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  • 1
    Online Resource
    Online Resource
    CONCERNING THE COMPLIANCE OF THE LEGISLATION OF UKRAINE ON CRIMINAL LIABILITY IN THE SPHERE OF ILLEGAL DRUG TRAFFICKING WITH INTERNATIONAL REGULATORY LEGAL ACTS
    Donetsk State University of Internal Affairs ; 2020
    In:  Law Journal of Donbass Vol. 73, No. 4 ( 2020), p. 95-102
    Details
    In: Law Journal of Donbass, Donetsk State University of Internal Affairs, Vol. 73, No. 4 ( 2020), p. 95-102
    Abstract: The public danger of illegal drug trafficking, drug addiction and related phenomena is obvious; therefore the world community is making significant efforts to counter these phenomena, because only through joint efforts it is possible to ensure an effective counteraction to drug trafficking. For this purpose, states adopt a significant number of international normative legal acts. The issues of countering the illegal drug trafficking, psychotropic substances, their analogues and precursors are considered both within the framework of general documents on combating crime, and in special acts. Taking into account the European integration course of Ukraine, the expansion of international cooperation in the sphere of combating the illegal drug trafficking drugs, psychotropic substances, their analogues and precursors, the following issues should be marked as ones of great importance: observance by Ukraine of its international legal obligations; integration into the world system of counteracting drug trafficking; bringing national legislation in line with the provisions of international regulatory legal acts. This article is devoted to the outlined questions. In particular, the provisions of the national legislation in the sphere of illegal drug trafficking, psychotropic substances, their analogues and precursors are analyzed, and the compliance of domestic norms with international regulatory legal acts in the sphere of combating illegal drug trafficking is concluded. The classification of international regulatory legal acts in the sphere of illegal drug trafficking in dependence to the authority that issued them is given. On the basis of the conducted analysis, the author suggests ways to further improvement of the domestic criminal legislation in the sphere of combating drug trafficking. In particular, it is proposed to criminalize the sowing and cultivation of any kind of narcotic drugs, as well as to partially revise the punishment for certain drug crimes.
    Type of Medium: Online Resource
    ISSN: 2523-4269
    Uniform Title: ЩОДО ВІДПОВІДНОСТІ ЗАКОНОДАВСТВА УКРАЇНИ ПРО КРИМІНАЛЬНУ ВІДПОВІДАЛЬНІСТЬ У СФЕРІ НЕЗАКОННОГО ОБІГУ НАРКОТИКІВ МІЖНАРОДНИМ НОРМАТИВНО-ПРАВОВИМ АКТАМ
    URL: Issue
    URL: Journal
    URL: Article
    DOI: 10.32366/2523-4269-2020-73-4
    DOI: 10.32366/2523-4269
    DOI: 10.32366/2523-4269-2020-73-4-95-102
    Language: Unknown
    Publisher: Donetsk State University of Internal Affairs
    Publication Date: 2020
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  • 2
    Online Resource
    Online Resource
    Regulatory response to pandemics in a developing country- the case of COVID-19 and the Ghana food and drugs authority (Ghana FDA)
    Society of Pharmaceutical Tecnocrats ; 2020
    In:  International Journal of Drug Regulatory Affairs Vol. 8, No. 4 ( 2020-12-17), p. 61-65
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 8, No. 4 ( 2020-12-17), p. 61-65
    Abstract: The emergence of the novel coronavirus (COVID-19) has demonstrated the challenge of a single infection to health systems across the globe. The World Health Organization (WHO) declared COVID-19 as a pandemic on 11th March 2020, pointing at the time to the over 118,000 cases of the coronavirus illness in over 110 countries around the world and the sustained risk of further global spread. Congruent to this declaration by the WHO, countries were expected to accelerate their individual efforts amidst striking the right balance between protecting health and preventing economic or social disruption. In response to the pandemic, regulatory authorities of food and drugs in various countries are also recognizing the new demands and obligations that the pandemic has brought and taking measures to meet them and provide the much-needed support.  The Ghana Food and Drugs Authority (FDA) has taken various accelerated actions to meet the local demands in managing COVID-19. The regulatory interventions not only aim to facilitate the authorization of medicines and health technologies, sensitize the public on disease prevention and ensure the uninterrupted availability of medical and food supplies but also seek to inspire and boost local industrial potential. The Ghana FDA’s efforts are multifaceted and include propping the Drug Supply Chain, expeditious testing of essential COVID-19 medicines, facilitating efforts at COVID-19 test kit evaluation, active post market surveillance and public sensitization on preventive measures. The outcomes of the FDA response have informed ample opportunities that can be leveraged on now and beyond the pandemic and sensitized the Authority on the need to simulate possible emergencies and be better prepared in future happenings.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v8i4.438
