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Background: Hypertension is a chronic disease and is a major risk factor for chronic heart disease, stroke, coronary heart disease, and its complications include heart failure, peripheral vascular disease, renal impairment, retinal hemorrhage, and visual impairment. Antihypertensive drugs are important to avoid such complications but compliance of patient is needed which may depend on the cost of therapy. Aim and Objective: This study aimed to assess the efficacy and safety of a branded generic with an economical generic. Materials and Methods: Out of 110 patients, 105 patients (53 patients in group A and 52 patients in group B) completed the study with follow-up over a period of 6 months. Group A patients received generic Telmisartan 40 mg in the beginning (0th day) which was continued for 12 weeks, cross-over was done with branded generic Telmisartan (Telma 40) which was given for further 3 months. Group B patients received the branded generic followed by generic Telmisartan in that sequence for 3 months each. Blood pressure (BP) was recorded at the baseline visit and at the end of 4, 8, 12, 16, 20, and 24 weeks. The adverse events were assessed throughout the study period. Results: Intra-group comparison show significant reduction in systolic (SBP) and diastolic BP (DBP) in each groups (P < 0.001) but when we compare the reduction of SBP and DBP in between the two groups the difference was not significant. Common adverse events were headache, dizziness, light-headedness, and vertigo. Conclusion: There was a huge difference between the prices of branded generic and unbranded generic. This study showed that both branded generic and unbranded generic are comparable in terms of efficacy, safety except the cost of therapy. Thus substitution of a Pharmacological generic (unbranded generic) drug could save lot of expenses.
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Coronavirus pandemic has brought forth the urgency of providing affordable health care to everyone. Generic medicines are often one-fourth to one-tenth of the cost of the branded drugs, and so offer a remarkable opportunity to significantly lower the health-care expenditure. However, the argument for promoting generic medicines is indisputable, we have to think about the other enabling conditions which are necessary for a successful health policy on encouraging generics without causing unintended adverse repercussions. This paper attempts to answer such questions by considering the motivations of the various stakeholders of the broader health services ecosystem in India and undertaking a systematic analysis of the winners and losers from such a policy. We argue that generic prescription will not be successful without prior improvement in the state capacity for quality control of drug manufacturing; rise in awareness among the doctors, patients, and pharmacists; improved trust in the medical systems; and innovative demand-side interventions.
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Background: Medicines play a main role in the process of human development. The rational utilization of medicines can decrease morbidity and mortality as well as improve quality of life. In an era of steeply rising health care expenses, generic medicines provide a less expensive alternative to branded medicines. Use of generic drugs can contribute to substantial savings in medicines expenditure and the issue of access and affordability is thus addressed.Methods: A sample of 500 patients selected from out patient department was randomly selected. A self-instructed questionnaire was used for the study for the duration of 1 month. Data was analyzed using IBM SPSS statistics Version 20 New York, United States. Summary statistics were expressed using mean and standard deviation (SD) for numerical variables (median and interquartile ranges [IQRs] when skewed) and counts and percentages for categorical variables.Results: Participants reported with 17.23% knowledge score, 40.65% attitude score, and 7.96% attitude score.Conclusions: In the study it was found that there is significant correlation between knowledge and attitude whereas no correlation was found between knowledge and practice regarding usage of generic drugs.
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Background: Generic substitution is preferred to reduce healthcare costs and improve patient adherence. The review of literature showed that physicians all around the world were not comfortable in prescribing generic medications due to the lack of evidence on their safety and efficacy.Methods: A prospective study was conducted over a period of one year in Pune. The patients were categorized on their age and were assessed for the clinical effectiveness data (no. of breakthrough seizures and seizure free days) and safety data (no. of ADR episodes). The mean number of patients controlled and the frequency of adverse events at the 3rd and 6th month were calculated.Results: Authors assessed 150 newly diagnosed pediatric epileptic patients who received anti-epileptic drug monotherapy for at least 6 months, out of which 46 (30.66%) received Oxcarbazepine and 104 (69.33%) received Sodium Valproate. At the end of 3 months of therapy 140 (93.33%) patients were seizure free and 145 (96.66%) patients were seizure free at the end of 6 months. Adverse effects were observed in 14 (30.43) patients on oxcarbazepine and 26 (25%) patients on sodium valproate. The most common adverse effect was weight gain in 34 (22.66%) patients with both the AEDs.Conclusions: Seizure control was achieved in majority of the patients. In addition to the seizure control, the frequency of adverse effects was few and tolerable by the patients when prescribed with low cost branded generics.
