Pharmaceuticals

Jai Ganesh · 2025-02-14 16:44:21

Pharmaceuticals

Gist

Pharmaceutical products - also known as medicines or drugs - are special preparations used in modern and traditional medicine. They are essential for the prevention and treatment of diseases, and protection of public health.

The use of ineffective, poor quality, harmful medicines can lead to therapeutic failure, exacerbation of disease, resistance to medicines and sometimes death. It also undermines confidence in health systems, health professionals, pharmaceutical manufacturers and distributors.

Pharmaceutics is the overall process of developing a new chemical entity into an approved therapy that is safe and effective in treating or preventing disease. It is a complex process requiring multiple scientific, medical, legal, commercial, and regulatory expertise.

Summary

Ensuring regular access to good quality, safe and affordable medicines is still a challenge for many countries. The WHO Regional Office for Eastern Mediterranean provides relevant expertise and technical assistance for Member States in the Region in the areas of quality assurance, regulation and legislation, safety and efficacy of medicines.

Pharmaceutical products - also known as medicines or drugs - are special preparations used in modern and traditional medicine. They are essential for the prevention and treatment of diseases, and protection of public health.

The use of ineffective, poor quality, harmful medicines can lead to therapeutic failure, exacerbation of disease, resistance to medicines and sometimes death. It also undermines confidence in health systems, health professionals, pharmaceutical manufacturers and distributors.

Ensuring regular access to good quality, safe and affordable medicines is still a challenge for many countries. The WHO Regional Office for Eastern Mediterranean provides relevant expertise and technical assistance for Member States in the Region in the areas of quality assurance, regulation and legislation, safety and efficacy of medicines.

Details

Pharmaceutical is a substance used in the diagnosis, treatment, or prevention of disease and for restoring, correcting, or modifying organic functions.

Records of medicinal plants and minerals date to ancient Chinese, Hindu, and Mediterranean civilizations. Ancient Greek physicians such as Galen used a variety of drugs in their profession. During the 16th century ad, after Western medicine began to recover from its long sleep during the Dark and Middle Ages, pharmaceutical practice began to develop rapidly. In 1546 the first pharmacopoeia (list of drugs and their preparation) appeared in Germany, and the profession of pharmacy is considered to have begun in 1617 with the founding of the Society of Apothecaries in London. Among the earliest modern pharmaceuticals were the anesthetics; morphine was first used in about 1804, ether in 1842, chloroform in 1847, and cocaine in 1860. Other substances isolated in the 19th century included strychnine (1817), quinine (1820), and nicotine (1828). Joseph Lister first used phenol (carbolic acid) to prevent infection in 1865.

Pharmaceuticals are generally classified by chemical group, by the way they work in the body (pharmacological effect), and by therapeutic use. Alkaloids were the first pure pharmaceuticals derived from natural substances (plants); they include quinine, nicotine, cocaine, atropine, and morphine. Drugs of animal origin include glandular extracts containing hormones, such as insulin for use in treating diabetes.

Antibiotics, vaccines, human blood-plasma fractions, and steroid hormones are other important pharmaceuticals manufactured from natural substances. Vitamins, which were formerly obtained from natural sources, are now often made in the laboratory.

In the preparation of dosages, many pharmaceuticals are ground to varying degrees of fineness. Many medicinal substances are added to water, alcohol, or another solvent so that they can be used in solution form. These may include spirits, elixirs, and tinctures. Ointments are one of many semisolid preparations, which also include creams, pastes, and jellies. Solid pharmaceuticals include pills, tablets, lozenges, and suppositories. In this form the compounds are more stable, with less risk of chemical reaction, and the dosage is easier to determine. Storage and packaging also is made simpler, and solid forms are more efficient to produce.

Additional Information

Pharmaceutical industry refers to the segment of business devoted to the design, development, and manufacture of chemical products for use in the diagnosis and treatment of disease, disability, or other dysfunction, or to improve function. Pharmaceutical companies may be private or public.

The pharmaceutical industry is a medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications and medical devices. Medications are then administered to (or self-administered by) patients for curing or preventing disease or to alleviate symptoms of illness or injury.

