Drug Bill Research Articles

Revamping homoeopathy from Drug and Cosmetic Act of 1940 to New Drugs, Medical Devices and Cosmetics Bill, 2022; A perspective. of 1

Government of India at its 72nd year of republic had drafted the new bill entitled “New Drugs, Medical Devices and Cosmetics Bill 2022” which seeks to replace the existing “Drugs and Cosmetics Act, 1940”. Earlier in this Act, Chapter V mentions the support of regulatory authority for Ayurveda, Siddha, Unani drug. However the new draft of bill includes Sowa Rigpa and Homoeopathic drugs and proposes to develop new innovative drugs by establishing their scientific research board. Owing to the new suggestions put forth in this new draft an opinion is addressed in this letter concerned with quality standards, drug proving trials, safety standards and efficacy standards for homoeopathic drugs.

PCP33 - COULD THE US ADMINISTRATION IMPOSE DRUG PRICE RAISES IN THE EUROPEAN UNION (EU)?

The United States pays the highest drug bill per capita despite unequal global distribution of drug prices and payment. President Trump has said that this “[is] ridiculous, and it’s not going to happen any longer.” His proposed solution is to fix trade through bilateral negotiation to raise US drug prices abroad. Opportunities for US drug price increase in the European Union (EU) were reviewed at the WTO level and among other international organizations. Currently, US drug prices in the EU are not subjected to value-added tax (VAT) or to a very low VAT rate. The customs drug tariffs are usually nonexistent or if applied, are low. Trump’s argument of American discrimination may not be legally valid. If pricing is well structured, transparent, and based on scientific grounds (ex. HTA processes) complemented by established economics rules (ex. funding processes) applicable to all products, regardless of origin, it is unlikely for opportunities through legal routes to impact prices. An alternative is through bilateral trade negotiations, where the US may have an advantage in negotiating. However, in response to Trump’s proposal to raise US drug prices abroad, the UK’s NHS has emphasized their commitment to provide affordable drugs to UK citizen. In Japan, the first US export market for pharmaceuticals, some experts have questioned the relationship between Trump’s visit and the 2-year delay for HTA implementation. Following timid AMNOG reform in Germany, which was expected to yield more, some questioned the potential influence of Trump’s administration. Despite no potential legal route for price raising of US pharmaceuticals in EU, it is likely that price of pharmaceuticals will be a focus of bilateral trade negotiations between individual EU countries and the US. However, increasing prices outside the US may not directly translate to lower prices within the US nor lead to benefiting US patients.

New voluntary pricing agreement could cut NHS drugs bill by almost £1bn a year

New voluntary pricing agreement could cut NHS drugs bill by almost £1bn a year

NHS drugs bill could hit £20bn by 2021, deputy chief pharmaceutical officer warns

NHS drugs bill could hit £20bn by 2021, deputy chief pharmaceutical officer warns

Ageing, health status and coverage rate effects on community prescription costs in Ireland

This paper aims to explore how GMS drug costs depend on age, gender, income, health status, community drug scheme coverage rates and whether they displaysignificant differences across regions of Ireland. We also aim to find out whetherthe GMS drug costs of high and low income cohorts respond similarly to changes in their health status. The paper projects GMS drug costs in 2026 and examines the separate cost of population ageing and population growth over the period. We also aim to simulate the estimated model to show how much giving free prescription drugs to all persons aged 'under 5' would add to 2026 GMS drug costs, and also how much giving universal GMS coverage to all persons in 2026 would add to 2026 GMS drug costs. We construct a multivariate logistic regression model of GMS community drug costs in Ireland. We progress the methodology used in earlier studies by explicitly modelling how regional incomes and regional health status interact in determining GMS drug costs in Ireland. An age cohort and region breakdown of the simulated GMS drug costs, of both projected demographic trends and public policy measures that have been adopted or are under consideration, are also investigated. We find that GMS drug costs depend on age-but not gender-onincome, health status, community drug scheme coverage rates, and they are significantly lower for all age cohorts in Donegal and the North West region. The GMS drug costs of high income cohorts tend to increase as their health status improves, whereas they tend to decrease as the health status of low income cohorts improves. A uniform 1% gain in health status has little impact on total GMS prescribing costs. Similarly, if the health status of all Irish regions improved to match that of the East region in 2010 it would only have reduced public prescription costs by around 32€ million of the 1.8€ billion GMS drugs bill. We find that giving free prescription drugs to all persons aged 'under 5' in 2010 would have only a minor impact on 2010 GMS drug costs, whereas giving universal GMS coverage to all persons would have doubled public prescription costs from 1.8€ billion to circa 3.6€ billion.