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Background: There is much debate regarding the importance of promoting the use of cheaper generic alternatives over brand-name drugs. While generic drugs have been noted to be comparable to brand-name drugs in their ability to treat conditions, significant debate surrounding their bioavailability or the concentration of the drug that reaches its site of action has arisen. Many experts continue to believe that generic and brand-name drugs are bioequivalent and equally viable options for effective drug treatment, as assumed in this review.Methods: Prices of commonly used branded and generic medicines in same concentration, dosage form and combination were compared with the help of Indian Drug Review, brochures of pharmaceuticals and pharmacies and Jan Aushadhi price list 2017. Mean of all the prices available of branded and generic medicine were calculated and the percentage difference in the mean costs of generic and branded medicines were calculated.Results: The mean cost of 47 branded medicines out of the selected 50 medicines was higher than their generic versions. Mean cost of 3 generic medicines was higher than branded ones. Percentage difference in the mean costs of branded and generic medicines varied from <10% to >70%.Conclusions: This study has shown a very noteworthy difference of prices between branded and generic drugs. Efforts should be taken to promote the generic medication. Misconception about low efficacy with generic drugs should be erased.
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Background: In an era of rapidly rising health care costs generic medicines provide a less expensive alternative to branded medicines. In addition to reducing the overall health care expenditure, it has been shown to improve adherence. Objective was to study knowledge and perception about generic drugs among patients coming to outpatient department of tertiary care centre.Methods: After ethical approval a cross sectional questionnaire based study was conducted. Patients (n=71) were interviewed according to questionnaire in vernacular language by investigator to fill questionnaire.Results: About 28% people think that price of generic drug is less than a branded drug while nearly 61% of people don’t know of it. Only 18.85% participants had taken generic medicine. Trusting efficacy of generic drugs only 30 participants were in favour it. Even they have not seen or heard publicity of generic drugs (61.97%). They (60.56%) opined that generic drugs never prescribe in our country.Conclusions: Limitation in knowledge and perception about generic medicines has been seen among participants.
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Background: The aim was to study the prescribing patterns of clinicians working in two different settings i.e. Teaching clinicians (clinicians working in teaching hospital) and Non-teaching clinicians (clinicians involved only in private practice).Methods: A comparative cross sectional study was carried out for a period of 6 months in two settings. The study is confined to teaching clinicians comprising of qualified medical practitioners in ACSR Government Medical College (ACSR GMC) and Non-teaching clinicians of qualified medical practitioners in private health sector (PMPs). 450 prescriptions were collected from clinicians belonging to various departments of ACSR GMC and 450 prescriptions from private practitioners of Nellore city. Data was coded and entered in MS Excel. Data was analyzed on EPI INFO version 3.5.4.Results: In this study it was found that teaching clinicians prescribed 146 (12.85%) drugs by generic name, whereas non-teaching clinicians prescribed 112 (8.75%) drugs by generic name.Conclusions: The findings of the present study indicate that the drugs prescribed by the generic names were remarkably less in both teaching and non teaching clinicians. This indicates a need for improving the generic prescribing patterns in both the settings.
