of cost variation (17).
Cost ratio= Maximum cost/ Minimum cost
Percentage of cost variation was calculated as follows:
% Cost variation=Maximum cost - Minimum cost×100/ Minimum cost
Statistical Analyis
A simple descriptive analysis was performed on all the data collected, which was entered into Microsoft 365 (Version 2407) Excel spreadsheets.
(Table/Fig 1) illustrates the cost variation of oral fluoroquinolones in INR (Indian Rupees), cost ratio and percentage variation in cost from 2022 to 2024. Of the 25 drug formulations, levofloxacin 500 mg exhibited the greatest variance, at 11,048.64% in 2022 and 2,080.18% in 2024, with the cost for 10 tablets being Rs. 8.80 (2022) and Rs. 45.00 (2024) and Rs. 981.08, respectively. From 2022 to 2024, this broad fluctuation improved dramatically (11,048.64% vs. 2,080.18%). Although the variation is still considerable, it indicates a false positive change towards the improvement of variation. The minimum cost for levofloxacin has increased from Rs. 8.80 to Rs. 45.00, while the maximum price has remained the same. Hence, despite the percentage variation decreasing from 11,048.64% to 2,080.18%, this does not represent a true improvement. Only 4 of the 25 formulations had less than 25% cost variance in 2022 and none of the formulations in 2024 had a variance of less than 25%. The cost ratio and percentage variation are improving; however, the overall scenario remains comparable.
(Table/Fig 2),(Table/Fig 3) compares JAK generic prices to the minimum and maximum costs for 10 tablets of each formulation. In 2022, five JAK (generic) formulations cost less than their branded counterparts, one was equally priced and two were more expensive. In 2024, JAK generics of six formulations cost less than the branded versions, while two branded formulations were cheaper than their generic counterparts. This shows that generics were cheaper than the minimum branded prices for ciprofloxacin 250 mg, levofloxacin 250 mg, moxifloxacin 400 mg, ofloxacin 200 mg and ofloxacin 400 mg in both 2022 and 2024. However, in 2022, the price of ciprofloxacin 500 mg was equal to the minimum branded price and in 2024, the generic was not cheaper than the minimum branded price. For levofloxacin 500 mg, the generic was not cheaper than the branded version in 2022, but it was cheaper in 2024, whereas for norfloxacin 400 mg, the situation was reversed.
(Table/Fig 4) displays the minimum and maximum costs per 10 tablets in INR, cost ratio and percentage cost variation of oral fluoroquinolone combinations in various formulations. Twenty-five formulations were noted. In 2022, norfloxacin 400 mg and tinidazole 600 mg had the highest percentage variation (3,233.33%), followed by ofloxacin 200 mg and ornidazole 500 mg with 2,364.29%. In 2024, the highest percentage cost variation was observed for ofloxacin 200 mg and ornidazole 500 mg, at 1,029.73%, followed by norfloxacin 400 mg and tinidazole 600 mg. In 2022, 16 of the 25 formulations showed more than 100% variation. The percentage difference is improving and there are numerous combinations that are currently unavailable.
(Table/Fig 5) compares JAK generics to the minimum and maximum costs of 10 pills for branded formulations of oral fluoroquinolone combinations. In both 2022 and 2024, only one generic formulation was priced lower than the minimum cost of the branded formulations. One generic formulation, namely moxifloxacin 400 mg and cefixime 400 mg, was exclusively available through JAK and was not listed in drug formularies; hence, it could not be compared.
(Table/Fig 6) compares oral fluoroquinolone formulations on the NPPA list for April 2022 and May 2024, detailing the maximum cost per 10 pills and ceilings in rupees. The cost of all formulations, except for moxifloxacin 400 mg and cefixime 400 mg, listed by the NPPA in April 2022 exceeded the ceiling pricing, as they were not included in the drug formularies in 2024.
(Table/Fig 7) illustrates the comparison of cost variation for oral fluoroquinolones included in the NPPA list for April 2022 and May 2024, along with their ceiling prices, in a visual manner.
In India, different pharmaceutical companies, including the manufacturers, sell the same drug under various brand names. This results in a single formulation being available under different brand names and at different prices. Few studies have examined the cost variance of medication formulations available in the market. The significant cost variance of medications has puzzled prescribing clinicians, who presume that cheaper formulations may lack pharmacological efficacy (28) and may fail to treat disorders (29). Therapy failure can lead to patient distrust of the clinician and to health consequences that could have been prevented if the medication were not counterfeit. In 2021, many pharmaceuticals failed to meet FDA quality standards, resulting in the cancellation of licenses for 46 Indian pharmaceutical companies (30). Patients may lose wages and incur out-of-pocket costs if they opt for a more expensive brand. High drug costs can lead to non compliance, therapeutic failure and antibiotic resistance, especially in the case of fluoroquinolones.
