Regulatory Legislations Research Articles

Regulation Of Gambling in India: A Way Forward in The Direction of Responsible and Sustainable Gambling

This research paper explores the complex and multifaceted issue of gambling regulation in India. It begins by establishing the need and significance of gambling legislations, followed by a historical overview of gambling and its legislation during the periods of Ancient India, Mauryan Empire and British Rule. The paper then delves into the contemporary period, examining prohibitory, permissive, and regulatory legislations. A comprehensive cost-benefit analysis of the three types of legislations i.e. permissive legislation, regulatory legislation and prohibitory legislation is conducted to understand their implications. The study further investigates the regulation of gambling through legislations, formal and informal education, and the introduction of concepts such as Gambling-worthiness and Gamble scoring. Gambling is seen with a taboo primarily because of two reasons, firstly it hampers the economic stability of the individual & subsequently its family and secondly it creates addiction. Both of these psychological & economic issues can be dealt by GIBIL and the concept of Gambling-worthiness and gamble scoring. It will help in identifying problem gamblers and pathological gamblers, curbing loan sharking and protecting vulnerable section of society. It also examines the economic repercussions of regulatory legislations on gambling. The paper concludes with an analysis of the current situation and offers policy suggestions for regulation at the production, consumption, and market levels. The implications of these policies are also discussed, providing a holistic view of the gambling landscape in India. This paper aims to contribute to the discourse on gambling regulation and provide insights for policymakers, educators, and stakeholders in the gambling industry.

An innovative approach for enclosure design of power generators to meet noise regulation targets

The use of diesel-powered engine generators as a power source is very common for various industrial and residential applications. There are strict regulatory requirements and legislations to limit the noise levels from these generators below statutory limits. The purpose of the paper is to present an approach using statistical energy analysis (SEA) augmented by experimental inputs for the prediction of noise levels for the generators and propose strategies for optimized enclosure design that effectively mitigate noise to achieve regulatory requirements. The study begins by developing an SEA model that represents the acoustic behavior of the generator and enclosure. The airborne sources such as engine, alternator, radiator fan and exhaust are modelled explicitly using experimental noise source characterization. Based on the established SEA model and excitation sources, noise levels are predicted through the calculation of energy flow between subsystems. The predicted sound levels for an existing Diesel Generator with enclosure were validated with its test data to ensure correctness of SEA model. Parametric studies were carried out using simulations on key variables, including critical noise paths, panel thickness, and noise control treatments. These investigations helped identify optimal process parameters that reduce noise levels emitted by genset in adherence to noise regulations.

Comparative analysis of forestry systems in the United States and Turkey: Practices, technologies, and challenges

The current study provides a comprehensive comparative analysis of forestry systems in the United States (US) and Turkey, covering various aspects such as forest ownership, natural resources planning, fire management, technological applications, silviculture, forestry education and challenges faced by each country. The findings mainly stems from the author’s first-hand investigations, field observations, and experiences during a postdoctoral research period in the US from 2022 to 2024. Additionally, a variety of information sources, including US forest plans, publications from the US Department of Agriculture Forest Service, relevant peer-reviewed literature, and open-source data, was used in the work employing the verbal analysis method. While certain similarities emerge, particularly in technology utilization and the historical development of forestry education, significant disparities are evident in fire management strategies, land ownership structure, silvicultural practices, and forest planning approaches between the countries. These differences can be attributed to unique environmental and historical conditions, varying economic development levels, and distinct regulatory legislations. The outcomes of this study suggest that there are valuable forestry practices that each country can learn or adopt from the other, emphasizing the potential for mutual exchange and improvement in natural resources management practices.

