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The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) and strengths of final products.
Ayurveda is an alternative medicine system with historical roots in the Indian subcontinent. It is heavily practiced in India, Nepal, Bangladesh, Pakistan and Sri Lanka, where as much as 80% of the population report using ayurveda. The theory and practice of ayurveda is pseudoscientific; some ayurvedic medicines have been found to contain toxic substances.
Herbal medicine is the study of pharmacognosy and the use of medicinal plants, which are a basis of traditional medicine. With worldwide research into pharmacology, some herbal medicines have been translated into modern remedies, such as the anti-malarial group of drugs called artemisinin isolated from Artemisia annua, a herb that was known in Chinese medicine to treat fever. There is limited scientific evidence for the safety and efficacy of many plants used in 21st-century herbalism, which generally does not provide standards for purity or dosage. The scope of herbal medicine sometimes include fungal and bee products, as well as minerals, shells and certain animal parts.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use.
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
Ranitidine, previously sold under the brand name Zantac among others, was a medication used to decrease stomach acid production. It was commonly used in treatment of peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–Ellison syndrome. It was given either by mouth, injection into a muscle, or injection into a vein.
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
Nicorette is the brand name of a number of products for nicotine replacement therapy (NRT) that contain nicotine polacrilex. Developed in the late 1970s in Sweden by AB Leo in the form of a chewing gum, Nicorette was the first nicotine replacement product on the market.
Amfepramone, also known as diethylpropion, is a stimulant drug of the phenethylamine, amphetamine, and cathinone classes that is used as an appetite suppressant. It is used in the short-term management of obesity, along with dietary and lifestyle changes. Amfepramone has a similar chemical structure to the antidepressant and smoking cessation aid bupropion, which has also been developed as a weight-loss medicine when in a combination product with naltrexone.
A samskara is a process in ayurvedic medicine said to detoxify heavy metals and toxic herbs.
An online pharmacy, internet pharmacy, or mail-order pharmacy is a pharmacy that operates over the Internet and sends orders to customers through mail, shipping companies, or online pharmacy web portal.
Hamdard Laboratories (India), is a Unani pharmaceutical company in India (following the independence of India from Britain It was established in 1906 by Hakeem Hafiz Abdul Majeed in Delhi, and became a waqf in 1948. Some of its most popular products include Sharbat Rooh Afza, Safi, Roghan Badam Shirin, Sualin, Joshina and Cinkara. It is associated with Hamdard National Foundation, a charitable educational trust.
The pharmaceutical industry in Bangladesh is one of the most developed technology sectors within the country. Manufacturers produce insulin, hormones, and cancer drugs. This sector provides 97% of the total medicinal requirement of the local market. The industry also exports medicines to global markets, including Europe. Pharmaceutical companies are expanding their business with the aim to expand the export market.
In Ayurvedic medicine rasaśāstra(रसशास्त्र), refers to processes by which various metals, minerals and other substances, including most notably mercury, are purified and combined with herbs in an attempt to treat illnesses. Rasashastra is a pharmaceutical branch of Indian system of medicine which mainly deals with the metals, minerals, product of animal origin, toxic herbs and their use in therapeutics.
Because of the uncertain nature of various alternative therapies and the wide variety of claims different practitioners make, alternative medicine has been a source of vigorous debate, even over the definition of "alternative medicine". Dietary supplements, their ingredients, safety, and claims, are a continual source of controversy. In some cases, political issues, mainstream medicine and alternative medicine all collide, such as in cases where synthetic drugs are legal but the herbal sources of the same active chemical are banned.
Onasemnogene abeparvovec, sold under the brand name Zolgensma, is a gene therapy used to treat spinal muscular atrophy (SMA), a disease causing muscle function loss in children. It involves a one-time infusion of the medication into a vein. It works by providing a new copy of the SMN gene that produces the SMN protein.
Lumasiran, sold under the brand name Oxlumo, is a medication for the treatment of primary hyperoxaluria type 1 (PH1).
References
- ↑ Arsenic and mercury in Ayurvedic and traditional Chinese medicines Archived 2006-08-30 at the Wayback Machine Medicines and Healthcare products Regulatory Agency
- ↑ Some Ayurvedic medicinal products reported to contain high levels of heavy metals Archived 2008-01-07 at the Wayback Machine Health Canada
- 1 2 "Heavy metal warning for Ayurvedic medicinal products - Health - CBC News". CBC.ca . Archived from the original on 6 May 2013. Retrieved 21 March 2013.
- ↑ "Metal content in found in Ayurvedic drugs". IBN Live. Jan 5, 2006. Archived from the original on 6 June 2008. Retrieved 21 March 2013.
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