41 research outputs found
A Comparative Study of Marketing Authorization of Drug Eluting Coronary Stents (DES) in India and Developed Countries (USA & EU)
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Background: India presents a peculiar case for Drug Eluting Stents (DES). 85% of India's
stent need is met through imports which enjoy perception premium in terms of quality. Recently,
drug eluting stents' prices were capped to INR 30,000 in India by National Pharmaceutical
Pricing Authority (NPPA) of DES to curb soaring high prices. Indian Market offers tremendous
opportunities for stent makers. The total market for stents in India is estimated to be of US$ 531
mn by 2016 end and is expected to expand at a CAGR of 14.0% from 2016-2026) [1].
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Objective: This paper attempts to study and compare marketing authorization provisions and regulatory
standards that need to be met to obtain marketing approval for Drug Eluting Stents in the
three regions and provide recommendations for Indian regulatory system.
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Discussion: Regulatory authorities of developed countries outline their data expectation in the
form of non-binding guidance document for industry; however, there are no such equivalent
documents in India. Technical data ranging from specification of ‘stent platform&#39;, ‘eluting drug&#39;
and the ‘finished product&#39; is furnished to the Regulatory authority prior to grant of marketing
authorization. Data in application include both Clinical and Non-Clinical (Bench Tests) information
obtained during the course of device development. In USA, a Premarket Application (PMA)
should be submitted to FDA. In EU, an application dossier is to be submitted to the Competent
Authority and in India marketing authorization application is to be made to the CDSCO. Regulatory
authorities of developed countries outline their data expectation in the form of non-binding
guidance document for industry however, there are no such equivalent documents in India.
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Conclusion: This article enlists and provides a comparative grid of Regulatory requirements of
Drug Eluting Stents in the said regions. Any organization involved in regulatory affairs of DES
could use this article as point of reference on the subject.
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Overview of Provisions for Import of Medical Devices into India under Central Licensing Approval Authority (CLAA) Scheme and Medical Device Rules, 2017
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Background: The Government of India regulates medical devices through a specialized
division called, Medical Device and Diagnostics Division, CDSCO, Min of Health and Family
Welfare. Earlier, only 14 categories of Medical Devices, called Notified Devices were regulated
under CLAA scheme for the purpose Manufacture, Import, Sale and Distribution. On 17th October
2016, a draft of rules, called Medical Device Rules, was published by Ministry of Health and
Family Welfare, in Official Gazette, for feedback from industry.
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Objective: In this paper we would examine the provisions for import of Medical Devices under
CLAA scheme and Medical Device Rules, 2017 and make easier to grasp the regulatory system of
India for any manufacturer who wishes to enter Indian Market.
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Discussion: After due consideration, the Medical Device Rules, 2017 were passed and set for implementation
by 1st January 2018. This will create a separate registration and oversight system for
drugs and medical devices. Drug Controller General of India would remain the Licensing Authority
for Import of devices under the new system. Indian Medical Device Industry is primarily import
oriented. Indian Market presently offers tremendous opportunities for high-end sophisticated
device manufacturers as most of the high end innovative products are imported into the country.
The import of medical devices for the year 2016, stood at $208,230.65 million.
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A review on efficacy and tolerability of tea tree oil for acne
No full textAcne is common problem acquired generally after puberty. It ranges from mild to moderate: papules, pustules, nodules to severe cyst. Various natural therapy can be employed for treatment of acne including Tea tree oil (TTO). Tea tree oil has wide spectrum anti-microbial agent showing in treatment of acne. Usually it is utilized in various topical preparations. It contains more than 80-90% monoterpenes namely terpinen-4-ol, -cymene, α-terpinene, limonene 1,8-cineol, α-terpineol, terpinolene, 1,8-cineol, sabinene and α-pinene, The European cosmetic Association recommended not more than 1% use of tea tree oil in cosmetic preparations. In this review, we listed various efficacy and tolerability studies along with challenges in application of tea tree oil in cosmetics and dermatological preparations. TTO is a moderate sensitizer and upon oxidation it increases in its allergenic potency. This is a comprehensive review of using Tea tree oil against various microbial species. Various studies revealed the use of TTO as anti-bacterial, anti-fungal, anti- oxidant agent. TTO is effective treatment option that can further be utilized in preparation of novel formulations like liposomes, ethosomes along with combination with other anti-microbial and anti-oxidant agents.
Keywords: Acne, Tea-tree oil, Application, Antioxidant, Nano particles
Medical Devices Regulation in United States of America, European Union and India: A Comparative Study
No full textBibliometrics study of Malayan Law Journal articles
No full textThis article describes and analyses key bibliometric components of articles published in the Malayan Law Journal (MLJ). A total of 479 articles were picked by a stratified random sampling process from three different editorial periods. The study reveals that the publication has expanded over the years in terms of content, volumes and frequency of publication. A total of 280 authors contributed 479 articles over the period of study. Single-author contributions ranked the highest among all categories.