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Background: Worldwide, Hypertension is estimated to cause 7.5 million deaths, about 12.8% of the total of all deaths. This accounts for 57 million disability adjusted life years (DALYS) or 3.7% of total DALYS. Globally, the overall prevalence of hypertension in adults aged 25 and over was around 40% in 2008.Despite its benefits, treatment of hypertension is costly. Direct medical spending to treat hypertension totalled $42.9 billion in 2010, with almost half ($20.4 billion) in the form of prescription medications. Being, a silent disease, adherence to antihypertensive drugs is poor. One of the important factors of poor adherence to antihypertensives is the cost of the drugs. There is wide cost variation among different brands of the same antihypertensive drug. Clinician’s awareness of cost of therapeutics is poor. The costly brand of same generic drug is proved to be in no way superior to its economically cheaper counterpart.Methods: The minimum and the maximum cost in Rupees (INR) of a particular antihypertensive agent manufactured by various pharmaceutical companies in the same strength were noted. The cost of 10 tablets/capsules was calculated. The cost ratio and percent cost variation were calculated for each brand.Results: The cost variation observed in the present study was as high as 2337.50 % for Hydralazine. Other significantly high cost variations found in the present study were: 1315.25% (Telmisartan+Hydrochlorthiazide), 870.58% (Amlopdipine), 558.34% (Amlodipine+Atenolol), 537.68% (Valsartan), 394.44% (Metoprolol), 344.44% (Enalapril), 316.22% (Propranolol), 300% (Lisinopril), 290.90% (Carvedilol), 289% (Cilnidipine), 271.99% ( Labetolol), 268.04% (Indapamide), 256.31% (Losartan), 255.19% (Irbesartan), 226% (Methyldopa), 223.04% (Frusemide), 209.78% (Nitrendepine), 192.08% (Terazosin), 189.25% (Atenolol), 142.42% (Bisoprolol) and 120.51% (Felodipine).Conclusions: Financial constraints are a reality in almost all aspects of medicine. Doctors must consider drug costs to their patients. Increasing pharmaceutical costs negatively impacts patients. Given the increasing healthcare costs, there is growing interest in rational prescribing, which takes costs of medication into account.
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Background: The concept of generic prescription is widely accepted in various parts of the world. Nevertheless, it has failed to gain popularity in India due to factors such as non-availability and distrust on the product quality. Aim: To study cost-effective and cost-benefit analysis of antibiotic prescription in patients who had enteric fever and were given intravenous ceftriaxone. Methods: This was a prospective observational study conducted in a tertiary care cenre at World College of Medical Science and Research, Jhajjar, Haryana. 65 patients who have been diagnosed with enteric fever and were prescribed ceftriaxone were studied and their prescriptions were analyzed. 5 brands of most commonly prescribed ceftriaxone injections were chosen to analyse cost effective and cost-benefit analysis. Results: Out of 65 patients, 40 were females and 25 were males, diagnosed with enteric fever. Maximum number of patients were seen between age group of 36-50 years (38) and minimum patients belonged to age group of more than 65 years. Analysis of prescriptions revealed that majority of the patients were prescribed Branded drugs 53 (82%) than were prescribed generic drugs 12 (18%). The analysis of the cost of single dose of inj. ceftriaxone revealed that branded drugs were 8.52 % to 180.81% more in comparison with generic IV ceftriaxone. Conclusion: The cost of most commonly prescribed branded drugs was significantly higher than generic drug and prescribing branded drugs was associated with failure to take complete treatment as prescribed by treating physician.
