The Drugs and Cosmetic Act, 1945 | |
---|---|
Territorial extent | India |
Passed | 1940 |
Amended by | |
1955, 1964, 1972, 1982, 1986, 1995 | |
Summary | |
An act to regulate import, manufacture, distribution and sale of Drugs and Cosmetics. | |
Status: In force |
The Drugs and Cosmetics Rules, 1945 are the rules which the government of India established for the implementation of 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. [1] [2]
The Drugs and Cosmetics Rules, 1945 has provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule. [1] The Rule 67 details the conditions of licenses. The Rule 97 contains the labeling regulations. [3]
The notable Schedules include:
Other Schedules and their summary:
The Controlled Substances Act (CSA) is the statute establishing federal U.S. drug policy under which the manufacture, importation, possession, use, and distribution of certain substances is regulated. It was passed by the 91st United States Congress as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 and signed into law by President Richard Nixon. The Act also served as the national implementing legislation for the Single Convention on Narcotic Drugs.
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.
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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.
The Food and Drugs Act is an act of the Parliament of Canada regarding the production, import, export, transport across provinces and sale of food, drugs, contraceptive devices and cosmetics. It was first passed in 1920 and most recently revised in 1985. It attempts to ensure that these products are safe, that their ingredients are disclosed and that drugs are effective and are not sold as food or cosmetics. It also states that cures for disease listed in Schedule A, cannot be advertised to the general public.
The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), also known as the Poisons Standard for short, is an Australian legislative instrument produced by the Therapeutic Goods Administration (TGA). Before 2010, it was known as the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). The SUSMP classifies drugs and poisons into different Schedules signifying the degree of control recommended to be exercised over their availability to the public. As of 2024, the most recent version is the Therapeutic Goods Instrument 2024.
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Electronic Prescriptions for Controlled Substances (EPCS) was originally a proposal for the DEA to revise its regulations to provide practitioners with the option of writing electronic prescriptions for controlled substances. These regulations would also permit pharmacies to receive, dispense, and archive these electronic prescriptions. These proposed regulations would be an addition to, not a replacement of, the existing rule.
The Drug Quality and Security Act is a law that amended the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration more authority to regulate and monitor the manufacturing of compounded drugs. The bill was written in response to the New England Compounding Center meningitis outbreak that took place in 2012, which killed 64 people. The bill was signed by President Obama on November 27, 2013.
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 contain provisions for classification of drugs under given schedules and provide 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.
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Consumer Health Laws are laws that ensure that health products are safe and effective and that health professionals are competent; that government agencies enforce the laws and keep the public informed; professional, voluntary, and business organizations that serve as consumer advocates, monitor government agencies that issue safety regulations, and provide trustworthy information about health products and services; education of the consumer to permit freedom of choice based on an understanding of scientific data rather than misleading information; action by individuals to register complaints when they have been deceived, misled, overcharged, or victimized by frauds.
Drug labelling is also referred to as prescription labelling, is a written, printed or graphic matter upon any drugs or any of its container, or accompanying such a drug. Drug labels seek to identify drug contents and to state specific instructions or warnings for administration, storage and disposal. Since 1800s, legislation has been advocated to stipulate the formats of drug labelling due to the demand for an equitable trading platform, the need of identification of toxins and the awareness of public health. Variations in healthcare system, drug incidents and commercial utilization may attribute to different regional or national drug label requirements. Despite the advancement in drug labelling, medication errors are partly associated with undesirable drug label formatting.