Can drug price hikes via debranding be prevented?

Steep price hikes following the debranding of off-patent medicines are becoming increasingly common in the UK, adding hundreds of millions to the NHS drugs bill. But can anything be done to prevent this?

An In Vitro Aerosolization Efficiency Comparison of Generic and Branded Salbutamol Metered Dose Inhalers

Background: Due to the high rate of pulmonary diseases, respiratory drug delivery systems have been attracted excessive attention for the past decades. Because of limitations and growing drug bill, physicians are encouraged to prescribe generically whenever possible. The purpose of this study was to evaluate whether there was any significant difference in aerosolization performance between a reference brand Salbutamol (A) Metered Dose Inhalers (MDIs) and two generic products (B and C). Methods: The aerosolization performance of MDIs was evaluated by calculating aerosolization indexes including fine particle fraction (FPF), fine particle dose (FPD), geometric standard deviation (GSD) and mass median aerodynamic diameters (MMAD) by using the next generation impactor. Results: Although aerosolization indexes of MDI A were superior than the Iranian brands, but the differences were not statistically significant. Conclusion: These results verified that generic MDIs deliver similar quantities of Salbutamol to the reference brand and aerosolization performance parameters of generic Salbutamol MDIs did not differ significantly from the reference brand.

The motives, repercussions and potential outcomes of Punjab Drug (Amendment) Bill 2017

The motives, repercussions and potential outcomes of Punjab Drug (Amendment) Bill 2017

Cuts to community nursing affect diabetes care as drug bill reaches £1 billion a year

Cuts to community nursing affect diabetes care as drug bill reaches £1 billion a year

UK pharma helps fund NHS's 2016 drugs bill

UK pharma helps fund NHS's 2016 drugs bill

Drug and Cosmetic Amendment Bill in India – a Promising Hope for Healthy Medical Device Regulatory Environment

Background: Medical devices are the prevailing part of modern medical care. The quality of medical devices is depended largely on how effectively they’re regulated. In India, before 2005, there were no regulations on medical devices. Even though now in India, medical devices are regulated under the regulation of the Drugs and Cosmetics Act and Rules. Recently floated “draft medical device policy” (June 2015) have brought a promising scope for the formation of an autonomous National Medical Device Authority (NDMA). The draft changes have been publicly released for review comments. Objective: The aim of this manuscript is to give a thorough analysis of draft medical device policy, its impact and how this praiseworthy initiatives are separating the regulation of drugs, cosmetics and devices. Conclusion: This has become a ray of hope to improve so called unorganized medicinal devices regulatory environment efficiently and appropriately in India. India is always import driven and one of the largest medical device markets in Asia, so the formation of the country's first agency especially dedicated to the regulation of medical devices will catalyze the growth of medical device market of India. Keywords: Drug and cosmetic act, medical device, NDMA, regulation.

Need for a New Drugs Bill

Need for a New Drugs Bill

Nurses make ends meet through extra shifts and payday loans

More than half of nurses are taking on extra work or second jobs outside nursing to boost their income, according to a survey of more than 1,200 Nursing Standard readers. Our UK-wide snapshot found that 54 per cent are doing extra shifts, while one in ten is working outside of the profession to pay their bills. Nursing Standard’s exclusive research reveals the effects of a two-year pay freeze in 2010-12 and a pay rise of only 1 per cent last April. Health unions are at loggerheads with employers who want to reintroduce a pay freeze, despite an announcement by chancellor George Osborne in March that rises should be capped at 1 per cent until 2016. Yesterday (November 12) unions gave evidence to the NHS Pay Review Body, which advises the government on pay. They called for a minimum 1 per cent rise for nurses in 2014/15. Responding to Nursing Standard’s survey, NHS Employers chief executive Dean Royles said: ‘I know many will argue there are other savings to be had, in areas like procurement or drug bills, but these are not “either-or” options. We have to restrain costs everywhere if we are to maximise job security.