Academicians contributed the most articles. The average citations per article varied from 6.47 to 62.4. Land Law was the most written subject area
Regulatory aspects of medical devices in India
No full text<p>Today millions of patients depend on medical device based treatment for the management and diagnose of several diseases. Quality and safety of device is depends upon the regulatory guidelines. Medical device manufacturing in India should be taken seriously due to large population and the potential severity of the consequences of introducing inferior and unsafe products to the market-place. Therefore a law containing adequate guidelines of rules and regulations are required for monitoring the entry of such devices into the use in public health. The regulations define requirements of medical device design, development and manufacture to ensure that products reaching market are safe and effective. Presently in India regulatory body CDSCO is governing regulation for regulation of devices which with time, amendment introducing in the law will provide safety assurance to public health. This review provides a study on different regulatory aspects of medical device implemented in India. The present review discuss about the classification of medical devices and regulations aspects in India.</p></jats:p
Patient satisfaction with access, affordability and quality of diabetes care at Mohalla Clinics in Delhi, India
Get PDFIntroductionMohalla Clinics have been set up to provide curative care for minor ailments free of cost within walking distance in the urban slums, thus making primary care more accessible and affordable. Studies evaluating patient satisfaction with treatment of chronic conditions, such as diabetes, in these clinics are lacking.MethodsA survey of 400 type 2 diabetes patients was conducted, split equally between Mohalla clinics (MC) and Private clinics (PC) in Delhi. Responses were analyzed using STATA17, applying appropriate statistical tests for the data type (Chi-square test, Mann–Whitney U test, Wilcoxon signed rank test, or two-sample t test).ResultsSatisfaction level was high in both groups with no significant difference between mean satisfaction scores of MC patients and PC patients (Mean 3.79 vs. 3.85 respectively, p = 0.4). However, MC patients reported a significant improvement in their satisfaction score after switching to MC (Mean 3.79 vs. 3.3 for the previous facility, p < 0.05). Physician interaction with the patients was the most important factor in influencing the satisfaction score. Proximity to the clinic was the second most important factor for MC patients but was not as important for PC patients. Surprisingly, treatment success was considered an important factor for satisfaction level by < 10% MC and < 20% PC patients only, pointing to the need for patient education across both the groups. None of the MC patients mentioned free treatment as a contributory factor to high satisfaction, perhaps because most shifted from a government setup to MC. PC patients had more frequent follow-up visits and blood glucose monitoring, and longer consultation duration compared to MC patients, which were offset by access factors, thus not causing much difference to the satisfaction score between the two groups.ConclusionMohalla clinics are making diabetes treatment accessible and affordable for the marginalized population of Delhi, despite not being designed or fully equipped to care for chronic diseases such as diabetes that require multi-specialty care to monitor and manage multiple co-morbidities and long-term complications. Positive perception of physician interaction and convenient location of the clinics are the two major contributors to the high satisfaction patients expressed with diabetes care at these clinics
Diabetes mellitus treatment using herbal drugs
Get PDFDiabetes mellitus is becoming a common metabolic disorder which has serious threat to public health in the world. There are chemicals and biochemical agent that helps in controlling diabetes but there is no permanent remedy available which helps to get recovered completely from this disorder. By conducting large number of research work, numerous traditional medicines have been found for diabetes. Substances and extracts isolated from different natural resources especially plants have always been a rich arsenal for controlling and treating diabetes problem and complication arising due to it. So this review helps the reader to understand the importance of various types of herbal and polyherbal formulations present traditionally which can be used to treat diabetes mellitus
Microneedles for drug delivery into oral cavity
No full textTransmucosal drug delivery has induced tremendous research interest in recent decades. Among the different mucosal surfaces in the body, oral cavity mucosa is easily accessible, greatly vascularised, and fast healing, all of which make it especially attractive as a drug and vaccine delivery route. In this doctoral thesis research, a methodology of applying microneedles into the oral cavity is established so that the benefits of microneedles can be extended to this anatomical region to achieve improved clinical effectiveness for various classes of drugs. Three applications are investigated: (1) The feasibility of microneedle-based vaccine delivery to the oral cavity has been explored, which is the first study of its kind to achieve oral immunity. (2) A doxorubicin-poly(lactic-co-gycolic) acid microparticle/microneedles combined drug delivery device has been developed. The device was designed to address poor treatment outcome of oral carcinomas. (3) Local anesthetic (lidocaine) has been coated on microneedles using a novel molten coating method. This study provides the first demonstration of obtaining coatings on microneedles using molten mixtures of water insoluble drugs, and the approach has potential for oral and transdermal delivery of numerous classes of water insoluble drugs including anesthetics and anti-tumor drugs.This dissertation won 1st Place in the Texas Tech University Outstanding Thesis and Dissertation Award, Mathematics, Physical Sciences & Engineering, 2014.Embargo status: Restricted from online display. To request an access exception from the author, click on the PDF to the left
