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  • 11
    Online Resource
    Online Resource
    Preventing Prescription Drug Misuse: A Regulatory Perspective in the United States, Europe, and India
    Society of Pharmaceutical Tecnocrats ; 2021
    In:  International Journal of Drug Regulatory Affairs Vol. 9, No. 4 ( 2021-12-28), p. 46-52
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 9, No. 4 ( 2021-12-28), p. 46-52
    Abstract: Prescription medicines, such as analgesics, stimulants, steroids, anti-depressants, psychotropics, and certain antibiotics are commonly mishandled in a variety of ways, including overdosing, abuse, diversion, and drug trafficking. Because of the considerable risk to public health, they are subject to strict regulatory oversight. The drugs possess abuse potential at specific dose and hence prone to abuse therefore they are categorized as Controlled substances. Therefore, they are subject to constant vigilance over the pharmaceutical supply chain. The complete clinical data as well as post marketing surveillance study of such drugs are critical to be in place as per the regulatory requirements. The countries have kept up with the times by constantly updating the system with regulatory laws and strategies to prevent cases of misuse. The current review will give a quick summary of how prescription medications and prohibited substances are regulated in the United States, Europe, and India. It will also emphasize current trends in drug usage, as well as the issues that these countries face and the preventive policies implemented to manage and prevent drug misuse. It will also make recommendations for new regulatory initiatives to address the current drug- misuse-related concerns. As a result, a review of the regulatory system in various countries will present current challenges and new lessons for countries around the globe.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v9i4.502
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2021
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  • 12
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    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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  • 13
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    Online Resource
    A study of Regulatory aspects on Registration of Orphan Drugs in US and EU
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 4 ( 2022-12-15), p. 45-52
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 4 ( 2022-12-15), p. 45-52
    Abstract: The medicinal products used in the treatment, prevention, and diagnosis of rare disease like Myoclonus disease, Huntington's disease, Tourette syndrome are called as Orphan drugs, when it comes to defining rare disease and approving them as “Orphan designations.” The Criteria varies from country to country based on severity, prevalence of the disease and alternative therapies available. In 1983, the US government brought the Orphan Drug Act to facilitate and encourage pharmaceutical company to develop orphan drugs without which they show reduced interest in the research and development of these drugs. The reason being their low market value and sales of orphan a drug is so miniscule that it will not enable them to even recover a fraction of the investment made in them. After the inception of “Orphan Drugs” act 4500 orphan designations have been approved, 730 biologic drug products have been approved to treat 250 Orphan designations. In the past decades, orphan designations have doubled in number when compared to its preceding decade but only 1/5th of the developed medications to treat them and received regulatory approval.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v10i4.563
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
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  • 14
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    Online Resource
    Regulatory aspects on repurposing of drugs in the management of COVID-19
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 1 ( 2022-03-15), p. 1-13
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 1 ( 2022-03-15), p. 1-13
    Abstract: Drug repurposing involves the disquisition of using medicines for new remedial purposes. With the increasing waste production, given the costs and tiresome pace of new medicine search, repurposing of medicines already in the market to treat all kinds of conditions is decreasingly getting a selective approval because uses the composites that have been de-risked, with lesser development costs and shorter timelines of developing the drug. Colourful and experimental data approaches have been used for the identification of the medicines to be repurposed. There are also major technical and non-supervisory challenges that need to be addressed. In this review, we present the different kinds of approaches used for medicine repurposing, study the challenges faced by the scientists during repurposing as well as recommend ways by which these challenges could be overcome to help realize the full potential of medicine repurposing. Drug displacing is the repurposing of an already existing medicine for the treatment of a different complaint or medical condition than that for which it was firstly developed. This is one line of scientific exploration which is being pursued to develop safe and effective COVID-19 treatments. Other exploration directions include the discovery of a COVID-19 vaccine and convalescent tube transfusion. Several being antiviral specifics, preliminarily developed or used as treatments for SARS, MERS, HIV/ AIDS, and malaria, have been delved as implicit COVID‐19 treatments, with some moving into clinical trials. Monoclonal antibodies under disquisition for repurposing include anti-IL-6 agents (tocilizumab) and anti-IL-8 (BMS-986253). This is in resemblance to new monoclonal antibody medicines developed specifically for COVID-19.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v10i1.503
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 15
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    Good e-Governance: Xtended Licensing, Laboratory & Legal Node (XLN) - An effective tool for Good Regulatory Practice in field of Drugs and Cosmetics Regulation
    Society of Pharmaceutical Tecnocrats ; 2023
    In:  International Journal of Drug Regulatory Affairs Vol. 11, No. 1 ( 2023-03-17), p. 43-46
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 11, No. 1 ( 2023-03-17), p. 43-46
    Abstract: Food & Drug Control Administration (FDCA), can be credited with an iron hand and will of the regulator combined with the strict vigil and a friendly hand holding for all of its stake holders i.e., manufacturers of drugs, wholesalers, retailers, stockiest, C & F agents etc. The enforcement mission targets to fulfill the objective of making available the safe and effective medicines by ensuring that the menace of manufacture of spurious /substandard drugs is eradicated. For the enforcement activities it is vital to have immediate and accurate access to information as well as there is a need to communicate effectively and quickly with the stake holders. Prior to the initiative of implementation of software, SMS alerts etc. the enforcement task was dependent on manual means of actions and communications. Gujarat FDCA implemented web-based software - Xtended Licensing & Laboratory Node (XLN), http://xlnfda.guj.nic.in/login.aspx, with data stored in the central server. The aim behind e-governance was to create a system to bring about transparency, traceability, simplicity, effectiveness, harmonization, speed, accuracy and accountability in various G2G, G2C and G2B functions of the department and to attain & maintain FDCA’s leadership in drug regulations in India.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v11i1.579