Assessment of the sensitivity and specificity of Xpert MTB/RIF assay as an early sputum biomarker of response to tuberculosis treatment

An accurate biomarker is urgently needed to monitor the response to treatment in patients with pulmonary tuberculosis. The Xpert MTB/RIF assay is a commercially available real-time PCR that can be used to detect Mycobacterium-tuberculosis-specific DNA sequences in sputum samples. We therefore evaluated this assay with serial sputum samples obtained over 26 weeks from patients undergoing treatment for tuberculosis. We analysed sputum samples from 221 patients with smear-positive tuberculosis enrolled at two sites (Cape Town, South Africa, and Mbeya, Tanzania) of a multicentre randomised clinical trial REMoxTB of antituberculosis treatment on a weekly basis (weeks 0 to 8), then at weeks 12, 17, 22, and 26 after treatment initiation. The Xpert MTB/RIF results over time were compared with the results of standard smear microscopy and culture methods. We obtained and analysed 2741 sputum samples from 221 patients. The reduction in positivity rates with Xpert MTB/RIF were slower than those with the standard methods. At week 8, positive results were obtained for 62 (29%) of 212 sputum samples with smear microscopy, 46 (26%) of 175 with solid culture (Löwenstein-Jensen medium), 77 (42%) of 183 with liquid culture (Bactec MGIT960 system), and 174 (84%) of 207 with Xpert MTB/RIF; at 26 weeks, positive results were obtained for ten (5%) of 199, four (3%) of 157, seven (4%) of 169, and 22 (27%) of 83 sputum samples, respectively. The reduction in detection of quantitative M tuberculosis DNA with Xpert MTB/RIF correlated with smear grades (ρ=-0·74; p<0·0001), solid culture grades (ρ=-0·73; p<0·0001), and time to liquid culture positivity (ρ=0·73; p<0·0001). Compared with the combined binary smear and culture results as a reference standard, the Xpert MTB/RIF assay had high sensitivity (97·0%, 95% CI 95·8-97·9), but poor specificity (48·6%, 45·0-52·2). The poor specificity precludes the use of the Xpert MTB/RIF assay as a biomarker for monitoring tuberculosis treatment, and should not replace standard smear microscopy and culture. Global Alliance for TB Drug Development, Bill & Melinda Gates Foundation, UK Medical Research Council, German Ministry of Science and Technology.

DSL-002 A Pharmacoeconomic Comparison Between a County Hospital in Chania and a Central Hospital in Athens, Greece

Background‘Agios Georgios’ Chania General Hospital (CGH) on the island of Crete has 460 beds and Sismanoglio General Hospital (SGH), in the capital of Greece, Athens, has 439 beds. In the...

Prescription for change

Nurse clinician Rajesh Karimbath was concerned that patients were being discharged from the hospital where he works with medicines they already had at home. Keen to prevent waste and supported by a pounds 10,000 fellowship from the NHS Leadership Academy, he led a project to reduce medicines duplication on discharge and improve the outpatients' medicines management pathway.

Drugs bill for alcohol dependence rockets over decade

Drugs bill for alcohol dependence rockets over decade

The prescribing year: 2012

AbstractHighlights this year included a further 62 guides from NICE and, among a number of notable new drugs, the first nasal flu vaccine. Surveys confirmed that many patients either don't collect or use their medicines. Branded drugs coming off patent included atorvastatin, triggering a welcome cut in the drugs bill.

Paying for Patented Drugs is Hard to Justify: An Argument about Time Discounting and Medical Need

abstractDrugs are much more expensive whilst they are subject to patent protection than once patents expire: patented drugs make up only 20% of NHS drugs prescriptions, but consume 80% of the total NHS drugs bill. This article argues that, given the relatively uncontroversial assumption that we should save the greater number in cases where all are equally deserving and we cannot save both groups, it is more difficult than is usually thought to justify why publicly funded healthcare systems should pay for patented treatments. The claim to medical treatment of those who will be sick with a given condition once the patent runs out is just as strong as those who are sick with it now, but we will be able to treat more people with the same unit of resource in the future. Hence, when resource constraints entail that both cannot be funded, publicly funded healthcare systems ought to wait until patents expire before approving drugs for general use in the publicly funded system.

Targeted Issue Advertising and Legislative Strategy: The Inside Ends of Outside Lobbying

Interest group spending on issue advertising is growing dramatically, but we know very little about its deployment and purpose in legislative advocacy. This article begins to fill the gap, examining where, when, and why interest groups run television issue advertisements. We start from the premise that issue advertising is a form of outside lobbying, but we argue that it can serve two legislative ends. We hypothesize, first, that group strategists will target areas represented by committee allies they want to mobilize more than pivotal members they want to convert. When a roll call is approaching and the vote is likely to be close, however, groups will expand their advertising targets to include floor voters near the chamber pivot. Our statistical tests use data on television issue ads concerning the 2003 Medicare prescription drug bill. The analysis provides consistent support for the first hypothesis and mixed support for the second.