독일 베를린주 임대차 규제에 관한 공법적 검토

Criticism has been raised over the legislative process to the extent that the revised legislation on the so-called Three Rent Acts in 2020 is called legislative dictatorship. The rent law is the subject of civil law, but from public law perspective, it can be regarded as one of regulatory legislations as part of a kind of housing policy. It can be said that it is a very important element of evaluation of the regulatory legislation whether it has undergone an appropriate process of deliberation based on our economic reality. This study deals with the regulation on the rent control in Berlin, which has recently become a problem in Germany, and the decision on unconstitutionality of the German Federal Constitutional Court. The Berlin’s rent cap is a very radical legislative attempt comparable to our Three Rent Acts. But, it is difficult to compare them in that German civil law as a whole, because of regulations that are not in Korean civil law. The above decision has a simple logical structure that the Act that introduced the Berlin’s rent cap is unconstitutional because the federation used competitive legislative authority completely. However, by devoting very long pages to explaining the German legislative history on social rent law, it warns that the rationality and prudence of legislation are important. Through the discussion on German rent regulations, the level of avoiding ideological discussions shown by German law, the systematic and balanced German civil law system, and the importance of a step-by-step and unified response to housing rent regulation can be seen. The level of Korean law has already well developed for a long time, and it is exceeding the level of simply translating foreign law. Therefore, it is silly to imitate German legislation without analyzing or deliberating on our economic situation.

Perspectives on strategies for improving ultra-deep desulfurization of liquid fuels through hydrotreatment: Catalyst improvement and feedstock pre-treatment

Reliance on crude oil remains high while the transition to green and renewable sources of fuel is still slow. Developing and strengthening strategies for reducing sulfur emissions from crude oil is therefore imperative and makes it possible to sustainably meet stringent regulatory sulfur level legislations in end-user liquid fuels (mostly less than 10 ppm). The burden of achieving these ultra-low sulfur levels has been passed to fuel refiners who are battling to achieve ultra-deep desulfurization through conventional hydroprocessing technologies. Removal of refractory sulfur-containing compounds has been cited as the main challenge due to several limitations with the current hydroprocessing catalysts. The inhibitory effects of nitrogen-containing compounds (especially the basic ones) is one of the major concerns. Several advances have been made to develop better strategies for achieving ultra-deep desulfurization and these include: improving hydroprocessing infrastructure, improving hydroprocessing catalysts, having additional steps for removing refractory sulfur-containing compounds and improving the quality of feedstocks. Herein, we provide perspectives that emphasize the importance of further developing hydroprocessing catalysts and pre-treating feedstocks to remove nitrogen-containing compounds prior to hydroprocessing as promising strategies for sustainably achieving ultra-deep hydroprocessing.

European regulations on prevention use of antimicrobials from january 2022.

Over the past several years significant progress on achieving better antibiotic stewardship in the veterinary sector has been achieved through regulatory legislations both in the USA and the European Union, including the implementation of US FDA GL 209 and 213. The EU is now taking measures to phase out the routine use of antibiotics for disease prevention, reserving prophylactic use for exceptional circumstances. This article intends to add some clarifications regarding antibiotics for disease prevention that are embedded in two EU regulations which came into force on 28th January 2022, Regulation (EU) 2019/4 on Medicated Feed and Regulation (EU) 2019/6 on Veterinary Medicinal Products.

Practice Of Ophthalmic Self-Medication Among Patients In Central India: Questionnaire Based Study

Purpose: To identify and analyze the practice of ocular self-medication in adult patients attending an ophthalmology clinic in central India. Methods: A cross sectional, descriptive, questionnaire-based observational study was carried out at Durg, Chhattisgarh, India over a period of eight months from July 2017 to February 2018. The study included 1490 consecutive and consenting adult patients reporting for the first time in a private ophthalmology clinic. Self-medication was defined as the use of ophthalmic medicines used in the past one year without consultation of health care professionals. Responses to a semi-structured questionnaire covering socio-demographic details and various aspects of eye medication usage like duration, source, reason etc. were obtained with a face-to-face interview. The relationship between self-medication and demographic factors was analyzed using chi-square test of association, univariate analysis and multivariable logistic regression. Results: 432 subjects (29%) reported using ophthalmic medications without consulting an ophthalmologist. Patients used medications commonly for itching of eyes (41%), burning sensation (39%) and watering (38%). The most common used eye drops were ayurvedic and herbal (21%), antibiotics (17%) and antibiotic-steroid combination (10%). Of the patients who self-medicated, majority used medications recommended by pharmacist or relatives and friends. Males (OR: 1.51, p= 0.0007), married subjects (OR: 2.05, p= 0.0001) and rural patients (OR: 1.29, p= 0.046) were more likely to self-medicate. No significant difference was found in self-medication practices according to age (p=0.291) and level of education (p=0.983). Conclusion: Arbitrary practice of ophthalmic self-medication is prevailing. This warrants educational efforts, public awareness and regulatory legislations to lessen the consequences.

