Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 2, Issue 3, 2015

Background: By 2020, the pharmaceutical business is expected to be more than two folds i.e. US$ 1.3 trillion, in the E7 nations - Brazil, India, China, Mexico, Indonesia, Russia and Turkey - book keeping around for one fifth of worldwide pharmaceutical sales. The paradigm is shifting from developed markets such as the United States and Western Europe to evolving markets such as Brazil, India, China, Mexico, Indonesia, Russia and Turkey. The reasons include growth patterns in developed markets that tend to flatten due to patent expiry, stringent expectation of regulatory authority. Also, high gross domestic product growth rate, large population, high per capita income, high median age population, growing health care needs of the large middle class aging population, emerging health care and insurance sector, etc. are fascinating growth aspects of emerging markets. Objective: The present paper explores the opportunities and challenges associated with Pharmerging markets. Conclusion: The emerging markets promises for profitability, a broad range of variability is observed in drug development, regulatory filing, handling deficiency, managing post approval changes, intellectual property right issues, phase lag, rudimentary healthcare system, lack of infrastructure and markets vulnerable to policy change with regard to marketing are observed. So, it’s obvious that, there can be no “one-strategy for all” approach for emerging markets.

Background: Quality, the basic requirement, is meeting stated as well as implied needs of customer. It holds paramount significance when it is specifically related with health care products especially drugs and other related products. These traditional therapies are being explored today for its overwhelming roles in health care sector. However, lot many consequences are associated with traditional medicine with respect to their efficacy, safety and quality. Methods: For the present article, literature has been reviewed in context to current approaches, used for quality control of pharmaceuticals, probiotics and herbal across the globe. Results: This review has been compiled to discuss various factors associated with safety concern of selected health care products. It highlights various concerned factors associated with effective monitoring of the safety of traditional medicines including herbal products and live microorganisms i.e. probiotics and nutraceuticals in comparison to widely accepted pharmaceuticals. Conclusion: Safety is supposed to be the major concern regarding health claiming products hence relevant regulatory regimes should be enforced to deliver quality as per demand of the consumer.

Background: Medical devices are the prevailing part of modern medical care. The quality of medical devices is depended largely on how effectively they’re regulated. In India, before 2005, there were no regulations on medical devices. Even though now in India, medical devices are regulated under the regulation of the Drugs and Cosmetics Act and Rules. Recently floated “draft medical device policy” (June 2015) have brought a promising scope for the formation of an autonomous National Medical Device Authority (NDMA). The draft changes have been publicly released for review comments. Objective: The aim of this manuscript is to give a thorough analysis of draft medical device policy, its impact and how this praiseworthy initiatives are separating the regulation of drugs, cosmetics and devices. Conclusion: This has become a ray of hope to improve so called unorganized medicinal devices regulatory environment efficiently and appropriately in India. India is always import driven and one of the largest medical device markets in Asia, so the formation of the country's first agency especially dedicated to the regulation of medical devices will catalyze the growth of medical device market of India.

Background: Cosmetics are products meant for cleaning, perfuming, beautifying, promoting attractiveness or altering the appearance on application to human body, without involving any physiological activity. In general, the term cosmetic includes a vast range of products mainly used for external care of the human body. To safeguard consumer’s health, each country has its guidance or regulations for cosmetic products. These regulations are legal tools for simplifying and reducing administrative work and ambiguities. Methods: We undertook a structured search of regulations available for cosmetic products in major countries. All countries have been selected basis their well developed and highly recommended regulations and guidance documents. All regulations have been studied and presented here in a comparative manner for their regulatory framework for cosmetics in Canada, United States, European Union and India. All information was collected from mentioned countries regulatory databases maintained and updated by authority of these countries and appropriate review literatures available online. Results: Regulations and guidelines have been studied thoroughly and appropriate information was included in the review through regulatory Authority website available on the internet. Majority of regulatory information for Canada, United States, European Union and India were available at website maintained by their respective authorities. In addition few review articles have been also consulted for introductory part of the manuscript. As per respective country regulations, Import, manufacture and sale procedures of cosmetics must be compliant with legislative regulatory system of respective country. Health Canada regulations on cosmetic products are mentioned in Food and Drugs Act and the Cosmetics Regulations. Cosmetics Notification, essential minimum labeling for consumers are few basic requirements that must be followed by manufacturers for Canadian market. Except for colour additives, United States, Food and Drug Administration (FDA) do not require cosmetic products and ingredients premarket approval. However, manufacturers are always advised to carry out necessary tests and establish safety of their product and all ingredients used in the preparation. New European Community Cosmetics Regulation 1223/2009 has replaced earlier Cosmetics Directive 76/768/EEC and other national provisions that were applicable to cosmetics. The Objective of new Regulation is to have a harmonized rule for all EU member countries. In India, cosmetics are regulated under the scope of Drugs and Cosmetics (D) Act 1940 and Rules 1945. Conclusion: The finding of this review is to conclude the comparative regulatory framework for cosmetic products with respect to applicable acts, regulations, ingredients, heavy metals, labeling, notification procedures etc. for different countries. Despite of many differences among these regulations, the availability of quality products in market is the prime objective of each country’s laws and regulations.

