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Drugs and Cosmetics Act

The Drugs and Cosmetics Act of 1940 regulates the import, manufacture, and distribution of drugs in India to ensure they are safe, effective, and meet quality standards. It was originally passed in 1940 and has since undergone several amendments. The Act defines drugs broadly and also covers medical devices and cosmetics. It was later amended to include regulation of Ayurvedic and Unani medicines. The related Drugs and Cosmetics Rules of 1945 provide classifications and guidelines for drugs and restrictions on the storage, sale, and prescription of different drug schedules.

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0% found this document useful (0 votes)
70 views

Drugs and Cosmetics Act

The Drugs and Cosmetics Act of 1940 regulates the import, manufacture, and distribution of drugs in India to ensure they are safe, effective, and meet quality standards. It was originally passed in 1940 and has since undergone several amendments. The Act defines drugs broadly and also covers medical devices and cosmetics. It was later amended to include regulation of Ayurvedic and Unani medicines. The related Drugs and Cosmetics Rules of 1945 provide classifications and guidelines for drugs and restrictions on the storage, sale, and prescription of different drug schedules.

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Jagrity Singh
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© © All Rights Reserved
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Drugs and Cosmetics Act

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.[1] 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.[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.

This act was originally known as the Drug Act and was passed in 1940. The original act was prepared
in accordance with 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, diagnostic 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.

As per Part XII B (H) Criteria for blood donation:

No person shall donate blood and no blood bank shall draw blood from a person, suffering from
Diabetes-controlled on insulin.

As per Schedule J:

Diabetes comes under Disease and ailment, which a drug may not purport to prevent or cure or
make claims to prevent or cure.

DMRA

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