According to Article 21 of India’s Constitution, every individual has the right to health care (31). The Indian government has consistently provided this right. The DPCO governs drug prices in India. The government issues the DPCO under Section 3 of the Essential Commodities Act, 1955, to set and regulate the prices of essential bulk drugs and their formulations. The NPPA regulates the prices of medicines in India (13). It periodically adjusts the prices of controlled bulk medications and formulations. The NPPA also recovers overcharges and regulates the pricing of decontrolled medicines.
The recent NPPA list allows pharmaceutical companies to set prices below the ceiling (4). As a result, these medicines should be sold at lower prices. The latest NPPA list was issued in May 2024 and on April 22, prior to present study analysis. Present study investigation indicated that all formulations with NPPA list ceiling prices from April 2022 had prices that exceeded the CIMS and IDR ceiling prices from April to July 2022. A similar situation was observed in 2024.
Despite efforts to control drug pricing, certain studies have found considerable cost disparities for various pharmaceuticals of pharmacoeconomic relevance in India. Hetawal P et al., found substantial cost variations for fluoroquinolones in their analysis conducted in 2021 and 2022 (18). A similar trend was observed in present study. Six of the seven fluoroquinolones on the NPPA list in April 2022 (10 out of 11 formulations) had prices above the ceiling. This was also true for moxifloxacin 400 mg and cefixime 400 mg, which were exclusively available through JAK, a government initiative. Upon reassessment in 2024, present analysis found no changes in this situation. No studies were found comparing fluoroquinolone cost variation to NPPA list prices.
Present study discovered a notable improvement in price variation from 2022 to 2024; however, the cost variation was still far from achieving the dream of affordability and the expected ceiling prices set by the NPPA. Chawan VS et al., observed a similar issue in 2015 in their research titled “Fluoroquinolones in India: Are We Prescribing It Right? A Cost Variation Study” (17). Dhanvijay PV and Manwatkar SK obtained similar results in 2020 (19). This situation is concerning in India, the “pharmacy of the world” and a developing nation. India did an excellent job of distributing COVID-19 vaccinations internationally at a low price, demonstrating that Indians can afford high-quality, non spurious drugs.
The promotion of generic pharmaceuticals is an effective alternative strategy to lower patient medication costs. Generic medications are claimed to be the same as and bioequivalent to brand-name drugs in terms of dosage, intended use, effects, side-effects, route of administration, risks, safety and strength. However, the efficacy and bioequivalence of generic drugs have been questioned in comparison to branded drugs. In 2008, India launched the Jan Aushadhi Scheme to provide cheaper generic medications to the public. Jan Aushadhi generics are reported to have comparable therapeutic efficacy to branded medications. However, there is a common misconception that generic medications are always inexpensive. Present study observations indicated that not all JAK formulations were the cheapest. Hetawal P et al., and Atal S et al., found similar results [18,32].
Prescribers’ skepticism regarding the efficacy of generic drugs must be addressed [33,34]. Regular quality assurance studies can determine the exact drug content in the claimed product and formulation drug content analyses are essential to rule out counterfeit pharmaceuticals. This approach will help make safe, inexpensive and effective pharmaceuticals accessible to everyone.
Incorporating pharmacoeconomics as a practical lesson in undergraduate and postgraduate medical curricula, where students compute the cost of their prescriptions, may assist them in understanding its implications and fostering the necessary mindset. Information about bioequivalence should be included in CIMS and IDR books, along with cost data. Increasing public awareness of this significant price range will help healthcare providers, payers, government agencies, policymakers and pharmacists to collaborate and take action.
Limitation(s)
This analysis utilised ready reckoner drug formulary pricing. Since these are Maximum Retail Prices (MRPs) and do not include pharmacy discounts or exemptions, the actual market rates at which these pharmaceuticals are supplied to consumers remain unknown. Additionally, the materials may lack certain drug brands.
There is a wide cost variation in the formulations of oral fluoroquinolones in India in the years 2022 and 2024. The costs of all the formulations of oral fluoroquinolones listed in the NPPA list of April 2022 and the NPPA list of May 2024 were not within the set ceiling prices. Although improvements have been observed, we are still far from the goal of affordable medication for all, as outlined by the ceiling prices set by the NPPA. There is a need to sensitise all stakeholders to achieve the vision of safe, affordable and effective medications for everyone. Future studies should be conducted at regular intervals to assess the situation and any improvements in the cost variation of this essential medicine, fluoroquinolone, to ensure that healthcare is accessible and affordable to those in need.
DOI: 10.7860/JCDR/2025/75332.20734
Date of Submission: Sep 08, 2024
Date of Peer Review: Nov 21, 2024
Date of Acceptance: Dec 19, 2024
Date of Publishing: Mar 01, 2025
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? NA
• For any images presented appropriate consent has been obtained from the subjects. NA
PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Sep 16, 2024
• Manual Googling: Dec 14, 2024
• iThenticate Software: Dec 17, 2024 (12%)
ETYMOLOGY: Author Origin
EMENDATIONS: 7
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