Legal Protection for Consumer of Pharmaceutical Products

The overall focus of the thesis involves the legal protection for consumers of pharmaceutical products.The work on “Legal Protection for Consumers of Pharmaceutical Products” is undertaken to study the legal framework that is existing for this purpose and the functioning of regulating mechanism that is envisaged under it. The purpose of the study is to analyse how far these measures are effective in adequately protecting various aspects of consumer interest. Methodology adopted for the study is analytical.The present study revealed that the theory of freedom of contract is only an ideal relevant when the parties are assumed to be on equal footing.In a more complicated social and economic society, it ceased to have any relevance. Many countries in the world enacted legislations to protect the consumers of pharmaceutical products.The meaning of ‘consumers of drugs’ provided in the law is inclusive and not exhaustive one. The definition of ‘drug’ as interpreted by the courts is comprehensive enough to take in it not only medicines but also substances. The meaning of the word substances has been widened by the interpretation of the courts so as to include all the things used in treatment.The definition of the word ‘consumer’ has been liberally interpreted by the courts so as to provide protective net to a large section of the public.The studies subsequent to this report also revealed that there is a shortage of essential drugs necessary to cure local diseases like tuberculosis and malaria where as drugs containing vitamins and other combinations which are more profitable for the manufacturers are produced and marketed in abundance.The study of the provisions in this regard revealed that the duty of the drug controlling authorities is confined to scrutinize the data of the clinical test already conducted by the sponsor of the drug.Study of the clinical trial procedure under the U.S. law revealed that there is a continuous supervision over clinical trials and controls are provided on the treatment use of an investigational productStudy of the clinical trial procedure under the U.S. law revealed that there is a continuous supervision over clinical trials and controls are provided on the treatment use of an investigational product.the study of the provisions of the Drugs and Cosmetics Act and the rules framed under it revealed that the law in this regard is comprehensive to protect the consumer provided it is sufficiently supported by adequately equipped enforcement machinery.

Legal Control of Industrial Pollution

Industries constitute the main spring of development. Without industrial development no country could reach a stage in which a decent living for its citizens would be achieved. Increasing production to meet the basic needs of society augmented scientific invention and machine oriented industrial order.Environmental pollution ls a burning global issue. It is more serious and dangerous than terrorism. Started with the discovery of fire and development of civilization. Pollution went unnoticed throughout the centuries of human growth until its adverse effects on human environment become explicit.National concern tor environment started in our country only atter the cause of protection of environment received global attention. At present legal control ot industrial pollution is in a scattered framework of piece meal processes with overlapping provisions and authorities.Environmental protection- should be an item not only in the concurrent list of schedule 7 to the Constitution but also in the list of matters entrusted to the panchayati institutions in the Schedule 11. It is heartening to note that so far as municipalities are concerned the Constitution of India lives up to the expectation. In the wake of New Industrial Policy based on liberalisation a long list of small scale industries fall outside the purview of environmental clearance. The Indian concept of environmental im»act assessment introduced under the Environment Act by notification excludes the entire gamut of small scale industries and r.elates only to scheduled industries covered by the notifica~ion. Most of them are subjected to ETA only it the investment goes above ~.50 crores. This provision dilutes the impact assessment considerably A mandatory impact assessment with public partiCipation and with provision for a review by specialized environmental courts will eliminate the possible evils of this judicial passiveness.

A critical study of major construction projects in kerala vis-a-vis effectiveness in project implementation

Chapter 1 presents a brief note on the state at which the construction industry stands at present, bringing into focus the significance of the critical study. Relevance of the study, area of investigation and objectives of the study are outlined in this chapter. The 2nd chapter presents a review of the literature on the relevant areas. In the third chapter an analysis on time and cost overrun in construction highlighting the major factors responsible for it has been done. A couple of case studies to estimate loss to the nation on account of delay in construction have been presented in the chapter. The need for an appropriate estimate and a competent contractor has been emphasised for improving effectiveness in the project implementation. Certain useful equations and thoughts have been formulated on this area in this chapter that can be followed in State PWD and other Govt. organisations. Case studies on project implementation of major projects undertaken by Government sponsored/supported organizations in Kerala have been dealt with in Chapter 4. A detailed description of the project of Kerala Legislature Complex with a critical analysis has been given in this chapter. A detailed account of the investigations carried out on the construction of International Stadium, a sports project of Greater Cochin Development Authority is included here. The project details of Cochin International Airport at Nedumbassery, its promoters and contractors are also discussed in Chapter 4. Various aspects of implementation which led the above projects successful have been discussed in chapter 5. The data collected were analysed through discussion and perceptions to arrive at certain conclusions. The emergence of front-loaded contract and its impact on economics of the project execution are dealt with in this chapter. Analysis of delays in respect of the various project narrated in chapter 3 has been done here. The root causes of the project time and overrun and its remedial measures are also enlisted in this chapter. Study of cost and time overrun of any construction project IS a part of construction management. Under the present environment of heavy investment on construction activities in India, the consequences of mismanagement many a time lead to excessive expenditure which are not be avoidable. Cost consciousness, therefore has to be keener than ever before. Optimization in investment can be achieved by improved dynamism in construction management. The successful completion of coristruction projects within the specified programme, optimizing three major attributes of the process - quality, schedule and costs - has become the most valuable and challenging task for the engineer - managers to perform. So, the various aspects of construction management such as cost control, schedule control, quality assurance, management techniques etc. have also been discussed in this fifth chapter. Chapter 6 summarises the conclusions drawn from the above criticalr1 of rhajor construction projects in Kerala.