A method for classifying interrelation between sectoral regulatory laws and the ‘water-energy-agriculture nexus concept’ in Brazil

Abstract We propose a method to classify the level of interrelation between the water, energy and agriculture sectoral regulatory laws and selected main characteristics of the nexus concept. This method was created to be applied with sectoral regulatory laws so a study case was conducted in Brazil. The results show that all analysed legislations have low to medium interrelation with the criteria intrinsic to the nexus concept; the policies that stood out the most, regarding the number of criteria present in their scopes, were the national irrigation policy and the desertification policy; and in order to operationalize the nexus concept in management models in the Brazilian context, adjustments and a restructuring of regulatory laws are necessary. The proposed method was able to investigate the interrelation between regulatory legislations with the characteristics of the nexus concept as well as their strengths and weaknesses.

Comparison of Regulatory Requirements for Filing Drug Master File (DMF) in Emerging Markets - China, Brazil & South Korea

Background: A DMF consists of confidential information, usually related to Chemistry, Manufacturing and Control (CMC) of the drug substance. DMF is prepared and submitted by the pharmaceutical manufacturer solely to the regulatory authority of the respected country where he wants to market. Objective: Compare the regulations of the emerging markets with that of a regulated market and to highlight the stringent requirements imposed by emerging authorities. The similarities and differences of the requirements for filing a DMF in emerging markets are compared against the regulated market. Methods: The method carried out for every single study follows some patterns and certain pathways in order to reach its target. Method begins with scope and objective of regulatory perspective of DMF filing requirements for USA, China, Brazil and Korea. The information was collected from Regulatory authorities, Legislations, Guidelines and Experts opinion. Results: Regulatory requirements for filing a DMF for API registration vary from country to country. Even though a standard ICH-CTD format is available and most widely followed, there are some specific requirements recommended by drug authorities which are mandatory to be provided while filing to that particular country. Conclusion: Based on the current study it is clear that emerging markets possess more stringent requirements for API approval as compared to the regulatory market but the dispute is that the emerging markets do not have harmonized guidelines and are not transparent enough.

Social Control in Network Communities Analytic study

Background/Objectives: To define the new concept of social control in network communities and to answer the following questions: What is the new social control? What are the methods of this new social control? and how to reach a controlled use of network communities? Methods/Statistical Analysis: The study used the analytic descriptive methodology that is based on the research and study of the new concept of social control and its main patterns from different angles and qualitatively expresses them through studying the literature review of the problem and discussing it. The study categorized the methods of new social control into two major categories: First, official methods of social control, which are set by the society to enforce a kind of purposeful control of its members through guiding rules and instructions in forms of regulatory legislations to be adhered by all society institutions and individual alike; Second, non-official methods of social control, such as individuals’ following of societal criteria and values, through the process of socialization. We used 29 references of previous studies. Findings: The study defined the new concept of social control as the collective practices and behaviors of society upon its members to educate them, organize their behaviors or control them in order for their behaviors to be consistent with the prevailing criteria through a group of various methods that lead their behaviors to meet the society expectations, such as methods aim at preserving the growth and sustainability of the society and protecting its structure. To achieve the most suitable control of any given society, different societal bodies of two directions – integrated in roles and results – emerge. The first direction stems from inside, where the individual internally desires to adhere to societal criteria and values. This direction is achieved through proper introduction of individuals to the digital environment, starting from the early childhood to the teenage and continues if the individual uses network communities. The second direction is institutional that is reflected on the set laws and written regulations by official authorities such as the Electronic Transactions Law, and the Cyber Crimes Act. Improvements/Applications: The results of this study are confined to the predetermined goals that it sought to achieve and the questions that it sought to answer. Hence, conducting more studies about social control and their different social dimensions to achieve more generalized results is needed. The researcher recommends better dissemination of laws on the use of network communities as well as more attention to the digital socialization of children and adolescents, thus contributing to the development of active and disciplined members of society in the network communities. Keywords: Digital Communities, Network Society, Social Control