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2020
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 3
    Online Resource
    Online Resource
    Regulatory aspects of Impurity profiling
    Society of Pharmaceutical Tecnocrats ; 2020
    In:  International Journal of Drug Regulatory Affairs Vol. 8, No. 4 ( 2020-12-16), p. 45-54
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 8, No. 4 ( 2020-12-16), p. 45-54
    Abstract: Quality, safety and efficacy of pharmaceuticals play an important role in drug therapy. The safety attribute of drug is established by its pharmacological or toxicological profile along with adverse effects caused by impurities in bulk and dosage form. Impurities present in drug often possess undesired pharmacological or toxicological effects which outweighs the benefits of drug therapy. Recently, many impurity cases have been reported for e.g. NDMA (N-nitroso dimethylamine) impurity in drug product Ranitidine. This may be due to inappropriate follow of impurity related regulatory guidelines or critical voids in regulatory control of impurities or may be lack of appropriate analytical technique for impurity detection. Moreover, in June 2007, EMA became aware of contamination of Viracept® tablets. It was detected with presence of ethyl mesylate impurity, a known genotoxic substance in Nelfinavir mesylate (Viracept®). Due to this, the product was recalled from EU market. An impure drug is devoid of safety, quality and efficacy and can lead to adverse events. So, drugs of required quality standards should reach the market for patient’s safety. Therefore it is important and becomes mandatory to submit impurity data related to isolation, identification, qualification and control of impurities to respective regulatory authorities. This article is an attempt to deliver comprehensive understanding related to various attributes and details about impurity profiling in context with regulatory guidelines along with detail description of impurity data submission to regulatory authority for drug substance (API) to get market approval. This article also focus on ICH impurity guidelines ,sources, classification and quality control of impurities.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v8i4.433
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2020
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 4
    Online Resource
    Online Resource
    Cosmetics in US and India: Overview of Regulations and Registration process
    Society of Pharmaceutical Tecnocrats ; 2020
    In:  International Journal of Drug Regulatory Affairs Vol. 8, No. 4 ( 2020-12-15), p. 20-24
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 8, No. 4 ( 2020-12-15), p. 20-24
    Abstract: Cosmetics, for a long period of time have been used as beauty products for the care of body and face which eventually enhances a person’s appearance. These products are usually constituted from a mixture of different chemical compounds which are synthetic as well as organic in nature. For a long period of time, these products have not come under the ambit of regulatory authorities and have gone through the markets unchecked. The way a drug manufacturing and sale process is monitored by the regulatory authorities across the world, which includes careful monitoring of clinical trials, scrutinizing research results like safety, efficacy and quality of a drug has been avoided for a long period of time in case of parameters related to cosmetics. Some groups alleged that the industry practices are flawed, that there is little government regulation, and that cosmetics contain cancer-causing chemicals and other toxicants which are harmful for human body. Rules have certainly changed over time and major countries like India have started following guidelines while giving regulatory approval to cosmetics just like USA. The U.S. (FDA) functions include the banning and restriction of ingredients for safety purposes. The Cosmetic Ingredient Review (CIR) which is an independent review board that critically evaluates chemical ingredients used in cosmetics and publishes results of its findings. Similarly in India, CDSCO (Central Drugs Standard Control Organisation) and DCGI (Drug Controller General Of India), both are responsible for evaluating the composition of cosmetic products and their safety while referring to a drafted set of guidelines known as BIS( Bureau of Indian standards) guidelines. The article focuses on various aspects considered by USA and India while giving regulatory approval to cosmetic products.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v8i4.430
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2020
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 5
    Online Resource
    Online Resource
    Drug Registration requirements for Pharmaceuticals in Emerging markets
    Society of Pharmaceutical Tecnocrats ; 2020
    In:  International Journal of Drug Regulatory Affairs Vol. 8, No. 4 ( 2020-12-17), p. 73-82
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 8, No. 4 ( 2020-12-17), p. 73-82
