Drugs and Cosmetics Act, 1940

Drugs and Cosmetics Act, 1940
Territorial extent India (except Jammu and Kashmir)
Date passed 10 April 1940
Amendments
2008
Status: In force

The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture and dsitribution of drugs in India.[1] The primary objective of the act is to ensure that the drugs and comestics sold in India are safe, effective and conform to state quality standards.[2] 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.[2][3]


Summary

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]

The term "drug" as defined in the act includes a wide variety of substance, diagonstic and medical devices. The act defines "cosmetic" as any product that is meant to be applied to the human body for the purpose of beautifying or cleansing. The definition however excludes soaps. In 1964, the act was amended to include Ayurveda and Unani drugs.[2]

The Section 16 of the act defines the standards of quality for drugs. The Section 17 defines "misbranding". A drug is considered misbranded if it claims to be of more therapeutic value than it actually is. The manufacturer of such a drug may be asked to suspend manufacture of the drug under Section 18. Section 27 deals with fake and adulterated drugs. The act requires that ingredients of the drugs should be printed on the label.[2]

The Section 22 defines the powers of the drug inspectors and Sector 23 defines the strict procedure which should be followed by the inspectors during any raids.[4]

""" controversies related to Act """

No specific penalties could be imposed on the Bill and Melinda Gates Foundation-funded Programme for Appropriate Technology in Health (PATH) for violating norms in conducting the vaccination trials on tribal girls in Andhra Pradesh and Gujarat.As of now, there are no specific penalties for provisions relating to clinical trials under the Act. Therefore, as per the legal provisions prevalent at the point of time under the Act. [5]

See also

Rererences

  1. ↑ Dr. B. S. Kuchekar (8 January 2008). Pharmaceutical Jurisprudence. Pragati Books Pvt. Ltd. pp. 5.0–5.2. ISBN 978-81-85790-28-2. Retrieved 26 December 2014.
  2. ↑ 2.0 2.1 2.2 2.3 2.4 Dr. Lily Srivastava. Law & Medicine. Universal Law Publishing. pp. 216–. ISBN 978-81-7534-949-0.
  3. ↑ Pillay (30 November 2012). Modern Medical Toxicology. Jaypee Brothers Publishers. p. 30. ISBN 978-93-5025-965-8. Retrieved 22 February 2015.
  4. ↑ "Drugs and Cosmetics Act, 1940". Central Drugs Standard Control Organization. Retrieved 19 February 2015.
  5. ↑ http://indianexpress.com/article/india/india-others/cant-penalise-us-ngo-for-violating-drug-trial-norms/

Further reading