Occurrence of aflatoxins and ochratoxin A in Gaz, a traditional Persian confection, and its ingredients

The current study was aimed to investigate the presence of aflatoxins (aflatoxin B1 (AFB1), aflatoxin B2 (AFB2), aflatoxin G1 (AFG1) and aflatoxin G2 (AFG2)) and ochratoxin A (OTA) in Gaz, a traditional Persian confection, and its ingredients (almond, pistachio, egg and white wheat flour) collected from Isfahan, Kerman and Chaharmahal-Bakhtiari provinces using high-performance liquid chromatography with fluorescence detection (HPLC-FD) in 2017. The findings obtained in this study showed that 74.2%, 39.2%, 12.5%, 5.8% and 34.2% of total Gaz samples contained detectable levels of AFB1, AFB2, AFG1, AFG2 and OTA, respectively. Moreover, AFB1, AFB2, AFG1, AFG2 and OTA were found in 55.3%, 34.1%, 7.6%, 4.11% and 18.2% of ingredients of Gaz samples, respectively. The ranges for positive samples were 0.2–21.9 μg/kg AFB1, 0.2–5.6 μg/kg AFB2, 0.2–2.0 μg/kg AFG1 and 0.2–0.6 AFG2. OTA was found in 76.6%, 16.0%, 70.0% and 66.6% of white wheat flour, egg, Gaz coated with flour containing almond and Gaz coated with flour containing pistachio with mean concentrations of 17.8 ± 2.2, 0.4 ± 0.0, 3.4 ± 0.8 and 2.8 ± 0.9 μg/kg, respectively. With respect to the adverse effects of AFs and OTA on human health, more strict regulatory monitoring and legislations must be applied in order to reduce exposure of Iranian population to toxin residues due to consumption of different food products such as traditional Gaz confection.

Approach to Environmental Sustainability and Green Campus at Universiti Teknologi Malaysia: A Review

Environmental pollution is a complex and rapidly evolving challenge faced by urban environments. University campuses are susceptible to greenhouse gas (GHG) emissions arising from energy use, particularly due to vehicular movement, solid waste generation and disposal, and electricity generation. The impact of GHG emissions, particularly carbon dioxide (CO2) on climate change, mainly global warming, which has emerged a contemporary concern. The recent increase in the number of proposals for regulatory legislations on emission control indicates the need for a clear methodology to address GHG emissions, as well as their environmental impacts. This paper deals with CO2 emission arising from energy used and solid waste within the campus of Universiti Teknologi Malaysia, Johor Bahru. The objective of this study is only the environmental aspect, related to carbon emission from energy used in the study area under review. This emission sources on UTM campus include, transportation, electricity and waste generation. This work reviews the application of compliance plans and approaches for the monitoring and control of environmentally sustainable parameters and categories. The performance of each model which reflects the sustainability achievement goals was determined. Constraints to the practice of sustainability concepts are identified and measures to improve sustainability levels are suggested. It is concluded that by following the standard set by Universitas Indonesia (UI) ranking, sustainability coupled with, enabling environment will be enhanced for universities' dwellers.

Use of traditional eye medicine and self-medication in rural India: A population-based study.

