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.
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 rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
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.
The United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
The National Medical Products Administration is a national bureau responsible for drug supervision under the State Council of China and is managed by the State Administration for Market Regulation.
Hetero Drugs is an Indian pharmaceutical company and the world's largest producer of anti-retroviral drugs. Hetero's business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.
A food safety agency or food administration or Food Safety Authority is a government agency responsible for ensuring the safety, quality, and proper labeling of food products within a country or region. These agencies play a crucial role in protecting public health by establishing and enforcing regulations and standards to ensure that food produced, imported, processed, distributed, and sold is safe for consumption.
The National Agency for Food and Drug Administration and Control (NAFDAC) is a Nigerian federal agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale, and use of food, drugs, cosmetics, medical devices, chemicals, and packaged water.
Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad, which is primarily engaged in the manufacture of generic drugs. The company ranked 100th in the Fortune India 500 list in 2020.
The Ministry of Health and Family Welfare, also known by its abbreviation MoHFW, is an Indian government ministry charged with health policy in India. It is also responsible for all government programs relating to family planning in India.
The Ministry of National Health Services, Regulation and Coordination is a cabinet level ministry of the government of Pakistan with responsibility for national public health.
The Directorate General of Civil Aviation (DGCA) is a statutory body of the Government of India to regulate civil aviation in India. It became a statutory body under the Aircraft (Amendment) Act, 2020. The DGCA investigates aviation accidents and incidents, maintains all regulations related to aviation and is responsible for issuance of licenses pertaining to aviation like PPL's, SPL's and CPL's in India. It is headquartered along Sri Aurobindo Marg, opposite Safdarjung Airport, in New Delhi. The Government of India is planning to replace the organisation with a Civil Aviation Authority (CAA), modelled on the lines of the American Federal Aviation Administration (FAA).
Schedule H is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules, 1945 introduced in 1945. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor. The manufacture and sales of all drugs are covered under the Drugs and Cosmetics Act and Rules. It is revised at times based on the advice of the Drugs Technical Advisory Board, part of the Central Drugs Standard Control Organization in the Ministry of Health and Family Welfare. The most recent schedule H (2006) lists 536 drugs from abacavir to zuclopenthixol.
The Food Safety and Standards Authority of India (FSSAI) is a statutory body under the administration of the Ministry of Health and Family Welfare, Government of India. It regulates the manufacture, storage, distribution, sale, and import of food articles, while also establishing standards to ensure food safety. The FSSAI was established by the Food Safety and Standards Act, 2006, which consolidated all former acts and orders related to food safety that were previously handled by various ministries and departments.
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics, pharmaceuticals and medical devices. It serves a similar function to the Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union. The Indian government has announced its plan to bring all medical devices, including implants and contraceptives under a review of the Central Drugs and Standard Control Organisation (CDSCO).
The Food and Drug Administration (FDA) of the Philippines, formerly the Bureau of Food and Drugs, is a health regulatory agency under the Department of Health created on 1963 by Republic Act No. 3720, amended on 1987 by Executive Order 175 otherwise known as the “Food, Drugs and Devices, and Cosmetics Act”, and subsequently reorganized by Republic Act No. 9711 otherwise known as “The Food and Drug Administration Act of 2009”. The agency is responsible for licensing, monitoring, and regulation of cosmetics, drugs, foods, household hazardous products, medical devices and electromagnetic radiation emitting devices, pesticides, tobacco and related products, and vaccines for safety, efficacy, and quality in the Republic of the Philippines.
The Drugs and Cosmetics Act, 1940 is an act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards. The related Drugs and Cosmetics Rules, 1945 contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule.
Online pharmacy laws in India are still in nascent stage and there are no dedicated online pharmacy laws in India. The Information Technology Act 2000 governs some of the legal issues pertaining to online dealings but it is silent on the aspect of online pharmacy. As a result, illegal online pharmacies have been increasing in India. It has been said that, if properly regulated, online pharmacies in India could prove beneficial to various stakeholders.
The Drugs and Cosmetics Rules, 1945 are the rules which the government of India established through the Drugs and Cosmetics Act, 1940. These rules classify drugs under given schedules and present guidelines for the storage, sale, display and prescription of each schedule.
