Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 4, Issue 1, 2017

Background: Pyrogens are fever causing microbial and non-microbial constituents of variable chemical composition. Their presence in dialysis fluids, parenteral drugs, biopharmaceuticals, cosmetics and on solid medical devices is considered a major health concern worldwide. The main aim of this review is to summarize the scientific literature accumulated during the last few decades concerning health risks of pyrogens and regulatory requirements for quality control in parenterals and healthcare devices. Methods: We searched the scientific databases for peer-reviewed research articles using keywords pyrogen, endotoxin, lipopolysachharide, lipoteichoic acid, depyrogenation, endotoxin detection etc. Results: Analysis of the published scientific literature indicates that endotoxins from Gram-negative bacteria are the most common pyrogenic contaminants in various biopharmaceutical drugs and healthcare products which are difficult to remove due to heat stable nature. Endotoxins and other pyrogens trigger adverse reactions in human body ranging from mild influenza-like symptoms and fever to organ failure, septic shock and even death. Considering their significant health risks, highly sensitive and accurate detection of pyrogens, particular endotoxin, and their removal to the satisfaction of regulatory requirements is a key aspect in the development of biopharmaceutical and healthcare products. Pyrogen testing is based on either a 100 year-old Rabbit Pyrogen Test (RPT), the most widely used Limulus Amoebocyte Lysate (LAL) test or the broad spectrum and biologically relevant Monocyte Activation Test (MAT). Conclusion: Analyses of the available literature indicates significant progress towards understanding the nature, mechanism of action and health risks of pyrogens. However, there is still a need to develop universally acceptable, sensitive and integrated detection assays, to emphasize the minimization of animals use and to strengthen the regulatory framework in biopharmaceutical and healthcare production facilities.

The medical device includes a variety of sophisticated, simple and newer equipments, such as tongue depressors, hemodialysis machines, PET (Positron emission tomography), MRI (Magnetic resonance imaging) scanners and magneto encephalography devices etc. The regulation of these devices has become advanced and more effective to produce continuous and steady regulatory perspective. There are different regulatory guidelines and organizations in this world for different countries such as, U.S.A., Europe, Japan, India, Australia and many others. These regulatory groups laboured together to provide excessive first-class, inexpensive merchandise with secure and appropriate use and disposal of scientific devices. The current review discusses the various life span phases of medical device, different approval steps of FDA for placing the medical device inside the market and the brief information associated with the various regulatory authorities with respect to different countries. Since the early 1980s, especially the regulatory requirements for medical devices have been improved. With the supply of various regulations of the international locations on clinical gadgets, there is a need to harmonize rules to be able to curtail regulatory hurdles and to provide best, safety and efficacious scientific devices. To accelerate international medical device regulatory harmonization and convergence, IMDRF (International medical device regulators from) group has been constituted which has come together to build the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) around the world.

Herbal medicinal products are widely used for treatment of almost all human ailments in traditional systems of medicines. These are consumed not only as medicinal products but also as dietary supplement products to improve one's health. So, both types of these herbal products can be collectively termed as herbal health products. Growing demand of these health products in global market has raised issues on the quality and safety of herbal materials and finished products. The phytochemical complexity, and uncertainty about phytochemicals responsible for therapeutic effects of a herbal product are the most prominent challenging problems in deriving the criteria for evaluation of its quality. A practical approach to assess quality of a herbal product is evaluation of its stability during the proposed storage/shelf time. Regulatory agencies in various countries across the globe have recommended guidelines for establishing and ensuring quality, safety and efficacy of herbal products. The present review deals with the guidelines issued by drugs regulatory agencies of different countries or group of countries, and compiled those to understand the extent of coherence or agreement among various guidelines on the quality attributes of herbal products.

Background: Nutraceuticals are the concentrated nutrients that are isolated from food or food products and have therapeutic and preventive qualities. They are gaining wide popularity because beyond providing basic nutrition, they have several health benefits. The global nutraceutical market is forecasted to reach $ 241.1 billion by 2019. However, the safety and quality of nutraceuticals are the major issues that need attention. Objectives: The aim of this mini-review is to discuss the safety, quality and regulatory aspects of nutraceuticals. A little attempt has been made to provide information about global nutraceutical market, recent patents and marketed products. Discussion and Conclusion: Currently, nutraceutical industry is operating as a blend of regional regulations of different countries. The existing regulatory framework for nutraceuticals is disorganized with no global standards for compliance. Therefore harmonization of regulations is necessary to remove the regulatory flaws across the countries and to ensure the product quality.