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Background: To study cost-effective and cost-benefit analysis of antibiotic prescription in patients who had enteric fever and was given intravenous ceftriaxone. Methods: This was a prospective observational study conducted in a tertiary care hospital. 200 patients who have been diagnosed with enteric fever and were prescribed ceftriaxone were studied and their prescriptions were analyzed. 5 brands of most commonly prescribed ceftriaxone injections were chosen to analyse costeffective and cost-benefit analysis. Our study showed that there was a major difference of prizes between generic and 5 most commonly prescribed brands of the same drug. Use of branded drugs was associated with increase cost of treatment and in many cases was responsible for failure to take complete treatment as prescribed by treating physician. Results: This Study was conducted on 100 patients, 68 males and 32 females, diagnosed with enteric fever. Out of these patients Maximum number of patients were seen between age group of 30-40 years (34) and minimum patients belonged to age group of more than 60 years (8). Analysis of prescriptions revealed that 80 patients were prescribed Branded drugs and 20% were prescribed generic drugs. Out of these 80 patients who were prescribed branded drugs most common 5 brands were studied. The analysis of the cost of single dose of inj ceftriaxone revealed that branded drugs were 3.12 % to 200.84 % more in comparison with generic IV ceftriaxone. Analysis of cost of 1 day of treatment with IV ceftriaxone 1gm revealed similar figures. Total cost of treatment was Rs 595 for generic drug and 1790 for branded drug with maximum MRP. The Analysis of patients who discountinued treatment before completion revealed that most of them belonged to Brand E (30%) and minimum number of patients belonged to Generic group (5%.Conclusion: The cost of most commonly prescribed branded drugs was significantly higher (3%-200%) than generic drug and prescribing branded drugs was associated with failure to take complete treatment as prescribed by treating physician.
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In the last one decade, due to expiry of patented products as well as their exclusivity period, a drastic decline of branded pharmaceutical products and up streaming of generic drug market has been observed in developed as well as developing nations. This up rise in generic drug market is expected to rise in future till the arrival of new brand in market. This prevailing conditions could result in proliferation of generic drug manufacturing companies. The fact that generics do not undergo thorough extensive trials like innovator drugs, fuels further fears regarding their inferiority. Moreover, due to the hard competition amongst various companies to market their generics, the frequency of fraud and corruption have embarked doubts in consumers mind to reality. In order to blow away the doubts and re-establishing the credibility of generics in market, bioequivalence (BE) guidelines with stricter regulation should be the demand. The present study highlights the relevant regulatory guidelines for the conduct of bioequivalence studies in US, Europe, Canada, India, South Africa and South East Asian Nations. A comparative study of the differences in study design and specifications have also been addressed.
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Objective To compare the efficacy and safety between Chinese generic imatinib (Xinwei(R),Jiansu Hansoh Pharmaceutical Group Co.,Ltd.) versus branded imatinib (Glivec(R),Novartis) in patients with newly-diagnosed chronic myeloid leukemia in chronic phase (CML-CP).Methods Patients with newly diagnosed CML-CP were enrolled and assigned to receive either Xinwei or Glivec at an initial dose of 400 mg/d according to patients' financial capability.The efficacy and adverse effects were evaluated.Results From January 2014 to September 2015,145 eligible patients were assigned to Xinwei (n =89) or Glivec (n =56) group.All patients were treated and followed up at least 3 months.At 3 months,the complete response rates were 95.5％ (85/89) and 100％ (56/56),major cytogenetic response rates were 74.2％ (66/89) and 80.4％ (45/56),and the proportions of achieving BCR-ALBIS ≤ 10％ were 76.1％ (67/88) and 82.1％ (46/56) in Xinwei and Glivec groups respectively (all P ＞0.05).With a median follow-up of 12 months,2 patients in each group progressed to accelerate or blast phase.Hematologic and non-hematologic side effects were similar between the 2 groups.Conclusions Early hematological,cytogenetic and molecular responses between Xinwei and Glivec are comparable in newly-diagnosed CML-CP patients.The progression rate and side effects are also similar between the 2 groups.
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Background: The study was performed to analyze the extent of price variation amongst branded antihypertensive drugs in India and the relation of this price variation to number of pharmaceutical companies manufacturing/marketing these drugs. Methods: Price of different brands of antihypertensive drugs was collected from authentic sources. The data were segregated and the percentage price variation was calculated applying suitable statistical tools. Results: A total of 116 formulations from different companies representing 38 antihypertensive drugs were analyzed. Maximum price variation (3233.33%) was seen with 10 mg dose of propranolol. In general the price variations are proportionally correlated to the number of pharmaceutical companies. Conclusions: Price variation of great extent was found among many formulations. Physicians should be aware of these variations for choosing the appropriate brand for rational therapeutics. This will reduce the burden on patients and family.
