Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 6, Issue 1, 2019

Background: The healthcare is a highly regulated sector as it serves billions of population globally. The two imperative pillars of this sector are pharmaceutical industry and health regulatory authorities. While the industry acts as a supplier in this sector, regulators provide governance to ensure quality, safety and efficacy of the healthcare products. Even though organizational objectives of these two stakeholders are different, the by and large goal is to improve health outcomes for populations. Both these entities are confronted by an assortment of challenges. Objectives: This study aims to draw attention towards such pain points and the potential of collaboration and coordination efforts between these entities to mitigate these challenges. The industry faces challenges that are driven by business needs and regulations. The major challenges faced by the regulators are driven by the needs to ensure the safety, quality and efficacy of health care products. Some of these challenges may have an overlap. Market scenario, patent/ exclusivities/return on investment issues, development costs, cost containment, quality and GMP, scientific discovery productivity, novel therapies and technology, regulatory framework, counterfeiting, supply chain challenges, Product life cycle management (PLM), patient centricity approach, resources and financial constraints, process issues, protection of the public health, contemporizing and growth of regulatory framework, political scenario in the country/region, unethical clinical trials and research, healthcare policies, citizen participation, pharmacovigilance and safety measures comprise a non-exhaustive list of challenges that confront industry and regulators. Health authorities need to partner amongst them and with Pharmaceutical industry and continue to innovate for novel ways of working to conquer these challenges. Organizations of international/ regional repute are known for their unique contribution in regulating the healthcare sector. These bodies have helped to improve access to safe medicines more widely by harmonization of drug quality, safety, and efficacy standards. These coordinated efforts have the potential to reduce the numbers of challenges that confront the healthcare sector. Conclusion: The pharmaceutical industry and health regulators need to partner to achieve common goal of healthcare. There is a growing need for these parties to come together on common platforms and collaborate. The success of the strategies and approaches intended to deal with these challenges depends upon strategic-level leadership and new ways of collaborative working, which creates a room for potential synergies.

Background: The role of various probiotic microorganisms with a particular emphasis on their therapeutic use in human health and disease has been highlighted by diverse scientific research reports. Due to improvement and introduction of new technologies useful to understand the functionality and mode of action of probiotics with respect to nutritional as well as health perspectives, the research on probiotics has recently grabbed the attention of manufacturers, regulators as well as researchers. Currently there are clinical trial based evidences to support the effectiveness of probiotic interventions in various types of diarrheal diseases, chronic gastrointestinal inflammatory disorders, hypercholesterolemia, hypertension, diabetes, oral health etc. However, due to inadequate awareness about risks associated with the probiotics amongst physicians, regulatory authorities, consumers and manufacturers many attributes like quality, safety and efficacy require urgent attention. At the same time regulatory guidelines for these products face ambiguity. So, it is of utmost importance to evaluate the true status of probiotic products available in market with respect to all above mentioned parameters and to formulate harmonized regulatory guidelines for the manufacturing of probiotic products. Conclusion: The present compilation aims to highlight the progression of probiotic research related to therapeutic potentials of probiotics, clinical trials on probiotics, risks and regulatory concerns associated with probiotics and their use.

Background: Hair care cosmetics are meant for the purpose of cleansing, modifying, promoting growth and grooming the hair. These products are designed to provide nourishment and prevent hair damage; these are mainly comprised of shampoos, conditioners, grooming products, etc. The products have gained prominent deliberations across the globe due to increasing issues of hair related problems. As these problems are enhancing at a greater rate, use of hair care cosmetics should be regulated in order to make them safe and effective to the consumer. However, manufacturers across the globe are conducting safety analysis to ensure the safety, non- irritating potential of these products and that the product should not cause any allergic reaction. Objective: The review highlights several regulatory as well as clinical aspects of hair cosmetics that govern the use of hair products worldwide. Laws and regulations followed by various countries are highlighted. The write up also unfolds clinical and safety aspects of different hair care products. Methods: Regulatory guidelines and clinical reports have been retrieved using sites www.usfda.gov and www.clinicaltrials.gov, respectively. Conclusion: The FDA has recommended that hair care cosmetics should be evaluated for the type of allergic reactions and the products should not be contaminated. An appropriate antimicrobial agent must be added in order to prevent any type of microbial contamination. The product's safety should be observed in market-place via consumer comments and complaints.

Introduction: Nutraceuticals although is a widely accepted term and now well understood, there exists several nomenclature and definitions across the countries. The present article discussed the progression of Indian food product regulations over the years, mainly emphasizing on regulations of nutraceuticals and dietary supplements. Regulatory Progression in India: The regulatory structure of nutraceuticals in India has evolved after the establishment of Food Safety and Standard act in 2006, which brought together preexisting eight laws to one single law regulated by Food Safety and Standard Authority of India (FSSAI). After the introduction of this act, the regulatory framework of food products progressed year by year with continuous amendments to this Act. The major milestone in the field of nutraceuticals was in 2016 with the introduction of regulations of functional food and nutraceuticals. Under these regulations, various guidelines were laid down for nutraceuticals in terms of their safety standards, health claims along with permissible limits of active ingredients and excipients for the safe and effective use. Conclusion: India has progressed in the development of a strong regulatory framework for nutraceuticals; however, to effectively implement these guidelines and for ensuring the safe and nutritious food, a robust system and a better-coordinated actions are required.

Background: The product registration in rest of the world is a challenging task because they are not harmonized. ASEAN and GCC regions come under semi-regulated market. These regions have somewhat harmonized their regulatory organization. The significance of an emerging market is increasing globally. It is important for pharmaceutical companies to be up-to-date with the latest regulatory development. ASEAN used ACTD format and GCC used ICH CTD format for drug product Registration. ASEAN includes a group of countries like Singapore, Philippines etc. Whereas GCC includes Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and UAE. Conclusion: This review article focuses on general regulatory requirements of registration of pharmaceuticals in ASEAN and GCC region.