Drugs and Cosmetics Act

The Drugs and Cosmetics Act, 1940 is an Indian law that regulates the import, manufacture, distribution, and sale of drugs in India. The Act was last amended in 2008 to incorporate various changes that were required to ensure that the regulation of kept pace with advances in medical science and technology.

The main objective of this act is to ensure that drugs and cosmetics that are used in India are safe, effective, and of good quality. The Act provides for the establishment of the Central Drugs Standard Control Organization (CDSCO), which is responsible for regulating the import, manufacture, and sale of drugs in India. The CDSCO is also responsible for the approval of new drugs and clinical trials.

The Act defines various terms related to drugs and cosmetics, such as “drug,” “cosmetic,” “misbranded drug,” “spurious drug,” “adulterated drug,” and “new drug.” The Act also provides for the regulation of clinical trials, licensing of manufacturing units, import and export of drugs, and labeling and packaging.

Under the act, drugs are classified into different schedules based on their potential for harm and abuse. The Act also provides for penalties for violations of its provisions, such as manufacturing, selling, or distributing adulterated or spurious drugs, or selling drugs without a license.

Overall, the Act is an important piece of legislation that ensures that drugs and cosmetics that are used in India are safe, effective, and of good quality. The Act is periodically reviewed and amended to ensure that it remains relevant and effective in regulating the import, manufacture, and sale of drugs in India.

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