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Background: Ischemic heart disease is the most common cardiovascular disease in developed countries such as United States and Angina pectoris is the most frequent among them. If not managed adequately angina results in significant morbidity and mortality too due to the complications. Antianginal therapy is lifelong. Therefore, analysis of the price of drugs used in ischemic heart disease will help to improve patient compliance. Methods: Prices of various antianginal drugs of different strengths and combinations marketed by different companies was obtained from current index of medical stores. The variation between highest and lowest price of the same medication manufactured by various pharma companies and percentage variation in price for ten tablets was calculated. Results: In India, percentage variation in price for antianginal drugs was found to be: tablet isosorbide dinitrate (5 mg) 250%, glyceryltrinitrate (6.4 mg) 24.44%. In calcium channel blockers group, tablet amlodipine 10 mg shows maximum price variation of 1045%, closely followed by 5 mg of amlodipine with a variation of 1040%, while 120 mg of diltiazem shows the least variation of 262%. In betaadrenergic receptor blockers group, tablet atenolol 50 mg shows maximum price variation of 563%, whereas 100 mg of extended release metoprolol shows the least variation of 42%. Conclusions: To increase the benefit to the patient and reduce drug in compliance, doctors should be trained to be familiar from internship period itself about the brand names of cost-effective drugs with good safety profile for a long period.
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Background: Same drug can be sold for different prices under different brand names due to various reasons. Branded medicine is the original product that has been developed by a pharmaceutical company and generic medicine is a copy of the original branded product, marketed after the expiry date of the patent and hence supposed to be of low cost as compared to their branded versions. The objective was to compare the costs of various branded and generic medicine and to ascertain the rationality of emphasizing generic versus branded prescription. Methods: Prices of 50 commonly used branded and generic medicines available as both branded and generic forms and in same concentration, dosage form and combination were selected and the percentage difference in the mean cost of generic and branded medicines was calculated. Results: The mean cost of 26 generic medicines out of the selected 50 medicines was higher than their branded versions. Mean cost of 20 branded medicines was higher than generic ones, and cost of 4 medicines was approximately same. Percentage difference in the mean costs of branded and generic medicines varied from <10% to >70%. Conclusions: Most of the drugs available in the market have brand names whether they are branded or generic medicines. Hence, doctor should write a cheapest known brand with the name of the generic salt in bracket so that the patient can buy another if that brand is not available. Furthermore, the Drug Controller of India should release a website where every doctor should be able to fi nd the cheapest and approved drugs in the market.
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Background: Diabetes mellitus in early age is on the alarming rise in India, requiring lifelong treatment. There is a wide range of variation in the prices of antidiabetic drugs marketed in India. Hence, we decided to study price variations in the oral antidiabetic drugs available, either singly or in combination, and number of manufacturing companies for each, and to evaluate the difference in cost of different brands of same active drug by calculating percentage variation of cost. Methods: Cost of a particular drug being manufactured by different companies, in the same strength and dosage forms was obtained from “Current Index of Medical Specialties” July-October 2014 and “Indian Drug Review” July 2014. The difference in the maximum and minimum price of the same drug, manufactured by different pharmaceutical companies and percentage variation in price was calculated. Results: Percentage price variation among different group of drugs was found to be as follows: in sulfonylureas, it was highest in glimepiride 2 mg 836.44%, among biguanides - metformin 500 mg 245.55%, among thiazolidionedionespioglitazone 15 mg 600%, among α glucosidase inhibitors - voglibose 284.61% and meglitinides - repaglinide 0.5 mg 181.40%. Among combination therapy glimepiride 1 mg + metformin 500 mg 366.66%, pioglitazone + metformin 207.51%, pioglitazone + glimepiride 268.42% showed maximum variation in price. Conclusion: The average percentage price variation of different brands of the same oral antidiabetic drug manufactured in India is very wide. The appropriate changes in the government policy, sensitizing the prescribers about cost of therapy and proper management of marketing drugs should be directed toward maximizing the benefits of therapy and minimizing negative economic consequences.