Blood is considered as a life saving tissue. World Health Organization (WHO) has considered “Blood” under the definition of “Drug,” in Drug and Cosmetic Act, 1940. For the first time, in 1975, WHO World Health Assembly (WHA) under the resolution WHA (28.72), established the principles and guidelines for the managed and coordinated blood systems. For over fifty years, expert committee on biological standardization (ECBS), has been playing a key role in developing and updating norms and standards for collection, processing, storage, transfusion and manufacturing of pharmaceuticals derived from blood. In 2010, under the resolution WHA (63.12), WHO noted a number of international concerns about shortage of plasma derived products, unequal access of blood and blood products globally, quality and safety of blood and blood product transfusion. So, this review summarizes various regulatory requirements, which need to be followed for safety and quality assurance systems to control the quality and safety of blood and blood products and provision of safe blood products to meet the clinical need of patients.

The concept of connected health has gained traction in recent years as a new technology enabled and networked model of health care delivery. It is often used as an umbrella term for eHealth, digital health, health informatics, telemedicine, mHealth and involves the establishment and management of a network of stakeholders with the aim of improving health care quality and outcomes. Yet a lack of open interactions and knowledge networks and the missing integration of the larger constituency of interdisciplinary experts are limiting the execution of the model and restricting its potential to devise services and interventions around patient’s needs with shared health related data. Drawing parallels between the concept of connected health and open innovation, the networked innovation model, which involves efficient management of knowledge flows and complex networks for successful innovations; in this paper we outline the practice of open innovation in health care and suggest connecting stakeholders in the health care ecosystem in an open innovative format. In doing so we present a categorization of firms in the health care ecosystem into open innovation profiles for getting connected and propose an open innovative framework for maximizing the potential of the concept of connected health.

Background: Probiotic constitutes viable microorganisms that exhibit a beneficial effect on the host. Due to rapidly increasing awareness among consumers about wide therapeutic applications of probiotics, plenty of commercial probiotic formulations are entering to the market, hence market has shown significant rise has been observed in recent years. Probiotic products are gaining popularity across the globe, under different categories such as functional foods, dietary supplements, natural health products etc. Probiotics have been a functional component of health foods but till date no legal definition exists for the term ‘probiotic’. Discussion: The term is interpreted differently by different countries and hence regulatory guidelines vary as per their intended use. Due to the growing interest in using diverse organisms as probiotics, the identification of these microorganisms upto strain level is becoming essential. So, bacterial identification should have prime importance while formulating any probiotic dosage form. Identification up to a satisfactory level i.e. genus, species and even strain level can only be achieved by polyphasic approach by using combination of phenotypic and genotypic methods. Conclusion: Present review summarizes current status of various identification techniques, which are being used for probiotics, shortcomings of current scenario, and furthermore how it necessitated bringing polyphasic approach.

Background: Institutional Ethics Committees (IECs) in India are in their infancy stage which has significant implications in context to oversight of the protection of human participants. The critical and first step to support the protection of research participants and improve the scientific quality of health research is to understand how these IECs currently function. Objective: Authors assessed the functioning of IECs to understand the neglected status of IECs in health research institutes providing the graduate/postgraduate education under the jurisdiction of Baba Farid University of Health Sciences (BFUHS), Faridkot (A state govt. funded autonomous body). Method: A cross sectional study was done to assess the general information about IECs, training level, activity levels, application process and review procedures of IECs in health research institutions of Punjab, India. A structured self-administered questionnaire was developed and used for compilation of all the information. Results: In this study authors obtained response from 56% health research institutes of Punjab. Data revealed significant shortcomings in the existence of formal IECs (54%), non accreditated Drug Controller General of India (DCGI) status (86%), inadequate training level (85%), non allocation of dedicated budget for IECs (92%), poor documentation and standard operating procedures (75%), poor competence and exposure of IECs to review varied research proposal etc. Most of IECs review quantitative studies (67%) as well as most of IECs do not operate actively (irregular meeting in 74%). Conclusion: This study indicates very poor status of IECs in health research institutes of Punjab that need urgent attention of regulatory authorities. Therefore, authors suggest that the IECs must be registered with DCGI for the improvement in structure and functioning of IECs.