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Syllabus of Unit 1 :-

Drugs and Cosmetics Act, 1940 and its rules 1945
  1. Objectives, Definitions, Legal definitions of schedules to the Act and Rules
  2. Import of drugs - Classes of drugs and cosmetics prohibited from import, Import under license or permit. Offences and penalties.
  3. Manufacture of drugs - Prohibition of manufacture and sale of certain drugs,
  4. Conditions for grant of license and conditions of license for manufacture of drugs, Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan license and repacking license.

Summary of Drugs and Cosmetics Act 1940

The Drugs and Cosmetics Act, 1940 is an act of the Parliament of India which regulates the import, manufacture and distribution of medicine in India. the first objective of the act is to make sure 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 medication under given schedules and there are guidelines for the storage, sale, display and prescription of every schedule.

This act was originally called the Drug Act and was passed in 1940. the initial 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 called the Drugs and Cosmetics Act, 1940.

The term "drug" as defined within the act includes a large kind of substance, diagnostic and medical devices. The act defines "cosmetic" as any product that's meant to be applied to the flesh for the aim of beautifying or cleansing. The definition however excludes soaps. In 1964, the act was amended to incorporate Ayurveda and Unani drugs.

The Section 16 of the act defines the standards of quality for drugs. The Section 17 defines "misbranding". A drug is taken into account misbranded if it claims to be of more therapeutic value than it actually is. The manufacturer of such a drug is also asked to suspend manufacture of the drug under Section 18. Section 27 deals with fake and adulterated drugs. The act requires more of that ingredients of the drugs should be printed on the label.

The Section 22 defines the powers of the drug inspectors and Section 23 defines the strict procedure which should be followed by the inspectors during any raids