    Abstract: Registration of pharmaceutical drug products in emerging market is maximum worrying task. Although the requirements are harmonized in regulated international locations by way of CTD (Common technical document) submitting, yet others have considerable diversity in necessities. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe collectively for various factors of drug registration. But there is no such harmonized guideline for rising marketplace besides Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exists in clusters with their mutual situation. Quality, Safety and Efficacy information has significance importance in dossier registration. Pharmaceutical Industries has to conform with regulatory requirement in Emerging market and for betterment of public Health and protection. The business importance of markets is increasing globally. It is important for pharmaceutical enterprise to address the regulatory necessities for betterment of public and to ensure their place in the marketplace. The review additionally explains a short approximately extraordinary regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier software in Emerging marketplace.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v8i4.442
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2020
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 6
    Online Resource
    Online Resource
    Advancing the FDA/Office of Regulatory Affairs Mycotoxin Program: New Analytical Method Approaches to Addressing Needs and Challenges
    Oxford University Press (OUP) ; 2020
    In:  Journal of AOAC INTERNATIONAL Vol. 103, No. 3 ( 2020-06-01), p. 705-709
    Details
    In: Journal of AOAC INTERNATIONAL, Oxford University Press (OUP), Vol. 103, No. 3 ( 2020-06-01), p. 705-709
    Abstract: The U.S. Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) oversees FDA field laboratories, monitoring the occurrence and levels of toxic mycotoxins in domestic and imported human and animal food products that have the potential to impact human and animal health when consumed. The mycotoxins being routinely monitored in human and animal foods and feeds by the Agency include aflatoxins (B1, B2, G1, G2, and M1), fumonisins (FB1, FB2, and FB3), deoxynivalenol, ochratoxin A, patulin, and zearalenone. There has been an ongoing expansion of the Sample Collection Operation Planning Effort (SCOPE) for the mycotoxin program to monitor more mycotoxins in a wider variety of food and feed matrices. To meet this pressing need, we are in the process of modernizing and harmonizing the FDA/ORA mycotoxin program in the field laboratories using approaches such as adopting new analytical technologies/methods to further advance the service. This short perspective gives an overview of the FDA mycotoxin program in the field laboratories and the current program status, discusses the need to advance the program, strategies for modernization and harmonization by implementing liquid chromatography-mass spectrometry technologies for multi-mycotoxin analysis, benefits of doing this, and challenges in taking this new approach. Perspectives on finding solutions to tackle challenges and addressing emerging issues are also discussed.
    Type of Medium: Online Resource
    ISSN: 1060-3271 , 1944-7922
    URL: Article
    DOI: 10.1093/jaocint/qsz007
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
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  • 7
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    Online Resource
    An updated review on Materiovigilance for safe use of medical devices
    Society of Pharmaceutical Tecnocrats ; 2020
    In:  International Journal of Drug Regulatory Affairs Vol. 8, No. 4 ( 2020-12-15), p. 5-13
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 8, No. 4 ( 2020-12-15), p. 5-13
    Abstract: In the last two decades, there has been an upsurge in the volume of medical devices and thereby increasing medical device-related adverse events. So, materiovigilance is an essential system for identifying, collecting, reporting and analysing adverse events related to medical devices. The Vigilance programme for the medical device was initiated in many countries many years ago but, is a quite new concept for India. The Materiovigilance programme in India was launched on July 6 2015, at the Indian Pharmacopoeial Commission (IPC) with the objective of monitoring adverse events, thereby reducing risks related to use of medical devices and also creating awareness among different stakeholders for improving patients’ safety. The intent of this review article is to provide holistic understanding of medical device related adverse events; classification, reporting criteria, what, where, how, who and why, timeframe and tools used for reporting. Data collected using various search engines and compiled to give complete information regarding the subject matter. The thorough understanding of current status of materiovigilance programme in India including challenges involved in the programme and future directions for improving has been stated. Case studies have been reviewed for Johnson & Johnson’s faulty hip implant and Medtronic premature battery depletion. Implementation of Materiovigilance programme of India (MvPI) version 1.1 lead to safeguard the health of device user by preventing recurrence and risk associated with medical device.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v8i4.428