ObjectiveTo determine the type and nature of traditional eye medicine (TEM), their sources and use and practices related to self-medication for ophthalmic diseases in a rural Indian population.MethodsA population-based, cross-sectional study was conducted in 25 randomly selected clusters of Rural Gurgaon, Haryana, India as part of CORE (Cornea Opacity Rural Epidemiological) study. In addition to comprehensive ophthalmic examination, health-seeking behavior and use of self-medication and TEM was assessed in the adult population using a semi-structured questionnaire. Physical verification of available ophthalmic medications in the enumerated households was conducted by the study team. Descriptive statistics were computed along with multivariable logistic regression analysis to determine associated factors for use of self-medication and TEM.ResultsOf the 2160 participants interviewed, 396 (18.2%) reported using ophthalmic medications without consulting an ophthalmologist, mainly for symptoms like watering (37.1%), redness (27.7%), itching (19.2%) and infection (13.6%). On physical verification of available eye drops that were being used without prescription, 26.4% participants were practicing self-medication. Steroid, expired/unlabeled and indigenous eye drops were being used by 151(26.5%), 120(21.1%) and 75 (13.2%) participants respectively. Additionally, 25.7% (529) participants resorted to home remedies like ‘kajal’(61.4%), honey (31.4%), ghee (11.7%) and rose water (9.1%).ConclusionUse of TEM is prevalent in this population. The rampant use of steroid eye drops without prescription along with use of expired or unlabelled eye drops warrants greater emphasis on safe eye care practices in this population. Public awareness and regulatory legislations must be implemented to decrease harmful effects arising due to such practices.

Biosimilars in Brazil: The Beginning of an Era of Broader Access

Cancer is a major public health issue worldwide, especially in the developing world where 70% of the cancer-related deaths occur. During the last three decades, with the advent of targeted therapies using monoclonal antibodies, patients’ survival and quality of life have dramatically improved. Unfortunately, these great accomplishments came at the expense of high financial costs which most of the population living in low-and middle-income countries cannot afford. Biosimilars (biotherapeutic products that are similar to an already licensed reference biotherapeutic product in terms of quality, safety and efficacy) have been successfully used in Europe and in US with a substantial reduction in price of around 30%. Brazil is about to have trastuzumab as the first biosimilar available to treat cancer patients in the country. Based on strict regulatory legislations, biosimilars are expected to deliver affordable yet effective and safe treatment options all over the world, expanding the access to cancer treatment and reducing inequalities.

Cyberterror Regulatory Legislations and Extraterritorial Application of Domestic Law : Focused on Standards of Exercising Protective Jurisdiction

Cyberterror Regulatory Legislations and Extraterritorial Application of Domestic Law : Focused on Standards of Exercising Protective Jurisdiction

BIAS: A Regional Management of Underwater Sound in the Baltic Sea.

Management of the impact of underwater sound is an emerging concern worldwide. Several countries are in the process of implementing regulatory legislations. In Europe, the Marine Strategy Framework Directive was launched in 2008. This framework addresses noise impacts and the recommendation is to deal with it on a regional level. The Baltic Sea is a semienclosed area with nine states bordering the sea. The number of ships is one of the highest in Europe. Furthermore, the number of ships is estimated to double by 2030. Undoubtedly, due to the unbound character of noise, an efficient management of sound in the Baltic Sea must be done on a regional scale. In line with the European Union directive, the Baltic Sea Information on the Acoustic Soundscape (BIAS) project was established to implement Descriptor 11 of the Marine Strategy Framework Directive in the Baltic Sea region. BIAS will develop tools, standards, and methodologies that will allow for cross-border handling of data and results, measure sound in 40 locations for 1 year, establish a seasonal soundscape map by combining measured sound with advanced three-dimensional modeling, and, finally, establish standards for measuring continuous sound. Results from the first phase of BIAS are presented here, with an emphasis on standards and soundscape mapping as well as the challenges related to regional handling.

Screening of Blood Levels of Mercury, Cadmium, and Copper in Pregnant Women in Dakahlia, Egypt: New Attention to an Old Problem.