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OBJECTIVE: To compare the quality between imported branded and 3 domestic entecavir tablets to provide references for clinical use. METHODS: Tests of dissolution, content uniformity, related substances, influencing factor and preliminary stability were carried out between four products in batches, and the quality was compared and assessed. RESULTS: Parameters of dissolution, content uniformity and related substances of enticavir tablet A were superior than that of branded product and C. Compared with imported branded tablets in influencing factor tests, the quality of product A had no significant influence with high-quality during 3-year storage. CONCLUSION: The quality of enticavir tablet A is noticebaly superior than branded and other domestic generic agents.
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Objective of the study was to perform a cost minimization analysis of antibiotic prescriptions in pediatric cases.This was a prospective observational study conducted in the pediatric department of a teaching hospital. A total of 209 prescriptions, of both outpatients and inpatients, containing antibiotics were analyzed. Top five of the commonly prescribed antibiotics in this study were chosen as examples to illustrate the cost difference between the branded and generic versions. This study has shown a very significant difference of prices between branded and generic drugs. The cost of branded drugs prescribed was 20% to 218% more than the generic versions.
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OBJECTIVE: To compare the stability between imported branded and domestic entecavir active pharmaceutical ingredient(API) and among four Entecavir products (A for the original brand product and B-D for the domestic generic agents) and to provide references for clinical use. METHODS: The influencing factor tests and accelerated tests of the API and the four products were carried out. The stability of the imported and domestic API was studied. The stability of the product was studied by comparing the appearance, weight of tablets, API content, related substance and dissolution. RESULTS: The influence of illumination on the stability was the least, while high temperature and high humidity had the most significant influence. In the accelerated tests, product A was the most stable one while products B-D changed with varying degrees, which showed up in appearance, the API content, the related substances and the dissolution. CONCLUSION: The stability of the API from different sources appeared to be similar, while that of the four products showed differences. The stability of the original product was noticeably superior to the domestic generic agents. Copyright 2012 by the Chinese Pharmaceutical Association.
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Objective Allograft vasculopathy (AV), feature of chronic rejection, is a major serious long-term post-operation complication in organ transplantation. The accurate mechanisms for AV have not been definitively established, but extensive basic and clinical studies demonstrate AV is triggered by immune reaction and nonimmunologic factors, and also possibly attributed to the metabolism of branched-chain amino acids (BCAA). Methods The transplanted hearts from Lewis to Sprague-Dawely rats served as allografts and those from Lewis to Lewis rats as isografts based on Ono 's model. The differential proteins in transplanted hearts were separated by comparative proteomic technique, and some enzymes which regulated the metabolism of BCAA were identified and validated.Results All transplanted hearts at second week postoperation were characterized by lumen loss (total area-luminal area/total area) in coronary artery, but more predominant at 8th week. All samples from the left ventricles were analyzed by proteomic techniques and the subunits E1 a, E1β and E3 of branched-chain α-ketoacid dehydrogenase (BCKDH) complex were decreased in the heart allografts.Immunohistological detection also showed the expression of BCKDH was reduced not only in the cardiac muscle but also more significantly in blool vessels with cardiac allograft vasculopathy (CAV).BCAA concentrations were increased in the cardiac allografts, but there was no difference in the serum. Conclusion These findings suggest that the catabolic pathways of the BCAA may be inhibited owing to the reduced expression of BCKDH complex, and elevated intracellular concentrations of leucine. The vascular smooth muscle cell and cardiac muscle cell proliferation is stimulated via mTOR-dependent and mTOR-independent pathways, which is associated with the formation of myocardial hypertrophy and AV in the heart allografts.