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2020
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 8
    Online Resource
    Online Resource
    Donation of Contraceptive Products through Special Import Permits: A Case Study in Zambia and Nigeria
    Society of Pharmaceutical Tecnocrats ; 2020
    In:  International Journal of Drug Regulatory Affairs Vol. 8, No. 4 ( 2020-12-17), p. 55-60
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 8, No. 4 ( 2020-12-17), p. 55-60
    Abstract: Introduction: Securing a special import permit for the donation of an unregistered contraceptive product can be a viable option to import the product in an expedited manner. However, this process can be difficult due to varying country requirements and the availability of accurate and timely information. Case description: This paper will explore the process for securing import permits for donated contraceptive products in Zambia and Nigeria, comparing national guidelines to applicant experiences and providing recommendations to future applicants. Discussion and evaluation: In practice, application requirements and timelines for special import permits in Zambia and Nigeria differed from national guidelines. Despite these differences, special import permits can be secured more quickly than formal product registration, which is a slower but more sustainable solution. Conclusion: Due to a lack of comprehensive and up-to-date guidelines online for some low- and middle-income countries (LMICs), the regulatory community is encouraged to share their experiences with special import permit application processes.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v8i4.437
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2020
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 9
    Online Resource
    Online Resource
    Preventive measures of Ayurveda and Yoga for Covid-19 Prophylaxis
    Society of Pharmaceutical Tecnocrats ; 2020
    In:  International Journal of Drug Regulatory Affairs Vol. 8, No. 4 ( 2020-12-15), p. 14-19
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 8, No. 4 ( 2020-12-15), p. 14-19
    Abstract: Covid -19 outbreak is now a frustrating entity to the medical field and having dreadful impacts on the global health care system & its economy. A standard timeline of treatment for this entity is not yet being established. This situation demands an alternative search for its treatment in other science & also emphasises the importance of its prevention in the current situation by improving immunity. The basic aim of this paper is to search for various treatment & preventative regimes in Ayurveda, Yoga, Pranayama, and Meditation for the management of different communicable diseases. Various references in Ayurveda show that both preventative & curative aspect of airborne communicable diseases can be fulfilled with the help of Ayurveda. By the adopting Ayurvedic measures such as following proper Dincharaya, Rutucharya, Sadvritta, Achara Rasayana, Panchakarma , Shaman Cikitsa & Rasayana, Yogapachara , Spiritual therapies, Dhoopana Karma; both physical and mental health can be maintained & occurrence & spreading of such diseases can avoid. During this covid 19 pandemic, peoples maybe got stress and depression. To avoid such conditions used pranayama and meditation for better treatment. This was an encouraging development and a good initiative for the treatment.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v8i4.429
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2020
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 10
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    Online Resource
    Role of Instruments in Pharmacoeconomics Perspective-An Overview
    Society of Pharmaceutical Tecnocrats ; 2020
    In:  International Journal of Drug Regulatory Affairs Vol. 8, No. 4 ( 2020-12-15), p. 1-4
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 8, No. 4 ( 2020-12-15), p. 1-4
    Abstract: In health care usually physical scaling is helping in understanding the cure of a disease.  In abstract scaling, one has to give his or her own feelings that does not have a fixed scale to compare with, but defined, evaluated and used.  Documenting abstract scaling along with physical scaling is gaining its importance to assess a desired outcome achieved or not, which is usually not recorded. In certain circumstances, choice of treatment, therapy is up to the patient. Mathematical equations were established as cost, benefit, utility, effectiveness etc. Policies relating to health care are to increase lifespan of the individual so that losses in productivity or work are minimized. Holistically, in pharmacoeconomics, it is necessary to compile costs and benefits to come to scientific conclusions in selecting a treatment among the choices available and for reimbursements.  The current review article illustrates the various approaches, mathematical models and need of abstract scaling for economical effective therapies.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v8i4.426
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2020
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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