Background: Continuous innovation is the unique feature of a pharmaceutical industry and is also prerequisite for sustainment of this industry. However, the dipping number of new molecules, rising costs of drug development, heightened health authority scrutiny and increased competition from generic industry indicate that the innovation is endangered. Methodology: The methodology used is a comparative study on the basis of original empirical research. More specifically, the part of examination facts and regulation has been written by conducting empirical research on current international and national resources concerning the subject from books, various Guidelines, Rules and regulations, Articles, Published Reports and internets. Results: The importance of innovation has been fairly realized by the industry and regulatory authorities as evident from the rise in number of new molecules approved by US FDA in 2014. To safeguard innovation, Product Lifecycle Management (PLM) should be incorporated in the business models of a pharmaceutical company. It not only helps to maximize lifecycle of the product but also to improve the product development processes, make better business decisions and to deliver greater value to consumers. Conclusion: A pharmaceutical product’s life is always complex & unique in nature and can be described in five distinct phases- development phase, approval phase, introduction phase, commercialization & quality management phase and decline phase. Number of strategies to be applied at each stage and the strategies are generally coupled with regulations, and the choice of strategy may vary on country to country. In present manuscript, the scope of various PLM strategies for innovators in four different countries namely, USA, EU, Canada and India has been discussed. This may guide the innovators to have competency to uphold the basic necessity for their survival, i.e. innovation.

Background: Competition is a process of economic race between market participants to draw clients. The Indian competition law establishment is an early administration. Before the enactment of the Competition Act in May 2002, Monopolistic and Restrictive Trade Practices (MRTP) Act was the active law that managed certain parts of the opposition. Objective: This manuscript highlights the purpose of competition laws for grappling with the monopolies and restrictive trade practices with a particular focus on pharmaceuticals. Conclusion: The Competition Act highlights the main features of new competition law which put back the old MRTP act and also lets in the proscription of anti-competitive treaties, prevention of misuse of dominance and combinations which prove detrimental to the competition in the market.

Background: Biosimilar products (biosimilars) are highly similar versions of approved and authorized biological medicines (which are used to treat a wide range of diseases including cancer, rheumatoid arthritis, diabetes and anemia) that have come as revolutionary paradigm in therapeutics. They are similar copies of already approved biologicals (reference products), produced by more reliable methods. Biosimilars are able to reduce the cost of the reference product by 20% to 35%. Objectives: This mini-review article has been planned to discuss the regulatory aspects of the biosimilars as well as basic facts about the biosimilars. Recent developments in the area of biosimilars will be discussed along with future opportunities and challenges in the field of manufacturing and marketing of the biosimilars in biopharmaceutical industry. Discussion: The main driving force behind the development of biosimilars is the expiry of patents for the approved biological products worldwide. The patent protection for the approved biological products have either expired or about to expire. Thus the market is opening for ‘biosimilars’. The global market for biosimilars is expected to reach USD 6.22 billion by 2020 from USD 2.29 billion in 2015. The regulatory requirements for the approval of biosimilars are not as easy as that of the conventional generic drugs. Europe, United States, China, India, Japan, Canada & World Health Organization have published guidelines for biosimilars but there is no harmonised pathway for regulation of biosimilars.

Background: Usage of probiotic based products has shown a rapid and worldwide growth due to their unlimited therapeutic benefits. Though probiotics are being exploited since ancient times but now a days major issue of concern is their emergence as drugs. In concern to their exponentially increasing market value, their quality, safety and efficacy related affairs are becoming significantly important not only for the consumers rather for manufacturers as well as regulators. As per ongoing scenario, regulatory guidelines stipulating requirements of Good Manufacturing Practice (GMP) are not yet covered properly by any of the country except canada and hence regulatory regimes seems to be highly unsatisfactory. Methods: GMP issues related to probiotic based products were reviewed using secondary sources i.e. electronic databases including Google Scholar, Scopus, Pubmed along with open online resources from journals, market reports, proceedings, books and web pages of relevant regulatory authorities. Later various parameters were critically analyzed for their merits and demerits and future recommendations have been suggested. Results: This paper has been designed to outlook the current regulatory aspects specifically in context to GMP of the probiotic based drug products and to discuss various problematic issues of concern. Above all, the prime aim of the article is to recommend suggestive consolidations to be followed for the manufacturing of the probiotic products. Conclusion: Stringently controlled GMP therefore will remain a most important tool to ensure prescribed standards as well as adequately adopted control measures for meeting finished probiotic products with desired and acceptable quality before their release into market. Suggested recommendations for adopting GMP in production of probiotics in this paper may act as a baseline for regulatory agencies across the globe to formulate the guidelines for the same.

Background: Innovative medicines are critical for improving life expectancy and quality of life in patients worldwide. In order to expedite patient access to new medicines, savvy global strategic drug development programs that are well designed to fulfill local regulatory requirements are needed. Objective: The objective of this paper is to present strategies to enhance globalization and speed to market for innovative medicines. Results: The following four strategies are highlighted and examined: 1) targeting countries with a demonstrated unmet medical need in the disease area of interest and the infrastructure to support drug registration and launch, 2) harmonizing the regulatory submission dossier, 3) filing simultaneous, harmonized marketing applications in a timely manner and 4) utilizing digital data warehousing technology in combination with drug-development know-how. Conclusion: Both local and global regulatory intelligence are required to execute forward-thinking strategies for drug development, registration and globalization. By coupling existing know-how with data warehouse technologies, harmonized marketing applications can be simultaneously filed in a systematic manner to countries with specific unmet medical needs. Implementation of these strategies can result in enhanced globalization, speed to market and cost minimization.