Heavy metals toxicity is a prevalent health problem particularly in developing countries. Mercury and cadmium are toxic elements that have no physiologic functions in human body. They should not be present in the human body by any concentration. Copper, on the other hand, is one of the elements that are essential for normal cell functions and a deficiency as well as an excess of which can cause adverse health effects. To test blood levels of mercury, cadmium, and copper in pregnant women in Dakahlia, Egypt. Using atomic absorption spectrophotometry, blood levels of cadmium, mercury, and copper were measured in 150 pregnant women attending to the antenatal care in Mansoura University Hospital in Dakahlia governorate, Egypt. The mean ± SD of blood mercury, cadmium, and copper levels were found to be far from their levels in the population surveys carried in developed countries like United States of America (USA) and Canada. Heavy metal intoxication and accumulation is a major health hazard. Developing countries, including Egypt, still lack many of the regulatory policies and legislations to control sources of pollution exposure. This should be dealt with in order to solve this problem and limit its health consequences.

MNC CSR in Emerging Economy Conflict Zones– A Case Study of HUL's North-East Operations in India

For multinational corporations (MNCs) operating in emerging markets, the fast-growing wealth represents a tremendous opportunity. At the same time, these emerging markets also present a huge challenge to the MNCs due to underdeveloped institutional environment, weak public governance, widespread bribery and corruption, and lack of regulatory legislations and rules, public transparency, and respect for human rights. MNCs are likely to view foreign direct investment (FDI) in emerging economies as a major component of their cost minimization policies. As such, corporate social responsibility (CSR) initiatives, which are used by MNCs as a key source to gain sustainable competitive advantage in developed countries may get diluted in emerging economies. Such a myopic view may enhance short-term profits, but would not ensure long-term sustainability. Most of the research on CSR has focused on the strategies of companies in the developed world. The literature on MNCs in developing economies and CSR is still embryonic. As CSR becomes increasingly important to MNCs, it is crucial to understand how MNCs' subsidiaries approach CSR in emerging markets so as to realize the challenges MNCs' subsidiaries face in aligning their CSR approach with local practices. The questions of how MNCs' subsidiaries approach CSR in emerging markets and how they adapt to local CSR practices remain largely under-explored. Another area of recent research pertains to MNC CSR in ‘conflict zones’ and their potential. Can the otherwise mutually conflicting objectives of Corporate Social Responsibility and Corporate Financial Performance be seen going hand in hand in such ‘conflict zones’ Can a cause-effect relationship be posited, especially in such conflict zones, with the success of the latter riding on a satisfactory performance of the former? This paper analyses the CSR practices followed by HUL in its unit in DoomDooma, Assam in the period 2001–2004, a period which was one of the most tumultuous periods in the history of HUL operation in India. The largest personal care products factory set up in DoomDooma to take advantage of the government's concessions to encourage the region's development, witnessed serious challenges in the form of local bandhs (closures), followed by an attack by the militant group, ULFA. Yet, the productivity contribution of the Assam factory was one of the highest and in fact was responsible for the company's top line growth. It is suggested that the financial performance was due in no small measure, to the corporate responsibility measures undertaken internally and externally by the company. The former consisted of the measures undertaken vis-a-vis the key stakeholders, viz. employees, consumers, ecosystem, and business partners while the external CR measures were with respect to the specific CSR initiatives undertaken keeping in mind the needs and expectations of the local community. Thus, the company's CR initiatives helped in sustainable growth.

Esoteric Everydayness: the Problem of the Occult, Para-psychological, Esoteric, Magical Discourse in Lithuania

In this article, the author examines public discourse in Lithuania (of the beginning of twentyfirst century) concerning esoteric, occult, magic, paranormal, psychic phenomena and practices, in the context of formulation some regulatory legislations on their functioning in media. In this examination several categories of opposing these practices and phenomena attitudes have been identified. And finally, have been provided categorization of this type of movements and phenomena in Lithuania in accordance to definitions of esotericism, occultism, and magic, proposed by contemporary researchers in this field of scientific researches.

The Validity of broadcasting sponsorship contracts in violation of relevant regulatory legislations

The Validity of broadcasting sponsorship contracts in violation of relevant regulatory legislations