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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:
Schedule X is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules introduced in 1945. These are drugs which cannot be purchased over the counter without a valid prescription of a Registered Medical Practitioner (RMP).
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.
The Schedule J of the Drugs and Cosmetics Rules, 1945 of India contains "a list of diseases and ailments which a drug may not claim to prevent or cure".Under Rule 106 of the Drugs and Cosmetics Act, 1940, a drug cannot make claims to treat or prevent any of the diseases or reform the conditions listed.
This act was originally known as the Drug Act and was passed in 1940. The original act was prepared in accordance to the recommendations of the Chopra Committee formed in 1930. The related Drugs Rules was passed in 1945. Since 1940, the act has undergone several amendments and is now known as the Drugs and Cosmetics Act, 1940. [2]
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Pages in category "Cosmetics law" ... Drugs and Cosmetics Rules, 1945; E. EC Regulation 1223/2009 on cosmetics; F. Federal Food, Drug, and Cosmetic Act of 1938;