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2023
    detail.hit.zdb_id: 2738279-5
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  • 16
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    Online Resource
    A comparative evaluation of Regulatory requirements for Registration of Dietary Supplements in Brazil, Russia, India, China and South Africa
    Society of Pharmaceutical Tecnocrats ; 2023
    In:  International Journal of Drug Regulatory Affairs Vol. 11, No. 3 ( 2023-09-19), p. 53-61
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 11, No. 3 ( 2023-09-19), p. 53-61
    Abstract: Nutraceuticals are products that are rich in nutrients and provide health benefits, because of many factors like lifestyle changes and change in the dietary habits of people now a day, these products are widely used. Among all the other categories of Nutraceuticals Dietary supplement comprises huge part of Nutraceuticals. They are distinguishable from conventional food or drugs. They are intended to use to supplement the normal diet. The terms, nomenclature and definitions of the dietary supplements vary throughout the world. Different countries have their own regulation and legislative requirements. In regulated countries streamlined regulations are there, while well-structured and streamlined regulations for Nutraceuticals are lacking in other countries. In developing and emerging nations the regulation of dietary supplements are constantly evolving. It is necessary that the product complies all the regulatory requirements before they are placed on the market. The proposed study is based on the regulation and legislative requirements of dietary supplements in Brazil, Russia, India and South Africa.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v11i3.616
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2023
    detail.hit.zdb_id: 2738279-5
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  • 17
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    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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  • 18
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    Regulatory advances and prospects of variation filing for the registered parenteral products in USA and Europe
    Society of Pharmaceutical Tecnocrats ; 2021
    In:  International Journal of Drug Regulatory Affairs Vol. 9, No. 2 ( 2021-06-16), p. 52-65
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 9, No. 2 ( 2021-06-16), p. 52-65
    Abstract: Drug Regulatory Affairs (DRA) is a vital unit in a pharmaceutical company. It is concern about the healthcare product lifecycle, it provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safety and efficacy in pharmaceuticals, veterinary medicines, medical devices, cosmetics and complementary medicines, healthcare products to individuals around the world. Regulatory affairs (RA) professionals are employed in pharmaceutical industry, government, academic research and clinical institutions. As India is growing very rapidly in pharmaceutical sector, there is a need of regulatory affairs professionals to cater the current needs of industries for the global competition. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. A regulatory affair is a somewhat new profession which has developed from the desire of governments to defend public health. Substantial documentation and data are required in these types of submissions, resulting in large, complex applications. Today 35 member countries along with 11 candidate countries and 4 international agencies have joined together to create the Pharmaceutical Inspection Cooperation Scheme (PIC/S) to promote a globally accepted GMP. Current constrain of Regulatory Affairs reveals diverse countries need  to follow different regulatory requirements for  marketing authorization  Application (MAA) approval of new drugs. In this present exertion, study expresses the drug approval process and regulatory requirements according to US Food and Drug Administration (UDFDA), European Medical Agency (EMA) and Central Drug Standard Control Organization (CDSCO).
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v9i2.470
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2021
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 19
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    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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  • 20
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    Regulatory Compliance of Small-Scale Pharmaceutical manufacturing facilities in Addis Ababa, Ethiopia
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 3 ( 2022-09-15), p. 1-9
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 3 ( 2022-09-15), p. 1-9
    Abstract: Background: there is growing concern that medicines supplied to most of the developing countries are of substandard quality. Along with the establishment of strong regulatory systems for ensuring compliance and regulatory law enforcement, manufacturing facilities need to work to implement dependable systems at each stage of the production process to ensure the safety, efficacy, and quality of their products. Objective: the aim of this study was to assess the level of compliance with regulatory requirements by small-scale pharmaceutical manufacturing facilities in Addis Ababa, Ethiopia. Material & Method: A cross-sectional observational study was conducted using a structured questionnaire and checklist to assess the level of compliance of small-scale local pharmaceutical manufacturing facilities to regulatory requirements and also to identify the challenges faced by the manufacturing facilities. Result: This study indicated that the overall implementation status of regulatory requirements in the local small-scale pharmaceutical manufacturing companies is far below the minimum standard set by WHO and the national regulatory authority. Basic on specific regulatory requirement elements compliance: requirements related to QA were 26.9, requirements related to personnel qualification were 38.1, requirements related to Quality control were 25.9, and requirements related to sanitation and hygiene were 15.3. Of the total regulatory requirements, only 26.1% were found to be implemented. Major challenges faced by the local small-scale pharmaceutical manufacturing industry for the implementation of regulatory requirements were: human resource capacity constraints, limited investment, limited support from Governments and other stakeholders, and poor infrastructure. Conclusion: The study demonstrated that level of regulatory requirements implementation in the local small-scale pharmaceutical manufacturers is far below the minimum standard set by the national regulatory authority. Important gaps were reported particularly in materials management, production operations, quality control, and sanitation and hygiene.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v10i3.540
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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