The Pharmaceutical Sciences combine a broad range of scientific disciplines that are critical to the discovery and development of new drugs and therapies.
Pharmaceutical sciences can be broadly studied into the following main categories, with many specialized fields within each category.
Drug Discovery and Design, Drug Delivery, Drug Action and Clinical Sciences, Drug Analysis, Cost Effectiveness of Medicines (Pharmacoeconomics), Drug Regulatory Affairs etc.
Pharmacists dispense and educate patients about existing medicines; pharmaceutical scientists discover, develop, test and manufacture new medications. These highly trained experts spend most of their time in a laboratory, studying how different molecules and compounds interact with the human body and with the cells and organisms that cause disease. Developing new drugs takes a very long time and costs a great deal of money.
There are three stages to this process: Research, Testing & Manufacturing
Increasing number of hospitals, nursing homes and pharmaceuticals companies all over the world is a clear indication of the growing scope in this area. Pharmacy offers reasonably good career opportunities both by way of jobs as well as in terms of starting your own business the pharmaceutical industries throughout the world are moving ahead towards becoming more and more competitive, regulatory agencies are being established in various countries across the globe. Regulatory agencies and organizations play a vital role to meet the requirements of legal procedures related to drug development process in a country.
In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing and labeling of pharmaceutical products. USFDA(USA), MHRA(UK), TGA(Australia), CDSCO(India), HEALTH CANADA(CANADA), MCC(South Africa etc are the few regulatory agencies and organizations established in respective countries.
World Health Organization (WHO), Pan American Health Organization (PAHO), World Trade Organization (WTO), International Conference on Harmonization (ICH), World Intellectual Property Organization (WIPO) are some of the international regulatory agencies and organizations which also play essential role in all aspects of pharmaceutical regulations related to drug product registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection.
The major challenges of these regulatory agencies and organizations around the world are to ensure the safety, quality and efficacy of medicines and medical devices, harmonization of legal procedures related to drug development, monitoring and ensuring compliance with statutory obligations. They also play a vital role to ensure and increase regulatory implementation in non-regulated parts of the world for safety of people residing there. The present study describes a brief review of various regulatory bodies of major developed and developing countries and the scope and challenges of such regulatory organizations in drug development and delivery of safe and effective healthcare products to individuals around the world.
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs. Drug discovery is the process by which potential drugs are discovered or designed. In the past most drugs have been discovered either by isolating the active ingredient from traditional remedies or by serendipitous discovery. Modern biotechnology often focuses on understanding the metabolic pathways related to a disease state or pathogen, and manipulating these pathways using molecular biology or biochemistry. A great deal of early-stage drug discovery has traditionally been carried out by universities and research institutions.
Drug development refers to activities undertaken after a compound is identified as a potential drug in order to establish its suitability as a medication. Objectives of drug development are to determine appropriate formulation and dosing, as well as to establish safety. Drug discovery and development is very expensive; of all compounds investigated for use in humans only a small fraction are eventually approved in most nations by government appointed medical institutions or boards, who have to approve new drugs before they can be marketed in those countries. In 2010 18 NMEs (New Molecular Entities) were approved and three biologics by the FDA, or 21 in total, which is down from 26 in 2009 and 24 in 2008. On the other hand, there were only 18 approvals in total in 2007 and 22 back in 2006. Since 2001, the Center for Drug Evaluation and Research has averaged 22.9 approvals a year. This approval comes only after heavy investment in pre-clinical development and clinical trials, as well as a commitment to ongoing safety monitoring. Drugs which fail part-way through this process often incur large costs, while generating no revenue in return. If the cost of these failed drugs is taken into account, the cost of developing a successful new drug (new chemical entity, or NCE), has been estimated at about 1.3 billion USD (not including marketing expenses.
Charles Darwin University, Australia; Griffith University, Australia; Queensland University of Technology, Australia; China Pharmaceutical University, China; Leslie Dan Faculty of Pharmacy, Canada; Leslie Dan Faculty of Pharmacy; Canada
iGATE, Indegene, Intas Pharma, IPCA, Johnson & Johnso, Jalaja Technologies
Jaslok Hospital, Jubilant Clinsys, Kendle, Lambda, Merck, Medpace International, Metropolis
Mulbere Health Care, Narayana Hrudayalaya Research Centre
American Association of Pharmaceutical Scientists, USA; American Association of Pharmacy Technicians, USA; American College of Clinical Pharmacology, USA; American Institute of the History of Pharmacy, USA; American Pharmacists Association American Society for Clinical Pharmacology and Therapeutics, USA