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, Ru Read More

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 t Read More

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 Read More

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 product Read More

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 ba Read More

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 grappl Read More

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 t Read More

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 t Read More

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 medi Read More