Pharmaceutical companies may deal in generic drugs, branded drugs, or both, within different contexts. Generic materials are without the involvement of intellectual property, whereas branded materials are protected by chemical patents. The industry's various subdivisions include distinct areas, such as manufacturing biologics or total synthesis. The industry is subject to a variety of laws and regulations that govern the patenting, efficacy testing, safety evaluation, and marketing of these drugs. The global pharmaceutical market produced treatments worth a total of $1,228.45 billion in 2020. The sector showed a compound annual growth rate (CAGR) of 1.8% in 2021, including the effects of the COVID-19 pandemic.

In historical terms, the pharmaceutical industry, as an intellectual concept, arose in the middle to late 1800s in nation-states with developed economies such as Germany, Switzerland, and the United States. Some businesses engaging in synthetic organic chemistry, such as several firms generating dyestuffs derived from coal tar on a large scale, were seeking out new applications for their artificial materials in terms of human health. This trend of increased capital investment occurred in tandem with the scholarly study of pathology as a field advancing significantly, and a variety of businesses set up cooperative relationships with academic laboratories evaluating human injury and disease. Examples of industrial companies with a pharmaceutical focus that have endured to this day after such distant beginnings include Bayer (based out of Germany) and Pfizer (based out of the U.S.).

Research and development

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. Research in these areas generally includes a combination of in vitro studies, in vivo studies, and clinical trials. The cost of late stage development has meant it is usually done by the larger pharmaceutical companies. The pharmaceuticals and biotechnology industry spends more than 15% of its net sales for Research & Development which is in comparison with other industries by far the highest share.

Often, large multinational corporations exhibit vertical integration, participating in a broad range of drug discovery and development, manufacturing and quality control, marketing, sales, and distribution. Smaller organizations, on the other hand, often focus on a specific aspect such as discovering drug candidates or developing formulations. Often, collaborative agreements between research organizations and large pharmaceutical companies are formed to explore the potential of new drug substances. More recently, multi-nationals are increasingly relying on contract research organizations to manage drug development.

The cost of innovation

Drug discovery and development are 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 US$1.3 billion (not including marketing expenses). Professors Light and Lexchin reported in 2012, however, that the rate of approval for new drugs has been a relatively stable average rate of 15 to 25 for decades.

Industry-wide research and investment reached a record $65.3 billion in 2009. While the cost of research in the U.S. was about $34.2 billion between 1995 and 2010, revenues rose faster (revenues rose by $200.4 billion in that time).

A study by the consulting firm Bain & Company reported that the cost for discovering, developing and launching (which factored in marketing and other business expenses) a new drug (along with the prospective drugs that fail) rose over a five-year period to nearly $1.7 billion in 2003. According to Forbes, by 2010 development costs were between $4 billion to $11 billion per drug.

Some of these estimates also take into account the opportunity cost of investing capital many years before revenues are realized (see Time-value of money). Because of the very long time needed for the discovery, development, and approval of pharmaceuticals, these costs can accumulate to nearly half the total expense. A direct consequence within the pharmaceutical industry value chain is that major pharmaceutical multinationals tend to increasingly outsource risks related to fundamental research, which somewhat reshapes the industry ecosystem with biotechnology companies playing an increasingly important role, and overall strategies being redefined accordingly. Some approved drugs, such as those based on re-formulation of an existing active ingredient (also referred to as Line-extensions) are much less expensive to develop.

Marketing

Advertising is common in healthcare journals as well as through more mainstream media routes. In some countries, notably the US, they are allowed to advertise directly to the general public. Pharmaceutical companies generally employ salespeople (often called 'drug reps' or, an older term, 'detail men') to market directly and personally to physicians and other healthcare providers. In some countries, notably the US, pharmaceutical companies also employ lobbyists to influence politicians. Marketing of prescription drugs in the US is regulated by the federal Prescription Drug Marketing Act of 1987. The pharmaceutical marketing plan incorporates the spending plans, channels, and thoughts which will take the drug association, and its items and administrations, forward in the current scene.

To healthcare professionals

The book Bad Pharma also discusses the influence of drug representatives, how ghostwriters are employed by the drug companies to write papers for academics to publish, how independent the academic journals really are, how the drug companies finance doctors' continuing education, and how patients' groups are often funded by industry.

Direct to consumer advertising

Since the 1980s, new methods of marketing prescription drugs to consumers have become important. Direct-to-consumer media advertising was legalised in the FDA Guidance for Industry on Consumer-Directed Broadcast Advertisements.

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#1 2025-02-14 16:44:21

Pharmaceuticals

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