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What is Drugs and Cosmetics Act?
The Drugs and Cosmetics Act, 1940 regulates the import, manufacture and sale or distribution of drugs and cosmetics through licences and permits.
The Department of Health under the Ministry of Health and Family Welfare approved the Act after the Governor-General gave the assent on April 10, 1940, and the Act came into the effect on April 1, 1947.
What is a drug?
A drug includes medicines or medical devices for external or internal use for human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation prevention of any disease or disorder in human beings or animals. Drugs are extracts of certain plants, animal parts, herbs or minerals. A drug is any chemical substance (natural or manmade) that alters biological structure or functioning when absorbed.
What is a cosmetic?
The term cosmetic refers to any substance or product used to rub, pour, sprinkle or spray on, or introduce into, or otherwise apply to, the body or any part of any object for cleansing, beautifying, or improving the appearance.
What is Drugs and Cosmetics Act?
The Drugs and Cosmetics Act, 1940 regulates the import, manufacture and sale or distribution of drugs and cosmetics through licences and permits.
The Department of Health under the Ministry of Health and Family Welfare approved the Act after the Governor-General gave the assent on April 10, 1940, and the Act came into the effect on April 1, 1947.
Since 1940, the act has undergone various amendments and is now known as the Drugs and Cosmetics Act, 1940. The Act provides the regulatory framework to ensure the quality, safety and efficacy of medical products and devices.
To ensure the efficient functioning of the Act, there are organised administrative structures such as; Drugs Technical Advisory Board (DTAB), Drugs Consultative Committee (DCCB), Central Drugs Laboratory (CDL), Drug Control Laboratories, Government Analysts, Licensing and Controlling Authorities and Drug Inspectors.
Objectives
The Drugs and Cosmetics Act, 1940 prevents substandard services and adulteration in drugs and cosmetics to maintain high standards of treatment. Eventually, medical device and pharmaceutical companies also become accountable for the quality and safety of the products.
The Act regulates the manufacture and sale of Ayurvedic, Unani and Siddha drugs as well. The Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committees (DCC) are established under the Act for allopathic and allied drugs and cosmetics.
The Act also regulates areas such as biological drugs, stem cells research, regenerative medicines, medical devices and clinical trial/investigation.
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