Dr Pramod Karan Sethi 1927-2008 (original) (raw)
Related papers
2009
the ste M pa sec 72. car pe ple ev ad lin va R ye su rat we an fre ora ye C ser wo tur po bu pli Bioprostheses are prone to continuous degenerationand this may lead to structural valve deterioration (SV va the da era T
Traditional health sciences (THS) of various countries have evolved within different epistemologies and perspectives on disease, cause and cure. The epistemic framework, principles, concepts and practice are quite different from those of Western biomedicine. The traditional Indian sciences or shastras as they are called, possess qualitative standards that are derived by a subjective but impersonal approach to standardization. While there is a contemporary value in applying modern science and technology tools for creating objective and verifiable standards for traditional knowledge products and concepts, currently the approach to creating standards is one-sided. This is because it does not adequately consult the available qualitative THS standards and parameters. Furthermore, most therapies in THS involve both drug as well as non-drug interventions. Thus they also require a novel 'management trial' approach and compatible statistical designs in place of the conventional single-and double-blind drug trials to establish efficacy of treatment. This article cites constructive examples that illustrate the imperative for collaboration between scientists and traditional knowledge experts so as to promote mutual understanding and create relevant quality standards. It is such a collaborative approach involving in-depth consultation between traditional and modern health sciences that we refer to in this article as inter-cultural approach.
PUBLISHED KAP BIOMED BIHAR IJDSIR
would report needles and sharp injuries. Conclusion: The knowledge, awareness and practice was positive/maximum among the interns followed by the consecutive year of BDS from 4 th to 1 st year.
Medical Devices and Their Approval Procedure in India
International Journal of Drug Regulatory Affairs, 2016
Therapeutic treatment based on medical devices is providing technologically advanced solutions for the management of several diseases. Thereby continues to grow in market at tremendous rate. However, these treatments also carry significant risk with them, which if neglected can lead to life threatening consequences. Therefore rules and regulations are required for monitoring the entry of such devices into the market. Presently Regulatory bodies governing such regulations are at their initial stage and are improving at each step to safeguard public health as well as to ensure that effective and technologically advanced inventions reach out patient.
Current status of the regulation for medical devices
2008
, the Government of India released the Gazette indicating sterile devices as drugs (F. No. 11014/2/2005-DMS and PFA; Gazette No. 1077 dated October 6, 2005) under the sub-clause (iv) of clause (b) of section 3 of Drugs and Cosmetics Act 1940 (23 of 1946) 1. Earlier as per the sub-clause (iv) of the clause (b) of section 3 of Drugs and Cosmetics Act 1940 (23 of 1946) the definition of drugs included the items "such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals" as may be speciÞ ed from time to time by the Central Government by notiÞ cation in the OfÞ cial Gazette, after consultation with the Board 2. With this notiÞ cation various items have been speciÞ ed as drugs, as given in Table 1. It has been further notiÞ ed vide GSR 127 (E) dated 7/10/2005 that the control over manufacture of these devices would be exercised by CLAA i.e. DCG (I) under the provisions of sub-rule (1) of rule 68A of part VII of the Drugs and Cosmetics Rule, 1945. These rules have been approved by the Ministry of Health and Family welfare and the guidelines issued came in force from March 1, 2006. Some of the highlights of these guidelines are given in Table 1. Signifi cance of Medical Devices: The era of newer development and technology has decreased the morbidity and mortality of life. The medical development in terms of drugs and devices has brought about the robust change in the life of the people (as offered by the cosmetic treatment, dentist, face and cardiology devices). Medical devices have extended the ability of physicians to diagnose and treat diseases, making great contributions to health and quality of life. According to World Health Organization (Geneva), under Medical Device Regulations, the term "medical devices" includes everything from highly sophisticated computerized medical equipment down to simple wooden tongue depressors. The intended primary mode of action of a medical device on the human body, in contrast with that of medicinal products, is not metabolic, immunological or pharmacological. Medical devices include a wide range of products such as medical gloves, bandages, syringes, condoms, contact lenses, disinfectants, X-ray equipment, surgical lasers, pacemakers, dialysis equipment, baby incubators and heart valves. Medical device means any instrument, apparatus, implant, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related articles,
Current Science, 2007
Traditional health sciences (THS) of various countries have evolved within different epistemologies and perspectives on disease, cause and cure. The epistemic framework, principles, concepts and practice are quite different from those of Western biomedicine. The traditional Indian sciences or shastras as they are called, possess qualitative standards that are derived by a subjective but impersonal approach to standardization. While there is a contemporary value in applying modern science and technology tools for creating objective and verifiable standards for traditional knowledge products and concepts, currently the approach to creating standards is one-sided. This is because it does not adequately consult the available qualitative THS standards and parameters. Furthermore, most therapies in THS involve both drug as well as non-drug interventions. Thus they also require a novel 'management trial' approach and compatible statistical designs in place of the conventional single-and double-blind drug trials to establish efficacy of treatment. This article cites constructive examples that illustrate the imperative for collaboration between scientists and traditional knowledge experts so as to promote mutual understanding and create relevant quality standards. It is such a collaborative approach involving in-depth consultation between traditional and modern health sciences that we refer to in this article as inter-cultural approach.