Economics of Justice in Kerala

The focus of the present study is on issues related to Legal—Economics. The economic approach to legal issues is based on the belief held by both legal professionals and economists that law and economics are complementary disciplines and that collaboration is highly beneficial.The principles of economic analysis can help our understanding of the law. Economic approach has important effects on the costs and benefits that prospective litigants may expect from litigation and their decisions to litigate or to settle out of court. Economic consideration is also helpful to understand I 1 the significance of litigation costs, the practical problems of legal administration and the provision of legal servicesz. The economic approach to law is mainly based on the belief held by some economists that the core of economics, the theory of choice is in principle- applicable to all human and institutional behaviour.

Legal regime of quality control in goods

It has long been said that market itself is the ideal regulator of all evils that may come up among traders. Free and fair competition among manufacturers in the market will adequately ensure a fair dealing to the consumers. However, these are pious hopes. that markets anywhere in the world could not accomplish so far. Consumers are being sought to be lured by advertisements issued by manufacturers and sellers that are found often false and misleading. Untrue statements and claims about quality and performance of the products virtually deceive them. The plight of the consumers remains as an unheard cry in the wildemess. In this sorry state of affairs, it is quite natural that the consumers look to the governments for a helping hand. It is seen that the governmental endeavours to ensure quality in goods are diversified. Different tools are formulated and put to use, depending upon the requirements necessitated by the facts and circumstances. This thesis is an enquiry into these measures

Econometrics as an Academic Discipline in Higher Education: An Exploratory Study of the Need, Relevance and Significance

Econometrics is a young science. It developed during the twentieth century in the mid-1930’s, primarily after the World War II. Econometrics is the unification of statistical analysis, economic theory and mathematics. The history of econometrics can be traced to the use of statistical and mathematics analysis in economics. The most prominent contributions during the initial period can be seen in the works of Tinbergen and Frisch, and also that of Haavelmo in the 1940's through the mid 1950's. Right from the rudimentary application of statistics to economic data, like the use of laws of error through the development of least squares by Legendre, Laplace, and Gauss, the discipline of econometrics has later on witnessed the applied works done by Edge worth and Mitchell. A very significant mile stone in its evolution has been the work of Tinbergen, Frisch, and Haavelmo in their development of multiple regression and correlation analysis. They used these techniques to test different economic theories using time series data. In spite of the fact that some predictions based on econometric methodology might have gone wrong, the sound scientific nature of the discipline cannot be ignored by anyone. This is reflected in the economic rationale underlying any econometric model, statistical and mathematical reasoning for the various inferences drawn etc. The relevance of econometrics as an academic discipline assumes high significance in the above context. Because of the inter-disciplinary nature of econometrics (which is a unification of Economics, Statistics and Mathematics), the subject can be taught at all these broad areas, not-withstanding the fact that most often Economics students alone are offered this subject as those of other disciplines might not have adequate Economics background to understand the subject. In fact, even for technical courses (like Engineering), business management courses (like MBA), professional accountancy courses etc. econometrics is quite relevant. More relevant is the case of research students of various social sciences, commerce and management. In the ongoing scenario of globalization and economic deregulation, there is the need to give added thrust to the academic discipline of econometrics in higher education, across various social science streams, commerce, management, professional accountancy etc. Accordingly, the analytical ability of the students can be sharpened and their ability to look into the socio-economic problems with a mathematical approach can be improved, and enabling them to derive scientific inferences and solutions to such problems. The utmost significance of hands-own practical training on the use of computer-based econometric packages, especially at the post-graduate and research levels need to be pointed out here. Mere learning of the econometric methodology or the underlying theories alone would not have much practical utility for the students in their future career, whether in academics, industry, or in practice This paper seeks to trace the historical development of econometrics and study the current status of econometrics as an academic discipline in higher education. Besides, the paper looks into the problems faced by the teachers in teaching econometrics, and those of students in learning the subject including effective application of the methodology in real life situations. Accordingly, the paper offers some meaningful suggestions for effective teaching of econometrics in higher education

Sanctity of Human Life in the Context of Human Genetic Research

The study on the concept of sanctity of human life is a journey in finding out what is it said to be “human” in human life. It is an evaluation of the universal concept and the role it plays in controlling and moulding human conduct and relationships. This concept is a foundational principle of human rights law and the grundnorm of every legal system. However, of late, the challenges by way of certain advances in human genetic research had prompted the need to evaluate the significance and extent of the concept in human endeavours. Scientific advances by way of human genetic research promises significant diagnostic and therapeutic advances but at the same time pose threat to fundamental notions and assumptions on humanity, hence there is a global concern to derive common legal standards, Thus the major challenge is to analyse universal principles which can be a common criteria for evolving legal standards to control certain advances in human genetic research. Hence the relevance of the study. The study aims at analysing the content, scope, extent and limitation of the concept of sanctity of human life. In this attempt it evaluates the extent to which the concept had been accommodated by legal systems and international human rights regimes. The problem which had been undertaken in the study is the extent of intrusion made to the concept by virtue of certain advances in human genetic research.